从国际非专利名称纵观全球生物药发展

doi:10.13523/j.cb.1907011

中国生物工程杂志

2020, Vol. 40

Issue (1-2): 154-165 DOI: 10.13523/j.cb.1907011

行业分析

从国际非专利名称纵观全球生物药发展

曹萌^1,²,赵宇豪^1,³,郭中平^1,^*(

)

1 国家药典委员会北京 100061
2 上海药品审评核查中心上海 201203
3 上海市食品药品检验所上海 201203

A Review of the Global Bio-Therapeutics Development Process from the Perspective of International Nonproprietary Names

CAO Meng^1,²,ZHAO Yu-hao^1,³,GUO Zhong-ping^1,^*(

)

1 Chinese Pharmacopoeia, Beijing 100061,China
2 Shanghai Center for Drug Evaluation and Inspection, Shanghai 201203, China
3 Shanghai Institute for Food and Drug Control, Shanghai 201203, China

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摘要：

生物药(bio-therapeutics)是指采用生物技术制备的、临床上用于疾病治疗的大分子生物制品,具有结构复杂、异质性高等特点,科学严谨的生物药通用名命名,是区分生物药物质基础的主要依据,也是药品生命周期管理的重要基础。世界卫生组织(World Health Organization,WHO)协调建立的国际非专利名称(International Nonproprietary Names,INN)是全球药物命名的标准化体系。从INN的起源,以及生物药INN的类别、发生与发展为主线,以较为详实的数据统计和分析,呈现了全球生物药的衍化进程,从不同的角度纵览生物药技术发展历程,对生物药的研发设计、技术标准及监管策略的考量均具有一定的参考意义。

关键词： 生物药; 国际非专利名; 上市; 靶点; 适应证; 前沿生物制品

Abstract:

Bio-therapeutics refer to the macromolecular biological products prepared by biotechnology and applied in disease treatment. Because of their high complexity/heterogeneity on aspects of structure and activity, the scientific and rigorous generic names for bio-therapeutics are fundamental for identifying effective drug substances and regulating their life cycle. The International Nonproprietary Names (INN) Program was established by the World Health Organization (WHO) and coordinated to be a global standardization system for assigning nonproprietary names to medicinal substances.The origin and development of the INN system in particular the biologics INN system were introduced, the INN categories, substances and marketing situation were also illustrated to reflect the development trend of bio-therapeutics. Through detailed data analysis, the development process of global bio-therapeutics as well as related bio-technology were presented and reviewed from multiple perspectives, which could be harnessed as important reference significance for the R&Ds, technical standards, clinical applications and regulatory strategy considerations.

Key words: Bio-therapeutics INN Approval Targets Indications Advanced biological products

收稿日期: 2019-07-05 出版日期: 2020-03-27

ZTFLH:

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通讯作者: 郭中平 E-mail: guozp303@163.com

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引用本文:

曹萌,赵宇豪,郭中平. 从国际非专利名称纵观全球生物药发展[J]. 中国生物工程杂志, 2020, 40(1-2): 154-165.

CAO Meng,ZHAO Yu-hao,GUO Zhong-ping. A Review of the Global Bio-Therapeutics Development Process from the Perspective of International Nonproprietary Names. China Biotechnology, 2020, 40(1-2): 154-165.

链接本文:

https://manu60.magtech.com.cn/biotech/CN/10.13523/j.cb.1907011 或 https://manu60.magtech.com.cn/biotech/CN/Y2020/V40/I1-2/154

图1 生物制品和小分子药物INN发展历程与分布情况

图2 四大主要类别生物制品INN发展历程和分布情况

表1 INN生物药药学分类及数量统计

图3 INN生物药药学分类结构图

图4 单抗靶点的发展进程

图5 融合蛋白靶点的发展进程

图6 基因治疗产品靶点的发展进程

图7 细胞治疗产品靶点的发展进程

表2 针对白细胞表面抗原类靶点的单抗及融合蛋白INN数量

表3 针对肿瘤坏死因子类靶点的单抗及融合蛋白INN数量

表4 针对白介素类靶点的单抗及融合蛋白INN数量

表5 集中度较高的单抗靶点及上市产品情况统计

表6 集中度较高的融合蛋白靶点及上市产品情况统计

表7 上市生物药在INN收录品种的分布情况

表8 欧、美、日、中均上市的INN生物药品种*

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