5th Jan 2026 08:30
(Alliance News) - GSK PLC on Monday said mepolizumab, sold under the brand name Nucala, has been approved in China for use in adults with chronic obstructive pulmonary disease.
The London-based pharmaceuticals company said the approval is based on 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-to-severe exacerbations versus placebo plus standard of care in a wide spectrum of COPD patients with an eosinophilic phenotype.
The incidence of adverse events was similar between placebo and mepolizumab groups, GSK said.
Mepolizumab is the first and only monthly biologic approved in China and evaluated in COPD.
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, GSK said, including in Europe where mepolizumab was recently granted a positive opinion from the Committee for Medicinal Products for Human Use, the scientific body of the European Medicines Agency.
Shares in GSK were down 0.4% at 1,823.50 pence in London on Monday morning. The wider FTSE 100 index was up 0.3%.
By Jeremy Cutler, Alliance News reporter
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