GSK (NYSE:GSK) today announced that China’s National Medical Products Administration (NMPA) has granted approval for Exdensur (depemokimab) as an add-on maintenance treatment for severe asthma characterized by an eosinophilic phenotype.
The approval covers both adult and pediatric patients aged 12 years and older, introducing a high-affinity biologic designed to provide sustained suppression of Type 2 inflammation with only two doses per year.
The NMPA’s decision is underpinned by data from the global Phase III SWIFT-1 and SWIFT-2 trials, which were published in the New England Journal of Medicine.
In these studies, depemokimab achieved a significant 58% and 48% reduction in the annualized rate of asthma exacerbations compared to placebo over a 52-week period.
Furthermore, a pooled analysis of the trials revealed a 72% reduction in exacerbations requiring hospitalization or emergency department visits, representing a critical clinical benefit for a patient population at high risk of fatal attacks.
The approval addresses a substantial public health challenge in China, where approximately 46 million adults live with asthma.
While severe asthma affects roughly 6% of this group, it accounts for a disproportionate share of the healthcare burden, with 15% of all asthma patients in China requiring hospital visits due to exacerbations annually.
Results from Chinese participants in the SWIFT-1 trial remained consistent with the overall global population, confirming the therapy's efficacy and safety profile within the local demographic.
Exdensur is the first ultra-long-acting biologic approved in China for this indication, potentially redefining the treatment paradigm by moving away from monthly or bimonthly injections.
The drug is already approved for severe asthma in the United States, and for both asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) in the European Union, the UK, and Japan.
Beyond asthma, the NMPA is currently reviewing Exdensur as an add-on therapy for adult patients with severe CRSwNP who are inadequately controlled by systemic corticosteroids or surgery.