Core Viewpoint - Changchun High-tech (000661) announced that its subsidiary, Jinsai Pharmaceutical, received written notification from the FDA approving the clinical trial application for GenSci143, allowing trials to be conducted in the United States [1] Group 1: Product Development - GenSci143 is a dual-specific antibody-drug conjugate targeting B7-H3 and PSMA, indicated for advanced solid tumors, with potential dual therapeutic effects of targeted chemotherapy and tumor immunotherapy [1] - The drug has already been approved for clinical trials in advanced solid tumors in China, and the FDA approval will help the company expand its business structure and optimize its product portfolio [1] Group 2: Strategic Implications - The approval from the FDA enriches the product line layout in strategic areas for the company, indicating a positive step towards enhancing its market presence and competitiveness [1]
长春高新:子公司金赛药业注射用GenSci143临床试验获FDA批准