GSK expands Exdensur approval in China to CRSwNP

GSK plc (LON:GSK, NYSE:GSK) has announced that China’s National Medical Products Administration (NMPA) has approved Exdensur (depemokimab) as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control. This follows the NMPA’s recent approval for Exdensur as an add-on maintenance treatment of severe asthma characterised by an eosinophilic phenotype in adult and paediatric patients aged 12 years and older.¹ 

The approval of Exdensur in CRSwNP is based on data from the ANCHOR-1 and ANCHOR-2 phase III trials, which showed an improvement (reduction) from baseline in nasal polyp score (scale: 0-8) at 52 weeks [treatment difference (95% confidence interval) p-value: ANCHOR-1 -0.7 (-1.1, -0.3) p<0.001 and ANCHOR-2 -0.6 (-1.0, -0.2) p=0.004] and in nasal obstruction verbal response scale (scale: 0-3) over weeks 49-52 [ANCHOR-1 -0.23 (-0.46, <0.00) p=0.047 and ANCHOR-2 -0.25 (-0.46, -0.03) p=0.025].⁴ Across these trials, depemokimab was well-tolerated, with patients experiencing a similar rate and severity of side effects as those receiving placebo plus standard of care.²

Kaivan Khavandi, SVP, R&D Head Respiratory, Immunology & Inflammation (RI&I), and Head of Translational & Development Sciences, GSK, said: “Given the continued unmet need amongst patients with CRSwNP, today’s approval of Exdensur could redefine care by protecting from the debilitating symptoms of this disease in just two doses a year. This builds on Exdensur‘s recent approval in severe asthma, which means more patients in China could have access to this first and only ultra-long-acting biologic.”

Almost half of all patients with CRSwNP remain uncontrolled and up to 85% have underlying type 2 inflammation, which is associated with more severe disease.^3-5 An ultra-long-acting therapeutic option that provides sustained suppression of type 2 inflammation could support these patients who continue to face daily symptoms.

Exdensur has also been approved in the US and China for the treatment of severe asthma, as well as in Japan, the EU, and UK for the treatment of severe asthma and CRSwNP.^1,6-9

References

1. “Exdensur (depemokimab) approved in China for the treatment of severe asthma.” GSK, 30 Mar. 2026, https://www.gsk.com/en-gb/media/press-releases/exdensur-depemokimab-approved-in-china-for-the-treatment-of-severe-asthma/
2. Gevaert, P, et al. “Efficacy and safety of twice per year depemokimab in chronic rhinosinusitis with nasal polyps (ANCHOR-1 and ANCHOR-2): Phase 3, randomised, double-blind, Parallel Trials.” The Lancet, vol. 405, no. 10482, Mar. 2025, pp. 911-926, https://doi.org/10.1016/s0140-6736(25)00197-7.
3. Bachert, C, et al. “Burden of disease in chronic rhinosinusitis with nasal polyps.” Journal of Asthma and Allergy, Volume 14, Feb. 2021, pp. 127-134, https://doi.org/10.2147/jaa.s290424.
4. Seys, S, et al. “Real-life assessment of chronic rhinosinusitis patients using mobile technology: The mysinusitiscoach project by Euforea.” Allergy, vol. 75, no. 11, 19 June 2020, pp. 2867-2878, https://doi.org/10.1111/all.14408.
5. Bernstein, J. “Use of patient-reported outcome measures and inflammatory biomarkers to differentiate chronic rhinosinusitis with nasal polyp endotypes: Is it feasible?” Annals of Allergy, Asthma & Immunology, vol. 130, no. 4, Apr. 2023, pp. 409-410, https://doi.org/10.1016/j.anai.2023.01.004
6. “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/
7. “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/
8. “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/.
9. “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/