Core Viewpoint - Changchun Gaoxin announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., received written notification from the FDA regarding the acceptance of the clinical trial application for its drug GenSci143, which is a dual-specific antibody-drug conjugate targeting B7-H3 and PSMA, indicating potential dual therapeutic effects in chemotherapy and tumor immunotherapy [1]. Company Summary - Changchun Gaoxin's subsidiary, Changchun Jinsai Pharmaceutical, has developed GenSci143, which is a novel drug designed to target specific cancer markers [1]. - The acceptance of the clinical trial application by the FDA is a significant milestone for the company, potentially paving the way for further development and commercialization of GenSci143 [1]. Industry Summary - The drug GenSci143 represents advancements in the field of targeted cancer therapies, particularly in the area of dual-specific antibody-drug conjugates, which may enhance treatment efficacy [1]. - The FDA's acceptance of clinical trial applications is a critical step in the drug development process, reflecting regulatory confidence in innovative cancer therapies [1].
长春高新注射用GenSci143境外生产药品注册临床试验申请获得受理