关于《中华人民共和国药典》人用抗体偶联药物制品总论的思考  

Considerations on the General Principles of Human Antibody-Drug Conjugates in the Pharmacopoeia of the People's Republic of China

作　　者：倪永波 李萌[1] 于传飞[1] 李玮玉 张佳龄 赵雄 王兰[1] 李慧义[2] Ni Yongbo;Li Meng;Yu Chuanfei;Li Weiyu;Zhang Jialing;Zhao Xiong;Wang Lan;Li Huiyi(National Institutes for Food and Drug Control,Beijing 102629,China;National Pharmacopoeia Commission,Beijing 100061,China)

机构地区：[1]中国食品药品检定研究院,北京102629 [2]国家药典委员会,北京100061

出　　处：《中国药事》2025年第3期272-279,共8页Chinese Pharmaceutical Affairs

基　　金：国家重点研发计划“前沿生物技术”重点专项(编号2023YFC3404004);药品监管科学全国重点实验室课题(编号2023SKLDRS0118)。

摘　　要：目的:2025年版《中华人民共和国药典》即将收录人用抗体偶联药物(Human Antibody-Drug Conjugates,ADC)制品总论,针对其制造和检定部分进行阐述和讨论,为行业具体实施提供指导。方法:参考WHO、ICH、国家药典委员会和国家药品监督管理局药品审评中心的相关法规和指南,提出制定关于ADC总论的讨论和思考。结果与结论:欧美和其他国家药典中尚未对抗体偶联药物的生产和质量控制进行总体要求,目前国家药品监督管理局药品审评中心发布的《抗体偶联药物药学研究与评价技术指导原则》是首个已出台的相关药品规范生产和质量控制的指南。本文在参考相关法规的基础上,在建立国际化水平的标准编制指导思想下,主要讨论ADC总论中涉及的相关药物产品在研发、制备过程和质量控制中需遵循的一般原则和基本要求,为相关产业提供参考。Objective:The 2025 edition of the Pharmacopoeia of the People's Republic of China is about to include a general principles of Human Antibody-Drug Conjugates(ADC)for human use.This section will elaborate and discuss the manufacturing and testing of ADC products,providing guidance for specific implementation in the industry.Methods:Based on the relevant regulations and guidelines of WHO,ICH,the National Pharmacopoeia Commission,and the Center for Drug Evaluation of the National Medical Products Administration,the discussion and consideration on the general principles of ADC were put forward.Results and Conclusion:In the pharmacopoeias of Europe,America,and other countries,there are currently no overallrequirements for the production and quality control of Antibody-Drug Conjugates(ADC).The"Guiding Principles for Pharmaceutical Research and Evaluation Techniques of Antibody-Drug Conjugates"issued by the Center for Drug Evaluation of the National Medical Products Administration is the first guideline that has been introduced for the standardized production and quality control of such drugs.Based on the reference to relevant regulations and the guidance of establishing international standards,this article mainly discusses the general principles and basic requirements that need to be followed in the research and development,preparation process,and quality control of relevant drug products involved in the general principles of ADC.This aims to provide a reference for the relevant industries.

关 键 词：抗体偶联药物 药典标准 质量控制 制造 检定 

分 类 号：R95[医药卫生—药学]