GSK’s Exdensur secures NMPA approval in China for chronic rhinosinusitis

CHINA—GSK has secured approval from China’s National Medical Products Administration (NMPA) for Exdensur, a groundbreaking biologic therapy designed to treat chronic rhinosinusitis with nasal polyps (CRSwNP) in adults.

The medication works as an add-on therapy alongside intranasal corticosteroids for patients whose condition fails to respond adequately to systemic corticosteroids or surgical intervention.

This approval represents a significant expansion of Exdensur’s reach in the Chinese market, building on the NMPA’s recent authorization of the same drug for treating severe asthma in adults and adolescents aged 12 and older.

The drug distinguishes itself as the first and only ultra-long-acting biologic in its class, requiring just two doses per year for maintenance treatment.

Clinical evidence supporting efficacy

The NMPA’s decision rests on compelling data from two pivotal phase III trials, ANCHOR-1 and ANCHOR-2, which demonstrated meaningful improvements in patient outcomes.

After 52 weeks of treatment, patients receiving Exdensur showed notable reductions in nasal polyp scores and nasal obstruction, outperforming placebo when combined with standard care.

Importantly, the drug’s safety profile matched that of placebo, meaning patients experienced comparable rates and severity of side effects.

Kaivan Khavandi, senior vice president of research and development for respiratory, immunology, and inflammation at GSK, emphasized that this approval could fundamentally reshape how physicians manage CRSwNP.

With nearly half of all CRSwNP patients remaining inadequately controlled despite current treatments, and approximately 85 percent harboring underlying type 2 inflammation, Exdensur offers a novel approach to sustained disease suppression.

Earlier Asthma approval demonstrates broad efficacy

The company’s confidence in Exdensur comes partly from its recent approval for severe asthma, approved just one week prior, based on the SWIFT-1 and SWIFT-2 trials.

These studies revealed that depemokimab, Exdensur’s active ingredient, reduced annual asthma exacerbations by 58 and 48 percent respectively.

Even more striking, a pooled analysis showed a 72 percent reduction in severe exacerbations requiring hospitalization or emergency care.

Chinese patients who participated in these asthma trials experienced efficacy and safety outcomes consistent with the broader study populations, suggesting the drug’s effectiveness translates across diverse patient groups.

Global expansion underway

Exdensur has now been approved across multiple major markets, including the United States, Japan, the European Union, and the United Kingdom, for both severe asthma and CRSwNP treatment.

This international reach highlights the regulatory and clinical validation supporting the therapy’s use in managing type 2 inflammatory conditions that significantly impact patient quality of life.