The Investor
08 Apr 2026, 14:37
GSK plc announced that China’s National Medical Products Administration has approved Exdensur (depemokimab) for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP), marking the first ultra-long-acting biologic available for this condition in the country.
The approval allows Exdensur to be used as an add-on therapy for patients who do not achieve adequate disease control with corticosteroids or surgery. The decision is based on Phase III ANCHOR trials, which demonstrated statistically significant reductions in nasal polyp size and improvements in nasal obstruction symptoms over a 52-week period.
Exdensur, administered twice yearly, targets type 2 inflammation by inhibiting interleukin-5 (IL-5), offering a long-lasting treatment option for patients with persistent symptoms. The therapy has shown a safety profile comparable to standard care in clinical studies.
The drug has already received approvals in multiple markets, including the United States, Japan, the European Union, and the UK, for respiratory conditions such as severe asthma and CRSwNP.
The approval allows Exdensur to be used as an add-on therapy for patients who do not achieve adequate disease control with corticosteroids or surgery. The decision is based on Phase III ANCHOR trials, which demonstrated statistically significant reductions in nasal polyp size and improvements in nasal obstruction symptoms over a 52-week period.
Exdensur, administered twice yearly, targets type 2 inflammation by inhibiting interleukin-5 (IL-5), offering a long-lasting treatment option for patients with persistent symptoms. The therapy has shown a safety profile comparable to standard care in clinical studies.
The drug has already received approvals in multiple markets, including the United States, Japan, the European Union, and the UK, for respiratory conditions such as severe asthma and CRSwNP.