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Nucala for adults with COPD approved in China
GSK plc announced that China's National Medical Products Administration has approved Nucala (mepolizumab) for adults with inadequately controlled COPD characterized by raised blood eosinophils, making it the first and only monthly biologic approved in China for this indication, evaluated in patients with blood eosinophil counts as low as 150 cells/µL. This approval, based on the MATINEE and METREX phase III trials, demonstrated a clinically meaningful reduction in exacerbations, including those leading to hospitalisation or emergency department visits, with approximately 67% of patients inadequately controlled on triple inhaled therapy having elevated eosinophil counts. The drug's efficacy was shown in reducing the annualised rate of moderate or severe exacerbations compared to placebo, with a rate ratio of 0.79 in the MATINEE trial and 0.82 in the METREX trial. Disclaimer*
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[{"type":"text","content":"\n\nIssued: 5 January 2026, London UK\n \nNucala (mepolizumab) approved in China for use in adults with chronic obstructive pulmonary disease (COPD)\n \n· Nucala is the first and only monthly biologic approved in China studied in a wide COPD population with blood eosinophil count (BEC) starting as low as 150 cells/µL\n· Approval based on the positive MATINEE and METREX phase III trials\n· MATINEE data included reduction of exacerbations leading to hospitalisation and/or emergency department visits\n· Of patients inadequately controlled on inhaled triple therapy, 67% have a blood eosinophil count above 150 cells/µL\n \n \nGSK plc (LSE/NYSE: GSK) today announced that China's National Medical Products Administration (NMPA) has approved Nucala (mepolizumab) as add-on maintenance treatment of adult patients with inadequately controlled COPD characterised by raised blood eosinophils.\n \nThe 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. The incidence of adverse events was similar between placebo and mepolizumab groups.\n \nMepolizumab is the first and only monthly biologic approved in China and evaluated in COPD patients with a BEC starting as low as 150 cells/µL. Around 100 million people in China have COPD. Among those who continue to exacerbate despite inhaled triple therapy, about 67% have a BEC above 150 cells/µL.1,2 Recurrent exacerbations accelerates disease progression, higher hospitalisation and readmission rates, increased mortality and greater health system burden.3,4 COPD deaths in China represent over 30% of global COPD mortality.3\n \nKaivan Khavandi, SVP & Global Head, Respiratory, Immunology & Inflammation R&D, GSK said: \"Given the high incidence of COPD in China and a mortality rate that is above the global average, there is a clear need for novel options to address COPD. The approval of Nucala offers patients in China a monthly add-on maintenance treatment to reduce exacerbations, including those leading to emergency department...