CStone Pharmaceuticals (HKG: 2616), a leading biopharmaceutical company based in China, has submitted a market approval filing to the National Medical Products Administration (NMPA) for Gavreto (pralsetinib), an oral, once-daily, highly selective RET inhibitor. The company plans to manufacture the drug locally, marking a strategic shift from overseas supply. Gavreto was in-licensed from US-based biotech Blueprint Medicines in June 2018 and has received US FDA approvals for various cancer indications, including metastatic RET fusion-positive non-small cell lung cancer (NSCLC) and advanced or metastatic RET fusion-positive thyroid cancer .
CStone’s Gavreto is expected to be the second biosimilar version of Eylea in the Chinese market, following Qilu Pharmaceutical Co., Ltd’s aflibercept, which gained approval in December 2023. The drug’s potential approval in China will significantly impact the treatment landscape for patients with RET-driven cancers, offering a more accessible and cost-effective alternative.
In addition to Gavreto, CStone’s Ayvakit (avapritinib), a KIT and PDGFRA-targeted TKI also in-licensed from Blueprint Medicine, is awaiting a regulatory decision in China. Ayvakit is anticipated to gain market entry in China later this year, expanding CStone’s portfolio of targeted oncology therapies .
CStone Pharmaceuticals, led by Dr. George Chen, its co-founder, chairman, and CEO, continues to strengthen its position in the global oncology market with a focus on innovative and precision medicines. Dr. Chen brings extensive experience from leadership roles at multinational entities, including the US National Institutes of Health, Eli Lilly, GlaxoSmithKline, BeiGene, and Johnson & Johnson, as well as AstraZeneca .- Flcube.com
