长春高新:GenSci145片境内生产药品注册临床试验申请获批准

Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd. (referred to as "Jinsai Pharmaceutical"), has received approval from the National Medical Products Administration for the clinical trial application of GenSci145 tablets, a novel selective PI3Kα inhibitor intended for the treatment of locally advanced or metastatic solid tumors with PIK3CA mutations [1] Group 1 - The clinical trial approval for GenSci145 marks a significant milestone for Jinsai Pharmaceutical in the development of innovative drugs [1] - GenSci145 is classified as a Class 1 innovative chemical drug, indicating its potential to address unmet medical needs in oncology [1] - The drug targets specific mutations (PIK3CA) associated with certain types of cancer, highlighting its specialized therapeutic application [1]

CCHT-长春高新:GenSci145片境内生产药品注册临床试验申请获批准 - Reportify