Mabwell Reports 9MW1911 COPD Phase Ib/IIa Results

Shanghai, China, September 4, 2026

9MW1911 Shows Reduction in COPD Exacerbations

The 9MW1911-C03 Phase Ib/IIa study was designed as a randomized, double-blind, placebo-controlled, multiple-dose, dose-escalation trial primarily evaluating the safety, tolerability and pharmacokinetics of 9MW1911, while also providing a preliminary assessment of efficacy and immunogenicity. A total of 80 participants with moderate-to-severe COPD were enrolled and randomized to receive intravenous 9MW1911 at doses of 100 mg, 300 mg, 600 mg or 900 mg, or placebo, with treatment administered every four weeks. Participants were former smokers, and most had blood eosinophil counts of 300 cells/μL or lower. Mabwell reported that demographic characteristics were generally balanced across the treatment groups and placebo arm. The preliminary efficacy findings showed a numerical reduction in COPD exacerbations at the higher doses. Compared with placebo, the annualized rate of moderate-to-severe COPD exacerbations was reduced by 24% in the 600 mg group and 81% in the 900 mg group. The annualized rate of severe COPD exacerbations was reduced by 47% and 100%, respectively, in those dose groups. These findings represent preliminary clinical signals rather than definitive evidence of efficacy, and the relatively small Phase Ib/IIa study will need to be followed by larger controlled trials to establish the treatment effect.

Anti-ST2 Antibody Targets IL-33/ST2 Pathway

9MW1911 is an investigational monoclonal antibody targeting ST2, a receptor involved in the IL-33/ST2 signaling pathway associated with inflammatory responses. Mabwell developed the antibody using its proprietary high-efficiency B-lymphocyte screening platform and describes 9MW1911 as the first domestically developed anti-ST2 monoclonal antibody in China. By targeting ST2, the program is intended to modulate inflammatory signaling that may contribute to exacerbations and disease activity in COPD. Pharmacokinetic analysis from the Phase Ib/IIa study showed that trough concentrations reached steady state at approximately Week 12, while exposure increased approximately dose-proportionally across the 100–900 mg dose range. Mabwell also reported an overall favorable safety and tolerability profile for 9MW1911 across the evaluated dose levels. These pharmacokinetic and safety observations provide important information for dose selection and continued clinical development, although larger and longer studies will be needed to characterize the therapy’s safety profile more comprehensively.

Mabwell Advances 9MW1911 Toward Phase III

The Phase Ib/IIa results represent an important milestone in Mabwell’s respiratory drug-development program. The company has completed the Phase Ib/IIa study and reported that enrollment in its Phase IIb COPD study has also been completed. Mabwell expects to initiate a Phase III trial around the end of 2026, subject to the development and regulatory process. In parallel, the U.S. FDA has cleared an IND application for a Phase IIa clinical trial of 9MW1911 in patients with moderate-to-severe COPD, extending the development program into the United States. The program’s progression into larger clinical studies will be important for determining whether the preliminary reductions in COPD exacerbations observed at higher doses can be reproduced in broader patient populations. 9MW1911 remains investigational, and the Phase Ib/IIa findings do not establish regulatory approval or confirm long-term clinical benefit. Nevertheless, the results provide a meaningful clinical data point for the development of ST2-targeted biologic therapy in COPD and strengthen the rationale for continued evaluation of the candidate in later-stage trials.

Source: Mabwell press release