泽璟制药(688266.SH)：注射用ZGGS34获得药物临床试验批准

Core Viewpoint - The company Zai Lab (688266.SH) has received approval from the National Medical Products Administration for the clinical trial of its drug ZGGS34, which targets MUC17-positive advanced solid tumors [1] Group 1: Drug Development - ZGGS34 is a trispecific antibody drug developed by the company, classified as a trispecific T cell engager (TriTE) [2] - The drug targets CD3, CD28 on T cells, and the tumor-associated antigen (TAA) MUC17, which is highly expressed in various gastrointestinal cancers [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, making it more effective than typical BiTE molecules [2] - CD28 lowers the activation threshold of TCR, enhancing T cell proliferation, metabolism, and anti-apoptotic capabilities [2] Group 3: Preclinical Results - Preclinical studies have shown that ZGGS34 exhibits significant tumor suppression in various tumor models, indicating its strong tumor-killing capability [3] - Toxicology studies in non-human primates have demonstrated good safety characteristics for ZGGS34 [3]