CStone Pharmaceuticals (HKG: 2616), a China-based biopharmaceutical company, has received approval from the National Medical Products Administration (NMPA) to locally manufacture its Gavreto (pralsetinib tablets, 100mg), transitioning from overseas supply. Domestic production is anticipated to begin by late this year or early next year, following the approval of the 300mg specification in June.
Gavreto is an oral, once-daily, highly selective RET inhibitor that CStone in-licensed from U.S.-based Blueprint Medicines in June 2018. The drug is indicated for the treatment of unresectable or metastatic gastrointestinal stromal tumors (GIST) harboring PDGFRA exon 18 mutations, including the PDGFRA D842V variant, and is approved for use in mainland China, Taiwan, and Hong Kong. In a strategic move last month, CStone granted Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) exclusive promotion rights for Gavreto in mainland China.- Flcube.com
