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

Abstract

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 literature, 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 antibiotics and a recombinant antibacterial protein. Overall, despite there being 17 antibacterial clinical candidates, 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.