根据中国药物临床试验登记与信息公示平台官网，葛兰素史克已经在中国开展了多项depemokimab的3期临床研究，其中治疗嗜酸性粒细胞表型的重症未控制的成人和青少年哮喘的一项3期临床研究已经完成，针对CRSwNP的两项3期临床研究已经完成招募。在研究中，depemokimab的给药方式为每6个月一次或每26周一次皮下注射。Depemokimab (GSK3511294) is a long-acting IL-5 antagonist that has an extended half-life.
According to the Zhitong Finance App, on January 4th, the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration announced that GlaxoSmithKline (GSK.US) has submitted an application for a new indication for the Class 1 new drug depemokimab, which has been accepted. The first application for this drug was accepted by the CDE on January 1st of this year.
According to public information from GSK, depemokimab (GSK3511294) is a long-acting IL-5 antagonist that has an extended half-life and is expected to control patient symptoms with quarterly injections. The product has already achieved positive results in four Phase 3 clinical studies for treating severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP), and the results of these four trials will be used to support regulatory submissions globally.
According to the official website of the China Clinical Trial Registration and Information Disclosure Platform, GlaxoSmithKline has conducted multiple Phase 3 clinical studies of depemokimab in China, including one Phase 3 study for uncontrolled severe asthma in adults and adolescents with an eosinophilic phenotype, which has been completed, and two Phase 3 studies for CRSwNP that have completed recruitment. In the studies, the administration method of depemokimab was subcutaneous injection every six months or every 26 weeks.
