The Center for Drug Evaluation (CDE) has released its annual report, highlighting the growth in clinical trials for innovative drugs in China for the year 2023. The total number of general drug clinical trial applications reached a record high of 4,000, marking a 26.1% increase from 2022. Among these, applications for innovative drugs constituted 2,323, reflecting a 14.3% rise.
Chemical drugs accounted for half of the clinical trial filings, with biological products making up 40%. A significant portion, 1,606 trials, were registered for Category 1 drugs, which represented 69.1% of the total. Within this category, chemical drugs made up 53.7%, and anti-tumor drugs constituted 40.6%. In terms of clinical trial stages, Phase I, II, and III trials accounted for 42.1%, 21.3%, and 15.8% of the total, respectively.
The report also noted a near doubling of clinical trials for cell and gene therapy (CGT) products, with 81 applications filed in 2023 compared to 46 in 2022. There was a significant increase in clinical trials for rare diseases, with 119 filings compared to 68 in the previous year. Additionally, 104 clinical trials focused on the pediatric population, indicating a 62.5% year-over-year increase.
In 2023, 40 innovative drugs were approved for marketing, with domestic Marketing Authorization Holders (MAHs) holding over 90.0% of the total. The approved innovative drugs were primarily chemical drugs and biological products, with 19 and 16 varieties approved, respectively. Among these, 14 were anti-tumor drugs. The average time taken for innovative drugs to be approved for marketing in 2023 was 7.2 years, which is consistent with the approval time in 2022.- Flcube.com
