Exdensur (depemokimab) wins NMPA approval in China for severe eosinophilic asthma

China’s National Medical Products Administration (NMPA) has authorised Exdensur (depemokimab) as an add-on maintenance therapy for severe asthma with an eosinophilic phenotype in adults and adolescents aged 12 years and older.

This decision makes Exdensur the first ultra-long-acting biologic available in China for this patient population, offering a new option for those whose disease remains uncontrolled despite standard treatment.

Details of Phase III SWIFT-1 and SWIFT-2 trials in patients with eosinophilic asthma

The approval is supported by results from the phase III SWIFT-1 and SWIFT-2 trials, where depemokimab, given twice yearly on top of standard of care, led to a sustained reduction in asthma exacerbations compared with placebo. In these studies, Exdensur plus background therapy significantly lowered the annualised exacerbation rate by 58% in SWIFT-1 and 48% in SWIFT-2 versus placebo over 52 weeks.

A pre-specified pooled analysis also showed a 72% reduction in clinically significant exacerbations requiring hospitalisation or emergency department visits compared with placebo. Overall, depemokimab was generally well tolerated, with a side‑effect profile comparable to placebo across the trials.

What is the unmet need in severe asthma in China

Asthma remains a significant public health issue in China, affecting an estimated tens of millions of adults, with severe disease accounting for a sizeable minority of cases. Patients with severe asthma are at higher risk of frequent exacerbations, often needing emergency care or hospitalisation, and are more likely to experience life‑threatening attacks despite high‑intensity background therapy.

Real‑world data indicate that a notable proportion of people with asthma in China have had at least one exacerbation requiring a hospital visit in the previous year, underscoring the need for more effective and durable treatment options.

Key findings from the SWIFT programme

In SWIFT-1 and SWIFT-2, adults and adolescents with severe eosinophilic asthma received either depemokimab or placebo, on top of their usual therapy, for one year. Depemokimab reduced the annualised asthma exacerbation rate from 1.11 to 0.46 events per year in SWIFT‑1 and from 1.08 to 0.56 events per year in SWIFT‑2, corresponding to rate ratios of 0.42 and 0.52, respectively.

A pooled analysis demonstrated that exacerbations requiring hospitalisation and/or emergency department visits were markedly lower with depemokimab (annualised rate 0.02) compared with placebo (0.09), translating into a rate ratio of 0.28. Efficacy and safety outcomes in Chinese participants were consistent with the overall study population.

Broader development and additional indications

In addition to its new approval in China, Exdensur has already been authorised in the United States, Japan, the European Union, and the United Kingdom for severe asthma, and in several of these markets also for severe chronic rhinosinusitis with nasal polyps (CRSwNP).

In China, the NMPA is currently reviewing Exdensur as an add‑on treatment with intranasal corticosteroids for adults with severe CRSwNP who remain uncontrolled on systemic steroids and/or surgery.

Exdensur (depemokimab)  - Mechanism of action

Exdensur is an ultra‑long‑acting monoclonal antibody targeting interleukin‑5 (IL‑5), a central cytokine driving type 2 inflammation and eosinophil‑mediated disease. The molecule is engineered with high IL‑5 binding affinity, high potency, and an extended half‑life, allowing dosing just twice per year, in contrast to the more frequent injection schedules required with established IL‑5–directed biologics.

By providing durable suppression of type 2 inflammation and eosinophilic activity, depemokimab aims to simplify long‑term disease management and reduce the burden of severe asthma for patients and healthcare systems.