Mepolizumab Expansion Into Adult COPD Market: GSK's Strategic Win in China

GSK has secured regulatory approval from China’s National Medical Products Administration (NMPA) for Nucala (mepolizumab) as add-on maintenance therapy for adult patients with eosinophil-elevated COPD who remain inadequately controlled on standard care. This represents a significant expansion of the drug’s footprint in adulthood respiratory treatment paradigms across major markets.

Clinical Foundation for the Approval

The NMPA decision rested on compelling evidence from the MATINEE and METREX phase III clinical trials. Across both studies, mepolizumab demonstrated a statistically robust and clinically meaningful reduction in the annualized frequency of moderate-to-severe exacerbations relative to placebo combined with standard-of-care therapy. The benefit was observed across a diverse patient population characterized by eosinophilic COPD phenotypes—a critical finding for broadening therapeutic application in adulthood populations with varied disease presentations.

Expanding the Therapeutic Portfolio

The China approval extends mepolizumab’s existing indication landscape in the country. The medication already holds regulatory status for severe eosinophilic asthma in adults and adolescents aged 12 years and older, chronic rhinosinusitis with nasal polyps, and eosinophilic granulomatosis with polyangiitis. With COPD now added to this portfolio, the drug’s commercial potential in the region deepens considerably.

Global Regulatory Trajectory

Mepolizumab has already gained approval for COPD treatment in the United States, establishing proof of commercial viability in mature markets. Throughout Europe, the drug recently secured a positive Committee for Medicinal Products for Human Use (CHMP) opinion for COPD, signaling strong momentum toward eventual European authorization.

Market Response

GSK’s stock reflected modest enthusiasm to the regulatory milestone. Trading closed on January 2 at $49.63, having gained $0.59 or 1.20% during the session. Following overnight trading through 12:48 AM EST, the share price retreated marginally to $49.43, representing a decline of $0.20 or 0.40%—suggesting investors are weighing the approval’s significance against broader portfolio considerations.