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Exdensur approved for severe asthma in China
GSK plc announced that China's National Medical Products Administration has approved Exdensur (depemokimab) for severe asthma with an eosinophilic phenotype in adults and children aged 12 and older, marking the first ultra-long-acting biologic for this condition in China. The approval, based on the SWIFT trials, showed depemokimab significantly reduced exacerbations, with a 58% and 48% reduction in annualised rates in SWIFT-1 and SWIFT-2 respectively, and a 72% reduction in hospitalisation-requiring exacerbations. This approval addresses a significant unmet need in China, where an estimated 46 million adults have asthma, with approximately 6% experiencing severe forms. Exdensur is already approved in the US, Japan, EU, and UK for similar indications. Disclaimer*
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[{"type":"text","content":"\n\nIssued: 30 March 2026, London UK\n \nExdensur (depemokimab) approved in China for the treatment of severe asthma\n \n· Exdensur is the first and only ultra-long-acting biologic in China for the treatment of severe asthma with an eosinophilic phenotype\n· Approval based on SWIFT trials showing significantly lower rates of exacerbations in patients receiving depemokimab versus placebo\n· More than 2 million people in China are affected by severe asthma and experience increased risk of exacerbations requiring hospitalisation\n \n \n\nGSK plc (LSE/NYSE: GSK) today announced that China's National Medical Products Administration (NMPA) has approved Exdensur (depemokimab) as add-on maintenance treatment of severe asthma characterised by an eosinophilic phenotype in adult and paediatric patients aged 12 years and older.\n \nThe approval of Exdensur in severe asthma is based on data from the SWIFT-1 and SWIFT-2 phase III trials. In these studies, depemokimab demonstrated sustained exacerbation reduction with two doses per year versus placebo, both plus standard of care.1\n \nKaivan Khavandi, SVP, Global Head, Respiratory, Immunology & Inflammation R&D, GSK, said: \"Today's approval for Exdensur in China represents an important advance for patients with severe asthma with an eosinophilic phenotype. By providing sustained suppression of type 2 inflammation, an underlying driver of exacerbations and disease progression, Exdensur could redefine care in just two doses a year. With Exdensur now approved in several major markets, we are focused on transforming the treatment paradigm in severe asthma.\"\n \nAsthma is a major health burden in China affecting an estimated 46 million adults.2 Of those, approximately 6% experience severe asthma, which is associated with an increased risk of exacerbations requiring hospitalisation, and higher likelihood of potentially fatal asthma attacks.2-6 In China, around 15% of people with asthma have experienced an exacerbation requiring a hospital visit in the preceding 12 months.2\n \nIn the SWIFT-1 and SWIFT-2 trials, treatment with depemokimab resulted in a significant 58% and 48% reduction in the rate of annualised asthma exacerbations (asthma attacks) over 52 weeks, respectively [rate ratio (95% con...