GSK’s Ultra-Long-Acting Asthma Drug Depemokimab Approved in China with Twice-Yearly Dosing
GSK
Pharmaceutical R&D Manufacturer
On March 27, the NMPA website showed that GSK's "Dermoquimab" was approved for marketing in China, used forTreatmentEosinophilic Asthma(Application No.: JXSS2400113/4).
Depemokimab is a new generation anti-interleukin 5 (IL-5) monoclonal antibody developed by GSK, with a long half-life, high binding affinity, and high potency.World's First Biannual Super-Long-Acting IL-5 BiologicIn December 2025, Dermoquimab was successively approved for marketing in the United States, Japan, the European Union, and other countries and regions. This is the first time that the drug has been launched in the Chinese market.
GSK has a strong and industry-leading respiratory product pipeline. The recently approved Dermoquimab is the iterative product of the monthly IL-5 monoclonal antibody "Mepolizumab," which is expected to take over this 2025 revenue.$26.51 billionThe blockbuster, becoming the next market leader.
In addition to the two approved indications, GSK is also exploring the use of Dermoquimab for treatingCOPD,Eosinophilia Syndrome,Allergic Granulomatosis Angiitis, and have currently both initiated Phase III clinical trials.
Phase III Asthma Study Program Mainly Includes SWIFT-1 and SWIFT-2 Studies for Patients with Type 2 Inflammatory Asthma, and an Open-Label Extension Study (AGILE).
On September 9, 2024, GSK announced the full results of the Phase III clinical trials SWIFT-1 and SWIFT-2 at the European Respiratory Society International Congress, with simultaneous publication in the NEJM.
SWIFT-1 and SWIFT-2 are 52-week randomized, double-blind, placebo-controlled, parallel-group, multicenter Phase III clinical trials with identical primary and secondary endpoints. Both trials evaluated the efficacy and safety of demokizumab in adult and adolescent patients with severe asthma characterized by Type 2 inflammation (elevated blood eosinophil count).
In two trials, 792 patients were randomized, and 762 patients were included in the full analysis set; of these, 502 patients were assigned to receive dostarlimab and 260 patients received placebo.
Both trials met the primary endpoint. A pre-specified pooled analysis showed that, compared with placebo, over 52 weeksThe rate of disease deterioration significantly decreased by 54%.(95% CI 0.36 - 0.59, p < 0.001), specifically:
In the SWIFT-1 trial, the Dermoquab groupAnnual disease progression rate: 0.46(95% CI: 0.36 - 0.58), and 1.11 (95% CI: 0.86 - 1.43) in the placebo group (95% CI: 0.30 - 0.59; P < 0.001);
In the SWIFT-2 trial, the dermokine antibody groupAnnual disease progression rate: 0.56(95% CI: 0.44 - 0.70), and 1.08 (95% CI: 0.83 - 1.41) in the placebo group (95% CI: 0.36 to 0.73; P < 0.001).
In the pooled analysis of SWIFT-1 and SWIFT-2, compared with placebo,Requiring hospitalization or emergency department visitClinically Significant Deterioration in Condition This Secondary EndpointReduced by 72%(95% CI 0.13 - 0.61, p = 0.002). The annualized relapse rate for democizumab was 0.02, compared to 0.09 in the placebo group.
In terms of safety, the proportion of patients experiencing any adverse event (AE) was similar between the dermochimab and placebo groups. In the SWIFT-1 trial, 73% of patients in the dermochimab group had AEs, compared with 73% in the placebo group; in the SWIFT-2 trial, the rates were 72% in the dermochimab group and 78% in the placebo group. The investigators determined that no deaths or serious adverse events were related to the study treatment.
China's FirstUsed forTreatment of Severe Eosinophilic AsthmaOfAnti-Interleukin-5(IL-5) targeted biologics, from GSKMepolizumab Injection, approved in January 2024.
Benralizumab: On March 24, 2025, Benralizumab will be officially commercially launched in China. Benralizumab directly targets the IL-5R on the surface of eosinophils, not only blocking the binding of IL-5 to eosinophils but also rapidly clearing eosinophils through antibody-dependent cellular cytotoxicity. It efficiently inhibits the associated inflammatory cycle, reduces severe asthma exacerbations, improves lung function, and decreases the use of steroids. At the same time,Only 6 injections are needed annually during the maintenance period.Clinical studies show that Benralizumab can rapidly improve asthma symptoms after 3 days of treatment, and long-term treatment significantly reduces the annual acute exacerbation rate (AAER). Over 90% of patients reduced their dependence on oral corticosteroids (OCS) and inhaled corticosteroids (ICS-Formoterol).
Mepolizumab: As the first approved anti-IL-5 monoclonal antibody biologic, it has been approved in China for adult eosinophilic granulomatosis with polyangiitis (EGPA) and is used for maintenance treatment of severe eosinophilic asthma. Mepolizumab reduces the development, maturation, and activation of eosinophils by directly targeting and inhibiting the IL-5 molecule.
Reference: DXY Insight Database
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