长春高新子公司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., received the acceptance notice from the National Medical Products Administration for the clinical trial application of GenSci145 tablets, a novel selective PI3Kα inhibitor developed by the company [1] Group 1 - GenSci145 tablets have demonstrated 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, indicating its potential for clinical development [1] - GenSci145 tablets are expected to provide better treatment options for patients with locally advanced or metastatic solid tumors carrying PIK3CA mutations, highlighting its clinical development value and potential differentiation advantages [1]