GSK’s Nucala® (mepolizumab) has received approval in China and the UK as an add-on maintenance treatment for adult patients with inadequately controlled COPD characterised by raised blood eosinophils.
The approval by China’s National Medical Products Administration (NMPA) was announced by GSK on 5 January 2026 and followed submission of an application for the expanded indication in February 2024. Nucala® was previously approved in China for a number of indications, including as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP) (January 2025), and as add-on maintenance treatment for severe eosinophilic asthma in adults and adolescents aged 12 years and older (January 2024).
On 7 January 2026, PMLive reported that Nucala® also received approval for the same indication from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). The COPD indication was recommended by the European Medicines Agency’s CHMP in December 2025, nine months after its submission to the EMA in March 2025.
Nucala® is approved for COPD in the United States (May 2025). The COPD indication extension remains under review by Australia’s TGA (June 2025).
Bio-Thera is currently developing a mepolizumab biosimilar, BAT2606, which has completed Phase 1 trials (according to the company’s pipeline), and is the subject of an exclusive commercialisation deal struck in March 2024 with Costa Rican healthcare product distributor SteinCares for the marketing rights of the drug across Latin America.