长春高新技术产业（集团）股份有限公司关于子公司GenSci145片境内生产药品注册临床试验申请获得受理的公告

Core Viewpoint - The company, Changchun High-tech Industry (Group) Co., Ltd., announced that its subsidiary, GenSci Pharmaceutical Co., Ltd., has received acceptance for the clinical trial application of GenSci145 tablets from the National Medical Products Administration, which is aimed at treating locally advanced or metastatic solid tumors with PIK3CA mutations [1][2]. Group 1: Drug Information - Product Name: GenSci145 tablets [1] - Application: Clinical trial for domestic production [1] - Indication: Local advanced or metastatic solid tumors with PIK3CA mutations [1] - Acceptance Number: CXHL2501450, CXHL2501451, CXHL2501452 [1] Group 2: Clinical Context - PIK3CA mutations are found in up to 40% of HR+/HER2- primary and metastatic breast cancers, leading to significant risks of recurrence and mortality due to disease heterogeneity and resistance [2] - Current guidelines recommend endocrine therapy combined with CDK4/6 inhibitors as the first-line treatment for HR+/HER2- locally advanced or metastatic breast cancer, but targeted therapies like PI3K pathway inhibitors are needed for patients with PIK3CA mutations who have developed resistance [2] Group 3: Development and Competitive Advantage - GenSci145 tablets are a new generation of mutation-selective PI3Kα inhibitors, showing strong selective inhibition of various hotspot mutations in preclinical studies, with clear efficacy and good safety profiles in animal models [2] - The drug has significant clinical development value and potential differentiation advantages, aiming to provide better treatment options for patients with PIK3CA mutations [2]