| Objective: To analyze the new drugs approved by the U.S. FDA in 2023 and compare them with the new drug approvals in China during the same year, providing a reference for the pharmaceutical industry . Methods: By reviewing the "2023 New Drug Approval Summary Report" released by the US FDA, the "2023 Drug Evaluation Report" released by China's CDE, Drugs@FDA database, drug approvals published by the NMPA, and publicly available information on marketed drugs from the CDE, combined with relevant literature, data on new drugs approved by the FDA in 2023 were collected and statistically analyzed, and compared with the situation in China. Results and Conclusion: In 2023, the FDA approved a total of 55 new drugs, including treatments for various medical fields such as oncology, genetic/rare diseases, neurological disorders. 51% of the new drugs received orphan drug designation, 36% of the new drugs were recognized as “first-in-class”, 65% of the new drug approvals utilized at least one expedited program. Furthermore, the companies that have been approved for new drugs cover a wide range, from large pharmaceutical giants to small and medium-sized biotechnology firms, with varying numbers of new drug approvals. China approved 74 new drugs, and the breadth and diversity of disease fields are comparable to those of the FDA. However, the innovation of new drugs and the development of rare disease drugs need to be improved. 38% of the new drug approvals in China included at least one accelerated marketing process. The time required for new drug review has decreased compared to 2022, but the one-time pass rate has also decreased, reflecting the increasing strictness of regulation. Pharmaceutical companies need to improve the quality of their application materials, and regulatory authorities need to improve drug regulation laws, strengthen the training and education of drug regulatory personnel, and enhance their professional level and international perspective. China's pharmaceutical market is not only active with domestic enterprises but also attracts competition from international companies. Looking forward to the approval of more high-quality new drugs in the future and promoting the progress of drug regulation. |