Sumitomo Pharma's Amchepry receives formal approval from Japan's Ministry of Health, Labour and Welfare

Sumitomo Pharma/Amchepry (Raguneprocel)

Japan's Ministry of Health, Labour and Welfare formally approved Amchepry on March 6, 2026, making it the world's first commercial approval of an iPSC-derived therapy. Sumitomo Pharma received conditional and time-limited approval, a status that allows earlier market access while safety and efficacy data are collected.

• First-ever commercial iPSC therapy approval globally
• Conditional approval valid for seven years; requires ongoing data collection for full approval
• Target patient population: Parkinson's disease patients aged 50-69
• Developed jointly with Racthera Inc.