Mabwell Biopharmaceuticals’ innovative drug 9MW1911 completes Phase IIa clinical trial in COPD patients

December 1, 2025  Source: drugdu 54

"/On the evening of November 30, Mabwell Bio announced that its independently developed innovative drug...9MW1911 has completed a Phase IIa clinical trial in patients with moderate to severe chronic obstructive pulmonary disease (COPD), demonstrating good safety and tolerability in all dose groups. Currently, the company is actively advancing a Phase IIb clinical trial of 9MW1911 for the COPD indication.

The announcement indicates that 9MW1911 is an innovative monoclonal antibody independently developed based on a highly efficient B lymphocyte screening platform, and belongs to the category of therapeutic biological products.Class 1, which can bind to the ST2 receptor with high affinity, thereby blocking the IL33/ST2 signaling pathway. Currently, Mabwell Bio is rapidly advancing the Phase II clinical trial of this drug in China. The first dose was administered in the Phase IIb clinical trial targeting a larger sample size of COPD patients in July 2025, and it is expected that based on the evaluation of the Phase II clinical trial results, a Phase III clinical trial will be initiated by the end of 2026 to observe safety, efficacy and immunogenicity.
Meanwhile, Mabwell Biotech designed a Phase IIa clinical trial protocol in the United States based on clinical research data of 9MW1911 in China. This clinical trial application has recently been formally accepted by the U.S. Food and Drug Administration (FDA).

 

https://finance.eastmoney.com/a/202512013579062877.html

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