#China #Shanghai #Mabwell #COPD #9MW1911

Mabwell Showcases Phase Ib/IIa Results of 9MW1911 for COPD

At the European Respiratory Society (ERS) International Congress 2026, Mabwell, a pioneering biopharmaceutical firm, revealed the clinical findings of its innovative therapy, the anti-ST2 monoclonal antibody 9MW1911, targeted at patients with chronic obstructive pulmonary disease (COPD). This Phase Ib/IIa study, designated 9MW1911-C03, was a carefully structured randomized, double-blind, placebo-controlled trial that aimed to assess the safety, tolerability, and pharmacokinetic profile of the drug while preliminary assessing its efficacy and immunogenicity among individuals who were former smokers suffering from moderate-to-severe COPD.

In total, 80 participants were enrolled in this study, wherein they were administered either 9MW1911 at varying doses of 100 mg, 300 mg, 600 mg, or 900 mg, or a placebo, given through intravenous infusions every four weeks. The demographic distribution across the groups appeared balanced, with the majority of subjects presenting blood eosinophil counts of ≤300 cells/µL. Notably, pharmacokinetic evaluations suggested that trough concentrations reached a stable state around week 12, affirming the drug's consistent behavior within the body. The analysis of dose proportionality indicated an increase in drug exposure in correlation to higher doses, showcasing the uniformity of 9MW1911's profile as dosage increased.

On the efficacy front, compelling results emerged from the study. The annualized rate of moderate-to-severe COPD exacerbations was notably reduced by 24% in the 600 mg dosage group and by a striking 81% in the 900 mg group compared to the placebo cohort. Additionally, severe COPD exacerbation rates were reduced by 47% and an impressive 100% in the same 600 mg and 900 mg groups, respectively.

Such results preliminary endorse the promising therapeutic potential of 9MW1911, highlighting its role in mitigating the risk of COPD exacerbations and laying down a solid foundation for further clinical development focused on supporting COPD patients. This innovative monoclonal antibody marks a significant milestone as it is the first of its kind to target ST2 developed independently in China.

The completion of the Phase Ib/IIa study sets the stage for subsequent advancement, with enrollment for a Phase IIb study in a broader COPD patient population successfully concluded. Furthermore, plans for initiating a Phase III trial towards the close of 2026 are underway, in conjunction with recent approval from the FDA for a Phase IIa trial set to occur in the United States.

About Mabwell

Mabwell, traded on the Shanghai Stock Exchange (688062.SH) and Hong Kong Stock Exchange (02493.HK), is an innovation-oriented biopharmaceutical firm committed to delivering effective and accessible therapies tailored to meet evolving global medical needs. With expertise spanning the pharmaceutical value chain and a focus primarily on oncology and aging-related illnesses, Mabwell adheres to its mission of "Explore Life, Benefit Health," anchoring its vision on transforming innovative ideas into reality. More details are available on their official website: Mabwell.

This announcement not only signifies Mabwell's advancements but also reflects a promising future for COPD treatments that could potentially alter patient outcomes significantly. As they progress with their trials and research, the anticipation for further innovations in the biopharmaceutical landscape remains high.