Source disclosure: March 06, 2026, 09:20 JST
Published by Pulse News Wire: March 06, 2026, 09:25 JST
Sumitomo Pharma Co.,Ltd. [4506.T]
TOKYO, Mar 06 (Pulse News Wire) – Sumitomo Pharma CO.,LTD. (4506.T) secured conditional approval for its iPSC-derived cell therapy Amshippri® (Ragneprocell).
The therapy targets patients with Parkinson's disease who have inadequate responses to existing drug treatments. Developed in collaboration with RACTHERA, Amshippri® involves transplanting non-self iPSC-derived dopamine precursor cells into the brain to improve motor symptoms. The Phase I/II clinical trial results, published in Nature in April 2025, formed the basis for the application filed on August 5, 2025.
Sumitomo Pharma plans to handle sales, while manufacturing will be conducted by S-RACMO Corporation. The conditional approval requires post-marketing studies to ensure continued efficacy within set deadlines. This approval marks a significant milestone as Amshippri® becomes the world's first product derived from iPSCs for regenerative cellular medicine.
Sumitomo Pharma and RACTHERA aim to offer a novel treatment option for Parkinson's patients, contributing to improved patient outcomes beyond conventional pharmaceutical approaches.
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