首药控股：索特替尼片新药上市申请获得受理

Core Viewpoint - The company has received acceptance for the new drug application (NDA) of its self-developed drug, SY-5007, which is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who are positive for RET gene fusion [1] Group 1 - SY-5007 is a highly selective small molecule RET tyrosine kinase inhibitor and is the first of its kind to enter clinical research in China [1] - It is one of the fastest progressing domestically produced selective RET inhibitors in clinical development [1] - The primary endpoints of key Phase II and III clinical trials have been met, demonstrating a high and durable objective response rate in patients with RET gene fusion positive locally advanced or metastatic NSCLC [1] Group 2 - Efficacy data shows that the product achieves a high proportion of objective responses in the target patient population [1] - Most high-grade adverse reactions can be managed through dose adjustment, safety monitoring, and necessary symptomatic treatment [1]