综述

治疗A型血友病的非因子类产品研究进展

  • 王雨 ,
  • 李春燕 ,
  • 吴佳君 ,
  • 李小姣 ,
  • 梁洪 ,
  • 吴强 ,
  • 张航
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  • 1北京天坛生物制品股份有限公司科研管理部, 北京 100024; 2成都蓉生药业有限责任公司科研质量部, 成都 610219; 3北京天坛生物制品股份有限公司研发中心, 北京 100024; 4成都蓉生药业有限责任公司生产管理部, 成都 610219

网络出版日期: 2025-08-16

Research progress of non-factor products for treating haemophilia A

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  • 1Research Management Department, Beijing Tiantan Biological Products Co., Ltd., Beijing 100024, China;2Research Quality Department, Chengdu Rongsheng Pharmaceuticals Co., Ltd., Chengdu 610219, China;3R&D Center, Beijing Tiantan Biological Products Co., Ltd., Beijing 100024, China;4Production Management Department, Chengdu Rongsheng Pharmaceuticals Co., Ltd., Chengdu 610219, China

Online published: 2025-08-16

摘要

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。

本文引用格式

王雨 , 李春燕 , 吴佳君 , 李小姣 , 梁洪 , 吴强 , 张航 . 治疗A型血友病的非因子类产品研究进展[J]. 国际生物制品学杂志, 2024 , 47(3) : 186 -190 . DOI: 10.3760/cma.j.cn311962-20230726-00001

Abstract

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.
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