GSK's Mepolizumab, the First-in-Class Anti-IL-5 Monoclonal Antibody, Approved in China for EGPA

On November 19, the information on the pending collection of drug approval certificates from the National Medical Products Administration showed that GlaxoSmithKline (GSK)’s Mepolizumab Injection (mepolizumab, formerly known as Mepolizumab) has been approved for marketing in China.

It is reported that Mepolizumab is a "first-in-class" anti-IL-5 humanized monoclonal antibody and also the world’s first approved anti-IL-5 monoclonal antibody. It has been approved in many countries worldwide for the treatment of inflammatory diseases caused by eosinophilia, including severe eosinophilic asthma (SEA), eosinophilic granulomatosis with polyangiitis (EGPA), hypereosinophilic syndrome (HES), and chronic rhinosinusitis with nasal polyps (CRSwNP).

Public information shows that this application of the drug is for the treatment of adult patients with Eosinophilic Granulomatosis with Polyangiitis (EGPA).

Eosinophilic Granulomatosis with Polyangiitis (EGPA) is a rare autoimmune disease that can affect multiple systems throughout the body. It is mainly characterized by increased eosinophils in peripheral blood and tissues, infiltration, and necrotizing granulomatous inflammation of small to medium-sized vessels, and belongs to anti-neutrophil cytoplasmic antibody (ANCA)-associated systemic vasculitis.

Currently, there are two approved IL-5 monoclonal antibodies globally: Mepolizumab and Reslizumab (Teva), as well as one approved IL-5R monoclonal antibody, Benralizumab from AstraZeneca. In China, the IL-5 monoclonal antibody (610 anti-IL5 mAb) developed by 3SBio and the IL-5 monoclonal antibody SHR-1703 from Hengrui Medicine are in Phase I clinical trials. The biosimilar of Mepolizumab developed by Mabpharm and Zhengdatianqing is in the preclinical stage.