▎WuXi AppTec Content Team Report

Today (January 4), the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) announced,GSK's New Drug Depemokimab Submitted for Another New Indication and Accepted for ReviewThe first marketing application for this drug was accepted by the CDE on January 1st of this year.

According to the public information from GSK,Depemokimab (GSK3511294) is aLong-acting IL-5 antagonist，It has an extended half-life,Symptoms in patients could be controlled with an injection every six months.。The product has already been in treatmentSevere AsthmaAndChronic Rhinosinusitis with Nasal Polyps (CRSwNP)Positive results were achieved in four Phase 3 clinical studies.The results of these four trials will be used to support regulatory submissions worldwide.

Screenshot source:CDE Official Website

Interleukin-5 (IL-5) is a cytokine that regulates the growth, activation, and survival of eosinophils, and provides critical signals for the migration of eosinophils from the bone marrow to the lungs and other organs. Public data shows,The world's first approved anti-IL-5 monoclonal antibody is from GSK.Mepolizumab (mepolizumab）, itsBy binding to IL-5, it blocks the binding of IL-5 to the surface receptors on eosinophils, inhibits the biological activity of eosinophils, and continuously reduces their numbers to normal levels, thereby decreasing the growth of eosinophils and the inflammation and tissue damage mediated by eosinophils, maintaining a healthy state.

Although anti-IL-5 monoclonal antibodies have been approved for marketing, there are still unmet clinical needs in clinical practice, such as some patients still cannot be effectively controlled, andDue to frequent injectionsLead to low patient compliance, thus failing to achieve better clinical treatment outcomes. As aLong-acting IL-5 antagonist,The uniqueness of depemokimab lies inHigh affinity for IL-5, capable of long-term inhibition of IL-5 activity.

In September 2024, GSK announced the Phase 3 clinical trials SWIFT-1 and SWIFT-2Full results, These two trials evaluated depemokimab compared with placebo inAdult and adolescent patients with severe asthma characterized by Type 2 inflammation (marked by blood eosinophil count)Efficacy and safety. The analysis shows,Trial Meets Primary Endpoint, Therapy Significantly Reduces Asthma Exacerbations by 54% in Patients.Detailed data were simultaneously published in The New England Journal of Medicine. According to the press release,Depemokimab may become the first approved ultra-long-acting biologic that requires dosing only once every six months for the treatment of severe asthma.

In October 2024, GSK announced that depemokimab met the endpoints in two Phase III clinical trials, ANCHOR-1 and ANCHOR-2, for the treatment of patients with chronic rhinosinusitis with nasal polyps (CRSwNP).Primary Endpoint，Compared with placebo, depemokimab significantly improved patients' endoscopic nasal polyp scores at week 52; it also improved patients' average nasal congestion scores during weeks 49-52.

According to the official website of the Chinese Drug Clinical Trial Registration and Information Disclosure Platform, GSK has conducted several Phase 3 clinical trials of depemokimab in China, including treatmentEosinophilic Phenotype of Severe Uncontrolled Asthma in Adults and AdolescentsA Phase 3 clinical study has been completed, targetingCRSwNPTwo Phase 3 clinical studies have completed enrollment. In the studies, depemokimab was administered viaOnce every 6 months or once every 26 weeks, subcutaneous injection。

[1] Center for Drug Evaluation, National Medical Products Administration of ChinaWebsite. Retrieved Jan 4, 2025, from https://www.cde.org.cn/main/xxgk/listpage/da6efd086c099b7fc949121166f0130c

[2]GSK announces positive phase III results from ANCHOR trials for depemokimab in chronic rhinosinusitis with nasal polyps. Retrieved October 14, 2024, from https://www.gsk.com/en-gb/media/press-releases/gsk-announces-positive-phase-iii-results-from-anchor-trials/

[3]Depemokimab late-breaking data presented at ERS show a 54% reduction in severe asthma exacerbations. Retrieved September 9, 2024 from https://www.gsk.com/en-gb/media/press-releases/depemokimab-late-breaking-data-presented-at-ers-show-a-54-reduction-in-severe-asthma-exacerbations/