GSK plc has received approval from China’s National Medical Products Administration (NMPA) for Exdensur (depemokimab) as an add-on maintenance therapy for severe asthma with an eosinophilic phenotype in patients aged 12 years and above. The approval marks a significant expansion of GSK’s respiratory biologics portfolio in one of the world’s largest pharmaceutical markets.

The approval is supported by data from the Phase III SWIFT-1 and SWIFT-2 trials, where depemokimab demonstrated a sustained reduction in asthma exacerbations with just two doses per year, compared to placebo alongside standard of care. The trials showed reductions of 58 Percent and 48 Percent in annualised exacerbation rates over 52 weeks.

Exdensur’s differentiated profile lies in its ultra-long-acting biologic design, combining high interleukin-5 (IL-5) binding affinity with extended half-life, enabling twice-yearly dosing. By targeting type 2 inflammation—an underlying driver in over 80 Percent of severe asthma cases—the therapy offers a potential shift in treatment paradigms.

Clinical data also indicated a notable reduction in severe exacerbations requiring hospitalisation or emergency visits, with a pooled analysis showing a 72 Percent decrease compared to placebo. The therapy was well tolerated, with safety outcomes comparable to standard treatments.

China represents a significant opportunity, with approximately 46 million adults affected by asthma, of which around 6 Percent suffer from severe disease. The growing burden of respiratory disorders underscores the need for advanced biologics and scalable manufacturing capabilities to meet demand.

Beyond asthma, Exdensur is under regulatory review in China for chronic rhinosinusitis with nasal polyps (CRSwNP) and has already secured approvals in the US, Japan, EU, and UK. The therapy is also being evaluated across multiple Phase III programmes for other eosinophil-driven conditions, including EGPA, HES, and COPD.

For pharma manufacturing, the approval highlights increasing global demand for complex biologics and reinforces GSK’s focus on innovation-led production, advanced biologic development, and lifecycle expansion. The company continues to strengthen its respiratory pipeline through next-generation biologics, vaccines, and inhaled therapies aimed at improving outcomes and redefining care standards worldwide.