泽璟制药：注射用ZGGS34临床试验申请获得FDA批准

Core Viewpoint - Zai Jian Pharmaceutical (688266.SH) has received FDA approval for its investigational product ZGGS34, which is intended for the treatment of advanced solid tumors [1] Group 1: Product Development - ZGGS34 is a trispecific antibody drug developed by the company and its subsidiary Gensun Biopharma Inc. through its bispecific/multispecific antibody research platform [1] - The drug targets CD3 and CD28 on T cells, as well as the tumor-associated antigen (TAA) MUC17, making it a trispecific T cell engager (TriTE) [1] Group 2: Clinical Research - Preclinical studies have shown that ZGGS34 exhibits significant tumor suppression effects across various tumor models, leading to tumor regression, indicating its potent tumor-killing capabilities [1] - Toxicology studies conducted in non-human primates have demonstrated that ZGGS34 has controllable side effects and good safety characteristics [1]