LONDON, UK, April 8, 2026
GSK has announced that China’s National Medical Products Administration (NMPA) has approved Exdensur (depemokimab), a first-in-class ultra-long-acting biologic, for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP), marking a significant advancement in respiratory and inflammatory disease management. The approval positions Exdensur as the first and only twice-yearly biologic therapy in China for this indication, offering a new option for patients with inadequate response to existing treatments.
Phase III ANCHOR Trials Demonstrate Strong Clinical Efficacy
The regulatory approval is supported by data from the ANCHOR-1 and ANCHOR-2 Phase III clinical trials, which demonstrated statistically significant and clinically meaningful reductions in nasal polyp size and nasal obstruction symptoms. Patients treated with depemokimab showed consistent improvements compared to placebo, highlighting its potential as a highly effective add-on therapy.
Importantly, the trials confirmed that Exdensur is well-tolerated with a safety profile comparable to standard of care, reinforcing its suitability for long-term disease management. The drug’s extended half-life enables dosing only twice per year, significantly improving treatment adherence and patient convenience compared to more frequent biologic therapies.
CRSwNP is a chronic inflammatory condition driven by type 2 inflammation, often associated with severe symptoms such as nasal obstruction, loss of smell, facial pain, and sleep disturbances. Despite current therapies, nearly half of patients remain uncontrolled, underscoring the need for innovative treatment options.
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Innovative IL-5 Targeting Mechanism Drives Long-Acting Benefit
Exdensur (depemokimab) works by targeting interleukin-5 (IL-5), a key cytokine involved in type 2 inflammation, which plays a central role in the pathophysiology of CRSwNP and related respiratory diseases. By combining high binding affinity with an extended half-life, the biologic delivers sustained suppression of inflammatory pathways, enabling long-lasting therapeutic effects with minimal dosing frequency.
This mechanism represents a significant advancement in biologic drug design, addressing both efficacy and patient adherence challenges. The ability to maintain disease control with just two doses per year may redefine treatment standards, particularly for patients with severe or refractory disease who have limited options.
Additionally, Exdensur has already received approvals for severe asthma in multiple global markets, including the United States, Japan, and Europe, highlighting its broad therapeutic potential across inflammatory diseases.
Expanding Global Access to Advanced Biologic Therapies
The approval of Exdensur in China reflects GSK’s commitment to expanding access to innovative biologic therapies in high-need markets. With a large patient population affected by CRSwNP and significant unmet clinical needs, the introduction of an ultra-long-acting biologic therapy is expected to have a meaningful impact on disease management and patient quality of life.
Furthermore, the drug is being evaluated in additional Phase III programs for other conditions associated with type 2 inflammation, including eosinophilic granulomatosis with polyangiitis (EGPA) and hypereosinophilic syndrome (HES). This underscores its potential as a versatile biologic platform targeting multiple inflammatory diseases.
By leveraging advanced science, extended-duration biologics, and robust clinical data, GSK continues to strengthen its position in respiratory and immunology innovation, with Exdensur representing a key milestone in its pipeline.
The approval of Exdensur in China marks a major milestone in the treatment of chronic rhinosinusitis with nasal polyps, offering patients a novel, long-acting biologic therapy with proven clinical benefits and improved convenience. Backed by strong Phase III data and a differentiated mechanism of action, Exdensur is poised to redefine standards of care in inflammatory respiratory diseases, reinforcing the growing role of biopharmaceutical innovation in addressing unmet medical needs.
Source: GSK press release
