首药控股(688197.SH):RET抑制剂索特替尼片(SY-5007)新药上市申请获得受理
Core Viewpoint - The company, Shouyao Holdings, has received acceptance for its new drug application for SY-5007, a selective RET inhibitor, aimed at treating adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who are positive for RET gene fusion [1] Group 1 - The National Medical Products Administration has issued an acceptance notice for the new drug application of SY-5007 [1] - SY-5007 has demonstrated significant and durable efficacy in both treatment-naive and previously treated patients with RET fusion-positive NSCLC [1] - The drug shows good safety and tolerability, confirming its clinical potential as a highly selective RET inhibitor [1]