Shanghai – September 08, 2026 -- Mabwell (688062.SH, 02493.HK) reported that its anti-ST2 monoclonal antibody 9MW1911 reduced the annualized rate of severe COPD exacerbations by 100% in the 900 mg dose group compared with placebo, according to Phase Ib/IIa data presented as a poster at the European Respiratory Society International Congress 2026 (ERS 2026).
Trial enrolled 80 COPD patients across four dose arms
The randomized, double-blind, placebo-controlled study (9MW1911-C03) enrolled 80 former smokers with moderate-to-severe COPD, randomizing participants to intravenous 9MW1911 at 100 mg, 300 mg, 600 mg, or 900 mg, or placebo, every four weeks. Most participants had blood eosinophil counts of 300 cells/μL or below.
High-dose group shows 81% reduction in moderate-to-severe exacerbations
Compared with placebo, the annualized rate of moderate-to-severe COPD exacerbations dropped 24% in the 600 mg group and 81% in the 900 mg group. Severe exacerbation rates fell 47% at 600 mg and 100% at 900 mg. Mabwell said the results support continued clinical development in COPD.
Pharmacokinetics confirm dose-proportional exposure through week 12
Trough concentrations reached steady state at approximately week 12, and drug exposure increased approximately dose-proportionally across the 100 mg to 900 mg range. The company reported an overall favorable safety and tolerability profile for 9MW1911 in the trial.
Phase IIb enrollment completes as Phase III targets late 2026 start
9MW1911, developed on Mabwell's proprietary B lymphocyte screening platform, is described by the company as the first homegrown monoclonal antibody targeting ST2 developed in China. Enrollment for a larger Phase IIb COPD study has been completed, with Phase III initiation expected around the end of 2026.
FDA clears IND for U.S. Phase IIa trial in moderate-to-severe COPD
The U.S. Food and Drug Administration has cleared the Investigational New Drug application for a Phase IIa clinical trial of 9MW1911 in patients with moderate-to-severe COPD, extending the program's development into the American market.