文章摘要
张辉,辛中帅,邵颖,张彦彦,张象麟.我国已上市治疗用生物制品整体情况分析[J].中国药事,2019,33(9):972-981
我国已上市治疗用生物制品整体情况分析
Analysis of Overall Situation of Listed Biological Products for Therapeutic Use in China
投稿时间:2019-08-01  
DOI:10.16153/j.1002-7777.2019.09.002
中文关键词: 生物制品  注册管理制度  已上市药品信息  创新性分析  发展历程
英文关键词: biological products  registration management system  information of listed drugs  innovative analysis  development history
基金项目:
作者单位E-mail
张辉 国家药品监督管理局, 北京 100037  
辛中帅 复星医药万新医药科技(苏州)有限公司, 苏州 215123  
邵颖 沈阳药科大学亦弘商学院, 北京 100010  
张彦彦 沈阳药科大学亦弘商学院, 北京 100010  
张象麟 沈阳药科大学亦弘商学院, 北京 100010 zhangxianglin@yeehongedu.cn 
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中文摘要:
      目的:梳理我国已上市治疗用生物制品的整体情况,提炼出存在的问题,为行业提供参考信息,同时为完善我国治疗用生物制品注册管理制度体系提供数据支持。方法:基于我国已上市治疗用生物制品的数据,进行统计分析和对比分析。结果:对我国已批准治疗用生物制品信息进行了整合,并从批准上市产品的发展历程、创新程度、技术类别等不同维度进行了全方位深入分析。结论:与发达国家相比,我国治疗用生物制品的研发和产业化相对较晚,市场规模较为有限,但增速显著高于全球水平。
英文摘要:
      Objective:To analyze the overall situation of the listed biological products for therapeutic use in China, find out existing problems, provide references for the industry and provide data support for improving the registration management system of biological products for therapeutic use in China. Methods:Based on the dat a of the listed biological products for therapeutic use in China, statistical analysis and comparative analysis were carried out. Results:The information on biological products for therapeutic use approved in China was integrated. Different dimensions such as the development history, innovation degree and technology category of approved products were comprehensively and thoroughly analyzed. Conclusion:Compared with developed countries, the research and development, industrialization of biological products for therapeutic use in China are relatively new, and the market scale is not big enough, while the growth rate is significantly higher than that of the global level.
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