Steminent Biotherapeutics (仲恩生醫) has signed a Letter of Intent (LOI) with Japanese regenerative medicine leader Cyto-Facto for the contract manufacturing of its core product, Stemchymal®, as it nears the Japanese market.

Partnership & Pipeline Context:

• Manufacturing Excellence: Cyto-Facto (formerly the FBRI Cell Therapy R&D Center in Kobe) was Asia's first GMP facility to manufacture global CAR-T products. It is backed by heavyweights like Sumitomo Corporation and Fujifilm.
• Indication: Stemchymal® targets Spinocerebellar Ataxia (SCA). Phase II trials have been completed in both Taiwan and Japan.
• Regulatory Strategy: Partner REPROCELL is currently in intensive pre-submission consultations with Japan’s PMDA, aiming for conditional marketing authorization.
• Supply Chain Resilience: Chairperson Linda Wang noted that the LOI represents a proactive step to secure production capacity and ensure a stable supply chain upon potential approval in Japan.

Resource: 仲恩生醫與日本Cyto-Facto簽量產合作意向書 助攻細胞新藥日本上市