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3236714	无图 Copyright (C) 2025 The Japan Research Institute, Limited. All Rights Reserved.12025/7/29Creating a Sustainable Ecosystemfor InnovativeRegenerative Medical ProductsCopyright (C) 2025 The Japan Research Institute, Limited. All Rights Reserved.2Aim of white paper:• Raise awareness of the clinical and societal value of regenerative medicalproducts• Demonstrate that it is necessary to build an ecosystem that integrates R&D,manufacturing and supply, medical insurance systems, and treatments in orderto spread patient access to regenerative medical products.• Identify issues and search for opportunities. Advocate for policy improvements tosupport a sustainable ecosystem for regenerative medical products in Japan※This article reflects the opinion of the author and does not represent the official view of the JRI.ObjectiveBuild a sustainable ecosystem for Regenerative MedicalProducts to ensure access to transformative treatmentsfor patients with serious medical needs in JapanWhitepaper authors:• Japan Research Institute, Ltd.• Kazumasa OguroProfessor, Faculty of Economics, Department of Economics, Hosei University• Takanori TeshimaProfessor, Department of Hematology, Hokkaido University Graduate School of Medicine• Hiroshi NakamuraProfessor, Dean of the Graduate School of Business Administration, Keio University• Yoshimi YashiroProfessor, Center for Translational Research Support Education, Fujita Health University• Sponsored by Bristol Myers SquibbCopyright (C) 2025 The Japan Research Institute, Limited. All Rights Reserved.3White PaperCreating a Sustainable Ecosystemfor Innovative Regenerative Medical ProductsChallenges and Opportunities in the Development and Manufacturingof CAR-T Cell TherapyThe Need for and Expected Effects of Establishing an Ecosystemfor Regenerative Medical ProductsClinical and Social Value of CAR-T Cell TherapyChallenges in the Medical Insurance System and Provisionof CAR-T Cell TherapyActions and Policies Necessaryfor the Dissemination and Sustainability of Regenerative Medical Products12345Copyright (C) 2025 The Japan Research Institute, Limited. All Rights Reserved.CDMO: Contract Development and Manufacturing OrganizationOverview of sustainable regenerative medical products ecosystem• Explore new therapeutic targets• Develop advanced technology• Establish processes thatproperly reflect innovationin pricing and hospitalmedical fees• Establish treatmentdelivery system• Generate compellingclinical evidence• Establish tailor-mademanufacturing processes• Enhance CDMO and establishdedicated distribution infrastructure• Participate in global clinical trialspreventing drug lag/lossDevelopmentManufacturing& SupplyHealthcareSystemTreatmentResearchPharma / BiotechHospitalsAdministrativePharma / CDMOPatientCopyright (C) 2025 The Japan Research Institute, Limited. All Rights Reserved.5Abbreviations: DLBCL: Diffuse Large B-cell Lymphoma; OS: Overall Survival; R/R ALL: Relapsed/Refractory Acute Lymphoblastic LeukaemiaReferences: 1. ACGT 2022; 2. Gilead 2021; 3. Crump et al. 2017; 4. Neelapu et al. 2023; 5. Patel et al. 2021Clinical and social value of CAR Tan example of regenerative medical products• CAR T treatments are moving from later to earlier lines of therapy inhaematological disorders, with trials underway for solid tumours5• CAR T treatments are expanding into new disease areas, includingimmunology and neurologyCAR T 5-yearoverall survivalrates indicatetheir curativepotential(see footnotes 1-4)Revolutionizing treatment options, offering unprecedented outcomesPersonalized medicine that can transform patients’ livesCAR T cell therapy is atype of treatment where apatient's own immunecells (T cells) arecollected and modified ina lab in such a way thatallows them to betterrecognize and attackcancer cells. The modifiedcells are then infusedback into the patient tofight the cancer.It offers the potential tocure cancer with a one-time treatment, resultingin significant savings inhealthcare resources,including the cost ofcaregivers.CAR T-Cell Therapy: Image Details - NCI Visuals Online10.0% 12.5%55.0%43.0%R/R ALL R/R 3L+ DLBCLBefore CAR T With CAR TCopyright (C) 2025 The Japan Research Institute, Limited. All Rights Reserved.6CAR-T cell therapy has innovative clinical and social value that differs from that of conventional treatments.The importance of the clinical and societal value of CAR-T cell therapyClinical Value Social ValuePatients can berehabilitated.Reducing the burdenon patientsImprovement of QOLImprovement of thelabor productivity ofpatients and familiesReducing the burdenon caregivers andmedical institutionsRadical cure of severediseasesRadical treatment ofrare diseasesContinuation of long-term treatment-freestatusEstablished safetyprofileComplete withonly one dose• As a result of clinical trials, CAR-T cell therapy has the potential to cureserious disease and achieve a long-term treatment-free state.• Clinical trials have shown that CAR-T cell therapy has a very hightherapeutic efficacy after a single dose.• Post-marketing clinical trial data also show that CAR-T cell therapyachieves a high response rate and survival rate.• The safety profile of CAR T-cell therapy and how to manage side effectsare well established.• Advancing the development of CAR-T cell therapy will give it thepotential to be an innovative treatment for other diseases.• CAR-T cell therapy can improve the patient's quality of life (QoL) over along period of time with short-term treatment.• It supports the early reintegration of patients into society and theirresumption of economic activity, and helps improve productivity. It alsoindirectly helps reduce the overall burden on those involved, such asfamilies, caregivers, and the organizations and medical institutionswhere patients work.• CAR-T cell therapy is a single-dose personalized treatment that providessignificant economic value by reducing the consumption of medicalresources, reducing the need for long-term hospital visits, nursing care,and hospitalization.References: 1. BMS 「TRANSCEND trial」; 2. Gilead Sciences 2021, 3. Neelapu et al. 2023; 4. Abramson et al. 2023; 5. Crombie 2023; 6. Alliance for Regenerative Medicine 20201-5 6Copyright (C) 2025 The Japan Research Institute, Limited. All Rights Reserved.7Expected benefits of building a regenerative medical products ecosystem in JapanAs is A society achieved by the spread of regenerative medical productsHigh therapeutic effect with a single dose, possibility of radical cure.Early reintegration into society leads to a life that does not change.• Improved efficacy and expanded indications will increase treatment options for diseases that are currently difficult totreat.• As less long-term administration and care is required, the physical, mental and economic burden on patients isreduced.• The burden of nursing care in the daily life of the patient's family is also alleviated.Improving labor productivity and helping to maintain economic activity• It supports the early rehabilitation of patients and their resumption of economic activity.• In Japan, with the labor force contracting, the economy is suffering from significant labor shortages, so the per capitaeconomic value of workers is increasing.• Regenerative medical products contribute to economic activity by reducing the burden on society, including not onlythe patients themselves, but also their families, caregivers, the organizations where patients work, and medicalinstitutions.Creation of employment and development of highly skilled human resources will allow Japanto become a regenerative medicine hub for Asian countries• The development and consolidation of high-level human resources will promote the development of the medicalindustry, which also involves local industries, and contribute to the revitalization of local economies.• R&D, and practical application of core and related technologies through industry-academia collaboration will lead to thecreation of new industries and medical technologies, as well as boosting employment.• Japan is seen as an environment where some of the world's most advanced initiatives for research & development andpractical application of regenerative medical products originate. It has the potential to help create activity bases,revitalizing the economy of local regions and of the country as a whole, and, as an export industry, earning foreigncurrency.Long-term hospitalizationand recuperation.Limited reintegrationA heavy burdenon families, caregivers,and societyDeveloping as an industry.The market is not yetestablished.Patients Society IndustryCopyright (C) 2025 The Japan Research Institute, Limited. All Rights Reserved.8Source: FIRM Central Social Insurance Medical Council, Drug Pricing Subcommittee Statement of Opinion (July 2023)Category What is going well Areas for improvementCapabilities in basic clinical research for regenerative medicalproducts are among the best in the worldIncrease of participation in global trials;< 40% of RM drugs approved in JP vs. US/EU 1 ;< 20% RM drugs under Phase 3 in JP vs. US/EU 1Attract investment to local manufacturing in JP toupscale supply chain and support future R&D innovation inJP.Job creation and development of professionals withadvanced scientific knowledge.After regulatory approval under the Pharmaceuticals andMedical Devices Act, insurance reimbursement is made in ashort period of time under the universal health insurancesystem.A pricing system that appropriately evaluatesinnovation and a medical fee system thatappropriately reflects costs in the medical fieldImproved facility and capability to administerCAR T at key hospitals in JapanAppropriate support for the human resources andfacility resources of treatment facilities to ensure thatpatients in need continue to benefit from innovativetreatments.Honebuto 2025 by governmentPromoting R&D in regenerative medicines, cell therapy, and genetherapyEstablishment of manufacturing systems for pharmaceuticals,including biopharmaceuticals, and development and securing ofhuman resourcesCDMO subsidies by METI“Regenerative Medicines Manufacturing CapitalInvestment Support Business”Improvements to the ecosystem aimed at sustainably providing patients withregenerative medical productsResearchDevelopmentManufacturing& supplyHealthcaresystemTreatment123Copyright (C) 2025 The Japan Research Institute, Limited. All Rights Reserved.9Abbreviations: GMP: Good Manufacturing Practice. References: 1. McKinsey & Co. 2019; 2. Wang et al. 2016; 3. Ho et al. 2022; 4. Abbasi et al. 2022; 5. BMS DoF 2022; 6. Moutsatsou et al. 2019; 7. FiercePharma 2021• Living patient cells that must be stored and transported in cryogenic shippingcontainer1,6• Costly, GMP-grade viral vectors face supply shortages need to be procured 1,7Additionally, more than 500 points across the chain of identity exist throughout the entire processCAR T production process consists of a series of complex sequential stepsPatient enrolmentLeukapheresis CryopreservationShipment Quality checkProduction CryopreservationQuality check ShipmentInfusionDeep Dive 1Manufacturing & supplychallengesThe manufacture of completelypersonalized CAR T treatmentsis complex and differs fromthat of conventional medicines.At present, the U.S. leads inthis field, but if Japan canaddress various challenges, ithas the potential to become amanufacturing and supply hubin Asia.CAR T manufacturingPersonalized andno economies of scaleSpecialised facilitiesand equipment1,2Highly skilled andeducated workforce3Complex supply chainCopyright (C) 2025 The Japan Research Institute, Limited. All Rights Reserved.10Deep Dives 2 & 3Healthcare system &treatment challengesNeed to progress and improvethe health insurance processesthat govern pricing / repricing& medical cost coverage inorder to cover the investmentin R&D, manufacturing andadministration, the costs ofwhich are higher than forconventional treatments.Source: Gagelmann et al. 2022; 2. Buechner et al. 2018; 3. EBMT 2019Healthcare SystemPricing & repricing ofregenerative medical products Medical feesHospital resources• Need to invest in hospital bedsfor the provision of CAR-T celltherapyEstablishing facilities• Need to purchase and maintainexpensive medical equipment forapheresis, administration &monitoringHuman resources & training• Need to recruit & train medicalprofessionals with CAR Ttreatment expertise, includingexperience of adverse eventmanagement• No economies of scale✘ Personalized and complexmanufacturing✘ Mass production not feasible• Globally limited production and supply✘ Infrastructure building in Asia has beenslow, and supply to Japan is limited• Significant initial and ongoinginvestment in clinical trials and post-launch manufacturing needed• Specialized highly trained workforce isrequired for R&D and manufacturing• High standard of quality controlcapabilities and resources requiredCopyright (C) 2025 The Japan Research Institute, Limited. All Rights Reserved.11Source: FIRM Central Social Insurance Medical Council, Drug Pricing Subcommittee Statement of Opinion (July 2023)Category What is going well Areas for improvementCapabilities in basic clinical research for regenerative medicalproducts are among the best in the worldIncrease of participation in global trials;< 40% of RM drugs approved in JP vs. US/EU 1 ;< 20% RM drugs under Phase 3 in JP vs. US/EU 1Attract investment to local manufacturing in JP toupscale supply chain and support future R&D innovation inJP.Job creation and development of professionals withadvanced scientific knowledge.After regulatory approval under the Pharmaceuticals andMedical Devices Act, insurance reimbursement is made in ashort period of time under the universal health insurancesystem.A pricing system that appropriately evaluatesinnovation and a medical fee system thatappropriately reflects costs in the medical fieldImproved facility and capability to administerCAR T at key hospitals in JapanAppropriate support for the human resources andfacility resources of treatment facilities to ensure thatpatients in need continue to benefit from innovativetreatments.Honebuto 2025 by governmentPromoting R&D in regenerative medicine, cell therapy, and genetherapyEstablishment of manufacturing systems for pharmaceuticals,including biopharmaceuticals, and development and securing ofhuman resourcesCDMO subsidies by METI“Regenerative Medicines Manufacturing CapitalInvestment Support Business”Improvements to the ecosystem aimed at sustainably providing patients withregenerative medical productsResearchDevelopmentManufacturing& supplyHealthcaresystemTreatmentCopyright (C) 2025 The Japan Research Institute, Limited. All Rights Reserved.12A pricing system is required that takes into account the long-term efficacy of regenerative medical productsCurrent pricing, challenges in revising this, and suggested improvementsReflect overall usefulness in pricingIn order to promote the verification of clinical and social value over a long period of time, an additional process should be considered under whichthe evaluation of efficacy and safety after marketing is appropriately reflected in the price.This should be used as an incentive to develop a platform for collecting and analyzing data in actual clinical practice, and to promote reversetranslational research.CurrentShortcomingsImprovementsPricing doesn't reflect long-termclinical and societal valueRegenerative medical products are expected toprovide long-term clinical value, but it isimpossible to fully prove them in the period untilthe application is filed, and this cannot bereflected in the price calculation.Regenerative medical products have the potentialto contribute to society, such as through patientrehabilitation and a reduction in the burden ofnursing care, but these aspects of their socialvalue are not reflected in their pricing.Conventional Medicines Regenerative Medical ProductsChanges in medical costs depending on the course of treatmentCost ofmedical careTime(years)Cost ofmedical careTime(years)Treatment costs and labor loss costs areincurred for each treatmentNo ongoing treatment and labor losscosts because it is a one-time treatmentCost AccumulationCost AccumulationDirect Medical ExpensesIndirect Medical ExpensesIndirect Medical ExpensesDirect Medical ExpensesDirect Medical Expenses :Costs directly related to treatment.Examples: Outpatient expenses, hospitalization costs, examination costs, drug costs, etc.Indirect Medical Expenses :Expenses incurred in connection with medical treatment that are not directly linked to medical practice.Examples: Transportation expenses to hospitals, nursing care expenses, loss of work opportunities, etc.Copyright (C) 2025 The Japan Research Institute, Limited. All Rights Reserved.13It is impossible to reduce the cost of regenerative medical products because they are repeatedly produced in smallquantities; a pricing system is required that takes into account the unique manufacturing processesCurrent pricing, challenges in revising this, and suggested improvementsRevision of market expansion repricing rulesFor regenerative medical products that require complex and individualized manufacturing processes that do not have economies of scale, it isnecessary to review the market expansion repricing rules in order to secure a sustainable supply to patients in Japan.CurrentShortcomingsImprovementsManufacture of individualized productsdoesn’t yield economies of scaleThe per unit cost of manufacturing conventionalpharmaceuticals falls as the volume of productionincreases; market expansion repricing reflectthese economies of scale.Regenerative medical products require complexand individualized manufacturing processes; eveneven if the number of patients supplied increases,individual manufacturing and transportation andsupply lines need to be expanded. It is impossibleto reduce unit costs through mass production.While it is important to ensure a sustainablesupply of products in Japan amid limited globalsupply, manufacturing priorities will make itdifficult to ensure patient access if prices are keptdown.Changes in Manufacturing cost per product by production quantityFixed costs decrease in line withproduction volume, resulting ineconomies of scaleSmall-volume production is repeated,and no major economies of scale accrueManufacturingcost per productProductionQuantityFixedCostsVariablecostsManufacturingcost per productProductionQuantityFixedCostsVariablecostsConventional Medicines Regenerative Medical ProductsCopyright (C) 2025 The Japan Research Institute, Limited. All Rights Reserved.14RegulationPatentHuman ResourcesManufacturingQCTransportHealthcare ProvidersTarget PatientsR&DManufacturingTransportAdministrationRegenerative Medical Products Small Molecule and BiopharmaceuticalsHealthcare Providers• Homogenization of cells and genes is difficult, and the cost of diverseand multi-stage quality assurance tests (marker expression, virustesting) is high.• Japan's regulations (Cartagena, etc.) are barriers• Many patents are related (licensing fees increase)• There are few highly skilled human resources; there isaccordingly a high need for training• Requires expensive GMP-level vectors• Requires the introduction of a commercial perspective• Dedicated capital investment in accordance with GCTPministerial ordinances for each modality is required.• Mass production is not possible, and economies of scale do notaccrue.• Requires dedicated transport infrastructure (e.g. -150°C)• Limited to specialized facilities and dependent on doctors' procedures (e.g., training fees)• The upper limit of SG&A expenses for medical device calculations is an issue• Fewer due to it being designed to treat rare diseases• Autologous cells are completely personalized medicine• International harmonization through ICH• Protected by substance patents• Abundant• Equipment can be repurposed for the samemodality• Related industries are limited• Mass production capable and industrial• Easy to homogenize• Quality assurance testing to a certain extent• Can be transported with normal equipment• Widely used• Relatively common, including lifestyle-relateddiseases• It is necessary to collect cells as a starting point formanufacturing.• ー(No need to collect cells at medical institutions）Differences in the cost structure of regenerative medical products and conventionalpharmaceuticalsReferences: FIRM “Opinion on pricing of regenerative medical products” (July 09, 2025)Copyright (C) 2025 The Japan Research Institute, Limited. All Rights Reserved.15Japan's medical benefit costs are expected to reach approximately 60 trillion yen by fiscal 2025, and demand for medical care is expandingdue to the declining birthrate and aging population.In response to concerns about the rapid increase in the financial burden of medical benefit costs, we have repeatedly suppressed unit prices and quantities, but there is a riskthat the profits of pharmaceutical and others in the sector and will be squeezed, and there is unlikely to be sufficient return on investment to fund the development of next-generation innovations.The following three points have been proposed and discussed as major directions to solve this problem.Issues of the current pricing systemManage the total budget formedical benefits in line witheconomic growth rateIntroduce a guaranteed adjustment mechanism to cover nominal growth in total drug costs• Drug costs are managed by increasing the drug cost portion of medical benefits in line with the medium- to long-termnominal GDP growth rate.• By quantifying the upper and lower limits of the financial resources quota in advance, it is necessary to ensure theappropriate allocation of resources to innovative pharmaceuticals and to create a highly predictable environment inwhich sudden and mechanical drug price reductions do not occur.• Since any growth of the GDP deflator index is reflected in nominal GDP growth rates, it is reasonable to see increases indrug spending as a component of economic growth.Mechanism for evaluatinghigh-value medical careMechanisms to excludelow-value medical careIntroduce a system that evaluates diverse aspects of value and reflects these in drug prices• The current opaque process, which is effectively a centripetal operation of only Cost and QALY, should be reviewed. Afundamental adjustment should be made to value assessment, by incorporating a wide range of factors (impact onwork, health status of caregivers and family members, etc., and overall social impact).Introduce a "low-value healthcare" category• Drugs and technologies whose clinical efficacy or social benefits fall below a certain standard should be classified as"low-value medicine," and alternative treatments should be proposed, as well as gradual reductions in scores andwithdrawal from insurance coverage.References: Institute for New Era Strategies "Recommendations of the Association for the Revival of Drug Discovery Innovation" (May 13, 2025)Copyright (C) 2025 The Japan Research Institute, Limited. All Rights Reserved.16CAR-T cell therapy is eligible for medical fee reimbursement for autologous peripheral blood stem cell transplantation, which has a similar process, but thecost of medical care, such as the personnel and equipment required for implementation, is not covered.Issues with the current medical fee systemComparison with autologous peripheral blood stem cell transplantationAutologousperipheral bloodstem celltransplantation1, 2Follow-upFollow-upDepending on the caseCAR-TCell Therapy1, 3Follow-upPost-marketingsurveillanceDepending on the casePeripheral bloodstem cellcollectionCryopreservation (Anticancer drugs) →Stem cell transplantationApheresis Standby for production Transplantation1 week About 2~3 weeks (including engraftment)K921 17,440 K921 30,850Leukocytecollection(Lymphocyte removal) →CAR-T cell transplantation1 day About 5 weeks About 3 weeks• Specialized human resources andmultidisciplinary collaboration arerequired for collection.• Only one apheresis per CAR-Ttreatment is allowed as a medicalfee. In the case of reapheresis,the medical institution will haveto cover the cost.Transportation and the acceptance processare not covered by medical insurance.• Requires an ultra-low temperature shippingcontainer• The costs of strict transportation and acceptanceare not remuneratedAdditional procedures and human and physicalresources are required, but reimbursementpoints are not taken into account• Administration of the treatment requires specializedhuman resources, multidisciplinary collaboration, andequipment.• Strict management systems and equipment (e.g., ICU)are required for the management of adverse drugreactions (cytokine release syndrome, etc.) afteradministration.K921-3 19,410CryopreservationK922-2 30,850Bridging therapyTransportationDepending on the caseAcceptanceProduct manufacturingReferences: 1. Ministry of Health, Labour and Welfare Medical Fee Score Table, 2. Japan Red Cross Society Himeji Cross Hospital "Hematopoietic Stem Cell Transplantation" 3. BMS "Q&A for Patients Receiving both CART"Copyright (C) 2025 The Japan Research Institute, Limited. All Rights Reserved.17In order to provide CAR-T cell therapy to more patients at an optimal timing, it is necessary to improve the current system andstrengthen the network of medical institutions.Patient access challenges and countermeasures for CAR-T cell therapyOnset CompleteremissionTherapyDiagnosis Follow-upPatientReferrals1 Transfers Transfers2Specialized hospitalsin the region(referral facilities)Specialized hospitalsin the region,family physiciansFacilities offeringCAR-T cell therapyProposedMeasuresHypothesisPromote awareness-raising activities amongpatients to understand diseases and varioustreatment options, and to raise awareness ofimmunotherapy as a whole (including antibodydrugs and CAR-T)e.g. Support for providing information to patients toacademic conferences, patient associations, etc.,booklets and websites for patients, sharing experiencesof patients treated with CAR TPatients:Major changes to daily life, anxiety, lackof information about disease progressionand prognosis, or treatment options• Expand the medical fee system so that it appropriately reflects all medical costs, as well as providing coverage of the humanand financial cost incurred by facilities that can offer CAR T therapy• Create a forum where patients, academic societies, medical institutions, and pharmaceutical companies can share and discussthe latest information on treatments and products• Facilitate cooperation among medical institutions and promote the assignment of specialized coordinators (e.g. inhematopoietic stem cell transplantation, a coordinator is assigned to coordinate with medical institutions and provide care topatients.• Clarify the position of CAR-T cell therapy in clinical guidelines to secure treatment options for patientsPatients:• Anxiety about environmental changes, side effects, multiple hospital transfers, and follow-up• Facilities offering treatment are limited to certain medical institutions in urban areas, and access is difficult forpatients living in rural areas.Physicians and Medical Institutions:• Uneven distribution of medical resources across regions• Insufficient cooperation between medical institutions, lack of smooth provision of medical information, insufficientincentives for patient referrals, etc.• Increased effort in the apheresis department• Compared to U.S. clinical guidelines, the position of CAR-T cell therapy is ambiguous１ Diagnosis ~ Initial Treatment ~Recurrence 2 Access to CAR-T cell therapy ~ Therapy ~ Follow-upCopyright (C) 2025 The Japan Research Institute, Limited. All Rights Reserved.18Note 1 : Summary of discussions regarding the use of private insuranceIn Japan, there are concerns about the sustainability of the public health insurance system given that medical expenses areincreasing every year. A proposal to control social insurance premiums by excluding some high-priced drugs from publicinsurance coverage and making use of private insurance is currently under consideration.• While the public health insurance system aims to realize the concept of universal health coverage, which would allow everyone to be shieldedfrom significant risk and receive the medical services they need without significant financial burden, excluding costly medicines from publicinsurance coverage may threaten this concept.• In addition, as medical technology advances, with diversified treatments and increased patient choice, limiting options for economic reasonsgoes against the concept of improving the quality of healthcare and access to it.Regenerative medical products and related technologies should continue to be treated as reimbursable under thepublic health insurance system• The government intends to expand the scope of uninsured combination therapies so that cutting-edge medical technologies for which efficacy evaluations are notsufficiently evaluated can be used without any delay until they are covered by insurance.• At present, knowledge of regenerative medicine as a medical treatment not covered by insurance (medical technology under the Safety Assurance Act) is notfully utilized in the ecosystem. In the future, it is necessary to reflect it in the research and development of next-generation treatments through active reversetranslational research. For example, we believe that (a) research plans and treatment plans for which evidence is obtained should be recognized as uninsuredcombination therapies such as advanced medical care and patient-requested medical treatment, (b) the public should participate in research plans and treatmentplans for which evidence is obtained, (c) the number of patients receiving treatment should be increased by reducing the burden on them, and (d) the quality ofresearch and treatment should be improved.• In addition, it is desirable to alleviate the personal burden of medical expenses associated with this through the development and utilization of private insurance.Copyright (C) 2025 The Japan Research Institute, Limited. All Rights Reserved.19Note 2 : Cost-Effectiveness Evaluation SystemThe “Basic Policy on Economic and Fiscal Management and Reform 2025” (“Honebuto no Hoshin 2025”) 30 states:“Based on objective verification, further utilization of the cost-effectiveness evaluation system will be considered, includingappropriate evaluation methods, the scope of application, and the implementation structure, as well as its use in the drugpricing system and clinical practice.”This indicates a direction toward expanded application of the system in the future.Analyzing the European HTA landscape, 'cost-effectiveness evaluation,' or 'economic HTA,' is not applied to regenerativemedical products in key reference countries like Germany and France. The primary reason for this is that standard economicHTA lacks the flexibility to account for broader considerations, such as long-term economic and scientific values. Applyingstandard economic HTA could lead to significant drug lag and loss for regenerative medical products.• While economic HTA is not undertaken in countries like Germany and France, clinical HTA focuses on clinical value assessment, includingpatient-reported outcomes (PRO). However, regenerative medical products are highly complex, with challenges in blinding, randomization,endpoint selection, and choice of comparator, which results in uncertain evidence regarding their long-term value at the time of regulatorysubmission. Even clinical HTA has limitations in fully capturing the long-term, potentially lifetime, benefits of regenerative medical products.• However, for example, in Sweden, economic HTA is applied to with greater flexibility which helps regenerative medical products. Theyincorporate flexible thresholds for the Incremental Cost-Effectiveness Ratio (ICER), Quality-Adjusted Life Years (QALY), cost-benefit analysis,and budget impact to enable faster patient access to life-saving regenerative medical products. Sweden’s HTA system also systematicallyincludes ‘Indirect costs and benefits’, which supports their access as regenerative medical products have a positive impact on this domain ofHTA.Copyright (C) 2025 The Japan Research Institute, Limited. All Rights Reserved.20Note 3 : Price Stability and Manufacturing Incentives to Promote Innovation andInvestment in FranceIn France, a framework agreement between LEEM (The French Pharmaceutical Companies Association) and CEPS (TheEconomic Committee for Health Products) has established a system providing price stability and manufacturing incentives(currently under renegotiation). It incorporates incentives designed to promote domestic manufacturing, support exports, byensuring that prices for highly innovative medicines do not fall below those in other European countries.They include the following:• To promote domestic manufacturing of innovative medicines, for products rated ASMR 1–3 (indicating high added clinical value compared toexisting therapies), if all major manufacturing steps are conducted in France, the price must not be lower than the lowest price in either theUK, Germany, Italy, or Spain.• If current or future investments in manufacturing, R&D, or digital health related to the product are made within the EU—particularly inFrance—up to five years of price stability may be granted.• To encourage exports, products for which at least one significant manufacturing step is conducted in the EU (especially in France), batchrelease is performed in France, and more than 60% of production volume is exported, may be granted two years of price stability (renewableonce for up to two additional years).• For many innovative medicines rated ASMR 1–3, if the price is set by referencing other European countries and the health economicassessment is valid, net and list price stability is granted for the first five years after market launch (three years in other cases).In Japan, similar incentives may be necessary to promote the R&D and manufacturing of regenerative medicine and relatedproducts, and to support their development as an export industry. Specifically, ensuring that domestic prices do not fallbelow referenced European prices could be a key policy consideration.Copyright (C) 2025 The Japan Research Institute, Limited. All Rights Reserved.21Recommendation 1: Reform the pricing system and medical fee system to promote thespread of regenerative medical productsProduct pricingsystemMedical feesystemImprovement of the medical fee system to properly reflect medical costs• In addition to adequately covering the cost of the medical care required to provide regenerative medical products withincurrent medical fees, it is necessary to incorporate a mechanism that allows medical institutions to recoup their investment inequipment and human resources.Adequate reflection of the usability rating in the price• Regenerative medical products not only bring clinical value; they are also likely to make a positive impact on society byrehabilitating patients and reducing the burden of nursing care.• In order to facilitate the validation of long-term clinical and social value through reverse translational research, concreteresearch should be conducted into a system in which post-marketing efficacy and safety evaluations are sufficiently reflectedin prices.Revision of the application of the market expansion repricing• Economies of scale do not work for regenerative medical products, and it is impossible to reduce costs through massproduction. Current market expansion repricing are based on the assumption that economies of scale are applicable, and ifthese are applied, it will be difficult to continue ensuring patient access to the therapy.• In order to maintain an environment in which companies can sustainably supply innovative treatments, market expansionrepricing rules should be reviewed.The current health insurance system is hindering the development and operation of the current ecosystem in Japan.Academia, industry and the government should jointly establish a forum for discussions on the design of systems that take intoaccount the characteristics of regenerative medical products and other products.In order to make efficient use of limited medical resources, it is necessary to evaluate high-value medical technologiesand consider measures to reduce medical costs through appropriate use.Copyright (C) 2025 The Japan Research Institute, Limited. All Rights Reserved.22In order to develop an ecosystem of regenerative medical products, it is important to take a bird's-eye view to identifyissues, make improvements, and make further improvement to the next-generation technology cycle.Recommendation 2: Review Ecosystem Challenges and Continue with Policies that willEnhance Next-Generation CyclesStakeholderCollaborationReduce costsDevelopinfrastructure• The manufacturing, quality control and supply of regenerative medical products are still in the early stages ofcommercialization; these continue to be expensive to manufacture, but as technology advances, costs areexpected to fall, and more patients will be able to benefit from new therapeutic opportunities featuringregenerative medical products capable of treating a variety of diseases.• With the aim of achieving this, the government should promote the development of highly specialized humanresources and the necessary facilities; build a foundation for the upgrading of supply chains, construct a domesticecosystem, and establish a base for expansion across Asian countries.• Translational research is important for the efficient introduction of innovative technologies to the market.The government should support technology originating from universities and take measures to promotetechnology transfer to companies, including startups.• Data obtained from actual medical care will serve as a foundation for next-generation research, and patientparticipation will be an important factor, as will collaboration between treatment facilities, academia anddevelopment companies.• In order to provide regenerative medical products more smoothly, there is an urgent need to improve systemsand networks to effectively connect treatment providers and patient referral facilities. To ensure that patients inneed can receive treatment promptly and, when appropriate, we should promote clarification of clinical practiceguidelines and strengthen incentives for patient referrals.• In order to promote patient participation, it is essential to raise awareness and ensure access to treatment.Comprehensive and easy-to-understand guidance needs to be generated by creating a forum where patientgroups, academic societies, medical institutions, and pharmaceutical companies can collaborate to share anddiscuss the latest information on diseases and various treatment options, including immune cell therapy.Research& DevelopmentManufacturing& SupplyTreatmentCopyright (C) 2025 The Japan Research Institute, Limited. All Rights Reserved.23The spread of regenerative medical products will bring great benefits to Japan's medical, industrial, and socialsystems, and will strengthen the country’s global competitiveness by demonstrating its leadership in this field.Benefits accruing from the establishment of an ecosystem of regenerative medical products in JapanMedicalenvironmentin Japan• By manufacturing regenerative medical products for Japan-based patients in Japan, we will be able to addressglobal manufacturing constraints and enable a sustainable supply of these therapies.• Enabling patient access from an early stage of treatment for serious diseases will make a significant difference in thelives of patients in Japan and their families.• In addition to current demand, there is the potential to meet the therapeutic needs of various other diseases such asautoimmune diseases in the future.Active participationof human resourcesin Japan• By building an ecosystem, we can create a place where highly qualified human resources can play an active role inthe fields of R&D and manufacturing in Japan.• It will reduce the burden on healthcare professionals and create an environment where they can focus on treatingother diseases.• Patients and their families who have been cured of serious diseases will be able to resume social and economicactivity, boosting the economy and benefiting society as a whole.Globalcompetitiveness• We can quickly supply regenerative medical products to Asian countries.• Technologies related to regenerative medical products have the potential to become the foundation of Japan'sbiotechnology industry, leading to the acceleration of research and development originating here.• These will lead to opportunities for international leadership and expand Japan’s influence in Asian countries andglobally. Appendix｜Creating a Sustainable Ecosystem for　Innovative Regenerative Medical Products Appendix｜Creating a Sustainable Ecosystem for　Innovative Regenerative Medical Products(PDF:467 KB)	查看 40782	日本総合研究所	2025-08-08 06:35:35 2025-08-08 06:35:35	word
3236713	无图 - 1 -- 1 -ＣＯＮＴＥＮＴＳ1. Introduction: Purpose of the Project ....................................................................... 12. The Need for and Expected Effects of Establishing an Ecosystem for Regenerative MedicalProducts ............................................................................................................. 32.1. Why Focus on Regenerative Medical Products? .................................................. 32.2. Current Status and Challenges of the Regenerative Medical Products Market ......... 42.3. Government Initiatives for Regenerative Medicine .............................................. 52.4. Necessity of Establishing an Ecosystem for Regenerative Medical Products ............ 62.5. Benefits of Establishing a Regenerative Medical Products Ecosystem ..................... 73. Clinical and Social Value of CAR-T Cell Therapy ....................................................... 83.1. Overview of CAR-T Cell Therapy ...................................................................... 83.2. Clinical Value of CAR-T Cell Therapy ................................................................. 83.3. Societal Value of CAR-T Cell Therapy ................................................................ 94. Challenges and Opportunities in the Development and Manufacturing of CAR-T CellTherapy ............................................................................................................. 104.1. Manufacturing and Supply Process of CAR-T Cell Therapy .................................. 104.2. Challenges in the Development, Manufacturing, and Supply of CAR-T Cell Therapy114.3. Opportunities in the Development, Manufacturing, and Supply of CAR-T Cell Therapy.................................................................................................................. 125. Challenges in the Medical Insurance System and Provision of CAR-T Cell Therapy ....... 135.1. Challenges in Pricing and Repricing Systems ..................................................... 135.1.1. Long-term Clinical and Societal Value .......................................................... 145.1.2. Lack of Economies of Scale due to Personalized Manufacturing ....................... 165.2. Challenges in the Medical Fee System .............................................................. 185.3. Challenges in Patient Access to Treatment ....................................................... 185.3.1. Diagnosis to Initial Treatment and Relapse Process ....................................... 185.3.2. Access to CAR-T Cell Therapy ..................................................................... 195.3.3. From Treatment to Follow-up ..................................................................... 195.3.4. [Note 1] Summary of discussions regarding the use of private insurance ......... 205.3.5. [Note 2] Cost-Effectiveness Evaluation System ............................................. 215.3.6. [Note 3] Price Stability and Manufacturing Incentives to Promote Innovation andInvestment in France ................................................................... 22- 2 -6. Actions and Policies Necessary for the Dissemination and Sustainability of RegenerativeMedical Products ................................................................................................. 24Recommendation 1: ............................................................................................... 24Reform of the pricing system and medical fee system to promote the spread of regenerativemedical products ................................................................................................... 24 Adequate reflection of the usability rating in the price ................................... 24 Revision of the application of the market expansion repricing ......................... 25 Improvement of the medical fee system to properly reflect medical costs ........ 25Recommendation 2: ............................................................................................... 26Review Ecosystem Challenges and Continue with Policies that will EnhanceNext-Generation Cycles ......................................................................................... 26 Promote measures to strengthen stakeholder collaboration ............................ 26 Continue to reduce costs and develop infrastructure ..................................... 2711. Introduction: Purpose of the ProjectRegenerative medical products are products made by processing human or animal cells andtissues for the purpose of reconstructing, repairing and forming body parts, or treating diseases.These products have shown unprecedented treatment results and hold the potential torevolutionize approaches to diseases. In particular, one such regenerative medical product,CAR-T cell therapy, has been approved in Japan, the United States, and Europe as a treatmentaimed at achieving a cure with a single administration. It is an industrialized product that hasgarnered high expectations. CAR-T cell therapy has been put into practical use for treatingcancers such as leukemia, lymphoma, and multiple myeloma, showing more significanttherapeutic effects than conventional treatments. Its application is now being considered fornew disease areas, such as immune and neurological disorders. In addition to the expectedclinical value of such therapies, there is anticipation of their social value in reducing medicalexpenses, including long-term hospitalization and care costs, and in supporting patients'resumption of social and economic activity.On the other hand, CAR-T cell therapy requires significant investment for research anddevelopment, the establishing of a manufacturing and supply system, and the setting up of amedical delivery system before it can be put into practical use. However, there is currently nopricing or reimbursement system that adequately compensates for the complex and advancedprocesses involved, making it difficult to foresee profits that could be reinvested into newresearch and development. Additionally, the number of countries and regions capable ofmanufacturing CAR-T cells is limited, and overall supply is constrained, raising concerns aboutpotential issues such as drug lag and drug loss from the perspective of supply prioritization bypharmaceutical companies.If the insights and profits gained from treatments cannot be reinvested into the next generationof research and development, the cycle of producing innovative therapies will not continue. Forthe regenerative medicine and related sectors to keep advancing, it is necessary to build anecosystem that allows more patients to benefit from innovative treatments and ensures asustainable and progressive cycle of development. For example, establishing an ecosystem forCAR-T cell therapy, which involves fully individualized production from the patient’s own cellsand has a complex development and manufacturing process, could position Japan to take on aleadership role internationally. Moreover, the establishment of such an ecosystem is expectedto invigorate the future regenerative medicine industry, bringing significant benefits to patientsand their families, to the pharmaceutical industry, and to society as a whole.2To aim for a future where patients with serious medical needs in Japan can continuously receiveinnovative treatments, it is essential to establish a sustainable ecosystem for regenerativemedical products. Additionally, to drive reform, various stakeholders need to come together toengage in discussions from a mid- to long-term perspective. This project aims to take a definitivestep forward in these discussions by having experts in medical economics, regenerative medicalproduct technology development, and clinical practice discuss the barriers to the practicalimplementation of regenerative medical products and the formation of a supporting ecosystem,while exploring solutions from multiple perspectives. Based on the results of these discussions,we plan to identify the issues that need to be addressed in Japan and propose solutions to these.This white paper is presented by the Japan Research Institute Limited, which aims to contributeto society from a mid- to long-term perspective, and incorporates the viewpoints of public andhealthcare professionals, ensuring a fair and impartial perspective.32. The Need for and Expected Effects of Establishing an Ecosystem forRegenerative Medical Products2.1. Why Focus on Regenerative Medical Products?Regenerative medical products are those made by culturing or similar processing through theuse of human or animal cells and tissues. They are used for reconstructing, repairing, andforming the structure and functions of the human body, treating and preventing diseases, andfor gene therapy. 1 These products offer new treatment possibilities for conditions that aredifficult to cure with traditional methods and have the potential to significantly improve patients'quality of life.The target diseases and forms of regenerative medical products are diverse, and the latter areof high clinical value. They are likely to promote the social reintegration of patients, aid theirparticipation in economic activity, help mitigate the decline in the working population, andsupport economic stability. Furthermore, regenerative medical products have the potential tosignificantly reduce the burden not only on patients but also on their families, caregivers, theorganizations where patients are employed, and medical institutions. They are seen ascontributing to the improvement of overall productivity and sustainable economic growth forsociety as a whole.Research and development of regenerative medical products in Japan are steadily progressingwith the support of government policies and collaboration between industry and academia.2,3,4However, to strengthen competitiveness in the global market, it is urgent to build an ecosystemunique to Japan. In particular, fields such as regenerative medicine, cell therapy, and genetherapy are crucial areas that provide new treatment options for diseases that are difficult toaddress with traditional therapies. Facilitating the advancement of research, development,manufacturing technology, and market formation in these areas is a critical issue for Japan'shealthcare.42.2. Current Status and Challenges of the Regenerative Medical Products MarketIn Japan, laws related to regenerative medicine were established in 2013 & 2014, markingabout ten years since their enactment. At that time, technologies related to regenerativemedicine were earning a reputation for being innovative, with the potential to lead to early curesfor diseases and injuries and aid in the prevention of severe conditions, especially followingProfessor Shinya Yamanaka's Nobel Prize win in 2012. However, due to the unclear positioningwithin the regulatory system, there were high expectations for the government’s enactment ofappropriate laws. The resulting legal framework categorized regenerative medical productsunder the "Act on Securing Quality, Efficacy, and Safety of Products Including Pharmaceuticalsand Medical Devices" (Pharmaceuticals and Medical Devices Act) for insurance-covered medicaltreatments, and under the "Act on Securing the Safety of Regenerative Medicine" for treatmentsnot covered by insurance and for research purposes, thereby promoting entry and investmentalong these routes.However, the anticipated widespread adoption of domestically developed regenerativemedicines has not been realized, and it remains a technology handled by a limited number ofmedical institutions within Japan. Furthermore, the domestic ecosystem is evolving only slowly,and growth rates are not as high as originally envisioned. Under existing rules applying toconventional pharmaceuticals, only two regenerative products had been approved before theestablishment of a dedicated regulatory framework, but 20 products have now been approvedas of June 2025. However, the market size expected at the time of the legal establishment in20205 has not been reached, and the scale remains small relative to the global market, Japan’sshare of which is only about 3%. The development of many products approved in Europe andthe United States has not progressed in Japan, with fewer than 20% undergoing phase 3 clinicaltrials. 6 To overcome this stagnation, more aggressive investment in technology developmentand regulatory reforms are required.52.3. Government Initiatives for Regenerative MedicineThe Japanese government has undertaken numerous initiatives to promote research anddevelopment in the field of regenerative medicines. In addition to the establishment of aregulatory framework in 2013/2014, its "Healthcare and Medical Strategy” 7 was formulated in2014, clarifying the development of innovative medical technologies, including regenerativemedicines, as a national strategy. Further efforts have been made since 2018 to strengthen thesupport system for the social implementation of regenerative medical technologies through theformulation and revision of the "Integrated Innovation Strategy.” 8 At the beginning of the 2020s,the government identified regenerative medicine as a scientific field directly linked to nationalinterests in its "Basic Policy on Economic and Fiscal Management and Reform 2022" andemphasized enhancing the development of regenerative medical products to strengthen drugdiscovery capabilities in its "Basic Policy 2023." In line with these policies, the government, theMinistry of Economy, Trade and Industry, the Ministry of Health, Labour and Welfare, theMinistry of Education, Culture, Sports, Science and Technology, and the Japan Agency forMedical Research and Development (AMED) have allocated budgets to help fund research anddevelopment. Furthermore, the government’s "Basic Policy 2024" set forth its commitment toenhancing drug discovery capabilities and promoting healthcare, positioning the developmentof drugs and regenerative medical products using iPS cells as key measures. Its more recent"Basic Policy 2025" continues this approach, with efforts underway to achieve the earlyestablishment of industrial promotion hubs to lead regenerative medicine production.Additionally, the "Bioeconomy Strategy” 9 developed by the Healthcare and Medical StrategyPromotion Secretariat sets a goal of global expansion of the market for Japanese-originatedregenerative medical products by 2030, aiming at market establishment and industrializationboth domestically and internationally. The Ministry of Economy, Trade and Industry is promotingthe development of efficient manufacturing processes for regenerative medical products andstrengthening domestic industrial infrastructure. The recent "Support Project for Investment inRegenerative, Cellular, and Gene Therapy Manufacturing Facilities” 10 under the FY2024Supplementary Budget focuses on establishing domestic manufacturing bases for contractdevelopment and manufacturing organizations (CDMOs) and developing appropriate humanresources to ensure the smooth manufacturing of regenerative medical products and relateditems in Japan. While current efforts are still in progress, these comprehensive policies are seenas playing a crucial role in building the ecosystem's foundation and enhancing Japan'sinternational competitiveness.62.4. Necessity of Establishing an Ecosystem for Regenerative Medical ProductsRegenerative medical products are groundbreaking technologies that offer innovativetreatments, but there are numerous challenges that need to be overcome from the researchstage through to actual patient treatment. For example, during the research and developmentphase, it is necessary to address various issues related to cell and tissue processing. Additionally,it is essential to establish a specialized system for the stable supply of these products, one whichrequires unique processes such as cell culture and handling. Once a stable supply system isestablished, these products must undergo evaluation by various regulatory authorities to ensurethat they can be provided by medical institutions.Fig.1 Overview of a sustainable regenerative medicine ecosystemTo sustainably operate this entire process as an "ecosystem," it is essential to reinvest theoutcomes from actual clinical practice, as well as the insights and revenue gained, into theresearch, development, and manufacturing of the next cycle. This enables the development ofnext-generation products. Ensuring this ecosystem cycle operates sustainably will make it morelikely that innovative medical treatments can be delivered to more patients, whilesimultaneously achieving growth of the sector and advancements in medical care.72.5. Benefits of Establishing a Regenerative Medical Products EcosystemThe establishment and continuous proliferation of an ecosystem for regenerative medicalproducts are expected to bring significant benefits to Japan's healthcare industry and to societyas a whole, while also enhancing the country’s international competitiveness by demonstratingits leadership in this field.Producing regenerative medical products domestically for Japanese patients can address globalmanufacturing and storage limitations, ensuring a sustainable supply. This allows patients toaccess treatments for severe diseases at an early stage, positively impacting the lives ofJapanese patients and their families. It also has the potential to meet future treatment needsfor various conditions, such as autoimmune diseases, beyond current levels of demand.From the perspective of utilizing Japanese talent, building this ecosystem will createopportunities for skilled professionals in research, development, and manufacturing. It canalleviate the burden on healthcare workers, allowing them to focus on treating other diseases,and enable patients who have been cured of severe illnesses—and their families—to becomeactive again, contributing immeasurably to society and the economy.In terms of international competitiveness, the ability to quickly supply regenerative medicalproducts to Asian countries is crucial. The technology related to regenerative medical productscould become the foundation of Japan's bioindustry, accelerating research and developmentoriginating from here. This is expected to develop into opportunities for international leadership,expanding Japan's influence in Asia and globally.[1] Cabinet Bill "Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices."[2] Cabinet Office Health and Medical Strategy Promotion Headquarters Regenerative/Cell Therapy and Gene TherapyPromotion Council 9th Meeting Document 1-1: Cabinet Office Submission "Government's Overall Efforts in the Field ofRegenerative/Cell Therapy and Gene Therapy" (June 2023)[3] Cabinet Office Health and Medical Strategy Promotion Headquarters Regenerative/Cell Therapy and Gene TherapyPromotion Council "Future Efforts in the Field of Regenerative/Cell Therapy and Gene Therapy" (May 2022)[4] Cabinet Secretariat "New Capitalism's Grand Design and Execution Plan 2025 Revised Edition" (June 2025)[5] Ministry of Economy, Trade and Industry, Final Report on the Practical Application and Industrialization of RegenerativeMedicine (February 2013)[6] Ministry of Health, Labour and Welfare, Central Social Insurance Medical Council, Drug Price Special Committee (236thmeeting), Statement Materials, The Forum for Innovative Regenerative Medicine "Opinions on the Price Calculation ofRegenerative Medical Products" (July 2025)[7] Healthcare and Medical Strategy (Cabinet decision, July 2014), etc.[8] Integrated Innovation Strategy (Cabinet decision, June 2018), etc.[9] Bioeconomy Strategy (Integrated Innovation Strategy Promotion Council decision, June 2024)[10] Ministry of Economy, Trade and Industry, FY2024 Supplementary Budget "Support Project for Investment inRegenerative, Cellular, and Gene Therapy Manufacturing Facilities"83. Clinical and Social Value of CAR-T Cell Therapy3.1. Overview of CAR-T Cell TherapyThis white paper focuses on CAR-T cell therapy and identifies specific challenges involved in thedelivery of regenerative medical products. The reasons for this focus include the significantclinical and societal value of CAR-T cell therapy, the complexity of its manufacturing and qualitycontrol process, given that it’s a personalized medicine, and its approval and industrialization inJapan, the U.S., and Europe alongside other regenerative medical products.CAR-T cell therapy involves harvesting a patient's T-cells, reprogramming them using gene-editing technology to specifically recognize and attack cancer cells, and then expanding thesecells and administering them back into the patient as a regenerative medical product. Thisinnovative, fully personalized medical treatment is currently approved in Japan for five productsthat treat hematologic cancers such as B-cell acute lymphoblastic leukemia, large B-celllymphoma, and multiple myeloma. Additionally, CAR-T cell therapy shows potential efficacy forsolid tumors and autoimmune diseases, suggesting its potential for broader disease applicability.3.2. Clinical Value of CAR-T Cell TherapyThe clinical value of CAR-T cell therapy is assessed based on the outcome of clinical trials andon post-marketing clinical data. This treatment aims to provide a cure for severe diseases andcan achieve long-term remission. Clinical trial results indicate groundbreaking effects on overallsurvival (OS) and quality-adjusted life years (QALY) with a single administration for patientswith severe hematological cancers.11,12 High response rates and survival have also beenreported in post-marketing clinical trials.13 Furthermore, CAR-T cell therapy has an establishedsafety profile,14 it has significantly improved patient outcomes in cases of diseases that werepreviously challenging to treat, and as an innovative therapeutic has expanded treatmentoptions. The clinical value is validated by real-world data,15 suggesting a transformative impacton cancer treatment and potential application across a wide range of diseases.93.3. Societal Value of CAR-T Cell TherapyAs a one-time personalized therapy, CAR-T cell therapy reduces the need for long-termtreatment involving regular hospital visits, administration, and ongoing costs, improvingpatients' long-term quality of life (QoL). Improved health leads to early social and economicreintegration for patients, enhancing productivity and reducing the burden on families andcaregivers.From an economic standpoint, CAR-T cell therapy is of high societal value. For instance, U.S.estimates suggest a 30.3% cost reduction using cell therapy to treat multiple myelomacompared to standard treatments. This is attributed to a reduction in ongoing chemotherapycosts, hospitalization days, and outpatient visits; it also reflects a reduction in the loss of overalllifetime earnings for patients and of caregiver productivity.16 Additionally, efficient resourceallocation by organizations and medical institutions helps ensure sustainable healthcare,enhancing access to quality treatments for more patients.Given Japan's declining labor force and increasing individual economic value, CAR-T cell therapyis expected to significantly impact positively on a broad spectrum of society. As an importantmedical innovation, further dissemination of CAR-T cell therapy is anticipated.[11] Bristol Myers Squibb, "TRANSCEND trial: Largest pivotal trial in 3L+ large B-cell lymphoma, including patients withhigh-risk disease."[12] Gilead Sciences, "Yescarta® Is First CAR T-cell Therapy to Report Five-Year Survival Data From Pivotal Study ShowingDurable Long-Term Survival in Patients With Refractory Large B-cell Lymphoma" (December 2021).[13] Neelapu SS. Five-year follow-up of ZUMA-1 supports the curative potential of axicabtagene ciloleucel in refractory largeB-cell lymphoma. Blood. 2023;141(19):2307-2315.[14] Abramson JS. Lisocabtagene maraleucel as second-line therapy for large B-cell lymphoma: primary analysis of thephase 3 TRANSFORM study. Blood. 2023;141(14):1675-1684.[15] Crombie N. Real-world outcomes with novel therapies in R/R DLBCL. Hematol Oncol. 2023;41(3):453-468.[16] Alliance for Regenerative Medicine, "A Transformative Therapy Value Model for Rare Blood Diseases" (January 2020).104. Challenges and Opportunities in the Development and Manufacturing ofCAR-T Cell TherapyThe manufacturing of regenerative medical products involves a process distinct from that oftraditional pharmaceuticals, necessitating a specialized framework. Due to the personalizednature of these treatments, standardizing quality control and production processes poses achallenge. Recently, under the leadership of the Ministry of Economy, Trade and Industry,efforts to establish manufacturing infrastructure have been making steady progress. However,further improvements in manufacturing technology and cost reduction are essential to create asystem that can deliver treatment to more patients.On the supply side, it is crucial to enhance collaboration with medical institutions and optimizethe supply network to ensure that patients requiring treatment can access regenerative medicalproducts at the right time. Specifically, establishing a distribution system to ensure a stablesupply of products is vital.4.1. Manufacturing and Supply Process of CAR-T Cell TherapyCAR-T cell therapy is a fully personalized treatment produced by genetically modifying apatient’s own T-cells, and involves a complex manufacturing and supply process. Initially, T-cells are extracted from the patient using leukapheresis and transported to a pharmaceuticalcompany’s cell processing facility. There, genetic modification techniques are used to introducechimeric antigen receptors (CARs) into the T-cells, enabling them to specifically recognize andattack cancer cells. The genetically modified T-cells are then expanded in a culture environment.Throughout this process, quality control tests are conducted to ensure only qualified cells arefrozen and shipped as products. These are then transported to treatment facilities, thawed, andadministered to the patient under strict side-effect management protocols.114.2. Challenges in the Development, Manufacturing, and Supply of CAR-T CellTherapyWhile CAR-T cell therapy is innovative compared to traditional pharmaceuticals, it facesnumerous challenges in its development, manufacturing, and supply processes. Traditionalpharmaceuticals can be mass-produced uniformly through chemical synthesis or large-scalecultivation, and efficiently supplied to a large number of patients by maintaining inventory andutilizing logistics networks. In contrast, CAR-T cell therapy involves handling living cells derivedfrom the patient, requiring specialized facilities and equipment. The manufacturing and qualitycontrol processes rely heavily on personalized tasks carried out by highly specialized and trainedpersonnel. Furthermore, the technologies are covered by numerous patents, leading to highlicensing fees. The therapy also involves expensive, specialized raw materials, some of whichface supply shortages, driving up prices. Transportation requires dedicated logistics, includingspecific packaging and infrastructure (such as cold supply chains that maintain temperatures ofminus 150°C), necessitating transport from medical facilities to cell processing facilities andback for each patient. Currently, CAR-T cell therapies are primarily manufactured overseas, withtransport complexities and time lags posing unique challenges.CAR-T cell therapy, being a fully personalized treatment, incurs high production costs, R&Dexpenses, and distribution costs, unlike traditional pharmaceuticals where economies of scaleapply. Moreover, since the manufacturing process significantly impacts the efficacy and qualityof the final product, integrating commercial perspectives into the development process from anearly stage is crucial. Internationally, a startup ecosystem allows biotech startups tocommercialize academic seeds and secure funding from venture capital and investment markets.Leveraging this financial strength, pharmaceutical companies and CDMOs get involved early,accelerating development. In contrast, Japan's startup ecosystem is underdeveloped, and thecurrent pricing structure makes the domestic market less attractive compared to other countries.Consequently, attracting investment to finance the conducting of clinical trials andmanufacturing in Japan is challenging, delaying the shift towards a commercially-drivenmanufacturing process and, consequently, practical application.Overcoming these challenges requires technological innovation and an expansion ofmanufacturing scale. Standardizing and streamlining manufacturing technologies, optimizingsupply chains, developing highly specialized human resources, and establishing facilities areimperative. By achieving this, Japan will undoubtedly enhance its international competitiveness.124.3. Opportunities in the Development, Manufacturing, and Supply of CAR-T CellTherapyConversely, the development, manufacturing, and supply of CAR-T cell therapy presentsignificant opportunities for Japan. Currently, few countries offer CAR-T cell therapy, and Japanhas the potential to lead globally in manufacturing, clinical development, and evidencegeneration. Through initiatives like the Ministry of Economy, Trade and Industry’s "RegenerativeMedicine Industrialization Infrastructure Program," the Japanese government is activelyinvesting in the establishment of manufacturing facilities and CDMOs for regenerative-, cell-,and gene therapies, including CAR-T cell therapy. These initiatives aim to strengthen domesticmanufacturing capacity, position Japan as a hub for manufacturing and supply in Asia, andenhance the country’s international competitiveness.Government policies are expected to promote the development of specialized human resourcesand the establishment of facilities, providing a foundation for advancing supply chainsophistication. This will enable Japan to demonstrate leadership in this field, offering treatmentaccess to a wider range of patients and creating opportunities for new treatments.135. Challenges in the Medical Insurance System and Provision of CAR-T CellTherapyJapan's healthcare insurance system operates under a universal health coverage framework,enabling relatively swift reimbursement after approval. 17 Additionally, advanced medicalfacilities utilizing regenerative medical products are available nationwide, providing anenvironment conducive to patients receiving cutting-edge treatments. To offer regenerativemedical products as a treatment option for a wide range of diseases, it is crucial to establish asystem that ensures sustainable provision through the insurance reimbursement system.However, the pricing of products, reimbursement as medical technology, and investments inmedical facility infrastructure are designed as extensions of traditional systems, and it is difficultto say that the unique characteristics of regenerative medicine have been fully assessed. Inparticular, discussions are needed on how to reflect in the insurance reimbursement system thelong-term outcomes for patients, the reduction of burden on caregivers, and the contribution tosociety that regenerative medical products can offer. Consideration is also needed of how toalign with the current system, given that economies of scale based on manufacturing volumesdo not fully apply, and how to target investments in medical institutions in such a way thatinnovative treatments will be disseminated.5.1. Challenges in Pricing and Repricing SystemsIn Japan, keeping prices low facilitates quick and widespread insurance reimbursement. Incontrast, in Europe, companies tend to set higher prices, with reimbursement often delayed dueto cost-effectiveness evaluations. However, setting prices too low may reduce incentives forcompanies to engage in research and development, potentially leading to drug lags or losses.In Japan, product prices tend to be lower than in other countries. Although the number ofapproved CAR-T products is not large in Japan and other countries, a 2023 survey comparingCAR-T cell therapy product prices showed that each product cost approximately 33 million yenin Japan. In contrast, prices ranged from 68 million to 87 million yen in the U.S., 45 million to46 million yen in the UK, 37 million to 59 million yen in Germany, and 37 million to 59 millionyen in France. 18 The insurance-listed price in Japan for the allogeneic mesenchymal stem cellproduct Alofisel for the treatment of complex fistulas in Crohn's disease was about 5.6 millionyen, compared to about 6.9 million yen in France.19 For the gene therapy Zolgensma used totreat spinal muscular atrophy, the price in Japan was approximately 167 million yen, comparedto 230-280 million yen in the U.S.20 Meanwhile, Luxturna, approved for hereditary retinaldystrophy, was priced at about 50 million yen in Japan, roughly equivalent to the UK price andhigher than France's price of about 41 million yen. 21 However, the peak number of patients wasfive, suggesting minimal impact on healthcare finances. Currently, with the weakened yen,overseas prices denominated in yen have risen further, widening the gap with Japanese prices.14Additionally, while prices rarely increase post-reimbursement in Japan, overseas systems thatallow for price increases contribute to further widening the gap.5.1.1. Long-term Clinical and Societal ValueJapan's national medical expenses amounted to 46.6967 trillion yen in the fiscal year 2022 22and are expected to approach around 50 trillion yen by the fiscal year 2025, driven by increasingmedical demand resulting from the country’s declining birthrate and aging population. Inresponse to concerns about rapidly increasing financial burdens, the government has repeatedlysought to contain unit costs and quantities through measures such as medical fees and productpricing, which may put further pressure the revenues of healthcare institutions, pharmaceuticalcompanies, and related industries. Against this backdrop, companies face profitability challenges,healthcare institutions face issues with facilities, equipment, and human resources, and patientsface the risk of drug lags and losses. Moreover, a significant concern is the inability to reinvestprofits derived from innovations into next-generation development.As a fundamental reform proposal to address these issues, the following two points have beensuggested and discussed by the Institute for New Era Strategy.23 It is considered necessary todesign a system with a view toward the medium- to long-term future.a. Management of Total Healthcare Expenditure in Line with Economic GrowthDiscussions are underway on managing healthcare expenditure to a certain extent to preventexcessive healthcare cost containment from adversely affecting patient health and the qualityof care. For example, one proposal suggests managing the pharmaceutical cost portion ofhealthcare expenditure so that it grows in line with the long-term nominal GDP growth rate.By numerically indicating the upper and lower limits of the funding framework in advance, theproposal aims to create a highly predictable environment that prevents sudden andmechanical price reductions while ensuring appropriate resource allocation to innovativepharmaceuticals. Notably, nominal GDP growth includes the GDP deflator, allowing forappropriate reflection of price-related growth in pharmaceutical costs.b. Introduction of a System to Evaluate Diverse ValuesTo balance improving healthcare quality and sustainability, discussions are underway onimproving the opaque process of health technology assessment, which currently focusesprimarily on cost and QALY (Quality-Adjusted Life Years). Proposals include a fundamentalimprovement to value assessment by incorporating comprehensive value elements (theimpact on work, the health of caregivers and families, societal impact) while defining andclassifying pharmaceuticals and technologies with clinical effects and social benefits below a15certain standard as low-value healthcare. Gradual reductions in insurance points and exitsfrom reimbursement are being suggested, along with the presentation of alternativetreatments.Regarding the adjustment premiums in pricing, regenerative medical products require long-term observation of outcomes post-transplantation or administration, and it's often the casethat all required items are not thoroughly verified at the time of application. Moreover,regenerative medical products offer contributions that are not fully captured by the currentadjustment premiums. A significant challenge for Japan is the projected increase in overallmedical demand and per capita healthcare costs due to the aging population as the countryheads toward 2040, leading to increased burdens on the working population. Regenerativemedical products are particularly capable of addressing this challenge by offering potentialtreatments or cures for diseases that are difficult to resolve with conventional medicaltechnologies, thus potentially reducing long-term hospitalization and caregiving costs andimproving productivity through the reintegration of workers into society. In fact, when the cost-effectiveness of Kymriah was evaluated, estimations of productivity loss, though preliminary,yielded positive results. 24To establish a foundation for data collection and analysis in real-world clinical settings andpromote reverse translational research that feeds back clinical insights and challenges into next-generation R&D, it is necessary to give greater consideration to a premium system whereinnovations, once their post-market efficacy and safety are verified, are adequately reflected inthe pricing of existing products.The perception of value in healthcare varies depending on the recipient, and certain aspects ofthis may lead to conflicts of interest among stakeholders. However, a proposal for a systemdesign that allows the value provided by regenerative medical products to be presented withevidence data by companies and academic societies, and reflected as adjustment premiumswhen socially recognized, would be beneficial for the future of our country.16Figure 1Trends in costs of conventional pharmaceuticals and regenerative medicine products5.1.2. Lack of Economies of Scale due to Personalized ManufacturingJapan's drug pricing system includes mechanisms that can uniformly lower the price ofinnovative drugs even during their patent period, one of which is called “market expansionrepricing.” The market expansion repricing system is designed to optimize healthcare costs andefficiently manage budgets by reevaluating the price of a drug if its market size significantlyexceeds initial projections. The specific criteria for this system are as follows: If the market size is more than double the initial forecast and annual sales exceed 15billion yen. If the drug has not undergone cost-based price revisions and the market size is ten timesthe initial forecast, with annual sales exceeding 10 billion yen.This system operates on the premise that economies of scale can reduce the per-unit cost ofdrugs that can be mass-produced. However, CAR-T cell therapies require complex andpersonalized manufacturing processes that incur high costs for specialized personneldevelopment, quality control, logistics, and post-manufacturing operations. Even if the numberof patients supplied increases, production remains individualized, necessitating an expansion of17transport and supply lines, making cost reduction through mass production impossible.Additionally, global manufacturing and supply are limited, and if prices are suppressed due toJapan's pricing system or currency exchange rates, it could become challenging to maintainpatients’ access to the treatment due to prioritization decisions, potentially limiting treatmentoptions.Currently, CAR-T cell therapy products are not subject to market expansion repricing or"yoking," but with an increase in the number of eligible patients, they may become subject tothese in the near future. To ensure a sustainable supply for Japanese patients, it is reasonableto consider revising the market expansion repricing system.Figure 2Relationship between product manufacturing costs and production quantity ofconventional pharmaceuticals and regenerative medicine products185.2. Challenges in the Medical Fee SystemTo promote the widespread use of regenerative medical products, it is essential to establish asystem that allows medical institutions to actively invest in infrastructure and human resourcedevelopment while ensuring their profitability. Currently, there are challenges in building aframework that enables medical institutions to provide high-quality healthcare sustainably.Specifically, the setting of appropriate fees for procedures and management to enhance facilityinvestment and human resources is inadequate, making it difficult for medical institutions torealize a profit. For instance, the reimbursement for CAR-T cell therapy procedures is currentlybased on the system for autologous peripheral blood stem cell transplantation, which has asimilar process. However, the costs associated with the medical delivery system, such asnecessary personnel and equipment, are not fully covered by the existing reimbursement.Notably, only one apheresis is reimbursed per CAR-T cell production, and if the first apheresisdoes not meet the standards and must be repeated, it is not covered, becoming a financialburden for the medical institution.25 Additionally, the transportation and reception of cells to andfrom manufacturing facilities and the preparation of ultra-low temperature transport containersare necessary, but the cost of these is not reimbursed. Furthermore, CAR-T cell therapy requiresmuch more sophisticated and prolonged side-effect management compared to autologousperipheral blood stem cell transplantation, and this is not adequately considered in terms ofmanagement and medication.When designing the reimbursement system, it is necessary to create a framework allowingmedical institutions to proactively invest in infrastructure and human resource developmentwhile generating a profit. Addressing these challenges will improve the quality and accessibilityof regenerative medical healthcare and enable the sustainable development of appropriateproducts.5.3. Challenges in Patient Access to TreatmentEnsuring patient access to regenerative medical products and creating an environment wherethey can receive treatment with confidence requires the following challenges to be overcome:5.3.1. Diagnosis to Initial Treatment and Relapse ProcessPatients experience significant changes in their daily lives and feel anxiety about the disease'sprogression and prognosis throughout the process from diagnosis to initial treatment andrelapse. Additionally, due to a lack of understanding of the disease itself and of information ontreatment options, including regenerative medical products, patients find it difficult to determinehow best to proceed. Moreover, concerns that they may have to move from hospital to hospital19and worries over the side-effects of treatments are significant deterrents to undergoingtreatment.5.3.2. Access to CAR-T Cell TherapyIn clinical trials of CAR-T cell therapy, specific serious adverse events, such as cytokine releasesyndrome, have been reported. Due to safety considerations, treatment is only allowed atspecific eligible facilities. However, the number of facilities in Japan able to provide thistreatment varies by product, ranging from 36 to 67 facilities,26 making access particularlydifficult for patients living in rural areas. In the U.S., CAR-T cell therapy's status as a treatmentoption is well-established in clinical guidelines. 27 By contrast, in Japan it is merely listed as oneof many treatment options,28 influencing treatment choices by patients and physicians.Furthermore, there is no effective system or network to link treatment-providing facilities withreferral facilities, nor are there specialized coordinators, leading to a burden in providing medicalinformation and insufficient incentives for patient referrals. Consequently, access to appropriatetreatments for patients needing regenerative medical products is limited. This is especiallyproblematic in the case of acute diseases, where there is often a lack of smooth communicationand prior discussions about subsequent treatments, such as CAR-T cell therapy, betweenpatients and referring physicians prior to relapse.5.3.3. From Treatment to Follow-upPatients continue to experience significant anxiety from treatment through follow-up.Particularly, concerns about the latter are substantial; better follow-up mechanisms are neededto allow patients to handle their prognosis with confidence.205.3.4. [Note 1] Summary of discussions regarding the use of private insuranceIn Japan, the constantly increasing cost of healthcare is giving rise to concerns about thesustainability of the public health insurance system. Proposals are being considered to excludesome high-cost medications from public insurance coverage and to utilize private insurance tohelp contain social insurance premiums. The public health insurance system aims to achieve itsideal of Universal Health Coverage, ensuring that, when facing significant risks, everyone canaccess the medical services they need without any financial worries. However, excludingexpensive medications from public insurance coverage could pose a serious challenge to thisideal. Additionally, as medical technology advances and treatment options diversify, restrictingthese options due to financial reasons would be counterproductive to improving the quality andaccessibility of healthcare. From this perspective, it is desirable that regenerative medicalproducts and related technologies continue to be covered by the public health insurance system.On the other hand, the government plans to expand the scope of treatments that can be usedalongside those covered by insurance, specifically targeting cutting-edge medical technologieswhose effectiveness is not yet fully validated, as opposed to officially approved products likeCAR-T cell therapies.29 Currently, the insights gained from the use of regenerative medicine asa medical technology under safety assurance laws are not fully utilized in the formulation of thenext-generation ecosystem. Moving forward, it is necessary to implement measures that reflectthese insights in the research and development of next-generation treatments through proactivereverse translational research. For example, research and treatment plans aimed at acquiringevidence, such as advanced medical care or patient-requested therapies, should be madeavailable to those covered by public health insurance, to reduce the burden on patients,encourage public participation, accumulate case numbers, and improve the quality of researchand treatment. Additionally, supporting these systems requires collaboration with privateinsurance providers. For private insurance providers to cover a specific condition and forcoverage to become established and flourish, they must assume a lower disease risk, with alarge potential market size and a broad segment of the population facing the risk. In areasmeeting these conditions, it would be beneficial to consider the development and utilization ofprivate insurance to help alleviate individual burdens.215.3.5. [Note 2] Cost-Effectiveness Evaluation SystemThe “Basic Policy on Economic and Fiscal Management and Reform 2025” (“Honebuto no Hoshin2025”) 30 states:“Based on objective verification, further utilization of the cost-effectiveness evaluation systemwill be considered, including appropriate evaluation methods, the scope of application, and theimplementation structure, as well as its use in the drug pricing system and clinical practice.”This indicates a direction toward expanded application of the system in the future.Analyzing the European HTA landscape, 'cost-effectiveness evaluation,' or 'economic HTA,' isnot applied to regenerative medical products in key reference countries like Germany and France.The primary reason for this is that standard economic HTA lacks the flexibility to account forbroader considerations, such as long-term economic and scientific values. Applying standardeconomic HTA could lead to significant drug lag and loss for regenerative medical products.31While economic HTA is not undertaken in countries like Germany and France, clinical HTAfocuses on clinical value assessment, including patient-reported outcomes (PRO). However,regenerative medical products are highly complex, with challenges in blinding, randomization,endpoint selection, and choice of comparator, which results in uncertain evidence regardingtheir long-term value at the time of regulatory submission. Even clinical HTA has limitations infully capturing the long-term, potentially lifetime, benefits of regenerative medicine products.However, for example, in Sweden, economic HTA is applied to with greater flexibility whichhelps regenerative medical products. They incorporate flexible thresholds for the IncrementalCost-Effectiveness Ratio (ICER), Quality-Adjusted Life Years (QALY), cost-benefit analysis, andbudget impact to enable faster patient access to life-saving regenerative medical products.Sweden’s HTA system also systematically includes ‘Indirect costs and benefits’, which supportstheir access as regenerative medical products have a positive impact on this domain of HTA..225.3.6. [Note 3] Price Stability and Manufacturing Incentives to Promote Innovationand Investment in FranceIn France, a framework agreement between LEEM (The French Pharmaceutical CompaniesAssociation) and CEPS (The Economic Committee for Health Products) has established a systemproviding price stability and manufacturing incentives (currently under renegotiation). Itincorporates incentives designed to promote domestic manufacturing, support exports, byensuring that prices for highly innovative medicines do not fall below those in other Europeancountries.32They include the following:• To promote domestic manufacturing of innovative medicines, for products rated ASMR 1–3(indicating high added clinical value compared to existing therapies), if all majormanufacturing steps are conducted in France, the price must not be lower than the lowestprice in either the UK, Germany, Italy, or Spain.• If current or future investments in manufacturing, R&D, or digital health related to theproduct are made within the EU—particularly in France—up to five years of price stabilitymay be granted.• To encourage exports, products for which at least one significant manufacturing step isconducted in the EU (especially in France), batch release is performed in France, and morethan 60% of production volume is exported, may be granted two years of price stability(renewable once for up to two additional years).• For many innovative medicines rated ASMR 1–3, if the price is set by referencing otherEuropean countries and the health economic assessment is valid, net and list price stabilityis granted for the first five years after market launch (three years in other cases).In Japan, similar incentives may be necessary to promote the R&D and manufacturing ofregenerative medicine and related products, and to support their development as an exportindustry. Specifically, ensuring that domestic prices do not fall below referenced Europeanprices could be a key policy consideration.23[17] Institute of Health Industry Policy Studies, Policy Research News No. 66, "Why Do New Drugs Reach Patients 60 DaysAfter Approval?" (July 2022)[18] Medical and Pharmaceutical Comprehensive Research Institute, Drug Price and Distribution Policy Study Group, KusuriMirai Juku, "Aiming for a Bright Future as a Medical Powerhouse - Proposals for Pharmaceutical System Reform VII"(November 2023)[19] Ministry of Health, Labour and Welfare, Central Social Insurance Medical Council General Meeting (497th), "InsuranceApplication of Regenerative Medical Products" (November 2021)[20] Ministry of Health, Labour and Welfare, Central Social Insurance Medical Council General Meeting (458th), "InsuranceApplication of Regenerative Medical Products" (May 2020)[21] Ministry of Health, Labour and Welfare, Central Social Insurance Medical Council General Meeting (552nd), "InsuranceApplication of Regenerative Medical Products" (August 2023)[22] Ministry of Health, Labour and Welfare, "Overview of National Medical Expenses for Fiscal Year 2022" (October 2024)[23] the Institute for New Era Strategy (INES), "Proposals from the Council for Reviving Drug Discovery Innovation" (May2025)[24] Institute of Health Industry Policy Studies, Policy Research News No. 68, "The Past and Future of Japan's Cost-Effectiveness Evaluation System" (March 2023)[25] Internal Medicine Societies Social Insurance Federation, "Survey of Intentions for Proposals for the Fiscal Year 2023Revision" Submitted by the Japan Society for Hematopoietic and Immunotherapy (February 2023)[26] Number of Facilities Offering CAR-T Cell Therapy in Japan: Kymriah 49 facilities, Breyanzi 39 facilities, Yescarta 67facilities, Abecma 36 facilities, Japan Research Institute Survey (As of March 2025)[27] NCCN Clinical Practice Guidelines in Oncology (As of June 2025)[28] Japanese Society of Hematology, "Clinical Practice Guidelines for Hematological Malignancies Version 3.1 (2024 Edition)Web Version" (December 2024)[29] Cabinet Secretariat, "Grand Design and Action Plan for a New Capitalism, Revised 2025 Edition" (June 2025)[30] The Basic Policy on Economic and Fiscal Management and Reform 2025 (Cabinet Decision in June 2025)[31] Drummond M. How are health technology assessment bodies responding to the assessment challenges posed by celland gene therapy? BMC Health Serv Res. 2023 May 13;23(1):484.[32] Smart Pharma Consulting “Is France Attractive for Pharma Companies?” (March 2024)246. Actions and Policies Necessary for the Dissemination and Sustainability ofRegenerative Medical ProductsEfforts to establish a regenerative medical product ecosystem are being propelled somewhat bygovernment initiatives at various stages, including research, development, manufacturing, andsupply. However, there remains a lack of a comprehensive system in terms of healthcareinsurance and the establishment of a treatment-providing framework, indicating that the currentecosystem is insufficient for seamless operation.Recommendation 1:Reform of the pricing system and medical fee system to promote the spread ofregenerative medical productsJapan's healthcare insurance system operates on a principle of universal health coverage,providing an environment conducive to receiving advanced treatments. By keeping prices low,Japan facilitates rapid and extensive insurance reimbursement, whereas in Europe, high pricingset by companies often results in delayed reimbursement due to cost-effectiveness evaluations.However, setting prices too low could reduce the incentive for companies to invest in researchand development, potentially leading to drug lags or losses. Implementing systemic reformsthat reflect the innovation and characteristics of regenerative medical products could positionJapan as a global leader in this field, thereby delivering the benefits of treatment to morepatients.Ensuring sustainable access to regenerative medical products requires comprehensive reformof the healthcare insurance system. First, it is necessary to review pricing to properly assessinnovation and reconsider market expansion repricing. Additionally, in order to utilize limitedmedical resources efficiently, strategies to reduce medical costs, such as curbing excessivemedication usage and ensuring appropriate use, should also be considered. Adequate reflection of the usability rating in the priceRegenerative medical products not only offer clinical value over long periods but are also abenefit to society by aiding patient reintegration into society and reducing the burden oncaregivers. It is important to consider how these contributions over an extended timeframe canbe reflected in the form of adjustments to premiums within the healthcare insurance system.Furthermore, using this system as an incentive, it is necessary to promote the collection andanalysis of real-world clinical data and reverse translational research for verification.25 Revision of the application of the market expansion repricingRegenerative medical products undergo complex manufacturing and distribution processes,incurring significant costs in terms of specialized facilities, personnel, intellectual property,special quality control, and post-production operations. Additionally, these products areindividually manufactured for each patient, lacking economies of scale, and making costreduction through mass production difficult. Applying market expansion repricing, whichassumes economies of scale, could severely impact company revenues and hinder continuedpatient access. Therefore, reviewing current market expansion repricing rules, which assumeeconomies of scale for conventional pharmaceuticals, is necessary. At the very least,establishing a mechanism that prevents excessive price reductions during scope expansionswould help maintain an environment where companies can supply innovative treatments in asustainable manner. Improvement of the medical fee system to properly reflect medical costsTo enable the sustainable provision of regenerative medical products, support for facilityinvestment and human resource development at medical institutions is crucial. Thus, whensetting reimbursement rates, it is necessary to evaluate the costs of medical provision systems,including the personnel and facilities required for the provision of regenerative medical products,sufficiently within reimbursement rates. Additionally, it is important to incorporate systems thatallow medical institutions to recoup their investment in facilities and personnel.26Recommendation 2:Review Ecosystem Challenges and Continue with Policies that will Enhance Next-Generation CyclesTo develop an ecosystem for regenerative medical products, it is essential to make ongoingefforts to identify challenges, improve processes, and refine these; this will help enhance thenext generation of medical technologies. While the government currently supports theestablishment of research, development, manufacturing, and supply systems for regenerativemedical products, transient investments alone cannot sustain the ecosystem. To ensure Japanbecomes a more attractive market, it is essential to balance regulatory system enhancement,reinvestment of profits gained from initial cycles by private companies, and the furtherexpansion of government investment funds from a bio-industry development perspective. Promote measures to strengthen stakeholder collaborationIn innovative technology development, it is crucial to swiftly and efficiently introduce researchfindings to the market. Bridging research plays a vital role in this process. The government andrelevant ministries should promote policies that facilitate the transfer of university-originatedtechnologies to startups and push rapid product development.To ensure smoother provision of regenerative medical products, it is urgent to build systemsand strengthen networks in order to link referring facilities with treatment-providing facilitiesmore effectively. By enhancing collaboration among medical institutions, clarifying thepositioning of regenerative medical products in clinical guidelines, and boosting incentives forpatient referrals, a network should be developed to ensure that patients requiring regenerativemedical products receive treatment quickly and appropriately.To improve patient awareness and ensure their access to treatment, patient organizations,academic societies, medical institutions, and development companies need to collaborate inbuilding forums for sharing and discussing the latest information on diseases and the varioustreatment options, including immunotherapy, and create comprehensive and easy-to-understand guidance.Furthermore, evidence derived from real-world clinical data should be accumulated and fed backinto next-generation research and development. With the participation of treatment-providingfacilities, academia, development companies, and patients, it is important to verify the long-term value of regenerative medical products and build the kind of foundations that will helpensure their further development.27 Continue to reduce costs and develop infrastructureThe manufacturing, quality control, and supply of regenerative medical products remain in theearly stages of refinement, with many processes relying on manual labor by highly skilledpersonnel, resulting in high manufacturing costs. However, with technological advancementssuch as automation and robotics, future cost reductions are anticipated, allowing more patientsto benefit from new regenerative medical treatment opportunities across various diseases.The government should aim to nurture highly specialized human resources, promote facilitydevelopment, enhance supply chains, and establish a domestic ecosystem, solidifying Japan'sposition as a base for expansion into Asian countries.WHITE PAPERCreating a Sustainable Ecosystem for Innovative Regenerative Medical ProductsJuly 29, 2025[Authors]Keiichiro Noda, Ryosuke Kawachimaru, Mitsuhiro Nakato, Yukino Nozaki,Masaki Kawasaki, Shunichiro NagumoResearch & Consulting Division, Healthcare & New business Group,The Japan Research Institute, Limited[Co-authors]Kazumasa OguroProfessor, Faculty of Economics, Department of Economics, Hosei UniversityTakanori TeshimaProfessor, Department of Hematology, Hokkaido University Graduate School of MedicineHiroshi NakamuraProfessor, Dean of the Graduate School of Business Administration, Keio UniversityYoshimi YashiroProfessor, Center for Translational Research Support Education, Fujita Health University[Sponsor]Bristol-Myers Squibb K.K.This white paper proposal was created with the sponsorship of Bristol-Myers Squibb.※This article reflects the opinion of the author and does not represent the official view of theJRI. White Paper｜Creating a Sustainable Ecosystem for Innovative Regenerative Medical Products White Paper｜Creating a Sustainable Ecosystem for Innovative Regenerative Medical Products(PDF:1,782 KB)	查看 62377	日本総合研究所	2025-08-08 06:35:30 2025-08-08 06:35:35	word
3236712	无图 Recommendations for "Creating a Sustainable Ecosystem forInnovative Regenerative Medical Products"July 29, 2025Research & Consulting Division, Healthcare & New business GroupKeiichiro Noda, Ryosuke Kawachimaru, Mitsuhiro Nakato, Yukino Nozaki,Masaki Kawasaki, Shunichiro NagumoWhite PaperAppendixSummaryRegenerative medical products are those made by culturing or similar processingthrough the use of human or animal cells and tissues. They are used forreconstructing, repairing, and forming the structure and functions of the humanbody, treating and preventing diseases, and for gene therapy. These products offernew treatment possibilities for conditions that are difficult to cure with conventionalmethods and have the potential to significantly improve patientʼs quality of life.Research and development of regenerative medical products in Japan are steadilyprogressing with the support of government policy and collaboration betweenindustry and academia. However, compared to the global market, the Japan markethas not grown sufficiently, and many of the products approved in Europe and theUnited States have not been developed in Japan. In order to overcome thisstagnation of industrialization, more active investment in technology developmentand regulatory reforms are required.This white paper focuses on CAR-T cell therapy and identifies specific challengesin the research, development, manufacturing and supply, and treatment ofregenerative medical products, as well as in the healthcare insurance system thatsupports this entire process. The reasons for this focus include the significant clinicaland societal value of CAR-T cell therapy, the complexity of its manufacturing andquality control process, given that itʼs a personalized medicine, and its approval andindustrialization in Japan, the U.S., and Europe alongside other regenerative medicalproducts.CAR-T cell therapy 1 is a treatment that has the ability to harvest T cells frompatients, genetically modify them, and attack cancer, and has been put into practicaluse in leukemia and lymphoma, and is expected to be a treatment that can aim fora cure with a single dose. However, in Japan, where there is no sufficient pricingsystem and medical fee system to evaluate the advanced and complex process ofCAR-T cell therapy, sufficient investment in new research and development iscurrently underway. Furthermore, since the number of countries and regions thatcan produce CAR-T cells is limited, there are concerns that Japan will face the issueof drug lag and drug loss from the perspective of manufacturing priorities.In order to improve this situation and develop regenerative medical productssustainably, it is important to build an ecosystem where more patients can receiveinnovative medical care. In formulating this white paper, we will deepen discussionswith experts on the medical economy, technology development of regenerativemedical products, and medical treatment, clarify the barriers to the practicalapplication of regenerative medical products and the formation of an ecosystemthat supports them, and publish this white paper as a proposal for solutions.The need to build an ecosystem for regenerative medicinal productsRegenerative medical products are groundbreaking technologies that offerinnovative treatments, but there are numerous challenges that need to be overcomefrom the research stage through to actual patient treatment. For example, duringthe research and development phase, it is necessary to address various issuesrelated to cell and tissue processing. Additionally, it is essential to establish aspecialized system for the stable supply of these products, one which requiresunique processes such as cell culture and handling. Once a stable supply system isestablished, these products must undergo evaluation by various regulatoryauthorities to ensure that they can be provided by medical institutions.To sustainably operate this entire process as an "ecosystem," it is essential toreinvest the outcomes from actual clinical practice, as well as the insights andrevenue gained, into the research, development, and manufacturing of the nextcycle. This enables the development of next-generation products. Ensuring thisecosystem cycle operates sustainably will make it more likely that innovativemedical treatments can be delivered to more patients, while simultaneously1 CAR-T cell therapy: A completely personalized treatment method in which T cells, a type of lymphocytefrom a patient, are collected and reprogrammed to have the function technology, and the cells areproliferated and administered to the patient himself.achieving growth of the sector and advancements in medical care.Benefits of establishing an ecosystem of regenerative medical productsBenefits for Japan's healthcare environmentProducing regenerative medical products domestically for Japanese patients canaddress global manufacturing and storage limitations, ensuring a sustainable supply.This will bring many benefits to patients and their families. Since a single dose canprovide a high therapeutic effect, it is expected that patients who have requiredlong-term hospitalization can return to society as soon as possible, improve theirquality of life, increase treatment options, and reduce physical, mental, andeconomic burdens. Moreover, it is expected to meet the current demand as well asthe therapeutic needs of various diseases such as autoimmune diseases in the future.Benefits for human resource activityThe spread of regenerative medical products can create a place for highly skilledhuman resources related to biotechnology in Japan to play an active role in thefields of R&D and manufacturing. It can alleviate the burden on healthcare workers,allowing them to focus on treating other diseases, and enable patients who havebeen cured of severe illnesses—and their families—to become active again,contributing immeasurably to society and the economy.Benefits for international competitivenessTechnologies related to regenerative medical products have the potential tobecome the foundation of Japan's biotechnology industry, leading to theacceleration of research and development starting in Japan. This is expected todevelop into opportunities for international leadership, expanding Japan's influencein Asia and globally.Actions and Policies Necessary for the Dissemination and Sustainability ofRegenerative Medical ProductsRecommendation 1:Reform of the pricing system and medical fee system to promote the spreadof regenerative medical productsJapan's healthcare insurance system operates on a principle of universal healthcoverage, providing an environment conducive to receiving advanced treatments.By keeping prices low, Japan facilitates rapid and extensive insurancereimbursement, whereas in Europe, high pricing set by companies often results indelayed reimbursement due to cost-effectiveness evaluations. However, settingprices too low could reduce the incentive for companies to invest in research anddevelopment, potentially leading to drug lags or losses. Implementing systemicreforms that reflect the innovation and characteristics of regenerative medicalproducts could position Japan as a global leader in this field, thereby delivering thebenefits of treatment to more patients.Ensuring sustainable access to regenerative medical products requirescomprehensive reform of the healthcare insurance system. First, it is necessary toreview pricing to properly assess innovation and reconsider market expansionrepricing 2 . Additionally, in order to utilize limited medical resources efficiently,strategies to reduce medical costs, such as curbing excessive medication usage andensuring appropriate use, should also be considered. Adequate reflection of the usability rating in the priceRegenerative medical products not only offer clinical value over long periods butare also a benefit to society by aiding patient reintegration into society and reducingthe burden on caregivers. It is important to consider how these contributions overan extended timeframe can be reflected in the form of adjustments to premiums2 Market expansion recalculation: A system to reduce drug prices for drugs whose annual sales value hasincreased relative to the expected sales amount set by the indications and effects at the time of drug pricelisting.within the healthcare insurance system. Furthermore, using this system as anincentive, it is necessary to promote the collection and analysis of real-world clinicaldata and reverse translational research 3 for verification. Revision of the application of the market expansion repricingRegenerative medical products undergo a complex and personalizedmanufacturing and distribution process, which requires a lot of money for highlyspecialized personnel, intellectual property, facilities and equipment, special qualitycontrol, transportation, and post-manufacturing operations. Additionally, theseproducts are individually manufactured for each patient, lacking economies of scale,and making cost reduction through mass production difficult.Applying market expansion repricing, which assumes economies of scale, couldseverely impact company revenues, and hinder continued patient access. Therefore,reviewing current market expansion repricing rules, which assume economies ofscale for conventional pharmaceuticals, is necessary. At the very least, establishinga mechanism that prevents excessive price reductions during scope expansionswould help maintain an environment where companies can supply innovativetreatments in a sustainable manner. Improvement of the medical fee system to properly reflect medicalcostsTo enable the sustainable provision of regenerative medical products, support forfacility investment and human resource development at medical institutions iscrucial. Thus, when setting reimbursement rates, it is necessary to evaluate thecosts of medical provision systems, including the personnel and facilities requiredfor the provision of regenerative medical products, sufficiently withinreimbursement rates. Additionally, it is important to incorporate systems that allowmedical institutions to recoup their investment in facilities and personnel.Recommendation 2:3 Reverse translational research: A research method that feeds back problems and questions observed inclinical practice to basic research and obtain new discoveries and findings.Review Ecosystem Challenges and Continue with Policies that will EnhanceNext-Generation CyclesTo develop an ecosystem for regenerative medical products, it is essential to makeongoing efforts to identify challenges, improve processes, and refine these. This willhelp enhance the next generation of medical technologies. While the governmentcurrently supports the establishment of research, development, manufacturing, andsupply systems for regenerative medical products, transient investments alonecannot sustain the ecosystem. To ensure Japan becomes a more attractive market,it is essential to balance regulatory system enhancement, reinvestment of profitsgained from initial cycles by private companies, and the further expansion ofgovernment investment funds from a bio-industry development perspective. Promote measures to strengthen stakeholder collaborationIn innovative technology development, it is crucial to introduce research findingsswiftly and efficiently to the market. Bridging research plays a vital role in thisprocess. The government and relevant ministries should promote policies thatfacilitate the transfer of university-originated technologies to startups and pushrapid product development.To ensure smoother provision of regenerative medical products, it is urgent tobuild systems and strengthen networks to link referring facilities with treatment-providing facilities more effectively. By enhancing collaboration among medicalinstitutions, clarifying the positioning of regenerative medical products in clinicalguidelines, and boosting incentives for patient referrals, a network should bedeveloped to ensure that patients requiring regenerative medical products receivetreatment quickly and appropriately.To improve patient awareness and ensure their access to treatment, patientorganizations, academic societies, medical institutions, and development companiesneed to collaborate in building forums for sharing and discussing the latestinformation on diseases and the various treatment options, includingimmunotherapy, and create comprehensive and easy-to-understand guidance.Furthermore, evidence derived from real-world clinical data should beaccumulated and fed back into next-generation research and development. Withthe participation of treatment-providing facilities, academia, developmentcompanies, and patients, it is important to verify the long-term value ofregenerative medical products and build the kind of foundations that will help ensuretheir further development. Continue to reduce costs and develop infrastructureThe manufacturing, quality control, and supply of regenerative medical productsremain in the early stages of refinement, with many processes relying on manuallabor by highly skilled personnel, resulting in high manufacturing costs. However,with technological advancements such as automation and robotics, future costreductions are anticipated, allowing more patients to benefit from new regenerativemedical treatment opportunities across various diseases.The government should aim to nurture highly specialized human resources,promote facility development, enhance supply chains, and establish a domesticecosystem, solidifying Japan's position as a base for expansion into Asian countries.This proposal is a compilation and presentation of opinions by the Healthcare andBusiness Creation Group of the Research and Consulting Division of the JapanResearch Institute, Inc., with a fair and equitable perspective in mind, based on thedesire to contribute to society from a medium- to long-term perspective.[Co-author]Kazumasa OguroProfessor, Faculty of Economics, Department of Economics, Hosei UniversityTakanori TeshimaProfessor, Department of Hematology, Hokkaido University Graduate School ofMedicineHiroshi NakamuraProfessor, Dean of the Graduate School of Business Administration, Keio UniversityYoshimi YashiroProfessor, Center for Translational Research Support Education, Fujita HealthUniversity[Sponsorship]Bristol-Myers Squibb K.K.. Bristol Myers Squibb - Bristol Myers Squibb※This article reflects the opinion of the author and does not represent the officialview of the JRI. Recommendations for "Creating a Sustainable Ecosystem for Innovative Regenerative Medical Products" Recommendations for "Creating a Sustainable Ecosystem for Innovative Regenerative Medical Products"(PDF:1,006 KB)	查看 14534	日本総合研究所	2025-08-08 06:35:25 2025-08-08 06:35:35	word
3236711	无图 <p>鹿児島県では線状降水帯が発生して、猛烈な雨が降り続くなど記録的な大雨となっていて、気象庁は午前5時に鹿児島県霧島市に大雨の特別警報を発表しました。</p><p>交通機関にも運転見合わせなどの影響が出ています。</p> <p> <p> JR九州鹿児島県通る在来線指宿枕崎線を除く全線運転取りやめ <p> <p>JR九州によります、大雨の影響で鹿児島県を通る在来線は指宿枕崎線を除くすべての路線で8日の始発から運転を取りやめています。</p><p>運転を取りやめているのは</p><p>▽鹿児島本線川内～鹿児島中央</p><p>▽日豊本線南宮崎～鹿児島中央</p><p>▽肥薩線吉松～隼人</p><p>▽吉都線吉松～都城</p><p>▽日南線田吉～志布志で、</p><p>いずれの路線もすべての区間で運転見合わせとなっています。</p> </p> </p> <p> 肥薩おれんじ鉄道熊本八代～鹿児島川内全線で運転見合わせ <p> <p>肥薩おれんじ鉄道によりますと、大雨の影響で、熊本県の八代駅と鹿児島県の川内駅の間の全線で上下線とも始発から運転を見合わせています。</p> </p> </p> <p> 九州自動車道鹿児島IC～栗野IC 上下線で通行止め <p> <p>西日本高速道路によりますと、九州自動車道は雨のため、鹿児島県の鹿児島インターチェンジと栗野インターチェンジの間の上下線で通行止めとなっています。</p> </p> </p> </p> 【交通影響】JR九州鹿児島県内の多くの在来線で運転取りやめ \| NHK \| 鹿児島県	查看 775	日本广播协会	2025-08-08 07:18:18 2025-08-08 06:35:18	word
3236710	无图 <p>鹿児島県霧島市は大雨特別警報が発表されたため、8日午前5時、市内全域の6万3139世帯12万2485人に「緊急安全確保」を出しました。</p> <p> <p> <p> <p>また、鹿児島市は、大雨の影響で河川が氾濫するおそれがあるとして、8日午前6時、市内の吉田地域を流れる思川の流域と、本名川の流域のあわせて328世帯643人に「緊急安全確保」を出しました。</p><p>5段階の警戒レベルのうち最も高いレベル5の情報で、近くの建物や自宅の2階以上、斜面から離れた場所など周囲の状況を確認し、少しでも安全な場所で命が助かる可能性の高い行動を取るよう呼びかけています。</p> </p> </p> <p> </p> </p> 鹿児島市内一部や霧島市全域に緊急安全確保命助かる行動を \| NHK \| 鹿児島県	查看 387	日本广播协会	2025-08-08 06:36:31 2025-08-08 06:35:18	word
3236709	无图 <p>鹿児島県霧島市に大雨の特別警報が発表されたことを受けて、気象庁と国土交通省は8日午前6時から会見を開きました。</p> <p> <p> <p> <p>このなかで気象庁の立原秀一予報課長は以下のように述べました。</p> </p> </p> <p> 「命の危険迫っている直ちに身の安全確保を」 <p> <p>「これまでに経験したことのないような大雨となっている。特に土砂災害警戒区域などでは何らかの災害がすでに発生している可能性が極めて高く、警戒レベル5に相当する。命の危険が迫っている。直ちに身の安全を確保して欲しい。浸水想定区域でも厳重な警戒が必要だ」</p><p>「少しでも沢や崖から離れた建物、浸水しにくい建物に移動するなど身の安全の確保をお願いしたい。今後、大雨の特別警報を発表する市町村が増える可能性がある。特別警報の発表を待ってから避難するのは手遅れになる。自分の命、大切な人の命を守るためにも避難に関する情報に直ちに従って身の安全を確保して欲しい」</p> </p> </p> <p> 「災害の危険度高い状態はしばらく続く」 <p> <p>「今夜にかけて前線の位置が変わらず、湿った空気が流れこみ続ける。九州では大雨への警戒が引き続き必要だ。鹿児島市の観測データをみると平年8月、1か月の雨量は220ミリで、今回はすでに24時間で500ミリ近くになっていて、気象の状況としては深刻だ」</p><p>「雨が弱まったとしても災害の危険度の高い状態はしばらく続く。雨が弱まったあとでも水位が高くなるおそれがあり、厳重な警戒を続けて欲しい。また、前線がかかっている西日本ではこのあと影響が広がる可能性がある。今後の情報には十分注意して欲しい」</p> </p> </p> <p> 「危機感が非常に高いという観点では昼過ぎまでと考えている」 <p> <p>立原課長は、発表されている特別警報の見通しについて問われ、「現在の見通しとしては、危機感が非常に高いという観点では昼過ぎまでと考えている。今後の雨の降り方や、危険度の高まりなどの推移を確認しながら、適切に状況を監視して情報を発表していきたい」と説明しました。</p> </p> </p> <p> 「ダムの容量に余裕があるうちに早めの避難を」 <p> <p>国土交通省島本和仁河川環境課長</p><p>鹿児島県の各地の川で氾濫危険水位を超えているとした上で、「すでに氾濫の危険度が高まっている河川では少しでも命を守るための行動を取って欲しい。これから氾濫の危険度が高まる見込みの川では、安全を確認しながら、早めの行動を取って欲しい。雨が弱まったとしてもこれまでに降った雨の影響で、水位の上昇が続く場合がある。九州南部では複数のダムで洪水調整を開始したので、ダムの容量に余裕があるうちに早めの避難をしてもらいたい」と説明しています。</p> </p> </p> </p> 気象庁と国土交通省が会見「災害危険度高い状態しばらく続く」鹿児島県霧島市に大雨特別警報 \| NHK \| 気象	查看 1433	日本广播协会	2025-08-08 07:02:21 2025-08-08 06:35:18	word
3236708	有图 <p>気象庁は8日午前5時、鹿児島県霧島市に大雨の特別警報を発表しました。</p><p>鹿児島県霧島市では、土砂崩れなどによる重大な災害がすでに発生している可能性が極めて高い状況です。</p><p>気象庁は、周囲の状況を確認し、避難場所までの移動が危険な場合には近くの頑丈な建物に移動したり、外に出るのがすでに危険な場合は建物の2階以上で崖や斜面と反対側の部屋に移動したりするなど、少しでも命が助かる可能性が高い行動を取るよう呼びかけています。</p> <p> <p> </p> 最新情報はNHKニュース・防災アプリで <p>雨雲レーダーなどお住まいの地域や現在地の最新の気象情報やニュースをご確認いただけます</p><p>ダウンロードはこちらから</p> <img src="https://www3.nhk.or.jp/news/html/20250808/K10014888351_2508080743_0808074408_02_03.jpg" rel="noopener noreferrer"> <p> <p> <p>特別警報は5段階の警戒レベルのうち最も高いレベル5にあたる情報で、土砂崩れや川の氾濫、浸水などによる重大な災害がすでに発生している可能性が極めて高い状況です。</p><p>何より安全な場所に避難して命を守ることが重要ですが、周辺にでるのはすでに危険な状況になっている可能性があります。</p><p>崖や川の近く、低い土地での警戒すべきポイントです。</p> </p> </p> <p> 崖や山の斜面の近くの場合 <img src="https://www3.nhk.or.jp/news/parts16/images/common/noimg_default.gif" rel="noopener noreferrer"> <p> <p>土砂災害の危険性が高まっています。</p><p>近くに崖や山の斜面はないでしょうか。</p><p>雨が強まっていない場合は離れた頑丈な建物に避難してください。</p><p>ただ、周囲がまだ暗い、浸水が始まっているなど危険な状況の場合は、近くや自宅の建物の少しでも高い階、さらに崖や斜面から離れた部屋に移動するなど少しでも安全な場所で身を守って下さい。</p> </p> </p> <p> 川の近くの場合 <img src="https://www3.nhk.or.jp/news/parts16/images/common/noimg_default.gif" rel="noopener noreferrer"> <p> <p>川の氾濫のおそれもあります。</p><p>川のすぐ近くにある家屋ではあふれた濁流に襲われると建物ごと壊される可能性があります。</p><p>離れた頑丈な建物の高い階へ避難することが何よりも重要です。</p><p>ただ、すでに浸水が始まっている場合は少しでも高い階へ移動し、助かる可能性の高い行動をとって下さい。</p> </p> </p> <p> 低い土地も注意を <p> <p>田んぼや畑の近くのほか、住宅地でも周囲より低い土地に住んでいる方も警戒が必要です。</p><p>急激に浸水の深さが増して被害に遭うおそれがあります。</p><p>見通しが悪い中で歩いて避難したり車で避難したりすると、側溝や用水路に落ちたり、車ごと流されたりする危険があり特に警戒が必要です。</p><p>見通しがよく浸水していない状況であればなるべく高い土地の安全な場所へ避難を、周囲の見通しが悪くすでに浸水が始まっているなど危険な状況であれば近くの高い建物の上の階に移動するなど、少しでも命の助かる可能性の高い方法をとるようにして下さい。</p> </p> </p> <p> 大雨の特別警報は昨年11月以来 <p> <p>大雨の特別警報が発表されたのは去年11月9日、鹿児島県の与論町に発表されて以来で、ことし初めてです。</p><p>鹿児島県では大雨特別警報が4年前の2021年7月に発表されています。</p> </p> </p> </p> 鹿児島霧島市に大雨特別警報命が助かる可能性が高い行動を \| NHK \| 鹿児島県	查看 2080	日本广播协会	2025-08-08 05:10:09 2025-08-08 06:35:18	word
3236707	有图 <p>前線に向かって暖かく湿った空気が流れ込み、鹿児島県では線状降水帯が発生して、猛烈な雨が降り続くなど記録的な大雨となっていて、大雨の特別警報が発表されています。</p><p>5段階の警戒レベルのうち最も高いレベル5にあたる情報で、最大級の警戒を続け、少しでも命が助かる可能性が高い行動をとってください。</p> <p> <p> </p> 最新情報はNHKニュース・防災アプリで <p>雨雲レーダーや気温などお住まいの地域や現在地の最新の気象情報やニュースをご確認いただけます</p><p>ダウンロードはこちらから</p> <img src="https://www3.nhk.or.jp/news/html/20250807/K10014888161_2508072207_0807220738_02_03.jpg" rel="noopener noreferrer"> <p> </p> <p> <p> <p>気象庁によりますと、低気圧からのびる前線に向かって暖かく湿った空気が流れ込んでいる影響で、鹿児島県ではきょう午前1時過ぎと午前5時前に線状降水帯が発生して「顕著な大雨に関する情報」が発表されるなど猛烈な雨が降り続き、記録的な大雨となっています。</p><p>これまでに経験したことのないような大雨になっているとして、気象庁は午前5時、鹿児島県の霧島市に大雨の特別警報を発表しました。</p><p>5段階の警戒レベルのうち最も高いレベル5にあたる情報で少しでも命が助かる可能性が高い行動をとってください。</p> </p> </p> <p> <p> <p>【鹿児島県内の雨】</p><p>▽午前5時までの1時間に姶良市で107ミリの猛烈な雨（県設置の雨量計）</p><p>▽午前7時までの1時間に鹿児島市で37ミリの激しい雨（国土交通省設置の雨量計）</p><p>【午前6時ごろまでの12時間に降った雨の量】</p><p>▽鹿児島県霧島市福山で495ミリ</p><p>統計を取り始めてから最も多くなり、平年8月の1か月分の1.5倍を超える雨がわずか半日で降っています。</p> </p> </p> <p> 宮崎新潟山形秋田青森でも土砂災害警戒情報 <p> <p>これまでに降った雨で鹿児島県と宮崎県、新潟県、山形県、秋田県、それに青森県では土砂災害の危険性が非常に高くなっているとして土砂災害警戒情報が発表されている地域があります。</p> </p> </p> <p> 今後の雨の予想は <p> <p>前線はこのあとも九州付近に停滞するため、九州南部と九州北部では10日にかけて雷を伴って非常に激しい雨が降るおそれがあります。</p><p>あす朝までの24時間に降る雨の量は、九州南部で200ミリ、九州北部で120ミリと予想されています。</p><p>特に宮崎県と奄美地方を除く鹿児島県では、8日昼前にかけて線状降水帯が発生して災害の危険度が急激に高まる可能性があります。</p><p>そのあとも前線は九州付近に停滞して雨が降り続き雨量が増える見込みで、九州南部と九州北部では10日朝までの24時間にさらに150ミリの雨が降ると予想されています。</p> </p> </p> <p> 命が助かる可能性が高い行動を <p> <p>鹿児島県では重大な災害がすでに発生している可能性が極めて高く、最大級警戒して、少しでも命が助かる可能性が高い行動をとってください。</p><p>このほか、宮崎県などでも雨量が多くなっていて、土砂災害や川の氾濫低い土地の浸水に厳重に警戒が必要です。</p> </p> </p> <p> 【動画】記者解説現在の雨の状況警戒のポイントは (5分18秒) <p> <p>8月8日のおはよう日本で放送した内容です。</p><p>※データ放送ではご覧いただけません。</p> </p> </p> <p> 鹿児島霧島市内各地で浸水や倒木の情報 <p> <p>大雨の特別警報が出された鹿児島県霧島市によりますと、市内各地から浸水や倒木などの情報が相次いでいて寄せられていて情報収集にあたっているということです。</p> </p> </p> <p> 道路の一部水につかっている様子も <p> <p>鹿児島県の霧島市国分名波町で8日午前4時すぎに撮影された映像です。</p><p>大雨により道路の一部が水につかっています。トラックが走るとたまった水が波立つ様子が確認できます。</p> </p> <img src="https://www3.nhk.or.jp/news/parts16/images/common/noimg_default.gif" rel="noopener noreferrer"> </p> <p> <p> <p>また、近くで撮影された別の映像は、住宅と隣の住宅の間を流れる水路の様子を写したもので、水が茶色に濁り、水かさが増している様子がわかります。</p> </p> <img src="https://www3.nhk.or.jp/news/parts16/images/common/noimg_default.gif" rel="noopener noreferrer"> </p> <p> <p> <p>撮影したのはいずれも近くに住む70代の男性で、「目の前の道路を車が走るとたまった雨が波立ち自宅の一部にまで水が入ってきているので、自宅が浸水しないか心配だ。30年近くこの場所に住んでいるが、これほどの大雨は初めてで不安だ」と話しました。</p> </p> </p> <p> 鹿児島姶良市で複数住宅が床下浸水の情報 <p> <p>鹿児島県姶良市の危機管理課によりますと、姶良市平松で複数の住宅が床下浸水しているという情報があるということです。市は引き続き情報収集を進めています。</p> </p> </p> <p> </p> <p> </p> </p> 鹿児島霧島に大雨特別警報線状降水帯が発生最大級の警戒を \| NHK \| 気象	查看 3179	日本广播协会	2025-08-08 07:59:58 2025-08-08 06:35:18	word
3236706	有图 <p>赤澤経済再生担当大臣は訪問先のワシントンで先の日米合意の内容が反映されずに一律15％の関税が上乗せされる状況になっていることについて、アメリカの閣僚と会談した結果、アメリカ側から、大統領令を適時修正する措置をとると説明があったと明らかにしました。</p><p>また同じタイミングで自動車などの関税を下げるための大統領令を発出することも確認したと説明しました。</p> <p> <p> <p> <p>赤澤経済再生担当大臣は訪問先のワシントンで「相互関税に関するアメリカ側の内部の事務処理で日米間の合意に沿っていない内容の大統領令が発出され、適用が開始されたことは極めて遺憾だ」と述べました。</p><p>また、「アメリカ側の閣僚からも今回のアメリカ側の手続きは遺憾だったという認識の表明があった」と話しました。</p><p>さらに、「アメリカ側から、今後、適時に大統領令を修正する措置をとる際には今月7日以降に徴収された相互関税のうち日米間の合意内容を上回る部分については7日にさかのぼって払い戻す『遡及効』にしたいという説明があった」と述べました。</p><p>大統領令の修正措置が講じられる時期については、「アメリカ側の内部の事務処理ということなので、アメリカ側が判断することだが一般的な理解として遡及する効果がついたまま半年や1年ということは当然ない。常識的な範囲でアメリカ側が対応すると理解している」としています。</p> </p> </p> <p> 赤澤経済再生相商務長官らと会談修正申し入れ <p> <p>アメリカのトランプ政権は日本時間の7日、世界の国や地域に対する新たな関税率を適用しましたが、日本にとっては先の日米合意の内容が反映されずに一律15％の関税が上乗せされる状況になっています。</p><p>こうした中、赤澤経済再生担当大臣は、訪問先のワシントンで日本時間の7日夜から8日未明にかけてアメリカ商務省でラトニック商務長官とおよそ3時間、8日朝にはアメリカ財務省でベッセント財務長官とおよそ30分間、会談しました。</p><p>一連の会談で双方は先の日米合意に基づき両国の利益となるような取り組みを着実に進めていく重要性を確認しました。</p><p>その上で赤澤大臣は相互関税についての合意内容を改めて確認し、合意に基づき、可及的速やかに大統領令を修正する措置をとるよう強く申し入れました。</p><p>さらに自動車など関税を引き下げる大統領令も発出するよう強く求めました。</p> </p> </p> <p> 日米合意の内容反映されず早期修正焦点に <img src="https://www3.nhk.or.jp/news/parts16/images/common/noimg_default.gif" rel="noopener noreferrer"> <p> <p>アメリカのトランプ政権は、日本時間の7日、世界の国や地域に対する新たな関税率を適用しました。</p><p>日本にとっては、先の日米合意の内容が反映されずに一律15％の関税が上乗せされる状況になっていて、合意内容に基づいた修正が早期に図られるかが大きな焦点になります。</p><p>アメリカは、先月31日の大統領令に基づいて、日本時間の7日午後、世界各国や地域への新たな関税率を適用し、日本の関税率は15％とされました。</p><p>これについて日本政府は、先の日米合意のあと、</p><p>▽従来の税率が15％未満の品目は税率が一律15％に引き上げられ、</p><p>▽従来の税率が15％以上の品目は新たな関税が上乗せされず、これまでの税率が維持される</p><p>などと説明していました。</p><p>しかし、アメリカの大統領令などにこうした記載はなく、従来の税率に一律で15％上乗せされる状況になっています。</p><p>たとえば牛肉の場合、元の26.4％になる見込みだった関税率が41.4％に引き上げられるなど、一部の品目で影響が大きくなるおそれがあります。</p><p>石破総理大臣は、7日夜、記者団に対し、「訪米中の赤澤経済再生担当大臣が、アメリカ側との間で合意の内容を改めて確認し、すでに適用が開始された大統領令を修正する措置を直ちにとるよう強く求めている」と述べ、閣僚レベルを含めあらゆる形で働きかける考えを示しました。</p><p>政府関係者からは、「アメリカの閣僚の間で、日本への関税率をめぐって認識のずれがあった可能性がある」といった声も出ていて、合意内容に基づいた修正が早期に図られるかが大きな焦点になります。</p> </p> </p> </p> 赤澤経済再生相関税措置めぐる大統領令 “適時修正と説明あった” 自動車関税も \| NHK \| 関税	查看 2094	日本广播协会	2025-08-08 08:35:29 2025-08-08 06:35:18	word
3236705	有图 <p>前線に向かって暖かく湿った空気が流れ込み、鹿児島県では線状降水帯が発生して、猛烈な雨が降り続くなど記録的な大雨となっていて、気象庁は8日午前5時に鹿児島県霧島市に大雨の特別警報を発表しました。</p><p>鹿児島県内では、浸水が相次いでいます。</p> <p> <p> 目次 <p>姶良市川に車が転落</p> <p>川の水住宅地に流れ込む</p> <p> <p>西佐多町を流れる思川の水あふれる</p> <p>《住宅の浸水も》</p> </p> 目次を開く </p> <p> 目次<img src="https://www3.nhk.or.jp/news/parts16/images/common/icon-toc-01.svg" rel="noopener noreferrer"> <p> <p>目次</p> <p> <p>姶良市川に車が転落</p> <p>川の水住宅地に流れ込む</p> <p>西佐多町を流れる思川の水あふれる</p> <p>《住宅の浸水も》</p> </p> <p> </p> <i></i> </p> </p> 鹿児島霧島に大雨特別警報最新情報はNHKニュース・防災アプリで <p>雨雲レーダーなどお住まいの地域や現在地の最新の気象情報やニュースをご確認いただけます</p><p>ダウンロードはこちらから</p> <img src="https://www3.nhk.or.jp/news/html/20250808/K10014888411_2508080746_0808075316_02_04.jpg" rel="noopener noreferrer"> <p> 姶良市川に車が転落 <img src="https://www3.nhk.or.jp/news/parts16/images/common/noimg_default.gif" rel="noopener noreferrer"> <p> <p>鹿児島県姶良市加治木町港町の網掛川の近くで8日午前5時半すぎに撮影された映像です。</p><p>茶色く濁った水が勢いよく流れる川に赤いランプが付いた黒い車が転落しています。</p><p>午前7時前に同じ場所で撮影された別の画像では、黒い車のほかにカーブミラーも川に落ちているように見えます。</p><p>堤防や道路の一部がなくなっている様子も写っています。</p><p>撮影した近くに住む55歳の男性によりますと、転落した黒い車には人が乗っているようには見えなかったということで、「車が落ちた場所は高さ150センチくらいのコンクリートの堤防があり、水の流れで堤防がえぐられたのだと思います。この場所に住んで20数年になりますが、こんな状況は初めてです」と話していました。</p> </p> </p> <p> 川の水住宅地に流れ込む <img src="https://www3.nhk.or.jp/news/parts16/images/common/noimg_default.gif" rel="noopener noreferrer"> <p> <p>鹿児島県姶良市平松で8日午前5時半ごろに撮影された映像です。</p><p>茶色く濁った川の水が道路や住宅地に流れ込んでいる様子が確認できます。</p><p>撮影した近くに住む60代の男性は「昨夜から激しい雨と雷で消防の呼びかけで避難した。ものが流れてきて橋桁にあたり大きな音がして恐怖を感じる」と話しました。</p> </p> </p> <p> 西佐多町を流れる思川の水あふれる <img src="https://www3.nhk.or.jp/news/parts16/images/common/noimg_default.gif" rel="noopener noreferrer"> <p> <p>鹿児島県が提供している河川カメラの映像では、午前5時ごろから水かさが上がり、川の脇の道路まで水があふれているのがわかります。</p><p>また、川沿いの道路は一面、茶色く濁った水がたまり、通行できなくなっています。</p> </p> </p> <p> 道路や駐車場茶色く濁った水につかる <img src="https://www3.nhk.or.jp/news/parts16/images/common/noimg_default.gif" rel="noopener noreferrer"> <p> <p>8日午前6時すぎ、鹿児島県の霧島市国分府中町で撮影された映像です。</p><p>道路や駐車場が茶色く濁った水につかる様子、それに用水路から水があふれている様子がわかります。</p><p>撮影した近くに住む40代の男性によりますと、「きのうの夜ごろから雨が降り続き、道路と用水路の境が分からなくなるほど雨が降っていて、近くの小学校に家族で避難しました。ここまで降ったのは初めてでかなりびっくりしました」と話していました。</p> </p> </p> <p> 道路の一部水につかっている様子も <p> <p>鹿児島県の霧島市国分名波町で午前4時すぎに撮影された映像です。</p><p>大雨により道路の一部が水につかっています。</p><p>また、近くで撮影された別の映像は、住宅と隣の住宅の間を流れる水路の様子を写したもので、水が茶色に濁り、水かさが増している様子がわかります。</p> </p> </p> <p> <img src="https://www3.nhk.or.jp/news/parts16/images/common/noimg_default.gif" rel="noopener noreferrer"> <p> <p>撮影したのはいずれも近くに住む70代の男性で、「目の前の道路を車が走るとたまった雨が波立ち自宅の一部にまで水が入ってきているので、自宅が浸水しないか心配だ。30年近くこの場所に住んでいるが、これほどの大雨は初めてで不安だ」と話しました。</p> </p> </p> <p> 《住宅の浸水も》 </p> <p> 霧島市床上・床下浸水の情報数件ずつ <p> <p>霧島市によりますと、午前6時40分時点で床上浸水や床下浸水の情報がそれぞれ数件ずつ寄せられているということです。また、霧島市役所前の道路が冠水しているということです。</p> </p> </p> <p> 薩摩川内市住宅1棟が床上浸水 <p> <p>鹿児島県薩摩川内市によりますと、避難指示が出されている祁答院地区では住宅1棟が床上浸水したということです。</p><p>この住宅に住む人は親戚の家に避難して無事だということで、市は、状況の確認を進めています。</p> </p> </p> <p> 曽於市複数の床下浸水の連絡 <p> <p>鹿児島県曽於市によりますと、曽於市役所大隅支所の周辺で床下浸水の連絡が複数寄せられているということです。市が状況の確認を進めています。</p> </p> </p> </p> 【大雨特別警報】鹿児島県で浸水相次ぐ各地の被害状況は \| NHK \| 気象	查看 4035	日本广播协会	2025-08-08 08:21:52 2025-08-08 06:35:18	word
3236704	无图 <p>■ Selected as Aeva’s supplier for an ultra-slim, ultra-long-range 4D LiDAR</p><p>■ Joint development of LiDAR for autonomous driving car?robots?industrial automation, along with the anticipated acquisition of 6.0% equity stake in Aeva</p><p>■ Announcement of cooperation roadmap at ‘Aeva Day’ event</p><p>LG Innotek has teamed up with Aeva, an American company specializing in LiDAR(Light Detection And Ranging) technology, to preempt the LiDAR market.</p><p>LG Innotek announced on July 29, 2025, the signing of a strategic partnership outlining the strategic supply and joint development of next-generation LiDAR technology.</p><p>Aeva developed the world’s first 4D LiDAR based on the frequency modulated continuous wave (FMCW) technology, which offers advanced long-range object-sensing capabilities. A leader in LiDAR technology, Aeva has gained prominence in the autonomous driving market. It has been producing 4D LiDAR since 2022 and currently counts major automakers such as Daimler Truck among its customers.</p><p>LG Innotek’s partnership with Aeva, which will result in a strategic collaboration and LiDAR supply agreement, will put the company’s LiDAR business on track and give it a competitive edge in taking the lead of the blossoming LiDAR market.</p><p>According to the industry, global LiDAR market is expected to grow from USD 2.4 billion in 2024 to USD 15.4 billion, at least at an average annual growth rate of 36% through 2030.</p><p>■ Selected as Aeva’s supplier for an ultra-slim, ultra-long-range 4D LiDAR</p><p>The first product that LG Innotek will manufacture and supply to Aeva is an ultra-slim, ultra-long-range FMCW LiDAR module that can detect objects up to 500 meters away.</p><p>This product is based on FMCW, which is considered the most advanced technology in the LiDAR industry, and accurately measures not only the distance but also the speed of moving objects, unlike conventional time-of-flight (ToF) LiDAR.</p><p>Compared to conventional LiDAR, which is typically mounted on the roof of a vehicle, this product offers automotive customers greater design freedom as it was developed to be mounted behind the front windshield of the vehicle. To achieve this, the size of the LiDAR module was reduced by 44% compared to existing LiDAR products.</p><p>The LiDAR module LG Innotek supplies will be combined with Aeva’s own software as a solution to be supplied to OEM car makers.</p><p>■ Joint development of LiDAR for autonomous driving car?robots?industrial automation, along with the anticipated acquisition of 6.0% equity stake in Aeva</p><p>As part of the strategic partnership, LG Innotek and Aeva have also signed a joint development agreement (JDA) for next-generation LiDAR.</p><p>Under the agreement, the two companies will jointly develop by the end of 2027, FMCW LiDAR for autonomous driving car, for a wide range of mobility applications including robots, robo-taxis, and also for industrial automation.</p><p>For its strategic and continued collaboration with Aeva, LG Innotek is planning to invest up to approximately USD 50 million in LiDAR business, including the anticipated acquisition of 6.0% stake in Aeva’s total equity.</p><p>Soroush SALEHIAN, CEO of Aeva said, “Our joint strategic collaboration underscores the growing recognition of FMCW as the future of sensing and perception technology. Together with LG Innotek, we see a tremendous opportunity to bring Aeva’s perception platform to a wide range of applications—wherever machines need to perceive and understand their surroundings.”</p><p>Hyuksoo MOON, CEO of LG Innotek said, “The ultimate goal of this partnership is for LG Innotek and Aeva to grow together as key players leading the next-generation LiDAR market through a long-term technology partnership that goes beyond the supply of products.” He went on to add, “Starting with this collaboration with Aeva, LG Innotek will continue to expand its LiDAR product lineup, which delivers differentiated customer value, and further solidify its position in the global market as a total mobility solution provider for the future.”</p><p>■ Announcement of cooperation roadmap at ‘Aeva Day’ event</p><p>LG Innotek will participate in ‘Aeva Day’ event held in New York on July 31(EDT), to announce the roadmap for its strategic partnership with Aeva.</p><p>The event will be attended by key executives from both companies. For LG Innotek, these include CEO Hyuksoo MOON; CTO and Executive Vice President S. David ROH; and John MIN, senior vice president and head of the LiDAR Business Division. For Aeva Technologies, there will be Co-founders CEO Soroush SALEHIAN and CTO Mina REZK, along with around 100 participants from the global automotive and electronic components industries and investors.</p><p>CEO MOON will participate as the keynote speaker at the event. Additionally, a fireside chat will follow with CTOs from both companies to discuss the significance of the partnership, technical collaboration and strategies for maximizing synergy between the two companies.</p><p>[Terminology] Frequency modulated continuous wave (FMCW): FMCW technology continuously emits laser signals to precisely measure the distance and size of objects. In addition, by leveraging the Doppler effect, it can also accurately detect the speed and direction of moving objects. Compared to conventional ToF LiDAR technology, it is more resistant to light interference and performs better in harsh weather conditions, leading to an increasing number of autonomous driving companies adopting it.</p> LG Innotek Teams Up with U.S. LiDAR Company Aeva in Preparation to Preempt the Market	查看 5551	LG集团	2025-08-07 08:00:00 2025-08-08 06:24:16	word
3236703	无图 <p>SEOUL, Korea (August 7, 2025) – LG Display, the world’s leading innovator of display technologies, announced today its participation in K-Display 2025 at COEX in Seoul for three days from Aug. 7, as the company is showcasing innovative technologies and products ranging from large, medium, and small-sized panels to automotive displays.</p><p>LG Display is presenting OLED innovations and display solutions that bridge the present and future under the theme, “Shaping the Future.”</p><p>In particular, the exhibition features an experience Zone where visitors can directly encounter the world"s first and best technologies, enhancing their understanding of LG Display’s capabilities.</p><p>The OLED Heritage exhibition space allows visitors to see at a glance the technological leadership LG Display has achieved since becoming the first in the world to successfully mass-produce large-sized OLED panels.</p><p>This journey covers the company"s 15-inch OLED panel prototype from 2009, which laid the foundation for OLED TV panels, as well as a Tandem OLED panel with a two-layer structure, the deuterium atom structure of second-generation OLED, the Micro Lens Array (MLA) technology of third-generation OLED, and the Primary RGB Tandem structure of fourth-generation OLED. All are presented so that visitors can more intuitively understand OLED technology.</p><p>At the booth"s entrance, visitors witness LG Display’s 83-inch OLED panel featuring fourth-generation OLED technology, which was newly unveiled by the company this year. Fourth-generation OLED achieves a maximum brightness of 4,000 nits based on the industry"s first Primary RGB Tandem technology, which stacks the three primary colors of light (red, green, and blue) as independent layers.</p><p>LG Display is demonstrating a comparison of the previous generation"s picture quality with that of fourth-generation OLED panels using ultra-large-sized panels, highlighting the incredible three-dimensionality and rich color reproduction of its latest technology.</p><p>In addition, it is unveiling the world"s fastest OLED monitor panel for the first time. LG Display"s 540Hz 27-inch OLED panel (QHD) applies Dynamic Frequency & Resolution (DFR) technology to achieve an ultra-high refresh rate of up to 720Hz (HD) depending on the user"s needs. Combined with fourth-generation OLED technology, it boasts the highest level of picture quality among OLED monitor panels, with 99.5% DCI-P3 color reproduction and a maximum brightness of 1,500 nits.</p><p>Also on show is a 45-inch 5K2K (5120×2160) OLED panel, which boasts the world"s highest resolution among existing OLED monitor panels. Visitors are able to play games using this panel and thereby discover the difference refresh rates make to gaming.</p><p>Those in attendance additionally have the chance to experience LG Display"s various automotive display technologies and products in an auto cockpit with a living space concept that facilitates fully autonomous mobility beyond software-defined vehicles (SDVs).</p><p>The 57-inch Pillar-to-Pillar LCD at the center of the cockpit is the largest automotive display currently available, providing information and entertainment functions as desired through its natural curved screen. There is also a 32.6-inch Slidable OLED for vehicles, which unfolds downward when needed, as well as an ultra-bright 29-inch Outdoor LCD, which can be used for both advertising and communication with the world outside the vehicle.</p><p>Moreover, LG Display is exhibiting a 47.8-inch LTPS LCD equipped with Switchable Privacy Mode (SPM) technology, allowing the screen in front of the passenger seat to be adjusted so that it is not visible from the driver"s seat. The company is also introducing the world’s first jog dial for vehicles that utilizes a Stretchable display that can stretch up to 53%. This innovative product maintains a smooth and flat form when not in use, but when a button is touched, it stretches to form a jog dial.</p><p>Additionally, there is a 14-inch Tandem ATO featuring LG Display’s Tandem structure for the first time in the industry, offering both high brightness with low power consumption while also enabling a thin and lightweight design with a single glass substrate structure. A 14.5-inch LCD unveiled alongside it uses advanced Oxide TFT and low-power backlight technology to maximize battery life, providing an optimized display solution for the AI era"s significantly higher power consumption.</p><p>“The LG Display-led technological evolution of OLED is changing the paradigm of displays,” said an official at LG Display. The official added, “We will secure sustainable technological competitiveness and provide differentiated customer value by not only bringing commercial technologies to maturity but also solidly preparing R&D capabilities for future technologies.”</p> LG Display presents world’s best OLED technologies alongside historic firsts at K-Display 2025	查看 4871	LG集团	2025-08-07 08:00:00 2025-08-08 06:24:16	word
3236702	无图 <p>DILI, 06 August 2025 (TATOLI) – President José Ramos-Horta welcomed Australia’s Minister for International Development, Anne Aly, at the Nicolau Lobato Presidential Palace on Wednesday, reaffirming the strong and growing partnership between Timor-Leste and Australia.</p><p>The meeting highlighted the enduring partnership between Timor-Leste and Australia, with discussions focused on shared development goals, economic collaboration, and Timor-Leste’s imminent accession to ASEAN.</p><p>Aly’s visit coincides with the Timor-Leste–Australia Economic and Business Conference (TLAUCON 2025), taking place from August 6–8 at the Dili Convention Center. Co-hosted by the Governments of Timor-Leste and Australia, aims to strengthen economic ties by promoting investment in key sectors, including agriculture, tourism, manufacturing, and mineral resources.</p><p>President Ramos-Horta expressed gratitude for Australia’s steadfast support, saying: “Australia has been a steadfast partner in Timor-Leste’s journey toward stability and prosperity. As we prepare to join ASEAN, we value the continued cooperation in trade, investment, and people-to-people ties that will drive sustainable growth for both our nations.”</p><p>Australia and Timor-Leste share a long-standing friendship, strengthened by strong people-to-people connections.</p><p>Since Timor-Leste’s independence in 2002, Australia has remained its largest development and security partner, the two nations are actively pursuing cooperation in various sectors, including Development, Economic diversification, the Pacific Australia Labour Mobility (PALM) scheme, major infrastructure projects, Education, Security and Defence, People to people connections, Support for Timor-Leste’s WTO membership and ASEAN accession</p><p>Journalist: Camilio de Sousa</p><p>Editor: Filomeno Martins</p> President Ramos-Horta Welcomes Australian Minister For International Development, Strengthening Bilateral Ties - TATOLI Agência Noticiosa de Timor-Leste	查看 1847	塔托利新闻社	2025-08-06 15:47:07 2025-08-08 06:12:12	word
3236701	无图 <p>DILI, 06 August 2025 (TATOLI) — President José Ramos-Horta has called for deeper economic cooperation between Timor-Leste and Australia during his opening remarks at the 2nd Timor-Leste–Australia Economic and Business Conference (TLAUCON2025), held in Dili from 6 to 8 August 2025.</p><p>Speaking to government officials, diplomats, business leaders, and development partners, President Ramos-Horta highlighted the importance of strengthening the Timor-Leste–Australia partnership through investment and trade.</p><p>“We share commitment to upscale Timor-Leste/Australia partnership through meaningful economic cooperation,” he said.</p><p>He expressed appreciation to both governments and the Chamber of Commerce and Industry Timor-Leste for organizing the conference for the second time, noting its significance in boosting bilateral ties: “Profuse appreciation is due to the Governments of Timor-Leste and Australia, Chamber of Commerce and Industry Timor-Leste, the TL/Australia Economic and Business Conference for hosting this gathering for the second time. We look forward to making it an annual milestone in our bilateral relations.”</p><p>Describing the event as more than a business gathering, the President emphasized the growing friendship between the two nations.</p><p>“Timor-Leste–Australia Economic & Business Conference 2025 is more than just a conference; it’s a bridge between our two nations. By coming together, we are strengthening our friendship, deepening our cooperation, and building a shared future of economic growth and development.”</p><p>He said Timor-Leste is entering a new stage of development, with a strong focus on economic diversification and regional integration. This includes the country’s accession to the World Trade Organization (WTO) in 2024 and its upcoming ASEAN membership in October 2025.</p><p>“Timor-Leste is entering a new phase in its development. With a renewed commitment to economic diversification and regional integration, we are preparing our nation to become a competitive player in Southeast Asia,” he said. “Our progress toward ASEAN membership in October 2025 and our WTO accession in 2024 reflects this vision, and opens up new horizons for trade, investment, and innovation.”</p><p>Ramos-Horta also mentioned the government’s efforts to improve the business environment through reforms that aim to make the country more transparent, efficient, and investor-friendly.</p><p>“We are actively investing in key sectors with high potential: Agriculture, Tourism, Manufacturing, and Natural Resources,” he added. “At the same time, we are implementing reforms to make ‘doing business’ in Timor-Leste more transparent, efficient, and investor-friendly.”</p><p>The President acknowledged Australia’s continued support since Timor-Leste’s independence, underlining the importance of long-term cooperation: “Today, we continue that partnership through trade, investment, innovation, and our shared commitment to sustainable and inclusive growth.”</p><p>“To the Australian business leaders and investors present today: Timor-Leste is open for business. We offer a young, motivated workforce, a growing regional outlook, and the opportunity to be part of our nation’s transformation story,” he said.</p><p>He invited Australian investors to explore the many opportunities in Timor-Leste and to partner with local businesses in shaping a resilient and prosperous future.</p><p>“Let this conference be a space for building relationships, forging agreements, and sharing ideas that will lead to meaningful and lasting change,” he said. </p><p>The three-day TLAUCON2025 conference brings together public and private sector leaders to discuss ways to boost trade, investment, and sustainable development across key sectors in Timor-Leste.</p><p>TATOLI</p> TLAUCON2025: Ramos-Horta Calls for Stronger Business Ties - TATOLI Agência Noticiosa de Timor-Leste	查看 3810	塔托利新闻社	2025-08-06 21:53:50 2025-08-08 06:12:12	word
3236700	无图 <p>DILI, 07 August 2025 (TATOLI) — Timor-Leste will host an international peace seminar in August 2026, bringing together Nobel Peace Prize laureates from around the world. </p><p>Spearheaded by President Jose Ramos-Horta, the event aims to reinforce Timor-Leste’s commitment to global peace and dialogue.</p><p>The initiative builds on the success of previous international forums and aims to consolidate the country’s role as a center for peaceful dialogue.</p><p>President Ramos-Horta, a Nobel Peace Prize laureate himself, will personally invite fellow Nobel winners, using his global influence to attract leading voices in peacebuilding, science, and human rights to the country.</p><p>During a productive meeting on Wednesday at the Presidential Palace, President Ramos-Horta assigned the Ministry of Higher Education, Science, and Culture, José Honório, to lead the preparations for the high-profile seminar.</p><p>This landmark seminar will be the result of a collaboration between the Presidency of the Republic and the Government, with the Civil House working in close coordination with Minister José Honório’s team to ensure its success.</p><p>A formal commission will be established, tasked with coordinating the logistical preparations for the 2026 event.</p><p>The event will be one of the cornerstones of the President’s vision to position Timor-Leste as a proactive contributor to peace and understanding on the international stage. </p><p>By bringing together experts in science, peace, and human rights, the seminar will address pressing global issues while also highlighting Timor-Leste’s unique journey and its enduring dedication to the principles of the Nobel Peace Prize. </p><p>Journalist: Camilio de Sousa</p><p>Editor: Filomeno Martins</p> Timor-Leste to Host Global Peace Seminar in 2026 - TATOLI Agência Noticiosa de Timor-Leste	查看 1765	塔托利新闻社	2025-08-07 09:17:01 2025-08-08 06:12:12	word
3236699	无图 <p>DILI, 07 August 2025 — (TATOLI) – Dili Municipality Health Service (SSMD) reported 181 dengue cases in the second quarter of 2025, bringing the total number of infections to 448 since the beginning of the year.</p><p>SSMD Director Mateus Pinto said that of the 181 dengue cases reported in the second quarter, 64 were recorded in April, 56 in May, and 61 in June.</p><p>Most of the patients were children aged 5 to 15 years, and cases were mainly reported in Vera Cruz, Cristo Rei, Nain Feto, and Dom Aleixo administrative posts.</p><p>To fight the spread of dengue, Pinto announced that the Wolbachia Method will be launched on 8 August in Dili. On 11 August, capsules containing Wolbachia-infected mosquito eggs will be released in high-risk areas.</p><p>The program is a joint effort between the Ministry of Health, Menzies School of Health Research, and the World Mosquito Program, with a team of 500 people, including 34 field workers assigned to release the mosquitoes in targeted communities.</p><p>“This program is supported by Australia’s Department of Foreign Affairs and Trade (DFAT),” said Maria Gama, the Menzies program coordinator. “Every two weeks, we send around 18,000 eggs to Monash University in Australia for analysis.”</p><p>Wolbachia is a naturally occurring bacterium found in about 60% of insect species, including fruit flies, dragonflies, and moths. It is harmless to humans. When Aedes aegypti mosquitoes carry Wolbachia, it blocks the transmission of the dengue virus.</p><p>The method involves releasing lab-bred mosquito eggs containing Wolbachia into affected areas. When these mosquitoes hatch and reproduce, the bacterium is passed on to future generations, gradually reducing the mosquitoes’ ability to spread dengue.</p><p>In 2022, Timor-Leste sent Aedes aegypti mosquitoes to Australia for the first time to breed them with Wolbachia-infected females, as part of a strategy to help control dengue in the country.</p><p>Journalist: Ivonia da Silva</p><p>Editor: Isaura Lemos de Deus</p><p>Translaiton: Camilio de Sousa</p> Dili Reports 181 Dengue Cases in Q2 - Timor-Leste to Launch Wolbachia Program - TATOLI Agência Noticiosa de Timor-Leste	查看 2061	塔托利新闻社	2025-08-07 09:35:26 2025-08-08 06:12:12	word
3236698	无图 <p>By: Dionisio Babo Soares</p><p>The dispute over Judge Carmona’s eligibility erupted this year (2025), swiftly exposing a yawning gap in Timor-Leste’s constitutional architecture. This controversy over the appointment of Judge Afonso Carmona as President of Timor-Leste’s Court of Appeal crystallizes fundamental questions about the balance between executive prerogative and judicial independence. At its heart lies the constitutional amendment embodied in Article 2 of Law No. 4/2025, which expanded the pool of eligible candidates for the Court of Appeal presidency to include ordinary judges, rather than reserving that office exclusively for members of the Supreme Court. The Court of Appeal’s July 31, 2025, ruling that this amendment exceeded constitutional limits has generated a fierce debate over the proper contours of separation of powers and the mechanisms through which the Constitution of the Democratic Republic of Timor-Leste (CRDTL) can be invoked to police legislative and executive action.</p><p>The philosophical underpinnings of this dispute draw on Montesquieu’s articulation of the separation of powers and A.V. Dicey’s conception of the rule of law, both of which emphasize that no branch of government should usurp functions reserved to another. In the Timorese context, the Constitution vests judicial organization and the appointment of appellate judges in a framework designed to safeguard judicial autonomy from political interference. As Hans Kelsen’s Pure Theory of Law reminds us, constitutional norms occupy the apex of a normative hierarchy and must govern the creation and application of all subordinate legal acts. By altering the composition of the judiciary’s leadership, can the amendment threaten to invert that hierarchy and blur the accountability channels between the executive and the judiciary?</p><p>Judicial independence, a cornerstone of democratic constitutionalism, requires formal guarantees against removal or undue influence and substantive protections that ensure courts can adjudicate without fear or favor. Legal theorists such as John Hart Ely have argued that the legitimacy of judicial review derives from transparent procedures and clear lines of authority. In requiring that the President of the Court of Appeal be chosen from the Supreme Court bench, the original text of Law No. 4/2014 provided an internal checks-and-balances mechanism within the judiciary. By extending eligibility to ordinary judges, the ruling implies, the 2025 amendment risked diluting the signals of seniority and shared institutional culture that bind the judiciary together, potentially subjecting the appellate bench’s leadership to external influence.</p><p>The Court of Appeal’s decision turned on a close reading of Articles 106 and 107 of the Constitution, which delineate the powers of the President of the Republic, the Parliament, and the judiciary. In what is seen as a landmark interpretation, the Court held that the legislature’s amendment to Law No. 4/2025 violated the non-delegation principle implicit in Articles 104 and 125, which protect judicial functionaries from ad hoc expansions of executive authority. By insisting that the law contravened the Constitution’s structural commitments to an independent judiciary, the Court affirmed its role as guardian of constitutional integrity, exercising “fiscalização abstracta da constitucionalidade”, a preventive review of normative acts to ensure they comport with higher norms.</p><p>President of the Republic, José Ramos-Horta, rejected the Court’s ruling as procedurally flawed, insisting that he had a constitutional right to be heard in any dispute concerning his decrees. His position drew upon the due‐process guarantees enshrined in Article 37 of the CRDTL, which speak to the right of any public official to defend against allegations before a final determination. The President pointed to the absence of formal notification to his office as a violation of fundamental procedural fairness and raised questions about potential conflicts of interest among some magistrates. Framing the decision as an overreach of judicial authority, he emphasized that Carmona’s 24 years of service fully satisfy the Constitution’s 20-year requirement for appointment.</p><p>The Ministry of Justice, aligning with the President, reiterated its confidence in Judge Carmona and characterized his appointment as part of a broader judicial modernization program. Emphasizing that the amendment facilitating Carmona’s appointment formed only one element of reforms to enhance access to justice, the Ministry urged serenity and mutual respect in public debate. Drawing parallels to Brazilian and Portuguese experiences of judicial reform, government supporters argued that expanding the talent pool for court leadership could inject fresh perspectives into the judiciary and break insular decision-making patterns, thereby reinforcing, rather than undermining, judicial capacity.</p><p>By contrast, opposition parties FRETILIN and the PLP invoked Articles 150 through 155 of the Constitution to request “fiscalização abstracta” before the promulgation of the law. Their preventive review petition underscored fears that the amendment would tilt the balance of power excessively toward the presidency and weaken the courts’ internal self‐governance. Echoing Montesquieu’s warning about “the accumulation of legislative and executive authority in the same hands,” these parties argued that only a rigorous constitutional vetting process could avert a long‐term erosion of institutional checks and balances. The Ombudsman and civil‐society legal experts added that ignoring the Court’s declaration could trigger a constitutional crisis and potential criminal liability under Article 130 of the Penal Code for abuse of function.</p><p>“Fiscalização abstracta”, as practiced in Timor-Leste until the Supreme Court of Justice is formally constituted, enables the Court of Appeal to review the normative content of laws in the abstract, detached from any concrete case or controversy. This mechanism, drawn from continental European models of constitutional adjudication, is integral to upholding the rule of law. Without it, the judiciary would be forced into case‐by‐case drills that risk delaying relief and perpetuating unconstitutional norms in the interim. Indeed, Kelsenian theory suggests that the preventive orientation of abstract review is essential to maintaining systemic coherence between statutory enactments and constitutional mandates.</p><p>In the present standoff, Judge Carmona’s legal status rests on the intersection of competing constitutional claims. His appointment by Presidential Decree No. 35/2025 stands on a shaky procedural foundation, yet it has not been formally revoked. The Court of Appeal’s ruling invalidates the enabling amendment but stops short of ordering his removal, a gap that leaves Carmona’s presidency in limbo. The President and Government’s steadfast support underlines enforcement and underscores the absence of a higher constitutional tribunal capable of issuing binding decisions in disputes between the political branches.</p><p>This institutional ambiguity raises pressing theoretical concerns about the durability of rule‐of‐law norms in nascent democracies such as Timor-Leste. The normative order becomes susceptible to dueling interpretations when the apex constitutional adjudicator lacks finality. As Dworkin posits in Law’s Empire, the integrity of law depends upon principled coherence generated through authoritative interpretation. In Timor-Leste’s case, the delay in establishing the Supreme Court of Justice undermines that authoritative function, inviting forum-shopping and legal uncertainty.</p><p>The tension between the Superior Council of the Judiciary and the executive branch further accentuates the stakes. The Council disputes Carmona’s eligibility on procedural grounds and has signaled that it may refuse to recognize decisions issued under his oversight. Such institutional non‐recognition risks paralyzing appellate review and eroding public confidence in the judiciary. Comparative experience in Eastern Europe demonstrates that litigation grids can leave citizens without clear avenues for redress when judicial councils and executive offices collide.</p><p>Beyond administrative paralysis, the legal implications can extend to criminal liability. Suppose judgments signed by Carmona as President of the Court of Appeal were later invalidated. In that case, questions will arise about whether executive or judicial actors responsible for their promulgation could face sanctions for issuing unlawful acts. Under the Penal Code’s provisions on abuse of office, knowingly applying an unconstitutional statute can constitute a crime, exposing judges and executive officials to potential prosecution. Such risks underscore the systemic need for precise, binding constitutional mechanisms to resolve conflicts expeditiously.</p><p>The absence of a Supreme Court of Justice, a specialized constitutional tribunal empowered to render final decisions, looms large in this saga. Constitutional design theory teaches us that a hierarchical court system with a dedicated constitutional chamber is essential for unifying interpretive practices and containing conflicts between branches. The delay in operationalizing this institution exacerbates the Carmona predicament and signals broader governance challenges in legal infrastructure.</p><p>Ethical dimensions of the controversy are equally salient. Allegations that the Superior Council of the Judiciary may have misrepresented procedural facts in its advisory opinions call for an inquiry into possible breaches of duty and abuse of function. Upholding judicial ethics codes and ensuring transparent disciplinary processes are prerequisites for maintaining public trust. Whether through parliamentary oversight committees or independent ombudsperson inquiries, institutional accountability must follow the rule‐based logic articulated in Articles 140 and 141 of the CRDTL.</p><p>In conclusion, the Carmona affair is not simply a dispute over one appointment but a litmus test for Timor-Leste’s commitment to constitutionalism, separation of powers, and the rule of law. Theoretical insights from Kelsen, Dworkin, and Montesquieu converge to remind us that without clear hierarchies of norms, final adjudicatory authority, and robust procedural safeguards, the promise of an independent judiciary can falter. Timor-Leste’s legislature, executive, and judiciary must collaborate to establish the Supreme Court of Justice without delay, refine the procedures for abstract constitutional review, and reinforce the ethical frameworks that govern judicial appointments. Only by doing so can the nation secure the foundations of its hard-won democracy and ensure that future conflicts are resolved within the stable, predictable structures envisioned by its Constitution. (*)</p><p>The opinion is personal and does not bind the institutions the authority represents</p> A Constitutional Crisis in Timor-Leste? Navigating Legal Ambiguity and Political Stakes - TATOLI Agência Noticiosa de Timor-Leste	查看 11069	塔托利新闻社	2025-08-07 11:43:38 2025-08-08 06:12:12	word
3236697	无图 <p>DILI, 07 August 2025 (TATOLI) – The Timor-Leste Chamber of Commerce and Industry (CCI-TL) and the East Kimberley Chamber of Commerce and Industry (EKCCI) signed a Memorandum of Understanding (MoU) in Dili today to deepen economic ties between the two regions.</p><p>The agreement was signed during the 2025 Timor-Leste–Australia Economic and Business Conference (TLAUCON2025), reinforcing efforts to build stronger partnerships between Timorese and Australian private sectors.</p><p>The MoU formalises a cooperative relationship between the two Chambers, recognising their shared role in representing the private sectors of East Kimberley and Timor-Leste, and their mutual interest in fostering economic growth, workforce development, and commercial partnerships.</p><p>Under the agreement, the parties have agreed to collaborate on workforce development and training, two-way business partnerships, and economic development. This includes promoting joint initiatives to enhance skills and employment outcomes, facilitating commercial exchange and trade between the regions, and identifying long-term projects that support shared investment, knowledge transfer, and sustainable economic growth.</p><p>The MoU establishes a framework for cooperation through activities such as technical missions, training programs, exchange of information, and annual high-level meetings. The agreement affirms the importance of mutual benefit, cultural respect, and regular communication between the Parties.</p><p>The East Kimberley region of Western Australia and Timor-Leste share more than just geographic proximity. Both regions are rich in natural resources, have strong agricultural potential, vibrant local cultures, and have a shared interest in advancing regional trade and driving sustainable development. The MoU represents a strategic partnership grounded in these common strengths and shared opportunities.</p><p>EKCCI President Amanda McLean said the agreement reflects the Chamber’s commitment to regional cooperation and practical outcomes.</p><p>“This is more than a formal agreement, it’s a commitment to action. We already have a strong and existing relationship with Timor-Leste through the valuable contributions that Timorese workers make in our region, and this partnership allows us to build on that foundation. We’re building on this relationship and laying the groundwork for trade and investment partnerships that will benefit businesses and communities in both East Kimberley and Timor-Leste,” McLean said.</p><p>CCI-TL President Jorge Manuel de Araújo Serrano also welcomed the signing, saying the agreement represents a significant step toward stronger regional collaboration.</p><p>“We welcome this important partnership with EKCCI. By working together, we aim to unlock economic potential, build mutually beneficial connections between our communities, ultimately supporting the growth and diversification of our private sector in Timor-Leste,” he said.</p><p>The MoU will remain in effect for an initial five-year term and represents only the first step in a broader, long-term vision – one that both parties are committed to advancing through ongoing collaboration, practical action, and measurable outcomes.</p><p>TATOLI</p> Timor-Leste and East Kimberley Chambers of Commerce Sign MoU to Deepen Economic Collaboration - TATOLI Agência Noticiosa de Timor-Leste	查看 3247	塔托利新闻社	2025-08-07 12:52:06 2025-08-08 06:12:12	word
3236696	有图 <p><img src="https://www.utusan.com.my/wp-content/uploads/2025/06/LOGO-POLIS.png" rel="noopener noreferrer"></p><p><img src="https://www.utusan.com.my/wp-content/uploads/2025/06/LOGO-POLIS.png" rel="noopener noreferrer"></p><p>BALING: Seorang warga emas lelaki maut dirempuh sebuah kereta yang dipercayai dicuri ketika dalam perjalanan ke Masjid Kampung Guar Cempedak, Kuala Ketil, pagi tadi. Dalam kejadian kira-kira pukul 6 pagi, mangsa, Jahaya Khamis, 63, menunggang motosikal jenis Modenas Kriss ke masjid berhampiran rumahnya untuk menunaikan solat Subuh berjemaah. Difahamkan, kereta Proton Wira itu dipercayai dicuri ... Read more</p><p>The post Bendahari masjid maut dirempuh kereta curi appeared first on Utusan Malaysia.</p> Bendahari masjid maut dirempuh kereta curi	查看 734	马来西亚前锋报	2025-08-08 00:09:24 2025-08-08 06:11:53	word
3236695	有图 <p><img src="https://www.utusan.com.my/wp-content/uploads/2025/08/IMG-20250808-WA0009-1024x732.jpg" rel="noopener noreferrer"></p><p><img src="https://www.utusan.com.my/wp-content/uploads/2025/08/IMG-20250808-WA0009.jpg" rel="noopener noreferrer"></p><p>KOTA BHARU: Penyanyi Bea Sobar Bea Eda Ezrin, 33 dan rakanya Nur Aida Mamat,33, kembali ke pangkuan keluarga masing-masing malam tadi selepas sembilan bulan menjalani tahanan sementara di Penjara Wilayah Narathiwat, Thailand. Sebelum itu, Eda Ezrin atau Wan Norshaheeda Azlin Wan Ismail, 30, dan Nur Aida menjalani proses rakaman percakapan di Balai Polis Rantau Panjang ... Read more</p><p>The post Eda Ezrin, Aida pulang ke pangkuan keluarga appeared first on Utusan Malaysia.</p> Eda Ezrin, Aida pulang ke pangkuan keluarga	查看 736	马来西亚前锋报	2025-08-08 00:29:28 2025-08-08 06:11:53	word
3236694	有图 <p><img src="https://www.utusan.com.my/wp-content/uploads/2025/08/doktor-768x1024.jpeg" rel="noopener noreferrer"></p><p><img src="https://www.utusan.com.my/wp-content/uploads/2025/08/doktor.jpeg" rel="noopener noreferrer"></p><p>KUALA LUMPUR: Seramai 705 pegawai perubatan dan 1,394 jururawat berpengalaman meletak jawatan dalam tempoh tiga tahun lalu. Menteri Kesihatan, Datuk Seri Dr. Dzulkefly Ahmad berkata, jumlah itu membabitkan mereka yang telah berkhidmat melebihi lima tahun di hospital dan fasiliti kesihatan awam dari 2022 hingga 2024. “Antara alasan utama peletakan jawatan ialah keinginan untuk berkhidmat di ... Read more</p><p>The post 1,394 jururawat, 705 doktor letak jawatan appeared first on Utusan Malaysia.</p> 1,394 jururawat, 705 doktor letak jawatan	查看 732	马来西亚前锋报	2025-08-08 06:00:42 2025-08-08 06:11:53	word
3236693	有图 <p><img src="https://www.utusan.com.my/wp-content/uploads/2025/08/IMG-20250807-WA0072-1024x682.jpg" rel="noopener noreferrer"></p><p><img src="https://www.utusan.com.my/wp-content/uploads/2025/08/IMG-20250807-WA0072.jpg" rel="noopener noreferrer"></p><p>SUNGAI GOLOK, THAILAND: Pihak berkuasa Thailand membenarkan penyanyi Bea Sobar Bea, Eda Ezrin dan rakannya, Nur Aida Mamat pulang ke Malaysia selepas dibebaskan sepenuhnya daripada Penjara Wilayah Narathiwat di sini kelmarin. Namun suami Eda Ezrin dan tiga lagi rakannya perlu bermalam di Depot Tahanan Imigresen Sungai Golok untuk melengkapkan proses dokumentasi pembebasan mereka. Jurucakap Pejabat ... Read more</p><p>The post Eda Ezrin dibenar pulang suami, tiga rakan masih ditahan appeared first on Utusan Malaysia.</p> Eda Ezrin dibenar pulang suami, tiga rakan masih ditahan	查看 780	马来西亚前锋报	2025-08-08 06:10:52 2025-08-08 06:11:53	word
3236692	有图 <p><img src="https://www.utusan.com.my/wp-content/uploads/2025/08/TYT-MELAKA-r.jpg" rel="noopener noreferrer"></p><p><img src="https://www.utusan.com.my/wp-content/uploads/2025/08/TYT-MELAKA-r.jpg" rel="noopener noreferrer"></p><p>Yang Dipertua Negeri Melaka, Tun Mohd. Ali Mohd. Rustam mengadakan lawatan ke ibu pejabat Media Mulia Sdn. Bhd. (Media Mulia) di Petaling Jaya, semalam. Ketibaan beliau pada pukul 3.30 petang disambut pengurusan tertinggi Media Mulia yang diketuai Pengarah Urusan dan Pengarang Kumpulan, Mohamad Azlan Jaafar; Ketua Pegawai Kewangan, Abdul Wahid Idris; Pengarang Utusan Malaysia/Mingguan Malaysia, ... Read more</p><p>The post Mohd. Ali lawat pejabat Media Mulia appeared first on Utusan Malaysia.</p> Mohd. Ali lawat pejabat Media Mulia	查看 732	马来西亚前锋报	2025-08-08 06:15:46 2025-08-08 06:11:53	word
3236691	有图 <p><img src="https://www.utusan.com.my/wp-content/uploads/2025/04/32-lead-pix-3-1024x683.jpg" rel="noopener noreferrer"></p><p><img src="https://www.utusan.com.my/wp-content/uploads/2025/04/32-lead-pix-3-scaled.jpg" rel="noopener noreferrer"></p><p>KUALA LUMPUR: Pengeksport semikonduktor Malaysia ke Amerika Syarikat (AS) setakat ini masih dikecualikan tarif timbal balas yang dikenakan oleh negara berkenaan. Ia berikutan perkembangan terbaharu mengenai tarif sekitar 100 peratus yang akan dikenakan AS ke atas cip semikonduktor yang diimport dari negara yang tidak menghasilkannya di negara itu. Menteri Pelaburan, Perdagangan dan Industri, Datuk Seri ... Read more</p><p>The post Pengeksport semikonduktor Malaysia masih terkecuali tarif AS appeared first on Utusan Malaysia.</p> Pengeksport semikonduktor Malaysia masih terkecuali tarif AS	查看 783	马来西亚前锋报	2025-08-08 06:24:40 2025-08-08 06:11:53	word
3236690	有图 <p><img src="https://www.utusan.com.my/wp-content/uploads/2025/08/PELABURAN-SHARIAH-BURSA936-30-1.jpg" rel="noopener noreferrer"></p><p><img src="https://www.utusan.com.my/wp-content/uploads/2025/08/PELABURAN-SHARIAH-BURSA936-30-1.jpg" rel="noopener noreferrer"></p><p>KUALA LUMPUR: Nilai pasaran modal Islam Malaysia mencecah RM2.56 trilion setakat akhir April 2025, bersamaan 63 peratus daripada jumlah keseluruhan pasaran modal domestik sebanyak RM4.04 trilion, kata Ketua Pegawai Eksekutif Bursa Malaysia, Datuk Fad’l Mohamed. Beliau berkata, seiring perkembangan itu, data terkini sehingga akhir Julai menunjukkan permodalan pasaran patuh syariah di Bursa Malaysia berjumlah RM1.3 ... Read more</p><p>The post Pasaran modal Islam Malaysia cecah RM2.56 trilion sehingga April 2025 appeared first on Utusan Malaysia.</p> Pasaran modal Islam Malaysia cecah RM2.56 trilion sehingga April 2025	查看 823	马来西亚前锋报	2025-08-08 06:33:04 2025-08-08 06:11:53	word

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