苏州泽璟生物制药股份有限公司关于自愿披露注射用ZGGS34临床试验申请获得FDA批准的公告

Core Viewpoint - Suzhou Zaiqian Biopharmaceutical Co., Ltd. has received FDA approval for the clinical trial application of its product ZGGS34, aimed at treating advanced solid tumors [2][3] Group 1: Drug Information - ZGGS34 is a trispecific antibody drug developed by the company and its subsidiary Gensun Biopharma Inc., utilizing a dual/multi-specific antibody research platform [3] - The drug targets T-cell markers CD3 and CD28, as well as the tumor-associated antigen MUC17, which is highly expressed in various gastrointestinal cancers [3] - ZGGS34 connects tumor cells and T-cells, activating T-cells to produce perforin, granzyme, and cytokines to kill tumor cells, demonstrating enhanced anti-tumor immune effects compared to typical BiTE molecules [3] Group 2: Preclinical Research Results - Preclinical studies have shown that ZGGS34 exhibits significant tumor suppression effects across various tumor models, indicating its strong tumor-killing capability [4] - Toxicology studies in non-human primates have demonstrated controllable side effects and good safety characteristics for ZGGS34 [4] Group 3: Financial Impact - The FDA approval of the clinical trial application for ZGGS34 is not expected to have a significant impact on the company's recent performance due to the lengthy and uncertain nature of drug development [2][5]