Mabwell's Anti-ST2 Antibody 9MW1911 Receives FDA IND Clearance for COPD Phase IIa Trial
核心洞察
Mabwell (搜索) received FDA IND clearance for 9MW1911, the first domestic anti-ST2 monoclonal antibody (搜索) to enter clinical trials for moderate-to-severe COPD (搜索) treatment.
Phase IIa results in China showed 9MW1911 reduced moderate-to-severe COPD (搜索) exacerbations by over 30% and severe exacerbations by over 40% at the recommended Phase IIb dose.
The company plans to launch Phase III clinical studies by the end of 2026 following evaluation of ongoing Phase IIb trial results.
Mabwell (搜索) has received IND clearance from the U.S. Food and Drug Administration (搜索) for its novel anti-ST2 monoclonal antibody (搜索) 9MW1911 to initiate a Phase IIa clinical study in patients with moderate-to-severe chronic obstructive pulmonary disease (搜索) (COPD (搜索)). The Shanghai-based biopharmaceutical company announced this regulatory milestone on December 24, 2025, marking a significant advancement for the first domestic anti-ST2 monoclonal antibody candidate to enter clinical trials.
Mechanism of Action and Clinical Development
9MW1911 binds to the ST2 (搜索) receptor with high affinity to block the IL-33 (搜索)/ST2 signaling pathway, a critical inflammatory cascade involved in COPD (搜索) pathogenesis. The antibody has already completed a Phase IIa study in China involving 80 patients with moderate-to-severe COPD, demonstrating promising safety and efficacy signals.
The completed Chinese Phase IIa trial showed that 9MW1911 was safe and well-tolerated across all dose groups compared to placebo, with a similar adverse event incidence of 70% versus 85% for placebo. Notably, immunogenicity was negative in all subjects, and no new safety risk signals were identified during the study period.
Efficacy Results and Dose-Response Relationship
Efficacy data from the Phase IIa study revealed that the annualized exacerbation rate of COPD (搜索) demonstrated a dose-dependent decrease in the treatment arms. At the recommended Phase IIb dose (RP2D), which included 30 patients, the annualized rate of moderate-to-severe COPD exacerbations was reduced by over 30% compared to the placebo group.
More significantly, the annualized rate of severe exacerbations at the RP2D was reduced by over 40%, with the proportion of patients experiencing severe exacerbations significantly lower than the placebo group at 13.3% versus 35%. These results suggest substantial clinical benefit in preventing the most serious COPD (搜索) complications.
Pharmacokinetic analysis showed that drug exposure increased with escalating doses, allowing researchers to establish a preliminary exposure-response model that defines the dose-effect relationship and provides a foundation for subsequent dose selection in larger trials.
Clinical Development Timeline
The Phase IIb clinical trial evaluating 9MW1911 in a larger COPD (搜索) population achieved its first patient dosing in July 2025. An interim analysis is planned after data from at least 120 patients are collected, which will inform the design and timing of subsequent development phases.
Based on the evaluation of Phase II outcomes, Mabwell (搜索) expects to launch a Phase III clinical study by the end of 2026 to further observe the drug's safety, efficacy, and immunogenicity in an expanded patient population. This timeline positions 9MW1911 as a potential breakthrough therapy for COPD (搜索) patients who currently have limited treatment options for preventing disease exacerbations.
Company Background and Strategic Focus
Mabwell (搜索) is an innovation-driven biopharmaceutical company with capabilities spanning the entire pharmaceutical value chain. The company focuses on developing therapies for oncology and aging-related diseases, operating under the mission "Explore Life, Benefit Health" and the vision "Innovation, from Ideas to Reality."
The FDA IND clearance for 9MW1911 represents a significant milestone in Mabwell (搜索)'s international expansion strategy and validates the company's research and development capabilities in developing novel therapeutic approaches for respiratory diseases.