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]

Core Viewpoint - Baiyunshan's subsidiary, Baiyunshan Pharmaceutical Factory, has received feedback from the National Medical Products Administration (NMPA) regarding its selective RET small molecule inhibitor, BYS10 tablets, which are intended for the treatment of advanced solid tumors such as non-small cell lung cancer and medullary thyroid carcinoma [1] Summary by Categories Product Development - BYS10 tablets have undergone research and development with an investment of RMB 146 million [1] - The NMPA has agreed to allow BYS10 tablets to apply for market approval through a Phase II single-arm clinical trial [1] Market Context - Currently, only two RET inhibitors, Pralsetinib (BLU-667) and Selpercatinib (LOXO-292), have been approved for market release globally [1]