An Update on the Clinical Pipelines of New Antibacterial Drugs Developed in China

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外文摘要：Antibacterial resistance is a global health threat that requires further concrete action on the part of all countries.In this context,one of the biggest concerns is whether enough new antibacterial drugs are being discovered and developed.Although several high-quality reviews on clinical antibacterial drug pipelines from a global perspective were published recently,none provides comprehensive information on original antibacterial drugs at clinical stages in China.In this review,we summarize the latest progress of novel antibacterial drugs approved for marketing and under clinical evaluation in China since 2019.Information was obtained by consulting official websites,searching commercial databases,retrieving lit-erature,asking personnel from institutions or companies,and other means,and a considerable part of the data covered here has not been included in other reviews.As of June 30,2023,a total of 20 antibacterial projects from 17 Chinese pharmaceutical companies or developers were identified and updated.Among them,two new antibacterial drugs that belong to traditional antibiotic classes were approved by the National Medical Products Administration(NMPA)in China in 2019 and 2021,respectively,and 18 antibacterial agents are in clinical development,with one under regulatory evaluation,five in phase-3,six in phase-2,and six in phase-1.Most of the clinical candidates are new analogs or mono-components of traditional antibacterial pharmacophore types,including two dual-acting hybrid antibi-otics and a recombinant antibacterial protein.Overall,despite there being 17 antibacterial clinical candi-dates,our analysis indicates that there are still relatively few clinically differentiated antibacterial agents in stages of clinical development in China.Hopefully,Chinese pharmaceutical companies and institutions will develop more innovative and clinically differentiated candidates with good market potential in the future research and development(R&D)of original antibacterial drugs.

外文关键词：

Antimicrobial resistanceNew antibioticsClinical pipelinesWHO priority pathogensNational Mega-Project for Innovative Drugs

作者：

Xinyi Yang、Congran Li、Xiukun Wang、Zhonghui Zheng、Peiyi Sun、Chunjie Xu、Luni Chen、Jiandong Jiang、Staffan Normark、Birgitta Henriques-Normark、Xuefu You

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作者单位：

Beijing Key Laboratory of Antimicrobial Agents/Laboratory of Pharmacology,Institute of Medicinal Biotechnology,Chinese Academy of Medical Sciences & Peking Union Medical College,Beijing 100050,China

Division for Medicinal Microorganism-Related Strains,CAMS Collection Center of Pathogenic Microorganisms,Chinese Academy of Medical Sciences & Peking Union Medical College,Beijing 100050,China

State Key Laboratory of Bioactive Substances and Functions of Natural Medicines,Institute of Medicinal Biotechnology,Chi

Shandong Xinhua Pharmaceutical Co.,Ltd.,Zibo 255005,China

Department of Microbiology,Tumor and Cell Biology,Karolinska Institutet,Stockholm SE-17177,Sweden

State Key Laboratory of Bioactive Substances and Function of Natural Medicines,Institute of Materia Medica,Chinese Academy of Medical Sciences & Peking Union Medical College,Beijing 100050,China

Institute of Medicinal Biotechnology,Chinese Academy of Medical Sciences & Peking Union Medical College,Beijing 100050,China

Clinical Microbiology,Karolinska University Hospital,Bioclinicum,Stockholm SE-17176,Sweden

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基金：

National Natural Science Foundation of ChinaNational Natural Science Foundation of ChinaCAMS Innovation Fund for Medical SciencesCAMS Innovation Fund for Medical SciencesNational Science and Technology Infrastructure of ChinaFundamental Research Funds for the Central Universities

项目编号：

3214100382330110CIFMS2021-I2M-1-039National Pathogen Resource Center-NPRC-322021-PT350-001

出版年：

2024

DOI：

10.1016/j.eng.2024.02.009

工程(英文)

CSTPCDEI

ISSN：2095-8099

年,卷(期)：2024.38(7)