中国抗体药物产业现状与发展前景

doi:10.13523/j.cb.20151216

中国生物工程杂志

2015, Vol. 35

Issue (12): 103-108 DOI: 10.13523/j.cb.20151216

医药生物技术专栏

中国抗体药物产业现状与发展前景

马杉姗^1,2, 马素永², 赵广荣¹

1. 天津大学化工学院天津 300072;
2. 北京诺思兰德生物技术股份有限公司北京 100085

The Status and Development Prospect of Chinese Antibody Drug Industry

MA Shan-shan^1,2, 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

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摘要：

我国抗体药物起步晚,研发与生产技术与国际水平相比尚有一定的差距,但我国抗体药物产业发展迅速,国家政策支持以及研发投入力度较大,目前已取得一定的成果,市场潜力巨大。根据近年来国内相关文献报道以及CFDA、CDE网站的数据库,对我国抗体药物的上市、注册、审批情况以及产业化现状、重点研发企业、发展方向等方面进行归纳总结。综述了我国抗体药物的研究进展及发展前景,为生物制药企业及从事生产研发的科研人员提供了参考依据。

关键词： 抗体药物; 产业化现状; 生产与注册情况

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 words: Industrialization status Production and registration Antibody drug

收稿日期: 2015-08-08 出版日期: 2015-12-22

ZTFLH:

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通讯作者: 赵广荣 E-mail: grzhao@tju.edu.cn

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引用本文:

马杉姗, 马素永, 赵广荣. 中国抗体药物产业现状与发展前景[J]. 中国生物工程杂志, 2015, 35(12): 103-108.

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.

链接本文:

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

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