文章摘要
俞颖慧,周斌.2020年美国FDA批准创新药分析[J].中国药事,2021,35(11):1276-1282
2020年美国FDA批准创新药分析
An Analysis to Innovative Drugs Approved by FDA in 2020
  
DOI:10.16153/j.1002-7777.2021.11.010
中文关键词: 创新药  美国食品药品监督管理局  新分子实体  新生物制品  获批
英文关键词: innovative drugs  FDA  NME  BLA  approval
基金项目:
作者单位
俞颖慧 中国医药工业研究总院,上海 201203 
周斌 中国医药工业研究总院,上海 201203 
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中文摘要:
      目的:对2020年FDA批准的创新药物进行分析,以供业界参考。方法:基于美国FDA网站发布的2020年和历年的创新药获批数据、药品审评和数据库的相关信息,并结合相关文献进行分析。结果与结论:2020年美国药品审评与研究中心共批准了53款创新药,其中包括40款新分子实体和13款新生物制品;36款创新药产品通过至少一种加速审评通道获得批准;突破性疗法认证药物批准数量创历年之最, 共批准了22个该认证药物。在新冠大流行背景下,FDA仍致力于支持罕见病药物的开发。抗肿瘤领域仍然是创新药开发的热门领域。小型生物技术企业和外部合作均促进了创新药的发展。
英文摘要:
      Objective: To conduct a brief analysis of innovative drugs approved by the FDA in 2020, as a reference for industry. Methods: Based on the data of the approved innovative drugs in 2020 and the years before on the FDA website and the relevant information of the drug approvals and databases, the analysis is conducted combined with relevant literature. Results and Conclusion: In 2020, the Center for Drug Evaluation and Research of the United States has approved a total of 53 innovative drugs, including 40 new molecular entities and 13 new biological products. 36 innovative drug products have been approved by at least one Expedited Program. A total of 22 drugs were approved by Breakthrough Therapy in 2020 ranking the highest number in history. Under the COVID-19 pandemic, FDA has been dedicated to its crucial role in the development of medicines for rare diseases. The anti-tumor field is still a hot area for innovative drug development. Both small biotech companies and external collaborations have promoted the development of innovative drugs.
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