GlaxoSmithKline plc Sponsored ADR (GSK.US) receives acceptance of a new indication for Type 1 new drug democlonal antibody.

On January 4th, the China National Medical Products Administration's Center for Drug Evaluation (CDE) website announced that a new indication for GlaxoSmithKline plc Sponsored ADR's (GSK.US) class 1 new drug depemokimab has been accepted for marketing application. The first marketing application for this drug was accepted by CDE on January 1st this year. According to publicly available information from GSK, depemokimab (GSK3511294) is a long-acting IL-5 antagonist with an extended half-life, which is expected to control patients' symptoms with just one injection every 6 months. The product has shown positive results in four phase 3 clinical trials for the treatment of severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP), and the results of these trials will be used to support regulatory submissions globally. According to the official website of the China Drug Clinical Trial Registration and Information Disclosure Platform, GlaxoSmithKline plc Sponsored ADR has conducted multiple phase 3 clinical trials for depemokimab in China. One phase 3 clinical trial for the treatment of severe uncontrolled asthma in adults and adolescents with an eosinophilic phenotype has been completed, and recruitment for two phase 3 clinical trials targeting CRSwNP has been completed. In these studies, depemokimab is administered via subcutaneous injection every 6 months or every 26 weeks.