GSK Submits NDA in China for Ultra-Long-Acting Asthma Drug Depemokimab, Requiring Only Two Injections Per Year

On January 1, the CDE website showed that GSK's depemokimab had submitted a marketing application in China. Based on the clinical trial progress, it is speculated that the indication applied for this time is severe eosinophilic asthma (SEA).

Dermoquimab is a new generation anti-interleukin 5 (IL-5) monoclonal antibody developed by GSK, with a longer half-life, high binding affinity, and high potency.Only requires injection once every six monthsPreviously, the first-generation IL-5 monoclonal antibody developed by GSKMepolizumab isOnce-a-month formulation, which was approved for marketing in the United States in November 2015. According to GSK's financial report, the global sales of Mepolizumab in 2023 were approximately 2 billion US dollars.

▍AboutMepolizumab

Results from two Phase III studies for SEA (SWIFT-1 and SWIFT-2) showed that after 52 weeks of treatment, the frequency of asthma attacks in patients receiving Dermoquimab was significantly reduced compared to the placebo group.

Source: NEJM

Results from two Phase III studies (ANCHOR-1 and ANCHOR-2) in patients with CRSwNP showed that after 52 weeks of treatment, the total nasal endoscopy polyp score in the derokizumab group was significantly reduced compared to the placebo group. Additionally, the nasal congestion score assessed by the Verbal Rating Scale (VRS) during weeks 49-52 was also significantly lower in the derokizumab group compared to the placebo group. Detailed data have not yet been released.

▍Two New Drugs Approved Within the Year

Previously, AstraZeneca'sBenralizumab InjectionNew Drug Application Approved by China's National Medical Products Administration (NMPA) in August 2024 for the Treatment of Severe Eosinophilic Asthma (SEA). Benralizumab, developed by AstraZeneca, is aMonoclonal Antibody Targeting IL-5 Receptor`, which has previously been approved by the U.S. FDA for the treatment of various types of asthma patients.`

Studies show that in patients with severe eosinophilic asthma receiving standard-of-care (SoC), treatment with GSK’s Benralizumab significantly reduced the annual asthma exacerbation rate (AAER) by up to 74% (0.49 for Benralizumab vs 1.88 for placebo, risk ratio 0.26, p<0.0001), demonstrating significant statistical and clinical benefits. Benralizumab met all primary and key secondary endpoints, improving lung function and asthma symptoms.

Compiled from: PharmaCube Info, PharmaView