Synthesis and clinical application of new drugs approved by NMPA in 2023

Lijuan Xie; Yingying Wang; Kunyu Wang; Wanying Chen; Fuwei Yang

doi:10.1016/j.ejmech.2024.117181

Synthesis and clinical application of new drugs approved by NMPA in 2023

Eur J Med Chem. 2024 Dec 19:283:117181. doi: 10.1016/j.ejmech.2024.117181. Online ahead of print.

Authors

Lijuan Xie¹, Yingying Wang¹, Kunyu Wang², Wanying Chen³, Fuwei Yang⁴

Affiliations

¹ Department of Vascularsurgery, China-Japan Union Hospital of Jilin University, Changchun, China.
² Jilin Provincial No.2 Institute for Endemic Diseases Control and Research, Jilin, China.
³ Department of Plastic Surgery, China-Japan Union Hospital of Jilin University, Changchun, China. Electronic address: chenwy1988@jlu.edu.cn.
⁴ Department of Neurology, China-Japan Union Hospital of Jilin University, Changchun, China. Electronic address: yfw@jlu.edu.cn.

PMID: 39709793
DOI: 10.1016/j.ejmech.2024.117181

Abstract

The National Medical Products Administration (NMPA) in China plays a crucial role in regulating drug approval and ensuring the safety and efficacy of pharmaceutical products. In 2023, the NMPA authorized the approval of 82 novel therapeutic agents, including 48 chemical drugs, 22 biological drugs, 4 vaccines, and 8 traditional Chinese medicines. These approvals span a broad spectrum of therapeutic areas, with a strong focus on oncology, central nervous system disorders, anti-infective treatments, hematology, cardiovascular diseases, ophthalmology, and immunomodulation. The review discusses the synthetic routes and clinical application of representative 36 new drugs, offering insights into the design, development, and optimization of these drugs. Our objective is to inspire innovation and contribute to the establishment of novel, efficient, and scalable synthetic approaches, thereby advancing the frontiers of pharmaceutical research and development.

Keywords: 2023; Clinical applications; Drugs Content; NMPA; Synthesis.