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中国生物工程杂志

China Biotechnology
China Biotechnology  2019, Vol. 39 Issue (3): 111-119    DOI: 10.13523/j.cb.20190314
    
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
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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 wordsMonoclonal      antibodies      Clinical      R&D      Commercial      deal     
Received: 18 September 2018      Published: 12 April 2019
ZTFLH:  Q51  
Corresponding Authors: Qian GAO     E-mail: gaoq@mail.whlib.ac.cn
Cite this article:

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.

URL:

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

Fig.1 Quantity distribution of monoclonal antibodies in R&D and industrialization
Fig.2 Global TOP10 countries/regions of monoclonal antibodies
Fig.3 Quantity distribution of each kind of launched monoclonal antibodies
排名 主要靶向作用 数量(个)
1 HER2酪氨酸激酶受体抑制剂 111
2 TNF-α配体抑制剂 109
3 TNF结合剂 90
4 B淋巴细胞CD20抗原抑制剂 80
5 程序性细胞死亡蛋白-1抑制剂 77
6 VEGF配体抑制剂 75
7 程序性细胞死亡蛋白-1配体抑制剂 68
8 表皮生长因子受体拮抗剂 56
9 HER2酪氨酸激酶受体调节剂 40
10 CD3调节剂 38
Table 1 TOP10 target-based actions of monoclonal antibodies
排名 药品名称(商品名) 公司 2017年销售额(亿美元)
总额 美国
(US)
欧洲
(EU)
日本
(JP)
亚洲
(ASI)
其他国家
/地区
1 Adalimumab (Humira) AbbVie Inc Eisai Co Ltd 187.67 123.61 3.4 60.66
2 Infliximab (Remicade) Johnson & Johnson Merck & Co Inc Mitsubishi Tanabe Pharma Corp 77.55 50.88 8.37 6.03 12.27
3 Rituximab(Rituxan;MabThera) Roche Holding AG 75.04 41.98 17.16 2.97 12.92
4 Trastuzumab (Herceptin) Roche Holding AG 71.24 27.39 21.56 2.99 19.28
5 Bevacizumab (Avastin) Roche Holding AG 67.93 29.39 18.03 8.29 12.19
6 Nivolumab (Opdivo) Ono Pharmaceutical Co Ltd
Bristol-Myers Squibb Co
58.86 31.02 9.38 18.46
7 Ustekinumab (Stelara) Johnson & Johnson 40.11 27.67 12.44
8 Denosumab (Pralia) Amgen Inc Daiichi Sankyo Co Ltd 38.31 24.29 2.88 11.14
9 Pembrolizumab (Keytruda) Merck & Co Inc 38.09 23.09 15
10 Ranibizumab (Lucentis) Roche Holding AG Novartis AG 33.24 14.36 18.88
11 Eculizumab (Soliris) Alexion Pharmaceuticals Inc 31.44 12.35 9.86 3.28 5.95
12 Golimumab (Simponi) Johnson & Johnson Merck & Co Inc Mitsubishi Tanabe Pharma Corp 28.76 9.54 8.19 2.24 8.79
13 Omalizumab (Xolair) Roche Holding AG Novartis AG 26.89 17.69 9.2
14 Pertuzumab (Perjeta) Roche Holding AG 22.3 10.28 7.79 1.21 3
15 Secukinumab (Cosentyx) Novartis AG 20.71 12.75 7.96
16 Natalizumab (Tysabri) Biogen Inc 19.73 11.13 8.59
17 Tocilizumab (Actemra) Roche Holding AG 19.56 7.67 3.08 6.4
18 Vedolizumab (Entyvio) Takeda Pharmaceutical Co Ltd 18.52 12.29 5.53 0.69
19 Certolizumab pegol (Cimzia) Astellas Pharma Inc UCB SA 16.77 10.36 4.17 0.69 1.53
20 Cetuximab (Erbitux) Eli Lilly & Co Merck KGaA 16.09 6.45 5.04 4.58
21 Ipilimumab (Yervoy) Bristol-Myers Squibb Co 12.44 9.08 3.36
22 Daratumumab (Darzalex) Johnson & Johnson 12.42 8.84 3.58
Table 2 The monoclonal antibodies of annual sales over $1 biliion in 2017
Table 3 2017 commercial deals of monoclonal antibodies TOP10
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