Please wait a minute...

中国生物工程杂志

China Biotechnology
China Biotechnology  2015, Vol. 35 Issue (12): 103-108    DOI: 10.13523/j.cb.20151216
    
The Status and Development Prospect of Chinese Antibody Drug Industry
MA Shan-shan1,2, MA Su-yong2, ZHAO Guang-rong1
1. School of Chemical Engineering and Technology of Tianjin University, Tianjin 300072, China;
2. Beijing Nothland Biotech Co., Ltd., Beijing 100085, China
Download: HTML   PDF(474KB) HTML
Export: BibTeX | EndNote (RIS)      

Abstract  

The current development of monoclonal antibody drugs industry in China has just entered the initial stage,there is a big gap compared with the United States and theEuropean Union. But the antibody drug industry is developping rapidly in our country,and the policy support was significantly increased and the market average annual compound growth rate increased year by year,antibody drug industry has a huge market potential. According to some reports and domestic literature in recent years,as well as the CFDA, CDE website database,the present situation of domestic therapecutic mABs through CFDA approval,registration,industrialization status were summarized and the research progress and development prospect of chinese antibody drug industry were reviewed, to provide comprehensive theoretical basis for research and development.



Key wordsIndustrialization status      Production and registration      Antibody drug     
Received: 08 August 2015      Published: 22 December 2015
ZTFLH:  Q819  
Cite this article:

MA Shan-shan, MA Su-yong, ZHAO Guang-rong. The Status and Development Prospect of Chinese Antibody Drug Industry. China Biotechnology, 2015, 35(12): 103-108.

URL:

https://manu60.magtech.com.cn/biotech/10.13523/j.cb.20151216     OR     https://manu60.magtech.com.cn/biotech/Y2015/V35/I12/103

[1] 王志明,高健,李耿.治疗性单克隆抗体药物的现状及发展趋势.中国生物工程杂志,2013,33(6):117-124. Wang Z M, Gao J, Li G. The status and development trend of the therapeutic monoclonal antibody drugs. China Biotechnology, 2013,33(6):117-124.
[2] 王兰,朱磊,徐刚,等.单克隆抗体类生物治疗药物研究进展.中国药学杂志,2014,49(23):2058-2064. Wang L, Zhu L, Xu G,et al. Progress of research and development of antibody-based therapeutics. Chinese Pharmaceutical Journal, 2014,49(23):2058-2064.
[3] 高云华,徐守军,刁天喜.抗体药物研究进展.中国新药杂志,2014,23(20):2414-2417. Gao Y H, Xu S J, Diao T X. Advances in research of antibody drugs. Chinese Journal of New Drugs, 2014,23(20):2414-2417.
[4] Reichert J M. Antibodies to watch in 2015. MAbs, 2015,7(1):1-8.
[5] IMS Institute for Healthcare Informatics.The global use of medicines:outlook through 2015.US:IMS Institute for Healthcare Imformatics, 2011.
[6] 李婷婷.我国与全球单克隆抗体药物产业的对比分析及发展趋势预测.济南:山东大学药学院, 2014. Li T T. Comparative analysis and development forecast of domestic and global monoclonal antibody drug industry. Jinnan:ShanDong University, School of Pharmaceutical Sciences, 2014.
[7] 葛良鹏,丁宁,兰国成,等.治疗性抗体的研究现状与未来,中国生物工程杂志,2013,33(9):85-93. Ge L P, Ding N, Lan G C,et al. Current situation and prospects of therapeutic antibody. China Biotechnology, 2013, 33(9):85-93.
[8] 归成,刘皋林.2011-2013年上海样本医院抗肿瘤药物使用情况分析.药物与临床, 2015,12(02):28-32. Gui C, Liu G L. Analysis of the medication on anticancer drugs in shanghai sample hospitals from 2011 to 2013. Drugs and Clinic, 2015,12(02):28-32.
[9] 黎苏,陈琴,项婧,等.2012~2014年辽宁省肿瘤医院抗肿瘤药物的使用情况分析.现代药物与临床, 2015,30(9):1150-1153. Li S, Chen Q, Xiang J,et al. Analysis on usage of anticancer drugs in Liaoning Cancer Hospital and Institute from 2012 to 2014. Drugs & Clinic, 2015,30(9):1150-1153.
[10] 田文志,朱祯平.抗体药物现状及发展趋势.生物产业技术, 2013, 5:7-21. Tian W Z, Zhu Z P.The status and development trend of antibody drugs. Biotechnology & Business. 2013, 5:7-21.
[11] Pasquetto M V,Vecchia L,Covini D,et a1.Targeted drug delivery using immunoconjugates:principles and applications. J Immunother, 2011, 34:611-628.
[12] 张莹,何金生,洪涛.重组抗体药物研究进展及应用.中国生物工程杂志,2009,29(8):102-106. Zhang Y, He J S, Hong T.Advances and application of recombinant antibody drugs. China Biotechnology, 2009,29(8):102-106.
[13] Doneanu C E,Xenopoulos A,Fadgen K,et al.Analysis of hostcell proteins in biotherapeutic proteins by comprehensive online two-dimensional liquid chromatography/mass spectrometry. mAbs, 2012, 4(1):24-44.
[14] ACQUITY UPLC H-Class Bio System.Waters Application Note,2011,720003482EN.

[1] WU Rui-jun,LI Zhi-fei,ZHANG Xin,PU Run,AO Yi,SUN Yan-rong. Development and Prospect of Antibody Drugs for SARS-CoV-2[J]. China Biotechnology, 2020, 40(5): 1-6.
[2] LIU Guo-fang,LIU Xiao-zhi,GAO Jian,WANG Zhi-ming. Effects of Host Cell Residual Proteins on the Quality and Their Quality Control of Monoclonal Antibody[J]. China Biotechnology, 2019, 39(10): 105-110.
[3] Yi HUANG,Xiao-yu LI,Fang TIAN,Xiao-hong QIAN,Wan-tao YING. Identification and Quantitative Study on Glycosylation Chain Modification of Antibody Drugs by Mass Spectrometry[J]. China Biotechnology, 2018, 38(1): 32-41.
[4] REN Hua-jing, LIU Xiao-zhi, WANG Zhi-ming, GAO Jian. Progression of Central Nervous System Disease Therapeutic Antibody Drug Application[J]. China Biotechnology, 2016, 36(9): 54-58.
[5] LIU Bo-ning. The Progress of Therapeutic Antibody Drug and the Industrial Key-technology of Antibody Production[J]. China Biotechnology, 2013, 33(5): 132-138.
[6] ZHANG Ying, HE Jin-Sheng, HONG Chao. Advances and Applications of Recombinant Antibody Drugs[J]. China Biotechnology, 2009, 29(08): 102-106.