HutchMed (NASDAQ: HCM), a China-based biopharmaceutical company, has announced that the National Medical Products Administration (NMPA) has accepted its market approval filing for Tazverik (tazemetostat) for review. The company is seeking initial approval for Tazverik as a treatment for recurrent or refractory follicular lymphoma (FL), and the filing has been granted priority review status.
Tazverik, originally developed by Epizyme Inc., a unit of US firm Ipsen, was licensed to HutchMed for development in Greater China as part of a deal inked in August 2021. The molecule is an EZH2 methyltransferase inhibitor, which has already received fast-tracked approvals in the United States for the treatment of advanced epithelioid sarcoma and certain relapsed/refractory FL in January and June of 2020, respectively. Additionally, marketing approval has been obtained in Japan.
Under their strategic partnership with Ipsen, HutchMed is responsible for the research, development, manufacturing, and commercialization of the drug in mainland China, Hong Kong, Macau, and Taiwan.- Flcube.com
