Anti-ST2 Monoclonal Antibody 9MW1911 Cuts Severe COPD Exacerbations by Up to 100% in Phase Ib/IIa Trial as Phase III Initiation Approaches

InnoDexis has published its latest Innovation Intelligence Report covering respiratory biologics and COPD therapeutic development, analysing a high-significance clinical innovation from China's biopharmaceutical pipeline. The report reveals that Mabwell has presented Phase Ib/IIa results for 9MW1911 — a proprietary anti-ST2 monoclonal antibody developed using a high-efficiency B lymphocyte screening platform — demonstrating up to 100% reduction in the annualised rate of severe COPD exacerbations in high-dose groups, with Phase III initiation expected around end of 2026 across trials spanning China and the United States.

Key Findings

9MW1911 demonstrated up to 81% reduction in the annualised rate of moderate-to-severe COPD exacerbations in high-dose groups during the Phase Ib/IIa trial. This magnitude of reduction in a condition where exacerbations are the primary driver of disease progression and hospitalisation represents a clinically meaningful signal, provided it is sustained and replicated at Phase III scale.

Severe COPD exacerbations — the subset associated with the highest clinical burden and hospitalisation risk — were reduced by up to 100% in high-dose groups. This is the most clinically significant data point in the dataset. A complete elimination of severe exacerbations, if confirmed in Phase III, would materially alter the biologic management framework for moderate-to-severe COPD patients who currently have limited targeted therapeutic options.

Trough concentrations of 9MW1911 reached steady state at approximately week 12, establishing a defined pharmacokinetic profile for the drug candidate. This steady-state timeline is relevant for Phase III trial design, dosing interval decisions, and the assessment of long-term tolerability across a broader patient population.

9MW1911 is identified as the first homegrown Chinese monoclonal antibody to advance the ST2 mechanism into clinical evaluation. The antibody was developed using a high-efficiency B lymphocyte screening platform — a differentiated antibody discovery route that distinguishes the development pathway from conventional hybridoma or phage display approaches. FDA Investigational New Drug clearance and Phase III progression signal growing regulatory confidence in ST2 as a therapeutic target.

Phase III initiation is expected around end of 2026, with trial scope spanning China and the United States. This dual-market trial design is strategically significant — positioning 9MW1911 for regulatory pathways in both the Chinese and US markets simultaneously, and generating a dataset with cross-population validity that single-market trials cannot produce.

Strategic Insight and Trend Analysis

The strategic significance of 9MW1911 extends beyond the clinical results of a single Phase Ib/IIa trial. COPD remains one of the leading causes of chronic morbidity globally, yet biologic options for moderate-to-severe patients have remained limited relative to the breadth of targeted therapies available in comparable inflammatory conditions such as asthma. The ST2 pathway — which mediates type 2 inflammatory signalling — has had no targeted biologic therapy at scale prior to 9MW1911's clinical advancement. This positions the drug candidate as a potential first-in-class entrant in a mechanistically defined but therapeutically underserved space.

The shift this innovation represents is structural rather than incremental. Current COPD management is anchored in symptomatic and bronchodilator-based approaches that address airflow limitation without directly interrupting the inflammatory pathways driving exacerbation frequency. ST2 blockade, if validated at Phase III scale, would move COPD treatment from symptom management toward pathway interruption — a transition analogous to the shift that anti-IL-5 and anti-IL-4/13 biologics produced in severe asthma management over the past decade.

The origin of 9MW1911 within China's biopharmaceutical ecosystem carries its own strategic signal. As the first homegrown Chinese monoclonal antibody to advance the ST2 mechanism into clinical evaluation, 9MW1911 reflects a maturing domestic biologics capability that is progressing from biosimilar development toward novel mechanism origination. The dual China-US Phase III design amplifies this signal — it is not a domestically scoped programme but one structured for global regulatory validation from the outset.

Phase III results will be the definitive test. The translation from early-phase exacerbation elimination to Phase III efficacy at scale is not guaranteed, and the dataset notes the long-term translational risk inherent in early-phase clinical data. The question Phase III will answer is whether the ST2 blockade signal holds across a broader, more heterogeneous COPD patient population.

Global and Industry Implications

For corporates and R&D teams in respiratory biologics, 9MW1911's Phase Ib/IIa results validate the ST2 pathway as a clinically actionable target in COPD and establish a performance benchmark for competing programmes. Organisations with ST2-adjacent or exacerbation-focused pipeline assets should monitor Phase III initiation closely, as the trial design and patient selection criteria will define the competitive landscape for this mechanism class.

For investors and capital allocators, the dual China-US Phase III structure represents a risk-adjusted positioning that broadens the addressable regulatory outcome. A successful Phase III readout in both markets would establish 9MW1911 as a global biologic asset rather than a regionally scoped one. The early-phase elimination of severe exacerbations, while requiring Phase III confirmation, represents the most commercially significant clinical signal currently visible in the ST2 COPD pipeline.

For policymakers and national innovation bodies, 9MW1911 illustrates the strategic return on sustained investment in domestic biologics capability. China's progression from biosimilar manufacturing toward first-in-class mechanism origination — demonstrated here through the ST2 pathway advancement and FDA IND clearance — reflects a structural shift in the global biopharmaceutical innovation landscape that has direct implications for national health system access and supply chain resilience.

InnoDexis Statement

"9MW1911's Phase Ib/IIa data positions ST2 blockade as the most advanced biologic mechanism targeting COPD exacerbation frequency, with Phase III scope across China and the United States establishing the first global validation pathway for this therapeutic approach," noted InnoDexis in its latest intelligence report.

Conclusion

The COPD biologic pipeline is entering a structurally important phase as ST2-targeted therapy advances toward Phase III validation. If 9MW1911's early-phase exacerbation reduction translates at scale, it would establish a new therapeutic category in respiratory medicine and expand the biologic management options available to moderate-to-severe COPD patients globally. InnoDexis will continue to monitor ST2 pathway developments, Phase III trial progression, and the broader emergence of targeted biologics in respiratory disease. The complete Respiratory Biologics Innovation Intelligence Report is available to InnoDexis subscribers and enterprise clients.

About InnoDexis

InnoDexis is a global Innovation Intelligence platform that tracks, analyzes, and interprets breakthrough innovations, prototypes, and emerging technologies across industries and countries. Its intelligence helps corporates, investors, and policymakers understand the true structure and direction of global innovation. Learn more at innodexis.ai.