Mabwell (688062.SH, 02493.HK), an innovation-driven biopharmaceutical company with a fully integrated industry chain, announced the Phase Ib/IIa clinical results of its anti-ST2 monoclonal antibody 9MW1911 in patients with chronic obstructive pulmonary disease (COPD), which will be presented as a poster at the European Respiratory Society International Congress 2026 (ERS 2026). Preliminary efficacy results showed positive signals for 9MW1911 in reducing COPD exacerbations, and a numerical trend toward a reduction in COPD exacerbations was observed in the mid-to-high dose groups

This Phase Ib/IIa study (9MW1911‑C03) is a randomized, double‑blind, placebo‑controlled, multiple‑dose, dose‑escalation trial, with the primary objective of evaluating the safety, tolerability, and pharmacokinetic profile of 9MW1911 in former smokers with moderate‑to‑severe COPD, and a preliminary assessment of its efficacy and immunogenicity.

A total of 80 participants were enrolled and randomized to receive intravenous infusions of 9MW1911 injection (at doses of 100 mg, 300 mg, 600 mg, or 900 mg) or placebo, administered every 4 weeks. The demographic characteristics were generally balanced across the 9MW1911 dose groups and the placebo group. Most participants had blood eosinophil counts ≤300 cells/μL. Pharmacokinetic data indicated that trough concentrations reached steady state at approximately week 12. Dose proportionality analysis showed that 9MW1911 exposure increased approximately dose-proportionally over the 100–900 mg dose range. 9MW1911 demonstrated an overall favorable safety and tolerability profile.

In terms of efficacy, compared with the placebo group, the annualized rate of moderate‑to‑severe COPD exacerbations were 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 results preliminarily demonstrate the therapeutic potential of 9MW1911 in reducing the risk of COPD exacerbations and further support its subsequent clinical development in the COPD patients.

9MW1911, independently developed by Mabwell based on its proprietary high-efficiency B lymphocyte screening platform, is the first homegrown monoclonal antibody targeting ST2 in China. The Phase Ib/IIa study in patients with moderate‑to‑severe COPD has been completed, and enrollment for the Phase IIb study in a larger COPD patient population is now complete. The Phase III trial is expected to be initiated around the end of 2026. In addition, the FDA has cleared the IND application for a Phase IIa clinical trial in patients with moderate‑to‑severe COPD in the United States.