长春高新子公司GenSci145片注册临床试验申请获得受理

Core Viewpoint - Changchun High-tech's subsidiary, Gensci Pharmaceutical, has received approval from the National Medical Products Administration for the clinical trial application of GenSci145 tablets, a new selective PI3Kα inhibitor aimed at treating advanced solid tumors with PIK3CA mutations [1][2]. Group 1: Clinical Development - GenSci145 is designed to target PIK3CA mutations, which are present in up to 40% of HR+/HER2- primary and metastatic breast cancer cases, providing a new treatment option for patients who have developed resistance to current therapies [1][2]. - Early-stage PI3Kα inhibitors have shown significant improvements in progression-free survival (PFS) but have limitations due to toxicity and impact on long-term treatment adherence, highlighting the need for new generation inhibitors like GenSci145 [2]. Group 2: Business Strategy and Market Position - The successful progression of the clinical trial for GenSci145 is expected to enhance the company's business structure, optimize product offerings, and strengthen its core competitiveness in the pharmaceutical industry [3]. - Changchun High-tech has been actively adjusting its strategy and increasing innovation investments, developing multiple core technology platforms with independent intellectual property rights, covering the entire process of innovative drug design, screening, evaluation, and formulation research [3]. - The company is focusing on high-demand therapeutic areas, particularly in endocrine metabolism and pediatric fields, to support sustainable development and diversification goals [3]. Group 3: Recent Developments - Recently, Gensci Pharmaceutical has disclosed multiple advancements in its drug development pipeline, including the approval of clinical trials for GenSci142 capsules and GS3-007a, both targeting specific medical conditions [4]. - The company has also received approval for GenSci140, a novel targeted antibody-drug conjugate for the treatment of advanced solid tumors, further expanding its product portfolio [4].