Mepolizumab Receives NMPA Clearance for COPD Treatment in Chinese Market

GSK’s stock performance showed modest gains on January 2, closing at $49.63 with a 1.20% increase, before retreating slightly to $49.43 in overnight trading—a move that followed the company’s latest regulatory win in one of the world’s largest pharmaceutical markets.

Regulatory Breakthrough in China

China’s National Medical Products Administration has granted marketing authorization for mepolizumab (marketed as Nucala) as an add-on therapy for adults with poorly managed COPD who present elevated blood eosinophil levels. This expansion marks a significant extension of the drug’s therapeutic reach in the region, building on its existing approved indications.

Clinical Evidence Supporting the Approval

The regulatory decision rested on compelling data from two pivotal phase III studies—MATINEE and METREX—which demonstrated that mepolizumab delivered substantial and statistically significant reductions in annual moderate-to-severe exacerbation rates when compared to standard care plus placebo. The trials encompassed a diverse patient population characterized by eosinophilic COPD phenotypes, underscoring the treatment’s broad applicability within this subgroup.

Expanding Global Presence

Within the Chinese market, mepolizumab already holds approvals for severe eosinophilic asthma in patients aged 12 and above, as well as for chronic rhinosinusitis with nasal polyps and eosinophilic granulomatosis with polyangiitis. The drug has established usage in the United States for COPD treatment, and regulatory pathways remain active across multiple regions. Notably, the European Medicines Agency’s Committee for Medicinal Products for Human Use recently issued a positive recommendation for mepolizumab in COPD, signaling continued momentum toward broader European approval.

This sequential series of regulatory clearances positions mepolizumab as a key therapeutic option in the eosinophil-driven disease space globally.