Core Viewpoint - The company, Shouyao Holdings (688197.SH), has received a notice of acceptance from the National Medical Products Administration for its new drug application (NDA) for SY-5007, a treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who are positive for RET gene fusion [1] Group 1: Drug Development - SY-5007 is a fully self-developed drug that has shown significant and durable efficacy in both treatment-naive and previously treated patients with RET fusion-positive NSCLC [1] - The drug demonstrates good safety and tolerability, validating its clinical potential as a highly selective RET inhibitor [1] Group 2: Market Implications - The approval of SY-5007 is expected to provide a new treatment option for patients in China with RET fusion-driven non-small cell lung cancer [1]
首药控股:RET抑制剂索特替尼片(SY-5007)新药上市申请获得受理