Biopharmaceutical company GSK plc (LSE: GSK) (NYSE: GSK) announced on Monday that China's National Medical Products Administration has approved Nucala (mepolizumab) as an add-on maintenance treatment for adults with inadequately controlled chronic obstructive pulmonary disease characterised by raised blood eosinophils.

Approval is based on positive phase III MATINEE and METREX data showing clinically meaningful and statistically significant reductions in annualised moderate to severe exacerbations versus placebo on top of standard inhaled triple therapy, with a comparable safety profile. MATINEE also demonstrated a reduction in exacerbations leading to hospitalisation and/or emergency department visits.

Nucala is the first and only monthly biologic approved in China evaluated across a broad COPD population with blood eosinophil counts starting at 150 cells/µL. Around 100 million people in China have COPD, and among patients inadequately controlled on inhaled triple therapy, about 67% have eosinophil counts above this threshold. COPD accounts for more than 30% of global COPD mortality in China.

Mepolizumab is already approved in China for severe eosinophilic asthma, chronic rhinosinusitis with nasal polyps and eosinophilic granulomatosis with polyangiitis, and is approved for COPD in the United States. Regulatory reviews are ongoing globally, including in Europe following a positive CHMP opinion.