TL1A抗体药物研发
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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
Shang Hai Zheng Quan Bao· 2026-02-09 18:39
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].
苑东生物EP-0210单抗注射液I期临床试验完成首例受试者给药
Bei Jing Shang Bao· 2026-02-09 12:12
Core Viewpoint - Yuan Dong Bio (688513) announced that its wholly-owned subsidiary Chengdu Youluo Biotechnology Co., Ltd. has initiated Phase I clinical trials for its monoclonal antibody EP-0210 injection, targeting inflammatory bowel disease, with the first patient dosing recently completed [1] Company Summary - EP-0210 is a humanized IgG1 monoclonal antibody that targets TNF-like ligand 1A (TL1A), aiming to treat inflammatory bowel disease by effectively binding to TL1A and blocking pro-inflammatory signaling pathways [1] - The development of TL1A antibody drugs is one of the most closely watched emerging targets in the field of inflammatory bowel disease, with no similar drugs currently available on the market globally [1] Industry Summary - The fastest global development progress for TL1A-targeting drugs is being made by Merck, Sanofi, and Roche/Pfizer, all of which have TL1A antibody drugs in Phase III clinical trials [1] - In China, companies such as 3SBio, ZhiXiang JinTai, and HuaShen ZhiYao have also entered Phase I clinical trials for similar TL1A-targeting drugs [1]