CDE Releases Annual Report on Clinical Trial Progress of New Drug Registration in China (2021)

Category:

Release time:2023-02-02

On June 7, 2022, CDE released the Annual Report on the Progress of Clinical Trials for New Drug Registration in China (2021). Based on the registration information of the drug clinical trial registration and information disclosure platform, the report comprehensively summarizes and analyzes the status quo of new drug registration clinical trials in China in 2021, and compares and analyzes the changing trend characteristics in the past three years.

According to the report, in 2021, the total number of clinical trials registered on the drug clinical trial registration and information disclosure platform exceeded 3,000 for the first time, an increase of 29.1% over the total annual registration in 2020. Among them, the number of new drug clinical trials (exploratory and confirmatory clinical trials registered with acceptance numbers) was 2033, an increase of 38.0% over the number of registrations in 2020, indicating that China's drug research and development momentum is strong and an innovative atmosphere has gradually formed.

First, the innovation and research and development of biological products has increased significantly

The "Report" shows that from the perspective of drug types, the proportion of various drugs has remained consistent over the years, but the proportion of biological products has increased significantly, with registrations in 2020 and 2021 increasing by 31.5% and 46.4% respectively compared with the previous year.

Second, the indications focus on the field of anti-tumor

The "Report" shows that the target indications of clinical trials of new biological products are mainly concentrated in the fields of anti-tumor and preventive vaccines. In 2021, the number of clinical trials of biological anti-tumor drugs was 3.1 times that of the second ranked preventive vaccine (406vs. 131), and the proportion trend was basically the same as in 2019 and 2020.

Affected by the new crown pneumonia epidemic factors, among the biological products for prevention, the new coronavirus vaccine is a research and development hotspot, and the number of clinical trials of the new coronavirus inactivated vaccine (Vero cell) is as many as 20.

Third, there are few clinical trials in special populations

In 2021, the proportion of clinical trials carried out in the elderly population and children (except preventive vaccines) is still low, and the types of diseases involved in clinical trials of rare disease drugs are still small, which needs to be paid attention to.

The report concludes that the number of new drug clinical trials in China is increasing, and most of them are new drug clinical trials initiated by domestic sponsors. With the increasing number of phase III clinical trials of new drugs, it is expected that the number of new drug applications in China will further increase and the process will accelerate to meet the new drug treatment needs of Chinese patients, including pediatric populations and clinical drug needs for rare diseases.

Related attachment: Annual Report on the Progress of Clinical Trials for New Drug Registration in China (2021) https://www.cde.org.cn/main/news/viewInfoCommon/1839a2c931e1ed43eb4cc7049e189cb0

key words: CDE Releases Annual Report on Clinical Trial Progress of New Drug Registration in China (2021)

relevant