China’s Center for Drug Evaluation (CDE) has released its 2023 Annual Report on the Development of New Drug Clinical Trials. The report provided a summary and analysis of the overall landscape of clinical trials, including the total number and basic characteristics of the trials.
In 2023, the total number of drug clinical trials in China reached a record high of 4,300, representing a 26.1% increase from 2022. Of these, new drug clinical trials accounted for 54%, while bioequivalence (BE) trials made up the remaining 46%. Notably, 91.7% of the clinical trials were applied by domestic companies.
Class 1 new drugs, which represent the innovative and original drugs accounted for 69.1% of the total new drug clinical trials. Within the Class 1 new drugs, chemical drugs had the highest proportion. However, the Class 1 new drugs were still in the early stages of research and development, as 47.1% of them were still undergoing Phase I clinical trials in 2023.
The report also identified the therapeutic areas that garnered the most attention for Class 1 new drug development. Antineoplastic drugs led the way, accounting for 40.6% of Class 1 new drug clinical trials. Other prominent areas included anti-infectives, dermatologic and ophthalmic drugs, preventive vaccines, endocrine drugs, as well as drugs for neurological and hematological system diseases.
Additionally, clinical trials targeting rare diseases increased from 68 in 2022 to 119 in 2023, with the scope of indications expanding to include oncology, hematology, neurology, respiratory, allergy, and rheumatic diseases. The number of pediatric-focused clinical trials also increased by 62.5% compared to the previous year, reaching 104.
The report highlights a surge in clinical trial activity over the past year though innovative drugs still have substantial room for further development. Given China's regulatory environment actively promoting innovation, the future prospects for new drugs in the Chinese market appear increasingly positive.
