SHANGHAI, Sept. 4, 2026 /PRNewswire/ — 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.

About Mabwell

Mabwell (688062.SH, 02493.HK) is an innovation-driven biopharmaceutical company with capabilities spanning the entire pharmaceutical value chain. The company is committed to providing more effective and accessible therapies to meet global medical needs, with a focus on oncology and aging-related diseases. Mabwell’s mission is “Explore Life, Benefit Health” and its vision is “Innovation, from Ideas to Reality.” For more information, please visit www.mabwell.com/en. 

Forward-Looking Statements

This press release contains forward-looking statements including, but not limited to, the potential safety, efficacy, regulatory review or approval and commercial success of our product candidates and those relating to the Company’s product development, clinical studies, clinical and regulatory milestones and timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. “Forward-looking statements” are statements that are not historical facts and involve a number of risks and uncertainties, which may cause actual results to be materially different from any future results expressed or implied in the forward-looking statements. These statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “potential,” “predict,” “project,” “should,” “would,” and similar expressions and the negatives of those terms.

Forward-looking statements are based on the Company’s current expectations and assumptions. Forward-looking statements are subject to a number of risks, uncertainties, and other factors, many of which are beyond the Company’s control, including, but not limited to: environment; politic; economy; society; legislation; our dependence on our product candidates, most of which are still in preclinical or various stages of clinical development; our reliance on third-party vendors, such as contract research organizations and contract manufacturing organizations; the uncertainties inherent in clinical testing; our ability to complete required clinical trials for our product candidates and obtain approval from regulatory authorities for our product candidates; our ability to protect our intellectual property; the loss of any executive officers or key personnel. In case one or more of these risks or uncertainties deteriorate, or any assumptions are incorrect, the actual results may be seriously inconsistent with the stated results.

The Company cautions all the persons not to place undue reliance on any such forward-looking statements, which speaks only as of the date of this press release. The Company disclaims any obligation, except as specifically required by law and the rules of the applicable Stock authority to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. All forward-looking descriptions, figures and assumptions in this press release are applicable to this statement.

View original content:https://www.prnewswire.com/news-releases/ers-2026–mabwell-presents-phase-ibiia-clinical-results-of-anti-st2-monoclonal-antibody-9mw1911-in-copd-patients-302870024.html

SOURCE Mabwell