长春高新(000661.SZ)子公司GenSci145片境内生产药品注册临床试验申请获得受理

Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd. (referred to as "Jinsai Pharmaceutical"), has received the Acceptance Notice from the National Medical Products Administration for the clinical trial application of GenSci145 tablets, indicating a significant step in the drug's development process [1] Group 1: Product Development - GenSci145 is a novel selective PI3Kα inhibitor developed by Jinsai Pharmaceutical, demonstrating strong selective inhibitory activity against various hotspot mutations in the PIK3CA helix and kinase domains during preclinical studies [1] - The drug has shown clear efficacy and good safety characteristics in animal models, supporting its potential for clinical use [1] Group 2: Clinical Relevance - GenSci145 is expected to provide better clinical treatment options for patients with locally advanced or metastatic solid tumors carrying PIK3CA mutations, highlighting its clinical development value and potential differentiation advantages [1]