长春高新(000661.SZ)：子公司注射用GenSci139境内生产药品临床试验获批

Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd. (referred to as "Jinsai Pharmaceutical"), has received approval from the National Medical Products Administration for clinical trials of GenSci139 in patients with advanced solid tumors [1] Group 1: Product Development - GenSci139 is a dual-specific antibody-drug conjugate (BsADC) independently developed by Jinsai Pharmaceutical, targeting EGFR and HER2 [1] - The product utilizes a proprietary, highly stable, and hydrophilic cleavable linker, covalently connected to a potent topoisomerase I inhibitor as an effective payload [1] - GenSci139 specifically recognizes and binds to tumor cells expressing EGFR and/or HER2, blocking the signaling pathways of EGFR homodimers, HER2 homodimers, and EGFR-HER2 heterodimers, thereby inhibiting tumor cell growth [1] Group 2: Mechanism of Action - The drug can internalize upon binding to tumor cells expressing EGFR and/or HER2, releasing the effective payload to kill tumor cells [1]