According to the report, in 2023, the total number of clinical trials registered on the drug clinical trial registration and information disclosure platform surpassed 4,000 for the first time, reaching 4,300 (in terms of CTR), the highest total number of registrations in history, an increase of 26.1% over the total number of registrations in 2022.
The Zhitong Finance App learned that on May 20, the official website of the Drug Evaluation Center of the State Drug Administration of China published the “Annual Report on the Progress of Clinical Trials Registration of New Drugs in China (2023)”. According to the report, in 2023, the total number of clinical trials registered on the drug clinical trial registration and information disclosure platform surpassed 4,000 for the first time, reaching 4,300 (in terms of CTR), the highest total number of registrations in history, an increase of 26.1% over the total number of registrations in 2022. Among them, the number of new drug clinical trials (registered under acceptance number) was 2,323. Compared with 2022, the number of clinical trials of new drugs increased by 14.3% in 2023 (2323 vs. 2033).
In recent years, both chemicals and biological products account for a high proportion of new drug clinical trials. Chemical drugs are the highest, all over 50%, and biological products are about 40%. According to registration classification analysis, a total of 1,606 tests were registered for drugs classified as Class 1 in 2023, accounting for 69.1% (1606/2323) of the total number registration tests. Among them, chemicals accounted for the highest proportion of 53.7% (862/1606). Clinical trials of Class 1 innovative drugs continued to be dominated by anti-tumor drugs, accounting for 40.6% of the total (652/1606).
A total of 81 clinical trials of cell and gene therapy products were registered in 2023, an increase of nearly 1 times over 2022 (46 items), mainly phase 1 anti-tumor drugs in China. The number of clinical trials of medical imaging drugs is 14, the highest in recent years.
According to the classification of new drug clinical trials and bioequivalence tests (BE tests), in 2023, new drug clinical trials accounted for 54.0%, and BE trials accounted for 46.0%. The share of applicants in China was over 90%, or 91.7%.
In terms of indications, the target indications for clinical trials of chemical drugs and biological products in 2023 are mainly in the field of anti-cancer, followed by anti-infective drugs, skin and facial medicine, neurological disease drugs, preventive vaccines, endocrine system drugs, and hematological disease drugs.
In terms of new drugs, a total of 40 innovative drugs were approved in 2023, and marketing license holders in China accounted for more than 90.0%. Innovative drugs are mainly chemicals and biological products, with 19 (47.5%) and 16 (40.0%) varieties, respectively, of which there are 14 (35.0%) varieties of anti-tumor drugs. The average time it took for innovative drugs to be approved for marketing in 2023 was 7.2 years, which is basically the same as the previous year.