The China Clinical Trials Applications for New Drug Registrations Annual Report 2023 has been issued by the China CDE (Center for Drug Evaluation). It provides valuable insights into the status of clinical trials for new drug registration in China. Below we present the key findings.
1. Number of registered clinical trials for new drugs hit a record high
In 2023, the total number of drug clinical trial registration application acceptances amounted to 4300 (in terms of Clinical Trial Registration-CTR), which is the highest number of all time and increased by 26.1% compared with 2022.
According to these latest statistics on new drug clinical trials (registered with acceptance number) and bioequivalence trials (BE trial, registered with filing number), 2323 new drug clinical trials were registered in 2023 (54.0%), an increase of about 17.7% compared to 2022 (1974). Bioequivalence trial registration acceptances totaled 1977 (46.0%), an increase of approximately 37.7% compared to 2022 (1436).
2. Proportion of drug types remains stable
The proportion of clinical trials of new chemical drugs remains the highest and continues to grow slightly, now accounting for more than 75% of all drug CTRs in China. Biological products hover between 20 and 25% of all clinical trials. Whilst Traditional Chinese Medicine trials have continued to decrease since 2019 when they accounted for 3.5%, to only 1.8% last year.
3. Overview of registration categories for 3 kinds of drugs
Chemical Drugs
The largest proportion of clinical trial registration acceptances for chemical drugs were for Class 1: Innovative Drugs at 66.6%, followed by Class 2: Improved Drugs, both classes not yet marketed anywhere in the world, accounting for 19.8%.
Biological Products
In 2023, Class 1 and Class 2 Biological Products that are not yet marketed anywhere in the world, were the main therapeutic biological products, accounting for 79.2% and 10.3%, respectively. The main biological products used for prevention were Class 1 and Class 3, accounting for 49.6% and 19.7%, respectively.
In 2023, the majority of clinical trial registrations for biological products were Therapeutic Products with 79.2% being Class 1: Innovative Therapeutics and 10.3% being Class 2: Improved Therapeutics, both not yet marketed anywhere in the world.
Regarding Biological Prevention Products, 49.6% of Clinical Trial Application (CTA) acceptances were for Class 1: Innovative Vaccines not yet marketed anywhere in the world, and 19.7% for Class 3: Biosimilars, already produced and marketed outside China.
4. Target indications are mainly anti-tumor
In 2023, the indications of chemical drugs were mainly for anti-tumor, accounting for 28.7% of the total, followed by anti-infection drugs (13.5%), skin and ENT drugs (7.1%), nervous system drugs (7.0%) and analgesics and anesthesiology drugs (6.7%).
Similarly, the indications of biological products were also dominated by anti-tumor drugs in 2023, accounting for 41.5% of the total, followed by dermatology & ENT drugs (12.3%), preventive vaccines (9.8%), endocrine system drugs (7.3%) and blood system diseases drugs (5.5%).
5. Increasing number of clinical trials of drugs for rare diseases
Clinical trials of rare disease drugs show an increasing trend year on year, with 119 registered in 2023, an increase of 42.9% (68) compared with 2022. In terms of the type of drug, chemical drugs account for 47% and biological products53% of rare disease clinical trial registration acceptances granted.
Regarding the indications of rare disease CTA acceptances, 2023 witnessed significant growth in anti-tumor, rheumatic & immune diseases, dermatology & ENT, and digestive system diseases.
6. Almost all clinical trials are domestic only
In 2023, drug clinical trials to be conducted in China accounted for 92.7% (3988), with international multi-center trials accounting for 6.7% (290). A small amount (22) was for single-center clinical trials that did not recruit participants in China or were conducted only abroad.
7. Annual analysis of innovative drugs (Class I)
According to the 2023 annual review report, 40 innovative drugs were approved in 2023, of which chemicals and biological products accounted for 19 and 16 varieties respectively, or 47.5% and 40.0% of the total-. The remaining 5 were for Traditional Chinese Medicine. Domestic Marketing Authorization Holders (MAH) were the majority, accounting for 90.0%
8. Efficiency analysis of clinical trial implementation
The average application time for new drug clinical trials (registered with acceptance number) was 78.5 working days and just 16.6 working days for Bioequivalence trials (BE trial registered with filing number).
Among the 2323 new drug clinical trials registrations that were accepted in 2023, only 10% (236) were completed in the same year (with trial status as “completed” and completion date within 2023). All of these were trials undertaken in China and consisted of Phase I clinical trials (165, 69.9%).
9. Analysis of listing time
Based on the date of the first clinical trial approval and the NMPA’s marketing authorization approval date, the average time it took for innovative drugs (Class I) to be approved for marketing in 2023 was 7.2 years and this remains largely consistent with 2022.
Further information
Read the original CDE announcement on China Clinical Trials Applications for New Drug Registrations Annual Report 2023 issued.
If you would like advice on the best regulatory pathway to market for your pharmaceutical, please contact Cisema.
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