Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd. (referred to as "Jinsai Pharmaceutical"), received written notification from the U.S. Food and Drug Administration (FDA) approving the clinical trial application for its injectable GenSci143, a dual-specific antibody-drug conjugate targeting B7-H3 and PSMA, which has potential dual therapeutic effects of targeted chemotherapy and tumor immunotherapy [1] Group 1 - Jinsai Pharmaceutical's GenSci143 is a self-developed drug aimed at treating various advanced solid tumors, including prostate cancer and lung cancer [1] - The drug is classified as a Class 1 biological product for therapeutic use [1] - The approval from the FDA marks a significant milestone for the company in the oncology drug development space [1]
长春高新(000661.SZ):子公司注射用GenSci143境外生产药品注册临床试验申请获得批准