迈威（上海）生物科技股份有限公司自愿披露关于9MW1911临床研究进展的公告

Core Viewpoint - The announcement details the progress of the clinical research for the innovative drug 9MW1911 developed by Maiwei Biotech, highlighting its safety, tolerability, and efficacy in patients with moderate to severe chronic obstructive pulmonary disease (COPD) [2][4]. Group 1: Drug Overview - 9MW1911 is an innovative monoclonal antibody developed using a high-efficiency B lymphocyte screening platform, targeting the ST2 receptor to block the IL33/ST2 signaling pathway [2]. - The drug has completed a Phase IIa clinical study involving 80 patients with moderate COPD, with a Phase IIb trial expected to start in July 2025 after enrolling at least 120 participants [2][3]. Group 2: Clinical Trial Results - The Phase IIa study (9MW1911-C03) was a randomized, double-blind, placebo-controlled trial assessing safety, tolerability, pharmacokinetics, and preliminary efficacy [3]. - Results indicated that all dosage groups of 9MW1911 showed good safety and tolerability compared to the placebo group, with an adverse event rate of 70% versus 85% for the placebo [4]. - The annualized rate of acute exacerbations in moderate COPD patients decreased by over 30% at the recommended Phase IIb dose compared to the placebo, and the rate of severe exacerbations decreased by over 40% [2][4].