文章摘要
辛中帅,张彦彦,晋小雁,杨建红.我国已上市治疗用单抗类产品分析[J].中国药事,2019,33(9):986-990
我国已上市治疗用单抗类产品分析
Analysis of Listed Monoclonal Antibody Products for Therapeutic Use in China
投稿时间:2019-08-01  
DOI:10.16153/j.1002-7777.2019.09.004
中文关键词: 生物制品  单抗类产品  上市分析  代次分析
英文关键词: biological products  monoclonal antibody products  listing analysis  generation analysis
基金项目:
作者单位E-mail
辛中帅 复星医药万新医药科技(苏州)有限公司, 苏州 215123  
张彦彦 沈阳药科大学亦弘商学院, 北京 100010  
晋小雁 沈阳药科大学亦弘商学院, 北京 100010  
杨建红 沈阳药科大学亦弘商学院, 北京 100010 yangjianhong@yeehongedu.cn 
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中文摘要:
      目的:分析我国已上市治疗用单抗类产品存在的差距,明确努力方向。方法:基于我国已上市治疗用单抗类产品批准数据进行统计分析和对比分析。结果:对我国单抗类药物的发展历程、上市时间、批准品种以及我国已批准上市的单抗类药物与FDA单抗类药物的批准情况进行了对比梳理。结论:单抗类药物在生物技术制药中占有重要地位,并逐渐成为生物医药领域发展的主要方向。我国单抗类药物中国产品种与进口品种存在差距,整体上与FDA存在差距。但随着近年来的改革,发展潜力及势头良好。
英文摘要:
      Objective:To analyze the gap of the monoclonal antibody products for therapeutic use in China and clarify the direction of efforts. Methods:Based on the approval data of the listed monoclonal antibody products for therapeutic use in China, the statistical analysis and comparative analysis were conducted. Results:The development course of monoclonal antibody drugs, listing time, approved varieties, and the approved monoclonal antibody drugs in China and U.S. FDA were compared. Conclusion:Monoclonal antibody drugs play an important role in biological products and gradually become the main direction of biomedical field. There is a gap between domestic product varieties and imported varieties, there is a gap with U.S. FDA as a whole. However, with the reforms in recent years, potentials for the development is promising.
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