By Fineline Cube 
GlaxoSmithKline (GSK, NYSE: GSK) China announced that China’s National Medical Products Administration (NMPA) approved Nucala (mepolizumab injection) as an add‑on maintenance treatment for adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) characterized by an eosinophilic phenotype. This marks the first IL‑5 biologic approved for COPD in China, supported by positive Phase III MATINEE and METREX trials.
Regulatory Milestone
| Item | Details |
|---|---|
| Approval Date | 22 Dec 2025 |
| Agency | NMPA (China) |
| Product | Nucala (mepolizumab injection) |
| Indication | Add‑on maintenance for eosinophilic COPD in adults |
| Mechanism | Humanized anti‑IL‑5 monoclonal antibody; inhibits eosinophil development/maturation/activation |
| Innovation | First IL‑5 biologic approved in China for COPD |
| Supporting Trials | Phase III MATINEE and METREX |
Clinical Evidence
| Trial | Key Efficacy | Safety Profile |
|---|---|---|
| MATINEE | Significant reduction in annual rate of moderate‑to‑severe exacerbations vs. placebo | Adverse event incidence similar to placebo |
| METREX | Clinically meaningful exacerbation reduction across broad eosinophilic COPD population | Comparable safety to placebo |
| Combined Result | Consistent efficacy in reducing COPD exacerbations | Well‑tolerated with standard of care |
Market Context
Nucala’s China Portfolio:
- Severe eosinophilic asthma (SEA) – adults & adolescents ≥12 years
- Chronic rhinosinusitis with nasal polyps (CRSwNP) – adults
- Eosinophilic granulomatosis with polyangiitis (EGPA) – adults
- COPD – adults (newly approved)
Global Status: Already approved for COPD in the United States.
Market Opportunity
| Metric | Value | Context |
|---|---|---|
| China COPD Patients | 100 million (2025) | ~10‑15% have eosinophilic phenotype (10‑15 M eligible) |
| China COPD Market | ¥80‑100 billion (≈ US$11‑14 B) | Dominated by bronchodilators and inhaled steroids |
| Biologic Penetration | <5% of eligible patients receive biologics | High growth potential with targeted therapies |
| Nucala Peak Sales | ¥2‑3 billion (≈ US$280‑420 M) by 2030 | 15‑20% share of eosinophilic COPD segment |
| Pricing Strategy | Premium biologic pricing | Potential for NRDL inclusion by 2026 |
Strategic Implications
- For GSK: COPD approval strengthens respiratory franchise in China; first IL‑5 biologic creates competitive moat; builds on US approval for global consistency; addresses high‑unmet‑need eosinophilic phenotype.
- For Patients: Add‑on therapy reduces exacerbation risk vs. standard of care; subcutaneous injection every 4‑6 weeks offers convenience; targeted mechanism minimizes systemic steroid exposure.
- For Market: IL‑5 inhibition expands beyond asthma into COPD, a larger patient population; MATINEE/METREX data supports payer acceptance; GSK’s respiratory leadership reinforced with differentiated biologic.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding Nucala’s market penetration, NRDL negotiations, and competitive positioning. Actual results may differ due to payer access, competitive responses, or safety profile changes.-Fineline Info & Tech