2020 new drug registration clinical trial status report released

A few days ago, the Center for Drug Evaluation of the State Food and Drug Administration issued the "Annual Report on the Current Status of Clinical Trials for New Drug Registration in China (2020)" (hereinafter referred to as the "Report")
.
Based on the registration information of the drug clinical trial registration and information disclosure platform in 2020, the "Report" conducts a comprehensive analysis of the current status of China's new drug registration clinical trials for the first time
.
The "Report" shows the warm atmosphere of drug research and development in China: the number of clinical trials of new drugs and the number of drug varieties have increased significantly compared with the past, with a relatively high proportion of category 1 new drugs, and new therapies accounting for 4.
3% of biological products
.
At the same time, the "Report" also reflects the obvious homogeneity of China's new drug research and development in some targets and indications, and the relatively low proportion of clinical trials in specific populations, which can provide a reference for enterprise 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 new drugs (ie non-bioequivalence clinical trial varieties) and generic drugs category (including generic drug quality and efficacy consistency evaluation), the number of clinical trial registrations is calculated, and the proportion of new drugs is 57% (1473 items)
.
Among new drug clinical trial registrations, chemical drugs registered the most, with a total of 801 (54.
4%), followed by biological products and traditional Chinese medicine, 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 of 43.
7% (643 items), followed by phase III and phase II, accounting for 24.
4% (359 items) and 19.
9% ​​(293 items) respectively.
Four of the 39 Phase IV clinical trials are real-world studies
.
According to the phase analysis of new drug trials according to the type of drugs, phase I of chemical drugs and biological products account for a relatively large proportion, and clinical trials of traditional Chinese medicines are mainly phase II clinical trials
.
The proportion of biological products entering phase III clinical trials (30.
7%) is higher than that of chemical drugs (20.
8%) and traditional Chinese medicines (9.
0%)
.
Judging from the time-consuming initiation of clinical trials and the completion of clinical trials, the implementation efficiency of clinical trials in my country needs to be improved after approval
.
Among the 1473 new drug clinical trials, 1203 (81.
7%) of the first domestic cases of informed consent have been registered, and 121 have been completed
.
According to analysis, the start-up time of clinical trials ranges 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
.
In the registration of clinical trials in 2020, less than half (45.
4%) of subjects were recruited within one year after the clinical trial was approved
.
Compared with the as many as 643 newly registered phase I clinical trials, only 93 phase I clinical trials will be completed in 2020, and the number of phase II and phase III clinical trials completed is even smaller
.
Anti-tumor is a popular indication.
From the "Report", the clinical trials of drugs registered in 2020 mainly focus on anti-tumor, endocrine and cardiovascular indications.
Most of the lung cancer indications are non-small cell lung cancer
.
At present, most of the innovative biological drugs under research in clinical trials are antibody drugs, and the target concentration is high
.
According to different drug types, a statistical analysis of the number of varieties involved in 1473 non-bioequivalence/consistency evaluation clinical trials found that 91% of TCM varieties only carried out one clinical trial; the top 10 varieties in chemical drug clinical trials were basically As anti-tumor drugs, the top 3 are apatinib mesylate tablets (15 items), mitoxantrone hydrochloride liposome injection (10 items), fluzoparil capsules (10 items); biological products development The top 10 varieties in clinical trials are mainly therapeutic biological products, and the top 3 are recombinant humanized anti-PD-1 monoclonal antibody injection (17 items), atilizumab injection (11 items), Bolizumab injection (11 items)
.
Analyze the targets, the top 10 targets of registered clinical trials are PD-1, CYP51A1, VEGFR, PD-L1, etc.
, and 9 of the top 10 targets have drug indications that 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.
Among them, the varieties of PD-1, VEGFR, PD-L1 and other targets have carried out more than 60 clinical trials
.
In terms of indications, clinical trials of new Chinese medicines mainly focus on the three indications of breathing, cardiovascular and digestion, accounting for about 61.
2% of the total clinical trials of Chinese medicines
.
Chemical drug indications are mainly anti-tumor drugs, accounting for 42.
1% of the total chemical drug clinical trials, followed by anti-infective drugs (10.
1%)
.
The indications for biological products are also mainly anti-tumor drugs, accounting for 47.
3% of the overall 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 there are relatively few clinical trials for specific populations in 2020.
There are only 3 and 33 clinical trials in the elderly and children, accounting for the annual clinical trials.
1.
4% of total registration
.
The research and development of drugs for special populations should arouse attention
.
There are 1038 clinical trials involving elderly subjects, accounting for 70.
5% of the total new drug clinical trials
.
There are only 3 clinical trials carried out in the elderly population, accounting for 0.
2% of the total new drug clinical trials, all of which are chemical drugs, including anti-tumor drugs (2) and reproductive system disease drugs (1)
.
There were 129 clinical trials involving pediatric subjects, accounting for 8.
8% of the total clinical trials of new drugs
.
According to the analysis of drug classification, the number of registrations of biological products is the largest, with 70 items; followed by chemical drugs and traditional Chinese medicines
.
According to the analysis of indications, the main indications are anti-tumor drugs, preventive vaccines, skin and ENT, etc.
; the main indications of biological products and chemical drugs are roughly the same, and the main indications of Chinese medicine are respiratory drugs
.
A total of 33 new drug clinical trials were registered in the children population alone, accounting for 2.
2% of the total new drug clinical trials
.
According to the analysis of drug classification, the number of registered biological products is the largest, with 21 items; followed by chemical drugs and traditional Chinese medicines, with 8 and 4 respectively
.
According to the analysis of indications, biological products are mainly preventive vaccines, chemical drugs are mainly skin and ENT drugs and anti-infective drugs, and Chinese medicine/natural medicines are respiratory and skin drugs
.