Sumitomo Chemical Company, Limited
Notice Regarding Approval for Manufacturing and Marketing of iPS Cell-Derived Product “Amshepli®” for Parkinson’s Disease Patients by Our Subsidiary
Sumitomo Pharma, a subsidiary of Sumitomo Chemical, obtained manufacturing and marketing approval on March 6, 2026, for the world's first iPS cell-derived regenerative medicine "Amshepli®". Sales exceeding 100 billion yen are expected in the 2030s.
Key Figures
- Approval Date for Manufacturing and Marketing: 2026年3月6日
- Projected Sales: Over 100 billion yen (2030s)
- Equity Ratio: Sumitomo Pharma 51.76%, RACTHERA 66.6%
AI要約
Overview of Approval for Manufacturing and Marketing
Sumitomo Pharma, a subsidiary of Sumitomo Chemical, together with RACTHERA, obtained conditional and time-limited manufacturing and marketing approval in Japan on March 6, 2026, for the non-autologous iPS cell-derived dopamine neural progenitor product "Amshepli®." This product is the world's first approved regenerative and cellular medicine derived from iPS cells, based on physician-led clinical trial results at Kyoto University Hospital. Manufacturing is handled by S-RACMO Co., Ltd., a CDMO with proven commercial production experience in regenerative and cellular medicines.
Future Outlook and Social Significance
The Sumitomo Chemical Group positions regenerative and cellular medicine as a core area for medium- to long-term new growth. This product is expected to become a blockbuster with sales exceeding 100 billion yen in the 2030s. As this is a conditional and time-limited approval, post-marketing clinical trials and usage surveys will be conducted aiming for full approval. The product provides a novel treatment option for Parkinson's disease patients different from conventional drug therapies, contributing to solving social challenges.
