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Mabwell Receives IND Clearance for Novel Anti-ST2 Monoclonal Antibody 9MW1911 to Initiate Phase IIa Study
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).
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[{"type":"text","content":"SHANGHAI, Dec. 24, 2025 /PRNewswire/ -- 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).","length":438,"tagName":"p"},{"type":"text","content":"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.","length":282,"tagName":"p"},{"type":"text","content":"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.","length":472,"tagName":"p"},{"type":"text","content":"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.","length":232,"tagName":"p"},{"type":"text","content":"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%).","length":517,"tagName":"p"},{"type":"text","content":"The Phase IIb clinical trial evaluating 9MW1911 in a larger COPD population achieved its first patient dosing in July 2025, with an interim analysis ...
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