首药控股RET抑制剂索特替尼片新药上市申请获得受理

Core Viewpoint - The company Shouyao Holdings (688197) has received a notice of acceptance from the National Medical Products Administration for its new drug application (NDA) for SY-5007, a treatment for RET fusion-positive non-small cell lung cancer (NSCLC) in adults [1] Company Summary - SY-5007 is a fully self-developed drug by the company, specifically designed for the treatment of locally advanced or metastatic RET fusion-positive NSCLC [1] - The drug has demonstrated significant and durable efficacy in both treatment-naive and previously treated patients with RET fusion-positive NSCLC [1] - SY-5007 shows good safety and tolerability, confirming its clinical potential as a highly selective RET inhibitor [1] - 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]