GSK Secures China Approval With Strong Phase III Data For Exdensur In CRSwNP, Expanding Its Use Beyond Severe Asthma

GSK plc has announced that the National Medical Products Administration of China has approved Exdensur (depemokimab) as an add-on treatment for adults with chronic rhinosinusitis with nasal polyps (CRSwNP) who do not achieve adequate control with standard therapies such as systemic corticosteroids or surgery. This marks an expansion of Exdensur’s use, following its recent approval in China for severe eosinophilic asthma in patients aged 12 years and older.

The approval is supported by data from the Phase III ANCHOR-1 and ANCHOR-2 trials, which demonstrated statistically significant reductions in nasal polyp size and improvements in nasal obstruction symptoms over 52 weeks. Patients treated with depemokimab experienced meaningful symptom relief compared to standard care, with consistent efficacy outcomes across both studies.

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.” 

Depemokimab was also found to be well tolerated, with safety outcomes comparable to placebo when used alongside standard treatments. The therapy’s ultra-long-acting mechanism is designed to provide sustained suppression of type 2 inflammation, a key driver of disease severity in a large proportion of CRSwNP patients.

With nearly half of CRSwNP patients remaining inadequately controlled and a high prevalence of type 2 inflammation, Exdensur offers a promising new option. The drug has already received approvals across multiple regions, including the United States, Japan, the European Union, and the United Kingdom, for both severe asthma and CRSwNP, reinforcing its global clinical relevance.