长春高新子公司GenSci145片境内生产药品注册临床试验申请获受理

Group 1 - The core announcement is that Changchun High-tech Industry (Group) Co., Ltd. has received approval from the National Medical Products Administration for the clinical trial application of GenSci145 tablets, a new selective PI3Kα inhibitor developed by its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd. [2] - GenSci145 is aimed at treating locally advanced or metastatic solid tumors with PIK3CA mutations, which are prevalent in up to 40% of HR+/HER2- primary and metastatic breast cancers, indicating a significant market opportunity [2] - The current standard treatment for HR+/HER2- locally advanced or metastatic breast cancer involves endocrine therapy combined with CDK4/6 inhibitors, but there is a clinical need for targeted therapies like PI3K pathway inhibitors for patients with PIK3CA mutations who develop resistance [2] Group 2 - Early-stage PI3Kα inhibitors have shown significant improvements in progression-free survival (PFS) in clinical studies but have limitations due to toxicity issues, highlighting the need for new generation PI3Kα inhibitors [3] - GenSci145 has demonstrated strong selective inhibitory activity against various hotspot mutations in the PIK3CA gene in preclinical studies, showing clear efficacy and good safety profiles in animal models [3] - The successful progression of the clinical trial application for GenSci145 could enhance Changchun High-tech's business structure, optimize product offerings, and strengthen its competitive edge in strategic areas [3]