关于创新型抗体药物药学评价的思考  

Research and development of innovative antibody-based drugs

作　　者：刘伯宁[1] 罗建辉[1] 

机构地区：[1]国家食品药品监督管理总局药品审评中心,北京100038

出　　处：《药学学报》2017年第12期1811-1819,共9页Acta Pharmaceutica Sinica

基　　金：国家科技重大专项"重大新药创制"课题资助项目(2015ZX09501008)

摘　　要：近年来,随着我国生物制药自主创新能力的提高,越来越多的创新型抗体药物申请注册临床试验。按照其技术特点,可分为全新序列抗体(改良型抗体或新靶点抗体)、双特异性抗体(或复方抗体)、抗体偶联物等三类。与生物类似药不同,创新型抗体的开发具有"创试性"、"阶段性"和"渐进性"等显著特点。与之相适应,其药学评价内容与技术要求也区别于生物类似药。本文总结了近年来国内外创新型抗体的发展趋势与申报现状,对代表品种的技术特点进行分析。并结合新药审评实践,着重就创新型抗体药学评价的关注点、一般考虑与评价要点展开探讨,以期促进此类药物由研发顺利转入早期临床试验阶段。With the development of antibody manufacturing technology and improvement in new drug research and development（RD） capabilities in domestic industry,more and more innovative antibody-based drugs were registered at the Investigational New Drug（IND）.This type of drugs could be divided into three categories：new sequence antibodies（biobetter or new target antibodies）,bispecific antibodies（or antibody cocktails）,and antibody drug conjugates.Comparing with biosimilar antibodies,the innovative antibodies RD was characterized by some significant features including ＂innovation＂,＂clinical phase-appropriate＂ and ＂progressing＂.The minimum requirements of Chemical,Manufacturing and Control（CMC） content for innovative antibodies were obviously different from biosimilar antibodies.Here,the recent progress of antibody engineering and IND date of innovative antibodies in domestic are summarized.The general regulatory requirement and special considerations for representative innovative antibodies were proposed.Some common problems concerning innovative antibodies RD are discussed.

关 键 词：创新型抗体 抗体工程 抗体药物偶联物 双特异性抗体 程序化细胞死亡受体1 

分 类 号：R916[医药卫生—药学]