GSK plc has received approval from China’s National Medical Products Administration (NMPA) for Exdensur (depemokimab) as an add-on therapy for adult patients with Chronic Rhinosinusitis with Nasal Polyps who remain inadequately controlled with systemic corticosteroids or surgery. The therapy is to be used alongside intranasal corticosteroids, offering a new treatment option for patients with persistent symptoms.

This approval follows the drug’s recent clearance in China as a maintenance treatment for severe asthma with an eosinophilic phenotype in patients aged 12 years and older, further strengthening its role in managing type 2 inflammatory diseases.

The decision is supported by data from the phase III ANCHOR-1 and ANCHOR-2 trials, which demonstrated significant reductions in nasal polyp size and nasal obstruction scores over 52 weeks. Exdensur was also well tolerated, showing a safety profile comparable to placebo when used with standard of care.

Exdensur is notable as the first ultra-long-acting biologic designed for twice-yearly dosing, targeting interleukin-5 (IL-5), a key driver of type 2 inflammation. With a large proportion of CRSwNP patients remaining uncontrolled, the therapy offers a promising option for sustained disease management and improved quality of life.