荨麻疹新型治疗药物--Ligelizumab  

A novel drug for urticaria therapy-Ligelizumab

作　　者：曾奇峰[1] 刘萍[1] 冯瑛琪 ZENG Qi-feng;LIU Ping;FENG Ying-qi(Department of Dermatology,the People's Hospital of ShiZhu,Chongqing 409100,China;School of Chemical Engineering and Pharmacy,Wuhan Institute of Technology,Wuhan 430205,China)

机构地区：[1]石柱土家族自治县人民医院皮肤科,重庆409100 [2]武汉工程大学化工与制药学院,武汉430205

出　　处：《临床药物治疗杂志》2022年第6期7-10,共4页Clinical Medication Journal

摘　　要：Ligelizumab(研发代号:QGE031)是诺华制药公司研发的新一代高亲和力抗免疫球蛋白E(IgE)人源化单克隆免疫球蛋白G1(IgG1)抗体。Ligelizumab的作用机制和临床研究表明,该药可通过阻断IgE/Fcε受体Ⅰ(FcεRⅠ)信号通路,达到治疗慢性自发性荨麻疹、重度哮喘等疾病的目的。Ligelizumab在多项临床试验中表现出比奥马珠单抗(Omalizumab)更好的缓解荨麻疹效果,且未出现明显安全性问题。目前Ligelizumab处于Ⅲ期临床试验阶段。美国食品药品管理局(FDA)已授予Ligelizumab突破性药物资格,用于治疗对H_(1)抗组胺治疗应答不足的慢性自发性荨麻疹患者。本文对Ligelizumab的作用机制、药物代谢动力学、临床前研究、临床疗效及安全性等进行综述。Ligelizumab(QGE031),developed by Novartis,is a novel humanized monoclonal immunoglobulin G1(IgG1)antibody against immunoglobulin E(IgE)with high affinity.The mechanism of action and clinical studies of Ligelizumab show that this compound can block the IgE/anti-mouse FcεreceptorⅠ(FcεRⅠ)signal pathway,so as to treat chronic spontaneous urticaria,severe asthma and others.At present,Ligelizumab is in phaseⅢclinical research stage,which shows better efficacy in alleviating urticaria than Omalizumab in a number of clinical trials with no obvious safety concerns.The Food and Drug Administration(FDA)has granted Ligelizumab breakthrough drug qualification for the treatment of chronic spontaneous urticaria patients with insufficient response to H_(1) antihistamine treatment.This paper comprebensively reviews the mechanism of action,pharmacokinetics,preclinical research,clinical efficacy and safety of Ligelizumab.

关 键 词：慢性自发性荨麻疹 Ligelizumab 单抗 免疫球蛋白G1 

分 类 号：R976[医药卫生—药品]