目前,已上市的预防治疗A型血友病的非因子类产品只有重组人源化IgG4双特异性单克隆抗体(单抗)艾美赛珠单抗,此产品具有良好的安全性和有效性,不受人凝血因子Ⅷ抑制物影响,并具有给药频率低等特点。此药于2017年首次在美国获批上市,2018年相继在欧盟、日本和中国获批上市。此文对艾美赛珠单抗的基本情况、组成结构与药理毒理学特性、临床研究、同类药品研发进展等方面进行综述,以供国内相似药物研发参考。
Emicizumab, the only non-factor product on market for the prevention and treatment of haemophilia A, is a recombinant bispecific humanized IgG4 monoclonal antibody. It has characteristics of good safety and effectiveness, not affected by human coagulation factor Ⅷ inhibitor, and low frequency of administration. The drug was first approved for marketing in the United States in 2017, and was subsequently approved in European Union, Japan and China in 2018. This article reviews the basic information, composition, pharmacological and toxicological properties of Emicizumab , as well as clinical research and research progress of similar drugs, providing reference for research and development of the domestic similar drugs.