Print（PDF/138KB） Feb. 13, 2026 Products

Regarding the Scheduled Review in Japan of the Allogeneic iPS Cell-Derived dopaminergic neural progenitor cells (AMCHEPRY)

Sumitomo Pharma Co., Ltd. (Head Office: Osaka, Japan; Representative Director, President and CEO: Toru Kimura) and RACTHERA Inc. (Head Office: Chuo-ku, Tokyo) submitted, on August 5, 2025, an application of manufacturing and marketing authorization for allogeneic iPS cell-derived dopaminergic neural progenitor cells (INN: raguneprocel) for indication of the improvement of motor functions during the off-time period of patients with advanced Parkinson’s disease. Sumitomo Pharma and RACTHERA announced today that the regenerative medical product AMCHEPRY® has been listed as an item for deliberation on the agenda of the upcoming meeting of the Ministry of Health, Labour and Welfare’s Pharmaceutical Affairs and Food Sanitation Council, Committee on Regenerative Medicine Products and Biotechnologies, scheduled to be held on February 19, 2026.

Following deliberation at the above committee, a decision will be made regarding the approval or disapproval of AMCHEPRY®, and other related matters. Any matters requiring disclosure will be communicated promptly. This development is expected to have no impact on the consolidated financial results for the fiscal year ending March 2026.