GSK wins China approval for Exdensur in severe asthma

GSK plc (LON:GSK, NYSE:GSK) has 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.

The 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

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.”

Asthma 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

In 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% confidence interval) p-value: SWIFT-1 0.42 (0.30, 0.59) p<0.001 and SWIFT-2 0.52 (0.36, 0.73) p<0.001] (AER depemokimab versus placebo: SWIFT-1 0.46 vs. 1.11 and SWIFT-2 0.56 vs. 1.08 exacerbations per year). In addition, efficacy and safety results from Chinese patients participating in SWIFT-1 were consistent with the overall population analysis (n=58).¹

In a secondary endpoint from SWIFT-1 and SWIFT-2, patients treated with depemokimab experienced numerically fewer exacerbations requiring hospitalisation and/or emergency department visits (1% and 4%) compared with placebo (8% and 10%), respectively. A pre-specified pooled analysis of the two trials showed there was a 72% reduction in the annualised rate of clinically significant exacerbations requiring hospitalisation and/or ED visits over 52 weeks for depemokimab compared with placebo [rate ratio 0.28, 95% CI (0.13, 0.61), nominal p=0.002] (AER depemokimab 0.02 versus placebo 0.09).¹ Across these trials, depemokimab was well-tolerated, with patients experiencing a similar rate and severity of side effects as those receiving placebo.¹ The full results from the SWIFT trials were presented at the 2024 European Respiratory Society International Conference and published in the New England Journal of Medicine.^1,7

The NMPA is also reviewing Exdensur as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP) for whom therapy with systemic corticosteroids and/or surgery does not provide adequate disease control. Exdensur has been approved in the US for the treatment of severe asthma, as well as in Japan, the EU, and UK for the treatment of severe asthma and CRSwNP.^8-11

References

1. Jackson D., et al. Twice-Yearly Depemokimab in Severe Asthma with an Eosinophilic Phenotype. NEJM. September 2024. Vol. 391 No. 24.DOI: 10.1056/NEJMoa2406673.
2. Huang, Kewu, et al. “Prevalence, risk factors, and management of asthma in China: A national cross-sectional study.” The Lancet, vol. 394, no. 10196, Aug. 2019, pp. 407-418, https://doi.org/10.1016/s0140-6736(19)31147-x.
3. Ding, Bo, and Mark Small. “Disease burden of mild asthma in China.” Respirology, vol. 23, no. 4, 20 Oct. 2017, pp. 369-377, https://doi.org/10.1111/resp.13189 .
4. National Heart, Lung, and Blood Institute. Guidelines for the Diagnosis and Management of Asthma (EPR-3). [Online]. Available at: https://www.nhlbi.nih.gov/health-topics/guidelines-for-diagnosis-management-of-asthma. Accessed January 2025.
5. Ambrosino, Nicolino, and Pierluigi Paggiaro. “The management of asthma and chronic obstructive pulmonary disease: Current status and future perspectives.” Expert Review of Respiratory Medicine, vol. 6, no. 1, Feb. 2012, pp. 117-127, https://doi.org/10.1586/ers.12.2.
6. Antonicelli, L et al. “Asthma severity and medical resource utilisation.” The European respiratory journal vol. 23,5 (2004): 723-9. https://pubmed.ncbi.nlm.nih.gov/15176687/
7. Jackson, D, et al. “Late breaking abstract – depemokimab efficacy/safety in patients with asthma on medium/high-dose ICS: The phase IIIA randomised SWIFT-1/2 studies.” European Respiratory Journal 2024, vol. 64, no. 68, 14 Sept. 2024, https://doi.org/10.1183/13993003.congress-2024.rct3718.
8. “Exdensur (Depemokimab) Approved by US FDA for the Treatment of Severe Asthma.” GSK, 16 Dec. 2025, www.gsk.com/en-gb/media/press-releases/exdensur-depemokimab-approved-by-us-fda-for-the-treatment-of-severe-asthma/
9. “Exdensur (depemokimab) approved in Japan for severe asthma and chronic rhinosinusitis with nasal polyps.” GSK, 6 Jan. 2026, https://www.gsk.com/en-gb/media/press-releases/exdensur-depemokimab-approved-in-japan/
10. “Exdensur (Depemokimab) Approved by the European Commission for Severe Asthma with Type 2 Inflammation and Chronic Rhinosinusitis with Nasal Polyps.” GSK, 17 Feb. 2026, www.gsk.com/en-gb/media/press-releases/exdensur-depemokimab-approved-by-the-european-commission/.
11. “Exdensur (Depemokimab) Approved in the UK for Treatment of Asthma with Type 2 Inflammation and Chronic Rhinosinusitis with Nasal Polyps.” GSK, 15 Dec. 2025, www.gsk.com/en-gb/media/press-releases/exdensur-depemokimab-approved-in-the-uk-for-treatment-of-asthma-with-type-2-inflammation-and-chronic-rhinosinusitis-with-nasal-polyps/