Biopharmaceutical company GSK plc (LSE: GSK) (NYSE: GSK) revealed on Wednesday that it has received approval from China's National Medical Products Administration for Exdensur (depemokimab) as an add-on treatment for adults with chronic rhinosinusitis with nasal polyps (CRSwNP) who remain uncontrolled with standard therapies.

Exdensur is the first ultra-long-acting biologic approved for CRSwNP in China and is administered twice yearly alongside intranasal corticosteroids. The decision follows recent approval in the country for use in severe eosinophilic asthma.

The approval is based on Phase III ANCHOR-1 and ANCHOR-2 trials, which demonstrated statistically significant reductions in nasal polyp size and nasal obstruction over 52 weeks versus standard of care. The treatment was well tolerated, with a safety profile comparable to placebo.

GSK said the approval addresses a significant unmet need, with a large proportion of CRSwNP patients remaining uncontrolled and experiencing persistent symptoms linked to underlying type 2 inflammation.

Exdensur is also approved in multiple markets, including the US, Japan, the European Union and the UK, for severe asthma and CRSwNP. The therapy is part of GSK's broader pipeline targeting inflammatory respiratory diseases.