Nucala Gains COPD Treatment Greenlight in China; GSK Eyes Global Expansion

GSK plc (GSK, GSK.L) has secured regulatory approval from China’s National Medical Products Administration (NMPA) for Nucala (mepolizumab) as an add-on maintenance therapy for adult patients with inadequately controlled COPD marked by elevated blood eosinophil levels.

Clinical Evidence Drives Approval Decision

The regulatory authorization draws strength from robust phase III trial data generated by the MATINEE and METREX studies. Results demonstrated that mepolizumab delivered clinically meaningful and statistically significant reductions in the annualized rate of moderate and severe exacerbations when compared to placebo combined with standard COPD treatment protocols. The efficacy gains were observed across diverse patient populations exhibiting eosinophilic phenotypes, validating the COPD treatment approach for this specific biomarker-defined subset.

Expanding Therapeutic Portfolio in Asia

This marks a significant expansion of mepolizumab’s indication profile in the Chinese market. The drug already holds approvals in the country for severe eosinophilic asthma in adults and adolescents aged 12 and above, as well as for chronic rhinosinusitis with nasal polyps and eosinophilic granulomatosis with polyangiitis, positioning GSK as a key player in eosinophil-mediated disease management across multiple therapeutic areas.

Global Regulatory Momentum Building

Beyond China, the COPD treatment pipeline continues advancing internationally. Mepolizumab is currently authorized for COPD use in the United States, while European regulatory authorities recently issued a positive CHMP opinion, signaling favorable momentum toward market access on the continent. Additional regulatory submissions remain under review across multiple jurisdictions globally.

Market Response

GSK shares closed on January 2 at $49.63, reflecting a gain of $0.59 or 1.20%. In overnight trading at 12:48 AM EST, the stock retraced slightly to $49.43, declining $0.20 or 0.40%, as investors digest the Chinese regulatory milestone against broader market dynamics.