成都苑东生物制药股份有限公司关于自愿披露EP-0210单抗注射液I期临床试验完成首例受试者给药的公告

Core Viewpoint - Chengdu Yuandong Biopharmaceutical Co., Ltd. has announced the completion of the first dosing of the EP-0210 monoclonal antibody injection in a Phase I clinical trial for treating inflammatory bowel disease, indicating progress in its drug development pipeline [1][3]. Group 1: Drug Overview - EP-0210 monoclonal antibody injection is a humanized IgG1 monoclonal antibody targeting TNF-like ligand 1A (TL1A), aimed at treating inflammatory bowel disease by blocking TL1A-mediated pro-inflammatory signaling pathways [1][2]. - Preclinical studies have shown that EP-0210 has a clear mechanism of action and significant efficacy in various inflammatory bowel disease models, demonstrating better target activity and efficacy compared to the foreign competitor RVT-3101 [2]. Group 2: Clinical Trial Details - The Phase I clinical trial for EP-0210 received formal approval from the National Medical Products Administration in January 2026, with the trial focusing on safety, tolerability, pharmacokinetics, and immunogenicity in healthy adult participants [3]. - As of the announcement date, the first dosing in the single-dose administration phase of the trial has been completed [3].