Mabwell (Shanghai) Bioscience Co., Ltd. has released a voluntary announcement detailing updated Phase Ib/IIa results for its investigational monoclonal antibody 9MW1911 in former smokers with moderate-to-severe chronic obstructive pulmonary disease (COPD). The data will be highlighted in a poster presentation at the European Respiratory Society (ERS) Congress 2026, scheduled for 5–9 September in Barcelona.
Developed on Mabwell’s high-efficiency B-cell screening platform, 9MW1911 is a Class 1 therapeutic biological product that targets the ST2 receptor to inhibit the IL-33/ST2 signaling pathway. The completed Phase Ib/IIa trial (N = 80; Study 9MW1911-C03) was a randomized, double-blind, placebo-controlled, multiple-dose escalation study assessing safety, tolerability, pharmacokinetics, immunogenicity, and preliminary efficacy.
Key efficacy signals: • Annualised moderate-to-severe COPD exacerbations fell 24% in the 600 mg cohort and 81% in the 900 mg cohort versus placebo. • Annualised severe exacerbations declined 47% and 100% in the 600 mg and 900 mg groups, respectively. • Pharmacokinetic assessment showed steady-state plasma concentrations at Week 12 with approximately dose-proportional exposure across the 100-900 mg range. • Safety and tolerability were deemed favorable across all four dose levels (100, 300, 600, 900 mg) administered every four weeks.
Development progress: • A Phase IIb trial in a larger COPD population commenced first-in-patient dosing in July 2025, completed enrollment in June 2026, and is now in follow-up. Interim analysis will begin after last-visit data from at least 120 participants. • Subject to interim findings, a global Phase III study is targeted to start around end-2026 to evaluate safety, efficacy, and immunogenicity. • The U.S. Food and Drug Administration has cleared Mabwell’s Investigational New Drug application for a U.S. Phase IIa study.
Regulatory and investment considerations: The company cautions that clinical outcomes may not guarantee eventual regulatory approval or commercial success. Timelines and approvals remain subject to uncertainties inherent in pharmaceutical development. Mabwell commits to timely disclosure of material updates in accordance with applicable regulations.