泽璟制药：注射用ZGGS34获得药物临床试验批准

Core Viewpoint - Zai Jian Pharmaceutical has received approval from the National Medical Products Administration for clinical trials of its drug ZGGS34, targeting MUC17-positive advanced solid tumors [1] Group 1: Drug Development - ZGGS34 is a trispecific antibody drug, classified as a trispecific T cell engager (TriTE), targeting CD3, CD28 on T cells, and the tumor-associated antigen MUC17 [2] - MUC17 is a transmembrane mucin highly expressed in gastric cancer, gastroesophageal junction cancer, pancreatic cancer, and colorectal cancer, making it a popular target for gastrointestinal tumor diagnosis and treatment [2] - ZGGS34 connects tumor cells and T cells, activating T cells to produce perforin, granzyme, and cytokines to kill tumor cells [2] Group 2: Mechanism of Action - The inclusion of a CD28 agonistic antibody in ZGGS34 enhances T cell activation, proliferation, and survival, providing stronger T cell activation capabilities compared to typical BiTE molecules [2] - CD28 binding lowers the T cell receptor activation threshold, enhancing T cell proliferation, metabolism, and anti-apoptotic abilities, thereby improving anti-tumor immune response [2] Group 3: Preclinical Results - Preclinical studies have shown that ZGGS34 exhibits significant tumor suppression in various tumor models, indicating its potent tumor-killing effects [3] - Toxicology studies in non-human primates have demonstrated good safety characteristics for ZGGS34 [3]