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

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.