全球单克隆抗体药物研发现状及发展趋势 <sup>*</sup>

doi:10.13523/j.cb.20190314

中国生物工程杂志

2019, Vol. 39

Issue (3): 111-119 DOI: 10.13523/j.cb.20190314

行业分析

全球单克隆抗体药物研发现状及发展趋势 ^*

高倩(

),江洪,叶茂,郭文娟

中国科学院武汉文献情报中心武汉 430071

Current Status and Trend of R&D of Monoclonal Antibodies

Qian GAO(

),Hong JIANG,Mao YE,Wen-juan GUO

Wuhan Library,Chinese Academy of Sciences,Wuhan 430071, China

全文: PDF(837 KB) HTML

摘要：

单克隆抗体药物以其独特的作用机制及高效性,在恶性肿瘤和自身免疫疾病的治疗中发挥了不可估量的重要作用,成为全球的研发热点。基于科睿唯安旗下的Cortellis数据库,采用定量分析和专家智慧相结合的方法,从总体研发和商业化现状、主要国家/地区、技术和种类、靶点及作用机制、市场份额、产品交易多个维度展现出全球单克隆抗体药物的研发和商业化全景。分析结果显示:全球已上市的单克隆抗体药物有133个,其中已上市的人源化单克隆抗体药物占已上市的单克隆抗体药物总数的37.6%。作用靶点主要集中在HER、TNF、CD20、PD-1/L1、VEGF以及CD3,其中作为HER2酪氨酸激酶受体抑制剂的药物数量最多。美国在单克隆抗体药物研发和商业化方面遥遥领先,中国在研和上市的单抗隆抗体药物总数排名第二,但中国上市的单抗隆抗体药物数量仅8个。2017年销售额高于10亿美元的单克隆抗体药物有22个。全球单克隆抗体药物的交易数量共有1 408次,药物开发与商业化许可是最主要的交易方式。未来,单克隆抗体药物的发展趋势将朝着新靶点、新适应症和新用药方案的方向发展,将会产生更多“重磅炸弹药物”。

关键词： 单克隆抗体; 临床研发; 商业化交易

Abstract:

Monoclonal antibodies have played an inestimable role in the treatment of cancer and autoimmune diseases with their unique mechanism and high efficiency, which have become the focus of research in biopharmaceutics. In this paper, all the data was extracted from Clarivate via Cortellis. Through the combination of quantitative data analysis and expert wisdom, the competitive landscape of monoclonal antibodies was presented from various dimensions, including the overall trend of R&D and industrialization, focus countries, technology and drug categories, targets, market share and commercial deal. The results showed that among the 133 kinds of launched monoclonal antibodies recently, 37.6% of them belonged to humanized monoclonal antibodies. HER, TNF, CD20, PD-1/L1, VEGF and CD3 were the “hot” antibody target molecule, of the total number of target-based actions which was the most numerous in HER2 tyrosine kinase receptor inhibitor. The total volume of monoclonal antibodies in China ranked second to the United States. But there were only 8 monoclonal antibodies approved in China, which was far below the level of United States. There were 22 launched monoclonal antibodies achieved annual sales over $1 biliion in 2017. Access to 1408 monoclonal antibodies deal records, drug development/commercial license was the primary agreement type. In the future, the development trend of monoclonal antibodies will be focused on new targets, new indications and new therapeutic schemes, and then more “blockbuster drugs” will be produced.

Key words: Monoclonal antibodies Clinical R&D Commercial deal

收稿日期: 2018-09-18 出版日期: 2019-04-12

ZTFLH:

Q51

基金资助: * 湖北省技术创新专项(软科学研究类)资助项目(2018ADC003)

通讯作者: 高倩 E-mail: gaoq@mail.whlib.ac.cn

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引用本文:

高倩,江洪,叶茂,郭文娟. 全球单克隆抗体药物研发现状及发展趋势 ^*[J]. 中国生物工程杂志, 2019, 39(3): 111-119.

Qian GAO,Hong JIANG,Mao YE,Wen-juan GUO. Current Status and Trend of R&D of Monoclonal Antibodies. China Biotechnology, 2019, 39(3): 111-119.

链接本文:

https://manu60.magtech.com.cn/biotech/CN/10.13523/j.cb.20190314 或 https://manu60.magtech.com.cn/biotech/CN/Y2019/V39/I3/111

图1 全球单克隆抗体药物处于研发和商业化各阶段的数量分布

图2 单克隆抗体药物数量TOP10的国家/地区

图3 各细分种类已上市单克隆抗体药物的数量分布

表1 药物主要靶向作用数量TOP10

表2 2017年销售额10亿美元以上的单克隆抗体药物汇总

表3 2017年单克隆抗体药物商业化交易金额TOP10

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