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On June 7, the Center for Drug Evaluation of the State Food and Drug Administration released the "Annual Report on the Progress of Clinical Trials of New Drug Registration in China (2021)" (hereinafter referred to as "Report.
The "Report" shows that in 2021, the total annual registration of the drug clinical trial registration and information publicity platform exceeded 3,000 for the first time, with a total of 3,358 items, an increase of 21% compared with the total annual registration in 202 The "Report" shows that according to the classification of chemical drugs, biological products and traditional Chinese medicines, from the data analysis of the past three years, the proportion of new drug clinical trials of chemical drugs and biological products is relatively high, with an annual average of 56% and 44% respectivel.
The target indications of clinical trials of chemical drugs and biological products are mainly concentrated in the fields of anti-tumor and preventive vaccine.
Affected by the new crown epidemic, the number of clinical trials of new coronavirus inactivated vaccines in 2021 ranks first in preventive vaccine trials (20.
In the past three years, traditional Chinese medicine has focused on four indications: respiration, digestion, cardiovascular and neuropsychiatr.
PD-1/PD-L1 is a popular target for tumor drug development in recent years, and a number of PD-1/PD-L1 inhibitor drugs have been successfully launched at home and abroa.
Compared with the data analysis of the past three years, the analysis of the "Report" found that whether it is based on the drug variety or the number of clinical trial registrations, the targets of anti-tumor drugs in domestic clinical trials are still relatively concentrated, among which PD-1 and PD-L1 are particularly promine.
, and the number of phase III clinical trials that have been carried out is relatively larg.
According to the statistics of drug varieties, the top 10 targets of registered clinical trials in 2021 are PD-1, PD-L1, VEGFR, HER2, e.
The number of varieties is as high as 71, 59, 46, 43, of which more than 90% of the drug indications for 5 targets (PD-1, PD-L1, HER2, EGFR and CD3) are concentrated in the anti-tumor field, and 4 targets (PD-1, PD-L1, HER2) and EGFR) drug indications are all concentrated in the field of anti-tumo.
According to the number of clinical trials, the top 10 targets with the largest number of clinical trials in 2021 are PD-1, PD-L1, HER2, EGFR, e.
, with as many as 84, 68, 57 and 53 respectively; among which PD -1 and PD-L1 target phase III clinical trials up to 36 and 21, respective.
In addition, the proportion of phase I clinical trials in the drug clinical trials of the 4 targets (VEGFR, GLP-1/GLP-1R, JAK1 and CD3) exceeds 40%, and the proportion of phase II clinical trials in each target is in Between 8% and 3
It is reported that, in order to fully grasp the progress of clinical trials of new drug registration in China, use information technology to improve drug supervision capabilities, and disclose clinical trial progress information in a timely manner, the Center for Drug Evaluation, based on the registration information of new drug clinical trials on the drug clinical trial registration and information publicity platform, will review the 2021 In 2018, the status of clinical trials of new drug registration in China was comprehensively summarized and analyzed, and the "Annual Report on Progress of Clinical Trials of New Drug Registration in China (2021)" was compile.
Report information on drug clinical trials registered in 2021, including drug type, variety and target characteristics, indications, sponsor type, registration classification, trial classification, trial staging, special population trials, clinical trial team leader units, and start-up ti.
Summarize and analyze the overall trend changes, main features, and outstanding problems of clinical trials from the perspectives of clinical trials and completion stat.
At the same time, compare the clinical trial registration data in the past three years, and summarize and analyze the trend characteristics in recent years, in order to provide new drug development and resource allocati.
and drug review and approval to provide referenc.
The "Report" concludes that the proportion of new drug clinical trials has increased year by ye.
Over the years, phase I clinical trials have accounted for the highest proportion, and most of them are domestic trials initiated by domestic sponsor.
The proportion of bioequivalence (BE) trials has shown a gradual downward trend in the past three year.
As the number of new drug Phase III clinical trials continues to increase, it is expected that the number of new drug marketing applications in China will increase and the process will be accelerated to meet the new drug treatment needs of Chinese patients, including the clinical needs of pediatric populations and rare disease.
The "Report" shows that in 2021, the total annual registration of the drug clinical trial registration and information publicity platform exceeded 3,000 for the first time, with a total of 3,358 items, an increase of 21% compared with the total annual registration in 202 The "Report" shows that according to the classification of chemical drugs, biological products and traditional Chinese medicines, from the data analysis of the past three years, the proportion of new drug clinical trials of chemical drugs and biological products is relatively high, with an annual average of 56% and 44% respectivel.
The target indications of clinical trials of chemical drugs and biological products are mainly concentrated in the fields of anti-tumor and preventive vaccine.
Affected by the new crown epidemic, the number of clinical trials of new coronavirus inactivated vaccines in 2021 ranks first in preventive vaccine trials (20.
In the past three years, traditional Chinese medicine has focused on four indications: respiration, digestion, cardiovascular and neuropsychiatr.
PD-1/PD-L1 is a popular target for tumor drug development in recent years, and a number of PD-1/PD-L1 inhibitor drugs have been successfully launched at home and abroa.
Compared with the data analysis of the past three years, the analysis of the "Report" found that whether it is based on the drug variety or the number of clinical trial registrations, the targets of anti-tumor drugs in domestic clinical trials are still relatively concentrated, among which PD-1 and PD-L1 are particularly promine.
, and the number of phase III clinical trials that have been carried out is relatively larg.
According to the statistics of drug varieties, the top 10 targets of registered clinical trials in 2021 are PD-1, PD-L1, VEGFR, HER2, e.
The number of varieties is as high as 71, 59, 46, 43, of which more than 90% of the drug indications for 5 targets (PD-1, PD-L1, HER2, EGFR and CD3) are concentrated in the anti-tumor field, and 4 targets (PD-1, PD-L1, HER2) and EGFR) drug indications are all concentrated in the field of anti-tumo.
According to the number of clinical trials, the top 10 targets with the largest number of clinical trials in 2021 are PD-1, PD-L1, HER2, EGFR, e.
, with as many as 84, 68, 57 and 53 respectively; among which PD -1 and PD-L1 target phase III clinical trials up to 36 and 21, respective.
In addition, the proportion of phase I clinical trials in the drug clinical trials of the 4 targets (VEGFR, GLP-1/GLP-1R, JAK1 and CD3) exceeds 40%, and the proportion of phase II clinical trials in each target is in Between 8% and 3
It is reported that, in order to fully grasp the progress of clinical trials of new drug registration in China, use information technology to improve drug supervision capabilities, and disclose clinical trial progress information in a timely manner, the Center for Drug Evaluation, based on the registration information of new drug clinical trials on the drug clinical trial registration and information publicity platform, will review the 2021 In 2018, the status of clinical trials of new drug registration in China was comprehensively summarized and analyzed, and the "Annual Report on Progress of Clinical Trials of New Drug Registration in China (2021)" was compile.
Report information on drug clinical trials registered in 2021, including drug type, variety and target characteristics, indications, sponsor type, registration classification, trial classification, trial staging, special population trials, clinical trial team leader units, and start-up ti.
Summarize and analyze the overall trend changes, main features, and outstanding problems of clinical trials from the perspectives of clinical trials and completion stat.
At the same time, compare the clinical trial registration data in the past three years, and summarize and analyze the trend characteristics in recent years, in order to provide new drug development and resource allocati.
and drug review and approval to provide referenc.
The "Report" concludes that the proportion of new drug clinical trials has increased year by ye.
Over the years, phase I clinical trials have accounted for the highest proportion, and most of them are domestic trials initiated by domestic sponsor.
The proportion of bioequivalence (BE) trials has shown a gradual downward trend in the past three year.
As the number of new drug Phase III clinical trials continues to increase, it is expected that the number of new drug marketing applications in China will increase and the process will be accelerated to meet the new drug treatment needs of Chinese patients, including the clinical needs of pediatric populations and rare disease.
