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At present, with a series of policies that encourage pharmaceutical innovation and the time for approval and review, China's innovative drugs have ushered in the spring of development
.
According to the “Annual Report 2020 on the Current Status of Clinical Trials of New Drug Registration in China” published by CDE on November 10, China has registered a total of 2,602 clinical trials in 2020, an overall increase of 9.
1% compared with 2019
.
Among them, clinical trials of innovative drugs accounted for more than half, up to 57%
.
From the above point of view, China's current innovative drug research and development momentum is strong
.
The industry predicts that with the support of a series of policies, the field of domestically-made innovative drugs will usher in major development opportunities.
In the next 5-10 years, the proportion of innovative drugs in China may increase to 40%-50%, and more domestically-made innovative drugs will continue to emerge , And continue to benefit more patients
.
On November 25, according to the State Food and Drug Administration, two more innovative drugs independently developed and marketed with conditions were approved for listing on the same day
.
They are aoribatinib tablets for the treatment of resistance to any tyrosine kinase inhibitor; innovative PD-L1 antibody drugs, suitable for unresectable or metastatic microsatellite highly unstable (MSI-H) or mismatch repair Envolimab injection for the treatment of adult patients with advanced solid tumors with genetic defects (dMMR)
.
Specifically, the class 1 innovative drug oribatinib tablet declared by Guangzhou Shunjian Biomedical Technology Co.
, Ltd.
is an innovative drug independently developed by China and has independent intellectual property rights.
It is used to treat any tyrosine kinase inhibitor resistance.
A fully validated detection method is used to diagnose adult patients with chronic myeloid leukemia with T315I mutation in the chronic or accelerated phase
.
This product is the first approved drug for chronic myeloid leukemia with T315I mutation in China, and provides effective treatment for patients who can be resistant to T315I mutation.
.
In addition, Envolimab injection is an innovative PD-L1 antibody drug declared by Sichuan Silu Kangrui Pharmaceutical Co.
, Ltd.
, which is suitable for unresectable or metastatic microsatellite highly unstable (MSI-H) or mismatch repair Treatment of adult patients with advanced solid tumors with genetic defects (dMMR), including patients with advanced colorectal cancer who have progressed after treatment with fluorouracil, oxaliplatin, and irinotecan, and patients with advanced colorectal cancer who have progressed after previous treatments and are unsatisfactory Alternative treatment options for other advanced solid tumor patients
.
In addition to the above two drugs, in fact, domestically-made innovative drugs have been approved for the market this year, showing a blowout trend
.
According to data, there are 27 innovative drugs that have passed the review in January-September, including cyclopofol injection, enovirin tablets, hytrapopaethanolamine tablets, hypertropin tablets, savotinib tablets, Levo Ornidazole Phosphate Disodium for Injection and other blockbuster drugs
.
It is worth mentioning that not only the number has far exceeded the number of innovative drug reviews passed in 2020
.
Since the beginning of this year, the approved innovative drugs have also become very rich in product categories, involving many clinically urgently needed therapeutic drugs in the fields of tumors, vaccines, and rare diseases
.
The industry believes that, with the support of the changes in the pharmaceutical market and a series of policies that encourage research and development, the development of domestic innovative drugs is continuously heating up, which will further promote the growth of the innovative drug market in the future
.
However, it should be noted that the clustering of targets is still a major problem faced by many enterprises in innovation
.
Taking PD-1 as an example, statistics show that the domestic track is already very crowded.
Among the 154 PD-1 products under research in the world, 85 are developed or jointly developed by Chinese companies, accounting for 55%
.
Therefore, the analysis believes that while seeing opportunities, Chinese innovative drug companies also need to keep a clear head, continuously improve the quality of innovation, and avoid blind "innovation
.
"
.
According to the “Annual Report 2020 on the Current Status of Clinical Trials of New Drug Registration in China” published by CDE on November 10, China has registered a total of 2,602 clinical trials in 2020, an overall increase of 9.
1% compared with 2019
.
Among them, clinical trials of innovative drugs accounted for more than half, up to 57%
.
From the above point of view, China's current innovative drug research and development momentum is strong
.
The industry predicts that with the support of a series of policies, the field of domestically-made innovative drugs will usher in major development opportunities.
In the next 5-10 years, the proportion of innovative drugs in China may increase to 40%-50%, and more domestically-made innovative drugs will continue to emerge , And continue to benefit more patients
.
On November 25, according to the State Food and Drug Administration, two more innovative drugs independently developed and marketed with conditions were approved for listing on the same day
.
They are aoribatinib tablets for the treatment of resistance to any tyrosine kinase inhibitor; innovative PD-L1 antibody drugs, suitable for unresectable or metastatic microsatellite highly unstable (MSI-H) or mismatch repair Envolimab injection for the treatment of adult patients with advanced solid tumors with genetic defects (dMMR)
.
Specifically, the class 1 innovative drug oribatinib tablet declared by Guangzhou Shunjian Biomedical Technology Co.
, Ltd.
is an innovative drug independently developed by China and has independent intellectual property rights.
It is used to treat any tyrosine kinase inhibitor resistance.
A fully validated detection method is used to diagnose adult patients with chronic myeloid leukemia with T315I mutation in the chronic or accelerated phase
.
This product is the first approved drug for chronic myeloid leukemia with T315I mutation in China, and provides effective treatment for patients who can be resistant to T315I mutation.
.
In addition, Envolimab injection is an innovative PD-L1 antibody drug declared by Sichuan Silu Kangrui Pharmaceutical Co.
, Ltd.
, which is suitable for unresectable or metastatic microsatellite highly unstable (MSI-H) or mismatch repair Treatment of adult patients with advanced solid tumors with genetic defects (dMMR), including patients with advanced colorectal cancer who have progressed after treatment with fluorouracil, oxaliplatin, and irinotecan, and patients with advanced colorectal cancer who have progressed after previous treatments and are unsatisfactory Alternative treatment options for other advanced solid tumor patients
.
In addition to the above two drugs, in fact, domestically-made innovative drugs have been approved for the market this year, showing a blowout trend
.
According to data, there are 27 innovative drugs that have passed the review in January-September, including cyclopofol injection, enovirin tablets, hytrapopaethanolamine tablets, hypertropin tablets, savotinib tablets, Levo Ornidazole Phosphate Disodium for Injection and other blockbuster drugs
.
It is worth mentioning that not only the number has far exceeded the number of innovative drug reviews passed in 2020
.
Since the beginning of this year, the approved innovative drugs have also become very rich in product categories, involving many clinically urgently needed therapeutic drugs in the fields of tumors, vaccines, and rare diseases
.
The industry believes that, with the support of the changes in the pharmaceutical market and a series of policies that encourage research and development, the development of domestic innovative drugs is continuously heating up, which will further promote the growth of the innovative drug market in the future
.
However, it should be noted that the clustering of targets is still a major problem faced by many enterprises in innovation
.
Taking PD-1 as an example, statistics show that the domestic track is already very crowded.
Among the 154 PD-1 products under research in the world, 85 are developed or jointly developed by Chinese companies, accounting for 55%
.
Therefore, the analysis believes that while seeing opportunities, Chinese innovative drug companies also need to keep a clear head, continuously improve the quality of innovation, and avoid blind "innovation
.
"
