#China #Shanghai #Mabwell #9MW1911 #anti-ST2

Mabwell's Revolutionary Anti-ST2 Monoclonal Antibody 9MW1911: Paving the Way for COPD Treatment

Mabwell, a prominent biopharmaceutical enterprise, has recently made headlines by securing IND clearance from the FDA for its innovative monoclonal antibody, 9MW1911. This milestone marks a significant leap in the ongoing battle against chronic obstructive pulmonary disease (COPD), offering hope to millions suffering from this debilitating condition.

The Significance of 9MW1911

As the first domestic anti-ST2 monoclonal antibody to enter the clinical trial arena, 9MW1911 aims to provide a promising therapeutic option for patients grappling with moderate-to-severe COPD. By effectively binding to the ST2 receptor, the antibody acts to inhibit the IL-33/ST2 signaling pathway, which is often involved in the inflammatory response characteristic of COPD.

Clinical Trials and Results

Mabwell has already completed a Phase IIa study in China, involving 80 patients diagnosed with moderate-to-severe COPD. The results have been encouraging, showcasing that 9MW1911 is both safe and well-tolerated compared to the placebo, with adverse event rates comparable between the groups (70% in the treatment group versus 85% in the placebo).

Notably, there were no significant safety concerns identified, and immunogenicity remained negative across all subjects. The pharmacokinetics of the drug indicated increased exposure with escalating doses, laying the groundwork for a preliminary exposure-response model that will aid in defining the optimal dosage for treatment.

A critical part of the study revealed a dose-dependent decrease in the annualized exacerbation rate of COPD. At the recommended Phase IIb dose, a substantial over 30% reduction in moderate-to-severe exacerbations occurred compared to the placebo. Additionally, the rate of severe exacerbations decreased by over 40%, underscoring the potential efficacy of this revolutionary antibody.

Next Steps in Clinical Research

Mabwell is now transitioning into Phase IIb clinical trials, which will involve a more extensive patient population. The first dosing began in July 2025, with plans for interim analyses once data from at least 120 patients is collected. Looking ahead, Mabwell anticipates launching a Phase III trial by late 2026, focusing on further evaluating the safety, efficacy, and immunogenicity of 9MW1911.

About Mabwell

Mabwell (688062.SH) is an innovation-driven biopharmaceutical firm dedicated to developing sophisticated therapies that address unmet medical needs. With a solid commitment to oncology and age-related diseases, the company strives to enhance life quality globally. Its mission, “Explore Life, Benefit Health,” encapsulates its vision to translate innovative ideas into actionable healthcare solutions.

As Mabwell continues to push the boundaries of medical science and innovation, the introduction of 9MW1911 could reshape the treatment landscape for COPD, offering new hope to patients worldwide, and demonstrating the company’s commitment to advancing health care.

For more information about their pioneering work and updates on clinical trials, you can visit their official website at Mabwell.

Conclusion

The FDA's recent IND clearance for Mabwell's 9MW1911 not only reflects the company's innovative capabilities but also underscores the importance of continued investment in biopharmaceutical research. As we await further results from clinical trials, there is optimism on the horizon for patients affected by COPD, thanks to advances like 9MW1911 that aim to change the trajectory of treatment for chronic diseases.