A few days ago, the Center for Drug Evaluation of the State Food and Drug Administration released the "Annual Report on the Status of Clinical Trials of New Drug Registration in China (2020)" (hereinafter referred to as the "Report"). Based on the registration information of the 2020 drug clinical trial registration and information publicity platform, the "Report" is the first to conduct a comprehensive summary and analysis of the current status of new drug registration clinical trials in my country.
The "Report" shows the enthusiastic atmosphere of my country's drug research and development: the number of new drug clinical trials and the number of drug varieties have increased significantly compared with the past, the proportion of Class 1 new drugs is relatively high, and new therapies account for 4.3% of biological products. At the same time, the "Report" also reflects the obvious homogeneity of some targets and indications in my country's new drug research and development, and the low proportion of clinical trials in specific populations, which can provide a reference for corporate research and development.
New drugs accounted for 57%
According to the "Report", a total of 2,602 clinical trials were registered in 2020, an overall increase of 9.1% over 2019. According to the statistics of clinical trial registrations of new drugs (ie non-bioequivalent clinical trial varieties) and generic drug categories (including generic drug quality and efficacy consistency evaluation), new drugs accounted for 57% (1473 items). Among the new drug clinical trial registrations, chemical drugs registered the most, with a total of 801 (54.4%), followed by biological products and traditional Chinese medicines, with 605 (41.1%) and 67 (4.5%), respectively.
Analyzing the staging of new drug clinical trials in 2020, Phase I clinical trials accounted for the highest proportion, accounting for 43.7% (643 trials), followed by Phase III and Phase II, accounting for 24.4% (359 trials) and 19.9% ​​(293 trials), respectively. Four of the 39 Phase IV clinical trials were real-world studies. The phases of new drug trials are analyzed according to the type of drugs. The proportion of chemical drugs and biological products in Phase I is relatively large, and the clinical trials of traditional Chinese medicine are mainly Phase II clinical trials. The proportion of biological products entering Phase III clinical trials (30.7%) was higher than that of chemical drugs (20.8%) and traditional Chinese medicines (9.0%).
Judging from the time taken to initiate clinical trials and the completion of clinical trials, the implementation efficiency of clinical trials in my country needs to be improved after they are approved.
Among the 1,473 new drug clinical trials, a total of 1,203 (81.7%) have been registered with the date of the first domestic case of informed consent, and 121 have been completed. According to the analysis, the time taken for the initiation of clinical trials ranged from 0 to 222 months, with an average of 23.4 months. The time taken to complete the clinical trial ranged from 6 to 735 days, with an average of 115.6 days.
Among the registered clinical trials in 2020, less than half (45.4%) of subjects were recruited within one year after the clinical trial was approved. Compared with as many as 643 newly registered Phase I clinical trials, only 93 Phase I clinical trials were completed in 2020, and the number of Phase II and Phase III clinical trials completed was even smaller.
Anti-tumor is a popular indication
According to the "Report", the clinical trials of drugs registered in 2020 mainly focus on anti-tumor, endocrine and cardiovascular indications, and most of the lung cancer indications are non-small cell lung cancer. Most of the innovative biological drugs currently under development in clinical trials are antibody drugs with a high degree of target concentration.
Statistical analysis of the number of varieties involved in 1473 non-bioequivalence/consistency evaluation clinical trials according to different drug types found that 91% of traditional Chinese medicine varieties have only carried out one clinical trial; the top 10 varieties of chemical drugs in clinical trials are basically For anti-tumor drugs, the top 3 are apatinib mesylate tablets (15 items), mitoxantrone hydrochloride liposome injection (10 items), fluzoparib capsules (10 items); biological products development The top 10 varieties of clinical trials are mainly therapeutic biological products, and the top 3 are recombinant humanized anti-PD-1 monoclonal antibody injection (17 items), atezolizumab injection (11 items), Paclitaxel Bolizumab Injection (11 items).
Analyzing the targets of action, the top 10 targets registered in clinical trials are PD-1, CYP51A1, VEGFR, PD-L1, etc. Among the top 10 targets, the drug indications of 9 targets are concentrated in the same indication field . The top 10 targets with the largest number of clinical trials are also concentrated in PD-1, VEGFR, etc., of which more than 60 clinical trials have been carried out for PD-1, VEGFR, PD-L1 and other target varieties.
In terms of indications, clinical trials of new Chinese medicines mainly focus on three indications, respiratory, cardiovascular and digestive, accounting for about 61.2% of the total clinical trials of traditional Chinese medicines. The main indications of chemical drugs were anti-tumor drugs, accounting for 42.1% of the total clinical trials of chemical drugs, followed by anti-infective drugs (10.1%). The indications of biological products are also dominated by anti-tumor drugs, accounting for 47.3% of the total clinical trials of biological products, followed by preventive vaccines (13.9%).
More attention should be paid to drug development for special populations
The "Report" shows that in 2020, there are relatively few clinical trials conducted for specific populations, with 3 and 33 clinical trials conducted only in the elderly and children, accounting for 1.4% of the total number of clinical trial registrations in the year. Attention should be paid to the development of drugs for special populations.
There were 1,038 clinical trials involving elderly subjects, accounting for 70.5% of the total number of new drug clinical trials. There are 3 clinical trials conducted only in the elderly population, accounting for 0.2% of the total clinical trials of new drugs, all of which are chemical drugs, namely anti-tumor drugs (2 trials) and reproductive system disease drugs (1 trial).
There were 129 clinical trials involving children, accounting for 8.8% of the total number of new drug clinical trials. According to the analysis of drug classification, the number of biological products registered is the largest, with 70 items, followed by chemical drugs and traditional Chinese medicines. According to the analysis of indications, the main indication areas are anti-tumor drugs, preventive vaccines, skin and ENT, etc. The main indications of biological products and chemical drugs are roughly the same, and traditional Chinese medicines are mainly respiratory drugs.
A total of 33 new drug clinical trials conducted only in children were registered, accounting for 2.2% of the total new drug clinical trials. According to the analysis of drug classification, the number of biological products registered is the largest, with 21 items, followed by chemical drugs and traditional Chinese medicines, with 8 items and 4 items respectively. According to the analysis of indications, biological products are mainly preventive vaccines, chemical drugs are mainly skin and ENT medicines and anti-infective drugs, and traditional Chinese medicine/natural medicines are respiratory and skin medicines.

(Source: Pharmaceutical Network)