GSK Wins China Approval for Exdensur in Nasal Polyps

China’s National Medical Products Administration (NMPA) has approved GSK plc’s 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.

The approval was based on two late‑stage trials showing modest but statistically significant reductions in nasal polyp size and nasal obstruction symptoms over one year when Exdensur was added to standard intranasal corticosteroids. Side‑effect rates were comparable to placebo.

Exdensur, known generically as depemokimab, was recently cleared in China as a maintenance treatment for severe eosinophilic asthma in patients aged 12 and older. GSK positions the drug as the first ultra‑long‑acting biologic in its class, requiring dosing twice a year.

Chronic rhinosinusitis with nasal polyps affects millions of patients worldwide, with nearly half failing to achieve adequate disease control. The condition is often driven by type 2 inflammation, which is also implicated in certain forms of asthma.

Exdensur has previously received approvals for severe asthma in the U.S. and China, and for both severe asthma and nasal polyps in Japan, the European Union and the U.K.