单克隆抗体类生物治疗药物研究进展

王兰,朱磊,徐刚领,高凯*

中国药学杂志 ›› 2014, Vol. 49 ›› Issue (23) : 2058-2064.

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中国药学杂志 ›› 2014, Vol. 49 ›› Issue (23) : 2058-2064. DOI: 10.11669/cpj.2014.23.002
综述

单克隆抗体类生物治疗药物研究进展

  • 王兰,朱磊,徐刚领,高凯*
作者信息 +

Progress of Research and Development of Antibody-based Therapeutics

  • WANG Lan, ZHU Lei, XU Gang-ling, GAO Kai*
Author information +
文章历史 +

摘要

目的 综述2013年国内外抗体药物的研究进展,为我国抗体药物研发和产业化提供参考。 方法 根据近年来国内外相关文献报道,对我国抗体药物在2013年的进展,从国内外现状、抗体生物类似药和质量控制三方面进行归纳总结。 结果与结论 抗体药物以其高特异性、高效性和半衰期长等特点具有独特的优势,创造出巨大的社会效益和经济效益。我国针对生物医药产业的瓶颈,紧紧抓住抗体药物研发的大趋势,快速推进抗体技术的进步并建立和完善相应的技术平台,逐步实现了研发产品的产业化与国际化。本文详细介绍了国内外抗体药物及其生物类似药研发现状,以及我国抗体药物质量控制方面的研究进展,为国内抗体药物的研发和质量评价提供参考。

Abstract

OBJECTIVE With the rapid progress and continuous development of modern biotechnology, the antibody-based biotherapeutics have emerged as a leading force and play an important role in the field of biotechnology industry.METHODS Due to unique advantages including high specificity, strong efficacy and long half-life, monoclonal antibodies have generated huge social and economic benefits. The antibody-based biotherapeutics made rapid progress in 2013, with three novel monoclonal antibodies licensed to the market. RESULTS AND CONCLUSION By overcoming the bottlenecks in the field of biotechnology industry, China has been keeping up with the overall R&D trend of antibody-based biotherapeutics, promoted technological progresses in antibody development, established and perfected antibody-related platform, and realized industrialization and internationalization of R&D antibodies. This review briefly introduced the progress of antibody-based biotherapeutics in China in 2013, focusing on the current situation at home and abroad, antibody biosimilars, and their quality control.

关键词

抗体药物 / 抗体偶联药物 / 双功能抗体 / 质谱 / 生物类似药

Key words

:antibody-based biotherapeutics / antibody-drug conjugate / bifunctional antibody / mass spectrometry / biosimilar

引用本文

导出引用
王兰,朱磊,徐刚领,高凯*. 单克隆抗体类生物治疗药物研究进展[J]. 中国药学杂志, 2014, 49(23): 2058-2064 https://doi.org/10.11669/cpj.2014.23.002
WANG Lan, ZHU Lei, XU Gang-ling, GAO Kai*. Progress of Research and Development of Antibody-based Therapeutics[J]. Chinese Pharmaceutical Journal, 2014, 49(23): 2058-2064 https://doi.org/10.11669/cpj.2014.23.002
中图分类号: R915   

参考文献

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基金

国家“重大新药创制”科技重大专项(编号2014ZX09304311-001、2012ZX09304010)
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