GSK plc - Form 6-K Filing

GSK plc announced that China's National Medical Products Administration (NMPA) has approved Exdensur (depemokimab) as an add-on therapy for adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP) whose disease is not adequately controlled by systemic corticosteroids or surgery. This marks the first and only ultra-long-acting biologic approved in China for CRSwNP. The approval was based on the ANCHOR-1 and ANCHOR-2 trials, which demonstrated significant improvements in nasal polyp size and nasal obstruction. Exdensur was found to be well-tolerated, with a similar side effect profile to placebo. This approval follows Exdensur's recent clearance in China for severe asthma and expands its availability in China, where CRSwNP remains a significant unmet medical need due to debilitating symptoms and underlying type 2 inflammation. Exdensur is also approved in other regions for severe asthma and CRSwNP.