CStone Pharmaceuticals (HKG: 2616), a leading biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to begin local manufacturing of Gavreto (pralsetinib tablets, 300mg), moving away from overseas supply. The company anticipates that domestic production will start by the end of this year or the beginning of the next.
Gavreto, a highly selective RET inhibitor, was in-licensed from US-based biotech Blueprint Medicines in June 2018. The orally administered, once-daily medication has been approved for the treatment of PDGFRA exon 18 mutant (including PDGFRA D842V mutation) unresectable or metastatic gastrointestinal stromal tumor (GIST) in mainland China, Taiwan, and Hong Kong. The 100mg dosage form of the drug is also expected to receive approval for local manufacturing in the near future.- Flcube.com
