Mabwell (688062.SH), an innovation-driven biopharmaceutical company with a fully integrated industry chain, announced that it has received IND clearance from the U.S. Food and Drug Administration (FDA) for its self-developed anti-ST2 monoclonal antibody (R&D code: 9MW1911) to initiate a Phase IIa clinical study in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).

As the first domestic anti-ST2 monoclonal antibody candidate to enter clinical trials, 9MW1911 binds to the ST2 receptor with high affinity to block the IL-33/ST2 signaling pathway. It has already completed a Phase IIa study (N=80) in patients with moderate-to-severe COPD in China.

Results showed that 9MW1911 was safe and well-tolerated across all dose groups compared to placebo (N=20), with a similar adverse event incidence (70% vs. 85%). Immunogenicity was negative in all subjects, and no new safety risk signals were identified. Regarding pharmacokinetics, drug exposure increased as doses escalated. An exposure-response model can be preliminary established to define the dose-effect relationship, providing a basis for subsequent dose selection.

Pharmacokinetic results suggested that drug exposure increased with escalating doses. An exposure-response model can be preliminary established to define the dose-effect relationship, providing a basis for subsequent dose selection.

Efficacy data revealed that the annualized exacerbation rate of COPD demonstrated a dose-dependent decrease in the treatment arms. At the recommended Phase IIb dose (RP2D, N=30), the annualized rate of moderate-to-severe COPD exacerbations was reduced by over 30% compared to the placebo group. Furthermore, the annualized rate of severe exacerbations at the RP2D was reduced by over 40%, and the proportion of patients experiencing severe exacerbations was significantly lower than the placebo group (13.3% vs. 35%).

The Phase IIb clinical trial evaluating 9MW1911 in a larger COPD population achieved its first patient dosing in July 2025, with an interim analysis planned after data from at least 120 patients are collected. Based on the evaluation of Phase II outcomes, the company expects to launch a Phase III clinical study by the end of 2026 to further observe the drug's safety, efficacy, and immunogenicity.