GSK’s Depemokimab Gains NMPA Approval, Delivering Significant Reduction In Asthma Exacerbations

GSK plc announced that China’s National Medical Products Administration has approved Exdensur (depemokimab) as an add-on maintenance therapy for severe eosinophilic asthma in patients aged 12 years and older. This approval marks an important expansion of treatment options for patients with difficult-to-control asthma in China.

The decision is supported by results from the Phase III SWIFT-1 and SWIFT-2 trials, in which depemokimab demonstrated sustained reductions in asthma exacerbations with just 2 doses per year when used alongside standard of care. The therapy significantly lowered annualised exacerbation rates compared to placebo, with reductions of 58% and 48% across the two studies.

Kaivan 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.” 

Additional findings showed fewer severe episodes requiring hospitalisation or emergency care among patients receiving depemokimab. A pooled analysis indicated a 72% reduction in clinically significant exacerbations requiring hospital visits. The drug was also well tolerated, with safety outcomes comparable to placebo, reinforcing its suitability for long-term management.

Asthma remains a major health burden in China, affecting an estimated 46 million adults, with a subset experiencing severe disease and frequent exacerbations. Beyond asthma, Exdensur is also under regulatory review in China for chronic rhinosinusitis with nasal polyps. The therapy has already received approvals in the U.S., Japan, the EU, and the UK, highlighting its growing global presence.

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