LONDON (dpa-AFX) - GSK plc (GSK, GSK.L) announced that China's National Medical Products Administration (NMPA) has approved Nucala (mepolizumab) as add-on maintenance treatment of adult patients with inadequately controlled chronic obstructive pulmonary disease or COPD characterised by raised blood eosinophils.
The approval was based on data from the positive MATINEE and METREX phase III trials. Across these trials, mepolizumab showed a clinically meaningful and statistically significant reduction in the annualised rate of moderate/severe exacerbations versus placebo plus standard of care in a wide spectrum of COPD patients with an eosinophilic phenotype.
Mepolizumab is already approved in China as an add-on maintenance treatment for severe eosinophilic asthma in adults and adolescents aged 12 years and older, as well as for adults with chronic rhinosinusitis with nasal polyps and eosinophilic granulomatosis with polyangiitis. It is currently approved for use in COPD in the US. Regulatory submissions are under review globally, including in Europe where mepolizumab was recently granted a positive CHMP opinion in COPD.
GSK closed trading on January 2 at $49.63, up $0.59 or 1.20%. In overnight trading at 12:48 AM EST, the stock eased slightly to $49.43, down $0.20 or 0.40%.
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