The year 2024 has been a year full of hope and breakthroughs for China's pharmaceutical field. The emergence of numerous new drugs not only reflects the continuous enhancement of pharmaceutical R&D capabilities but also brings a new ray of hope to a vast number of patients. This year, from tumor treatment to the conquest of rare diseases, and from innovations in traditional drug types to explorations of novel therapies, the development of new drugs has shown a trend of diversification and efficiency. To gain a deeper understanding of the current status of new drug innovation in China, this issue summarizes the information on new drug applications approved by National Medical Products Administration in 2024. By organizing the types of drugs and therapeutic areas, we aim to provide a reference for researchers in the field of biomedical innovation.
Overview of New Drug Approvals in 2024
Based on the drug approval documents issued by the National Medical Products Administration (NMPA) and the public information on marketed drugs from the Center for Drug Evaluation (CDE) of NMPA [1-2], as of December 31, 2024, a total of 220 new drugs (excluding in vitro diagnostic reagents, vaccines, biological analogues, and other biological products) have been approved by NMPA in 2024. These include 105 new drugs made in China and 115 imported new drugs. Among them, the number of approved pharmaceutical chemicals, therapeutic biological products, and traditional Chinese medicines are 118, 90, and 12, respectively (Figure 1), accounting for 53.6%, 40.9%, and 5.5% of the total number of new drug approvals in 2024.
Approval Status of Class 1 Innovative Drugs in 2024
Class 1 innovative drugs refer to innovative drugs that have not been marketed inside and outside China. These drugs contain new, structurally defined compounds with pharmacological effects and possess high levels of innovation, clinical value, and social benefits. Therefore, the development of Class 1 innovative drugs also represents a significant shift from exploratory innovation to innovation-driven development.
Class 1 innovative drugs refer to drugs that have not been marketed inside and outside China and belong to the first category in the drug registration classification. These drugs include traditional Chinese medicines and natural medicines, biological products, and pharmaceutical chemicals. In addition, the first-in-class typically feature novel molecular structures with clear pharmacological effects and clinical value. Specifically, Class 1 innovative drugs have the following characteristics:
APIs and their preparations obtained through synthesis or semi-synthesis methods;
New effective monomers and their preparations extracted from natural substances or through fermentation;
Optical isomers of known drugs and their preparations obtained through
resolution or synthesis methods;
Drugs prepared from multi-component drugs that are already on the market into fewer components;
New compound formulations;
New indications added to marketed preparations in China that have not been approved inside and outside China.
It can be seen that the R&D of Class 1 innovative drugs usually goes through multiple stages, including the discovery phase, preclinical research, clinical trials, and others. Only after being reviewed and approved by the drug regulatory authority can they be marketed.
Based on data from the Pharma ONE drug R&D big data platform, China National Pharmaceutical Industry Information Center, and NMPA's published drug approval documents (calculated based on approved Class 1 or 1.1 new drugs) [3-4], NMPA approved a total of 46 Class 1 innovative drugs for marketing in 2024, including 7 imported new drugs and 39 new drugs made in China (Figure 2). In terms of drug types, these approvals included 23 pharmaceutical chemicals, 20 therapeutic biological products, and 3 traditional Chinese medicines and natural products, marking an increase of 6 types compared with 2023 and reaching a record in number!
In addition, in terms of therapeutic fields, anti-tumor drugs still topped the list among the Class 1 innovative drugs approved by NMPA in 2024, accounting for 50% (23/46). Unlike the prev...
(All Rights Reserved)