Reprocell has submitted an application for manufacturing and marketing approval in Japan for the regenerative medicine product Stemchymal®, for which the company holds exclusive commercialisation rights in Japan.
The application seeks approval for the use of Stemchymal to suppress the progression of ataxia in patients with spinocerebellar ataxia (SCA3 and SCA6).
Under the established framework, Stemchymal will be manufactured by Taiwan-based Steminent Biotherapeutics, with Reprocell overseeing all sales and distribution activities within Japan.
Notably, Stemchymal was granted orphan regenerative medicine product designation (*1) by Japan’s Ministry of Health, Labour and Welfare (MHLW) in December 2018. Consequently, the product is eligible for priority review by the Pharmaceuticals and Medical Devices Association.
