Reprocell obtains regenerative medicine manufacturing license

Reprocell Co., Ltd. has obtained a regenerative medicine product manufacturing and sales business license from Kanagawa Prefecture, effective September 18, 2026.

This license is a significant milestone for the company’s regenerative medicine product, ‘Stemchymal’, for which Reprocell holds the exclusive commercialization license in Japan. The company has already applied for domestic manufacturing and sales approval for Stemchymal to treat ataxia progression in patients with spinocerebellar ataxia (SCA3 and SCA6 types).

With this license, Reprocell is prepared to take legal responsibility for quality control and post-marketing safety management, ensuring a smooth supply chain once product approval is granted. The company expects the impact on current financial results to be minor.