回顾分析:2011-2020年美国批准上市的抗感染药物  

Retrospective analysis:2011-2020 FDA approved anti-infective drugs

作　　者：王玉丽 张洪兵[3] 刘昌孝[3] 李虎玲 喻雨 Wang Yu-li;Zhang Hong-bing;Liu Chang-xiao;Li Hu-ling;Yu Yu(College of Chemical Engineering,Tianjin University,Tianjin 300072;Tianjin Pharmaceutical Group Research Institute Ltd,Tianjin 300171;State Key Laboratory Drug Delivery Technology and Pharmacokinetics,Tianjin Institute of Pharmaceutical Research,Tianjin 300462;Graduate School of Tianjin Medical University,Tianjin 300193)

机构地区：[1]天津大学化学与技术工程学院,系统生物工程教育部重点实验室,天津300072 [2]天津医药集团研究院有限公司,天津300171 [3]天津药物研究院,释药技术与药代动力学重点实验室,天津300462 [4]天津医科大学研究生院,天津300193

出　　处：《中国抗生素杂志》2022年第1期1-14,共14页Chinese Journal of Antibiotics

摘　　要：从宏观视角来看,面对疾病的全球化问题,全球传染病治疗药物(包括抗病毒药物、抗菌药物、抗真菌药物和其他传染病药物)是很有需求的研究开发领域。21世纪的全球卫生格局需要采取有效的全球行动。近10多年一些新药陆续上市,全球卫生时代变得更加多元化,组织关键行动者尽力对有限项目和投资问题进行协调。美国在21世纪初制定的一些优先发展抗感染药的政策指引下发生了一些变化。本文回顾分析了2011—2020年美国批准上市的抗感染药物:新型抗病毒药物、抗寄生虫药物、抗疟药物和新型抗菌药物,还就其发展情况,从重视抗感染药物耐药和滥用问题,重视抗病毒药物的基础和临床应用研究,抗感染新药成为“神药”有难度和受到资本迎新新抗生物研究乏力,保证药物供应有难度等四方面做了简要分析讨论。希望本文能对新的抗感染药物研发提供参考。From a macro perspective,in the face of globalization of infectious disease,the global infectious disease treatment(including antiviral,antibacterial and antifungal drugs,and other infectious diseases drugs)are of great demand in the research and development field.The global health landscape of the 21st century requires effective global action.A number of new drugs have come to market in the last decade or so.The new era of global health is more diverse,Key actors are organized to coordinate limited projects and investment issues.Some of the changes in the United States were guided by policies that prioritized the development of anti-infective drugs.This retrospective analysis reviewed and analyzed the basic situation of anti-infective drugs approved for listing in the United States from 2011 to 2020 in the aspects of new antiviral drugs,anti-parasitic drugs,anti-malarial drugs and new antibiotics.Finally,this paper also paid attention to the drug resistance and abuse of anti-infective drugs and the basic and clinical application research of antiviral drugs.This paper briefly analyzed and discussed the difficulty of new anti-infective drugs becoming"divine drugs",the lack of capital orientation,the difficulty of biological research,and the difficulty of ensuring drug supply,hoping to provide some information for new drug research and development.

关 键 词：抗感染药物 抗病毒药 抗寄生虫病药 抗疟药 抗菌药 

分 类 号：R978.1[医药卫生—药品]