In 2023, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) released its annual drug review report, which fully demonstrates the remarkable progress and efficient achievements of China's pharmaceutical industry in the R&D and approval of new drugs. During the year, the CDE accepted a record 2,997 New Drug Investigational (IND) applications, an increase of 33 compared to 202256%, reflecting the significant increase in the activity of China's innovative drug R&D activities; At the same time, the number of new drug marketing authorization applications (NDAs) was 470, a year-on-year increase of 4072%, showing that the speed of domestic drugs from R&D to commercialization has accelerated.
In the field of chemicals, the number of INDs approved by the CDE was 1,448, an increase of 15 percent year-on-year92%, with a compound annual growth rate (CAGR) of +24 from 2019 to 202369%。The number of chemical NDAs recommended for approval was 186, an increase of 21 year-on-year57%, with a five-year CAGR of +2058%。In addition, a total of 915 drug registration applications passed the consistency evaluation, a year-on-year increase of 1409%, with a CAGR of +36 over the same period97%, reflecting the continuous deepening of China's evaluation of the consistency of generic drug quality and efficacy.
*Biologics also showed strong growth, with 891 INDs approved for the year, up 22% year-on-year22%, with a CAGR of +31 for 2019-202394%, showing that the research and development of biotechnology drugs is increasing year by year. The number of NDAs recommended for approval of ** biological products was 132, a year-on-year increase of 1984%, with a five-year CAGR of +4348%, which indicates that China's innovation ability in the field of biopharmaceuticals is constantly improving.
In 2023, a total of 40 Class I innovative drugs will be approved for marketing by CDE, of which 9 varieties will be quickly approved through the priority review and approval process, accounting for 225%；There are 13 varieties conditionally approved for marketing, accounting for 325%；In addition, 8 varieties have been included in the breakthrough drug program in the clinical research stage, demonstrating that China's active support policy for innovative drugs with significant clinical value has achieved obvious results.
In the field of drugs for rare diseases, a total of 45 varieties were approved for marketing throughout the year, of which 15 varieties were accelerated through the priority review and approval channel, accounting for 33 of the total number of approved drugs for rare diseases3%, which greatly meets the demand for specific drugs for rare disease patients in China.
In terms of children's drug products, as many as 92 varieties were approved for marketing throughout the year, including 72 marketing authorization applications, of which 26 varieties were quickly approved through the priority review and approval process, accounting for about 28%; In addition, 20 varieties have been approved to expand the indications for children, so that more pediatric patients and families can benefit from these safe and effective drugs**.
Overseas marketed and domestic unmarketed original drugs (chemical drugs 5Class 1, biological products 3In terms of Category 1, a total of 86 varieties were approved throughout the year, including 62 newly approved varieties, including 1 variety included in the list of overseas new drugs urgently needed for clinical use, and 24 products with new indications, further enriching the types of drugs in the domestic market and improving drug accessibility.
It is worth mentioning that in 2023, the application and implementation of the breakthrough drug program will be strengthened, and 286 applications for the breakthrough drug program will be received throughout the year, and the number of applications agreed to be included in the program will reach 70, accounting for 24 of the total number of applications5%, an increase of 43% from 2022. The top three disease areas are anti-tumor drugs, neurological drugs, and digestive system diseases.
In terms of conditional approval, a total of 21 drugs received conditional approval in 2023, of which 16 were approved for the first time and 5 were new indications. In addition, 10 conditionally approved drugs have completed post-marketing studies and successfully converted to routine approval, indicating that China's post-marketing supervision of drugs is rigorous and effective.
The implementation of the priority review and approval system is also outstanding, with a total of 108 applications for priority review and approval (involving 80 varieties) included in 2023, an increase of 56 over the previous year9%。During the year, 85 cases (involving 59 varieties) were successfully approved for marketing in accordance with the priority review and approval procedures, reflecting the important role of this mechanism in promoting the rapid launch of drugs and meeting the public's medical needs.
In short, in 2023, China's drug review and approval work has made great progress, whether it is innovative drugs or generic drugs, or drugs for specific groups such as rare disease patients and pediatric patients, all of which have shown a positive development trend, which undoubtedly lays a solid foundation for the healthy development of China's pharmaceutical industry, and is expected to further drive the upgrading and optimization of the entire pharmaceutical industry chain in the future. The above data** is on the official website of the Center for Drug Evaluation of the State Food and Drug Administration, which is for reference only and is not intended as investment advice.
Note: The data and views in this article are provided by the team of Industrial Securities Pharmaceutical and are for reference only and do not constitute investment advice.
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