LONDON, UK — March 30, 2026
In a major advancement in respiratory medicine and biologic drug innovation, GSK plc announced that China’s National Medical Products Administration (NMPA) has approved Exdensur (depemokimab) as an add-on maintenance treatment for patients aged 12 years and older with severe asthma characterized by an eosinophilic phenotype. This approval marks a significant milestone in expanding access to ultra-long-acting biologic therapies, offering a new treatment paradigm for millions of patients suffering from severe respiratory disease.
Phase III Data Demonstrates Significant Reduction in Asthma Exacerbations
The approval of Exdensur is supported by robust evidence from the SWIFT-1 and SWIFT-2 Phase III clinical trials, which demonstrated substantial clinical benefits in reducing asthma exacerbations. Patients treated with depemokimab experienced a 58% and 48% reduction in annualized exacerbation rates, respectively, compared to placebo, highlighting the drug’s strong efficacy profile.
Furthermore, pooled analyses revealed a 72% reduction in severe exacerbations requiring hospitalization or emergency care, emphasizing the therapy’s potential to significantly reduce healthcare burden and improve patient outcomes. The trials also confirmed a favorable safety and tolerability profile, with adverse event rates comparable to placebo, reinforcing confidence in its clinical use.
Ultra-Long-Acting Biologic Redefines Treatment Approach
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Exdensur is the first ultra-long-acting biologic therapy approved in China for this indication, designed to target interleukin-5 (IL-5), a key driver of type 2 inflammation in severe asthma. Its unique pharmacological profile allows for twice-yearly dosing, significantly improving treatment adherence and patient convenience compared to existing therapies requiring more frequent administration.
By delivering sustained suppression of inflammation, Exdensur represents a transformative step in managing chronic respiratory diseases, particularly for patients with eosinophilic asthma, who often experience frequent exacerbations and hospitalizations. With more than 2 million people in China affected by severe asthma, the approval addresses a critical unmet medical need in a high-burden population.
Global Expansion and Regulatory Significance
This approval further strengthens Exdensur’s global regulatory footprint, following previous approvals in the United States, European Union, Japan, and the United Kingdom, underscoring its clinical and commercial potential worldwide.
From a cGxP and regulatory perspective, the approval highlights the importance of robust clinical development, regulatory compliance, and quality manufacturing standards in bringing innovative biologics to market. GSK is also advancing depemokimab in additional Phase III programs for other inflammatory diseases, including COPD and rare eosinophilic conditions, further expanding its therapeutic applications.
Industry Impact and Future Outlook
The approval of Exdensur reflects a broader shift toward long-acting biologics and precision medicine approaches in respiratory care, where targeted therapies are increasingly replacing traditional treatment models. By offering enhanced efficacy, reduced dosing frequency, and improved patient adherence, Exdensur has the potential to redefine the standard of care in severe asthma management.
As healthcare systems worldwide continue to prioritize value-based care and patient-centric outcomes, innovations like depemokimab are expected to play a critical role in reducing disease burden, improving quality of life, and driving the next wave of biopharmaceutical advancements in chronic disease treatment.
Source: GSK press release
