单克隆抗体药物研发进展  

Progresses in Research and Development of Monoclonal Antibodies

作　　者：付志浩[1] 徐刚领 黄璟 于传飞[1] 王兰[1] 王军志[1] FuZhihao;Xu Gangling;Huang Jing;Yu Chuanfei;Wang Lan;Wang Junzhi(Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products,National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院卫生部生物技术产品检定及标准化重点实验室,国家药品监督管理局生物制品质量研究与评价重点实验室,北京102629

出　　处：《中国药事》2021年第11期1253-1268,共16页Chinese Pharmaceutical Affairs

基　　金：“重大新药创制”科技重大专项(编号2018ZX09736016-007)。

摘　　要：目的:对单克隆抗体药物研发进展进行综述,为行业提供参考。方法:通过查阅文献和相关数据库,对经典的单克隆抗体药物,以及由此衍生的抗体偶联药物、双特异性抗体药物的研究进行汇总、梳理。结果与结论:自1986年第一个单克隆抗体药物上市以来,全球已有超过100种单抗药物获批上市。国内已获批的进口单抗药物达42个,国产单抗药物达31个。经过30多年的研究和发展,单抗药物以其高度特异性和疗效确切的特点,在肿瘤、自身免疫、代谢、病毒感染等疾病领域显示出独特的优势和广阔的应用前景。Objective: The research and development progress of monoclonal antibodies drugs was reviewed so as to provide references for the industry. Methods: Through referring to the literature and related databases,the research progress of classical monoclonal antibody drugs, as well as the derived antibody conjugate drugs and bispecific antibody drugs was reviewed and summarized. Results and Conclusion: More than one hundred therapeutic monoclonal antibodies(mAbs) have been approved worldwide since the first therapeutic mAb was marketed in 1986. 42 imported mAbs and 31 domestic mAbs have been approved in China. With more than 30 years of research and development, mAbs have showed special superiorities and wide application prospect in the fields of tumor, autoimmune, metabolism, virus infection and other diseases.

关 键 词：单克隆抗体 抗体偶联药物 双特异性抗体 肿瘤 自身免疫性疾病 

分 类 号：R95[医药卫生—药学]