Sumitomo Pharma Co., Ltd.
Announcement Regarding the Obtaining of Manufacturing and Marketing Approval in Japan for Allogeneic iPS Cell-Derived Dopaminergic Neural Progenitor Cell ‘Amsepre®’
Sumitomo Pharma obtained manufacturing and marketing approval with conditions and time limits for the allogeneic iPS cell-derived dopaminergic neural progenitor cell 'Amsepre®' in Japan, effective March 6, 2026. The impact on financial results for the fiscal year ending March 2026 is minor.
Key Figures
- Date of Manufacturing and Marketing Approval: 2026年3月6日
- Product Name: Amsepre® (Generic Name: Lagneprocel)
- Impact on Financial Results: Minor for fiscal year ending March 2026
AI要約
Overview of Manufacturing and Marketing Approval
Sumitomo Pharma Co., Ltd., in collaboration with RACTHERA, Inc., obtained manufacturing and marketing approval with conditions and time limits in Japan for the allogeneic iPS cell-derived dopaminergic neural progenitor cell product 'Amsepre®' effective March 6, 2026. This product is indicated for the improvement of motor symptoms in Parkinson’s disease patients who have an insufficient response to existing drug therapies including levodopa-containing formulations. It is the world’s first regenerative and cellular medicine derived from iPS cells. The application was based on physician-initiated clinical trial results conducted at Kyoto University Hospital.
Future Outlook and Manufacturing System
Following drug price listing, Sumitomo Pharma will handle sales while manufacturing will be undertaken by S-RACMO Co., Ltd. The approval is conditional and time-limited, with plans to conduct post-marketing clinical trials and usage surveys within the stipulated timeframe to achieve full approval. Sumitomo Pharma and RACTHERA aim to provide a new treatment option for Parkinson’s disease patients and contribute to therapeutic advancements.
