长春高新子公司注射用GenSci143注册临床试验申请获受理

Core Viewpoint - Changchun High-tech's subsidiary, Jinsai Pharmaceutical, has received approval for the clinical trial application of GenSci143, a dual-target antibody-drug conjugate aimed at treating tumors expressing B7-H3 and PSMA, which may enhance treatment efficacy and safety for a broader patient population [1][2]. Group 1: Clinical Trial Approvals - Jinsai Pharmaceutical's GenSci143, a dual-specificity antibody-drug conjugate, targets B7-H3 and PSMA, potentially overcoming tumor heterogeneity and resistance [1]. - The clinical trial application for GenSci143 has been accepted by the National Medical Products Administration, marking a significant step in its development [1]. - Other recent approvals include clinical trials for various drugs, such as the domestic production of Camyergoline tablets and a flu vaccine for individuals aged 60 and above [3]. Group 2: Business Implications - Successful progress in clinical trials is expected to broaden the company's business scope, optimize product structure, and enhance core competitiveness [2]. - The company has a diverse portfolio in biopharmaceuticals and traditional Chinese medicine, with investments in gene engineering, biological vaccines, antibody drugs, and modern Chinese medicine [2]. Group 3: Recent Product Approvals - Jinsai Pharmaceutical's injection of Fuxin Qibai monoclonal antibody has been approved for market release, targeting acute gout attacks in adults [4]. - Brillian Pharma's oral solution of Amlodipine Besylate has received FDA approval for treating high blood pressure and chronic stable angina in patients aged 6 and above [4].