Mabwell's 9MW1911 shows promise in reducing COPD exacerbations

SHANGHAI, Sept. 4, 2026 /CourierPR/ -- Mabwell, a leading innovation-driven biopharmaceutical company based in China, has announced significant progress in its clinical trial of an anti-ST2 monoclonal antibody, 9MW1911, for the treatment of chronic obstructive pulmonary disease (COPD). The results, presented as a poster at the European Respiratory Society International Congress 2026 (ERS 2026), show promising efficacy in reducing COPD exacerbations.

The Phase Ib/IIa study, titled 9MW1911-C03, was a randomized, double-blind, placebo-controlled, multiple-dose, dose-escalation trial aimed at evaluating the safety, tolerability, and pharmacokinetic profile of 9MW1911 in former smokers with moderate-to-severe COPD. The study also provided a preliminary assessment of the antibody's efficacy and immunogenicity. A total of 80 participants were enrolled and randomized to receive intravenous infusions of 9MW1911 at doses of 100 mg, 300 mg, 600 mg, or 900 mg, or a placebo, administered every four weeks.

Pharmacokinetic data indicated that trough concentrations of 9MW1911 reached steady state at approximately week 12. Dose proportionality analysis showed that the exposure of 9MW1911 increased approximately dose-proportionally over the 100-900 mg dose range, with no significant safety concerns observed across the different dose groups. The overall safety and tolerability profile of 9MW1911 was favorable.

Efficacy results revealed that compared to the placebo group, the annualized rate of moderate-to-severe COPD exacerbations was reduced by 24% and 81% in the 600 mg and 900 mg dose groups, respectively. The annualized rate of severe COPD exacerbations was reduced by 47% and 100% in the 600 mg and 900 mg dose groups, respectively. These findings indicate the potential of 9MW1911 in reducing the risk of COPD exacerbations and support its future clinical development in COPD patients.

9MW1911 is the first homegrown monoclonal antibody targeting ST2 in China, developed by Mabwell using its proprietary high-efficiency B lymphocyte screening platform. The company has completed the Phase Ib/IIa study and the enrollment for the Phase IIb study in a larger COPD patient population. The Phase III trial is expected to commence by the end of 2026. Additionally, the U.S. Food and Drug Administration (FDA) has cleared the IND application for a Phase IIa clinical trial in patients with moderate-to-severe COPD in the United States.

Mabwell, listed on the Shanghai Stock Exchange (688062.SH) and the Hong Kong Stock Exchange (02493.HK), is committed to providing more effective and accessible therapies to meet global medical needs, particularly in the areas of oncology and aging-related diseases. The company's mission is "Explore Life, Benefit Health," and its vision is "Innovation, from Ideas to Reality."

These clinical results underscore Mabwell's progress in developing innovative treatments for COPD, a condition affecting millions globally. The positive efficacy signals for 9MW1911 in reducing COPD exacerbations could have a significant impact on patient care and management.