Recently, the team of Lei Wang/Qidong You from School of Pharmacy of our university published a review article titled “Global first-in-class drugs approved in 2023-2024: Breakthroughs and insights” in the well-known academic journal The Innovation. The publication describes the breakthroughs and advances of global first-in-class small molecule drugs in the period of 2023-2024. Daichao Zhai and Qiuyue Zhang, associate professor of the School of Pharmacy, are the co-first authors; Lei Wang and Qidong You from the Department of Medicinal Chemistry of the School of Pharmacy, and Xiaoling Lu from the School of Basic Medical Sciences of the Naval Medical University are the co-corresponding authors; and China Pharmaceutical University is the first corresponding institution of this paper. First-in-class drug (FID) has novel drug target or mechanism of action, and is the original driving force for new drug development. The launch of first-in-class drugs not only brings huge economic profits, but also lays the foundation for new areas and directions of drug development, providing new therapies and excellent efficacy for patients with related diseases. The challenging research and development behind them requires a deep understanding of the relationship between drug molecules, targets, and diseases, making marketed first-in-class drugs an important resource for future drug design. This paper describes the breakthroughs and advances in global first-in-class drugs in 2023-2024 from a number of perspectives, with the United States, China, Japan, and the European Union as the representative regions.Global first-in-class drug achievements in 2023-2024 have been tremendous, with small molecules and large molecules advancing in parallel, demonstrating that the convergence of traditional drug design and novel biotechnology is taking place to jointly fuel first-in-class drug development. In this paper, the authors analyze the development of first-in-class drugs. In this paper, the authors analyze the types of diseases, molecules, and targets of first-in-class drugs, and comprehensively show the broad prospects of first-in-class drug development, and expect that future innovations and advances in the field of pharmaceuticals can make more contributions to global public health and human quality of life. This work was supported by the National Natural Science Foundation of China (82173741, 81930100), the Youth Fund of the National Natural Science Foundation of China (82304309), the Natural Science Foundation of Jiangsu Province (BK20230103, BK20231014), and the China Association for Science and Technology's Young Talent Support Project (2021QNRC001). Full Text Link: https://www.cell.com/the-innovation/fulltext/S2666-6758(25)00004-9
