长春高新注射用GenSci143境外生产药品注册临床试验申请获批

Core Viewpoint - Changchun Gaoxin announced that its subsidiary, Changchun Jinsai Pharmaceutical, received written notification from the U.S. Food and Drug Administration (FDA) approving the clinical trial application for GenSci143, a dual-specific antibody-drug conjugate targeting B7-H3 and PSMA, indicating significant progress in its oncology drug development [1] Group 1: Company Developments - Changchun Jinsai Pharmaceutical has developed GenSci143, which is a dual-specific antibody-drug conjugate (BsADC) targeting B7-H3 and PSMA [1] - GenSci143 is classified as a Class 1 biological product intended for the treatment of advanced solid tumors, including prostate cancer and lung cancer [1] Group 2: Industry Implications - The approval of GenSci143 for clinical trials highlights the growing focus on targeted therapies in oncology, particularly those that combine chemotherapy and immunotherapy [1]