By Fineline Cube 
Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) announced that its ST2‑blocking monoclonal antibody 9MW1911 has completed a Phase 2a study (N = 80) in patients with moderate‑to‑severe chronic obstructive pulmonary disease (COPD), meeting key efficacy and safety benchmarks.
Phase 2a Study Results Overview
| Parameter | Placebo (N = 20) | 9MW1911 RP2D (N = 30) | Lower‑Dose Cohorts (N = 30) |
|---|---|---|---|
| Annualized Moderate‑to‑Severe Exacerbations | Baseline | ↓ > 30 % | Dose‑dependent decline |
| Annualized Severe Exacerbations | Baseline | ↓ > 40 % | Trending lower |
| Patients with Severe Exacerbations | 35 % | 13.3 % | Lower incidence |
| Safety & Tolerability | — | Favorable; no dose‑limiting toxicities | Similar profile |
Mechanism of Action & Development Status
- Innovation: 9MW1911 is a Category 1 therapeutic biological product developed via Mabwell’s proprietary high‑efficiency B lymphocyte screening platform.
- Target: High‑affinity binding to ST2 receptor, blocking the IL‑33/ST2 signaling pathway—a key driver of airway inflammation and COPD exacerbations.
- Global Expansion: Phase 2 trial application formally accepted by FDA, enabling parallel development in the US while China studies continue.
Market Context & Strategic Outlook
- COPD Burden: Over 100 million patients in China; exacerbations drive >70 % of direct medical costs.
- Differentiation: No approved ST2‑targeted therapy for COPD; 9MW1911’s >30 % reduction in exacerbations positions it as a potential first‑in‑class option.
- Commercial Pathway: Mabwell aims to initiate Phase 2b in China by Q1 2026; US study start‑up planned for H2 2026. Analysts forecast ¥1.5 billion (≈ US$210 million) peak China sales.
- Pipeline Value: Positive Phase 2a data and FDA acceptance may unlock partnership opportunities with global respiratory players.
Forward‑Looking Statements
This brief includes forward‑looking statements about 9MW1911 development timelines, regulatory interactions, and market potential. Actual results may differ due to clinical, regulatory, and competitive uncertainties.-Fineline Info & Tech