Sumitomo Pharma's Two iPS Cell Products Get Conditional Approval, First Transplant Set for October 2026
Sumitomo Pharma received conditional approval in March 2026 for two iPS cell-based regenerative medicine products: Amseprely for Parkinson's disease and Rihart for severe heart failure, marking the world's first such approvals. The price of Amseprely is about 55.3 million yen. The company, currently in deficit, has just begun stable supply operations. Manufacturing currently yields only one dose per batch in clinical trials, and scaling up requires regulatory confirmation. The first transplant is planned for October 2026, with 35 patients to be treated and followed for two years.
Sumitomo Pharma's Parkinson's disease treatment product Amseprely and severe heart failure treatment product Rihart received conditional approval in March 2026 as the world's first iPS cell-based regenerative medicine products. The price of Amseprely is approximately 55.3 million yen. The company is currently in deficit, and its stable supply business has only just begun.
The manufacturing method can produce only one patient's dose at a time in clinical trials, and increasing production volume requires confirmation from regulatory authorities. The first transplant is planned for October 2026, with a total of 35 patients to receive transplants and be followed for two years. The medical team consists of neurologists, neurosurgeons, and nurses.
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