Uncertainty from changes in regenerative medicine regulations and intensifying competition

「In the regenerative medicine and cell therapy fields, as of 30 September 2025, 21 products, including the company's 5 products, had received marketing authorization, and social expectations continue to grow.」

「In the regenerative medicine and cell therapy fields, industrial development in regenerative medicine has progressed under the Act on the Safety of Regenerative Medicine and the revised Pharmaceutical Affairs Act, enacted in November 2014. However, following the non-approval and withdrawal of applications, respectively, for two products, HeartSheet and Collategene, that had been approved under the conditional and time-limited approval system, discussions are under way regarding the future of that system. Meanwhile, in July 2024, AKUUGO intracerebral implant, a treatment for brain injury manufactured and marketed by SanBio Company Limited, was newly approved. As of 31 March 2025, 19 products, including the company's 5 products, had received marketing authorization as regenerative medicine products, and social expectations for the expansion and growth of the field remain strong.」

「In the regenerative medicine and cell therapy fields, industrial development in regenerative medicine has progressed under the Act on the Safety of Regenerative Medicine and the revised Pharmaceutical Affairs Act, enacted in November 2014. However, following the non-approval and withdrawal of applications, respectively, for two products, HeartSheet and Collategene, that had been approved under the conditional and time-limited approval system, discussions are under way regarding the future of that system.」

「The market for the company's products is limited, and even if the company has secured a certain level of market share, sales may fluctuate significantly depending on the incidence of target patients and market entry by other companies.」

「In September 2022, Carvykti intravenous infusion, a CAR-T cell product for multiple myeloma developed by Janssen Pharma, received marketing authorization approval. As a result, Japan had 17 regenerative medicine products, including the company's 4 products, comprising cell-processed products and gene therapy products.」

「In the regenerative medicine and cell therapy fields, SAKURACY, a cell-processed product for reducing ocular surface adhesions associated with limbal stem cell deficiency, developed by Hirosaki LI, and Abecma intravenous infusion, a CAR-T cell product for relapsed or refractory multiple myeloma, developed by Bristol Myers Squibb, received marketing authorization approval in January 2022. As a result, Japan had 16 regenerative medicine products, including the company's 4 products, comprising cell-processed products and gene therapy products. New products continue to be launched, and the range of product types is also diversifying.」

「In the regenerative medicine and cell therapy fields, the Ministry of Health, Labour and Welfare's Pharmaceutical Affairs and Food Sanitation Council, Subcommittee on Regenerative Medicine Products and Biotechnology, approved the marketing authorization of two new regenerative medicine products in Japan at a meeting held in December. Expectations for the emergence of new regenerative medicine products increased in addition to the 14 products already approved.」

「In the regenerative medicine and cell therapy fields, Alofisel injection, a regenerative medicine product for treating complex perianal fistulas in patients with inactive or mildly active Crohn's disease, was newly approved in September 2021. As a result, Japan had 14 regenerative medicine products, including 11 products using cells.」

「In the regenerative medicine and cell therapy fields, two new regenerative medicine products were approved in June 2021: Ocural, a product developed by the company for treating limbal stem cell deficiency, and Delytact injection, a product developed by Daiichi Sankyo for treating malignant glioma. As a result, Japan had 13 regenerative medicine products, including 10 products using cells. The 2014 amendments to the relevant systems have accelerated the launch of products in Japan.」

「Against this backdrop, development of regenerative medicine products using allogeneic cells, the entry of pharmaceutical companies through technology in-licensing from Japan and overseas, and the advancement of iPS cell-based regenerative medicine into the clinical application stage are accelerating, while the number of approved regenerative medicine products is also increasing.」

「At the same time, new regenerative medicine-related regulations and systems in Japan have attracted increasing attention from other countries. In particular, the conditional and time-limited approval system for regenerative medicine products has drawn a range of views. Concerns are also growing that these advanced medical treatments could put pressure on public health insurance finances. As regenerative medicine becomes more of a reality, issues requiring resolution have gradually become apparent.」

「At the same time, development of regenerative medicine products using allogeneic cells, the entry of pharmaceutical companies through technology in-licensing from Japan and overseas, and the advancement of iPS cell-based regenerative medicine into the clinical application stage are accelerating.」

「In the regenerative medicine and cell therapy fields, an autologous bone marrow-derived mesenchymal stem cell product for treating spinal cord injuries, Stemirac injection (marketing authorization holder: Nipro), was approved in December as Japan's fifth regenerative medicine product. While the increase in companies entering the field is creating competition, it is also expected to contribute to the development of a more realistic market environment.」

「As the external environment surrounding regenerative medicine is improving, the number of entrants, including foreign-capital companies, is expected to increase, intensifying competition. If the company is unable to maintain the competitive advantage of its products because of competing products or new technologies, it may be unable to achieve its projected sales.」

「Commercialization in the medical and life sciences fields, as well as in regenerative medicine, takes many years and is significantly affected by laws and regulations. If new rules are applied in the future, they could have a material impact on the company's business strategy. In addition, as the number of entrants, including foreign-capital companies, is expected to increase, the risk of intensifying competition cannot be ruled out.」