关于我国单抗药物上市阶段药学评价的思考  

Chemistry, manufacturing and controls regulatory considerations for marketing authorization application of therapeutic antibody in China

作　　者：刘伯宁 徐刚领 罗建辉[1] LIU Bo-ning;XU Gang-ling;LUO Jian-hui(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)Abstract:The mark)

机构地区：[1]国家药品监督管理局药品审评中心

出　　处：《药学学报》2019年第11期2126-2134,共9页Acta Pharmaceutica Sinica

基　　金：国家“重大新药创新”资助项目(2015ZX09501008)

摘　　要：申报注册上市是药物生命周期的重要节点,标志着具有临床价值"候选物"成为可以上市销售的"药品"。目前,我国自主研发的抗体药物上市产品仅12个。注册生产阶段的单抗药物研发与评价,对于工业界和监管界而言均缺乏经验。与此同时,近年来单抗生物类似药产品已开始集中报产,国外单抗进口注册进程不断加快,未来单抗药物上市阶段的药学评价将为我国生物制品注册上市审评的重要工作。本文结合笔者从事单抗药物研发与评价的实践经验,重点对单抗药物注册生产阶段的药学研究内容、评价要点及现存问题展开讨论,以期促进工业界规范开展药学研究,加速此类产品注册上市进程。The marketing authorization application is a milestone of drug life cycle,which indicates a candidate has potential to become a commercial drug.As of now,there are only 12 domestic therapeutic antibodies approved in China.The chemistry,manufacturing and controls(CMC)development and evaluation of monoclonal antibody were more challenging for both industry and authority agency.As the result of domestic biopharmaceutical industry development and implement of priority review system,the marketing authorization application of domestic antibody biosimilar and imported antibodies had dramatic increased in recent years.Thus,the CMC evaluation of monoclonal antibody become the important task of biological product’s marketing authorization registration management.In the article,the CMC regulatory considerations for marketing authorization application based on author’s review experience was proposed,in order to accelerate development and registration of commercial antibody in China.

关 键 词：抗体药物 上市申请 药学评价 生产现场检查 单克隆性 质量源于设计 工艺变更 

分 类 号：R943[医药卫生—药剂学]