The Center for Drug Evaluation (CDE) has released its annual report on clinical trials in support of innovative drugs in China for the year 2022. The report provides insights into the trends and developments in the clinical trial landscape for innovative drugs within the country.
Record Number of Clinical Trial Filings
In 2022, the number of general drug clinical trial filings reached 3,410, a record increase of 1.5% compared to 2021. Of these, clinical trial filings for innovative drugs stood at 1,974, accounting for 57.9% of the total, despite a slight year-on-year decrease.
Bioequivalence Testing and Domestic IND Filings
A total of 1,436 filings, or 42.1%, were for bioequivalence testing (BE). Domestic applicants made 3,018 IND filings, which accounted for 88.5% of the total, although this represents a year-on-year decrease of 10%.
Chemical Drugs and Biological Products in Clinical Trials
Clinical trials for chemical drugs accounted for 73.8% of filings, followed by biological products at 24.4%. Notably, 46 clinical trials for cell and gene therapy (CGT) products were filed in 2022, with mesenchymal stem cell clinical trials leading at 12. There were also 11 clinical trials for medical imaging drugs, marking a new high. Additionally, 39 clinical trials for COVID-19 vaccines were conducted, accounting for 41.1% of the total for preventive vaccines.
Phase Distribution and Pediatric Clinical Trials
The proportion of clinical trials in each phase in 2022 remained largely the same as in 2021, with Phase I trials accounting for 43.0% of the total. The number of clinical trials conducted in the pediatric population slightly increased compared to 2021 (64 vs 61), with the highest proportion being in the Phase III stage (40.6%). The number of clinical trials for rare disease drugs also showed an upward trend (68 vs 43).
Efficiency in Clinical Trial Initiation
The efficiency of clinical trial initiation has seen further improvement, with 55.8% of clinical trials initiating subject enrollment within 6 months. The time taken to initiate enrollment in the same year after the clinical trial was approved was shortened to an average of 3.3 months. Among the 21 innovative drugs approved for listing in 2022, 76.2% are owned by domestic Marketing Authorization Holders (MAHs), and 47.6% of them were listed within 5 years, with an average listing time of 7.6 years.-Fineline Info & Tech
