Mepolizumab Becomes First IL-5 Inhibitor to Win COPD Approval in China Market

GSK has unveiled a significant milestone in respiratory medicine as China’s drug regulator greenlit Nucala (mepolizumab) for COPD management. The approval specifically targets adult patients with inadequately controlled chronic obstructive pulmonary disease marked by elevated eosinophil levels, positioning the therapy as a specialized add-on treatment alongside standard care protocols.

Clinical Evidence Supports Eosinophil-Driven Treatment Approach

The regulatory decision rested on compelling trial data from two phase III studies—MATINEE and METREX. Across both investigations, mepolizumab demonstrated statistically robust and clinically meaningful reductions in moderate-to-severe exacerbation rates when compared to placebo. This therapeutic advantage emerged consistently across diverse COPD patient populations exhibiting an eosinophilic disease phenotype, strengthening the case for targeted biologic therapy in this specific subset.

Expanding Treatment Portfolio in Asia-Pacific Region

The mepolizumab approval expands GSK’s respiratory franchise in China beyond severe eosinophilic asthma, where the drug already carries regulatory approval for patients ages 12 and older. The injectable monoclonal antibody currently targets four distinct conditions in the Chinese market: severe asthma, chronic rhinosinusitis with nasal polyps, eosinophilic granulomatosis with polyangiitis, and now COPD with eosinophilic characteristics.

Global Momentum Accelerates for COPD Indication

The China approval joins an expanding international footprint. Mepolizumab already holds U.S. clearance for COPD treatment, while European regulators recently delivered a positive Committee for Medicinal Products for Human Use opinion, suggesting approval likelihood in the EU market. Multiple regulatory dossiers remain under active review across additional jurisdictions worldwide.

Market Response Reflects Investor Confidence

GSK shares gained traction following the announcement, closing January 2 trading at $49.63, representing a $0.59 increase or 1.20% advancement. The stock moderated slightly in after-hours activity, settling at $49.43 with a marginal $0.20 decline from the previous close.