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In recent years, as the reform of the drug review and approval system continues to deepen, while the pace of domestic new drug R&D and market launches continues to accelerate, the pace of overseas new drug review and approval is also accelerating
.
According to data from the Center for Drug Evaluation (CDE) of the State Drug Administration of China, from December 6th to December 10th, 19 new class 1 new drugs (excluding supplementary applications) were added in China, involving Shuanglu Pharmaceutical and Zhengxiang Pharmaceutical , Simcere Pharmaceutical, and foreign-funded enterprises such as Biaoxin and BioInvent
.
From an overall point of view, analysts believe that a large number of domestic and foreign Class 1 new drugs are approved for clinical use, which will enable patients to usher in more drug treatment options
.
For example, Borui Medicine's BGC0228 for injection, the clinical research indication approved this time is advanced malignant solid tumor
.
Previously, its pre-clinical experiments proved that Borui Medicine's targeted polymer conjugated drugs can penetrate the blood-brain barrier and open a window for the treatment of glioma and tumor brain metastases
.
The Class 1 new drug approved by Shuanglu Pharmaceutical this time is a DT678 tablet jointly developed with Diapin Therapeutics
.
The drug can inhibit the binding of ADP to the receptor of platelet P2Y12, thereby inhibiting platelet aggregation and preventing thrombosis
.
The clinical research indications approved in China this time are: prevention and treatment of heart, brain and other arterial circulatory disorders caused by high platelet aggregation, and can be used to prevent and treat coronary heart disease, acute myocardial infarction, cerebral thrombosis, stroke and other thrombosis Sexual disease
.
In addition, it is also applicable to patients with CYP2C19 gene mutations in the P450 enzyme system
.
From an overall point of view, with the centralized procurement of generic drugs and the inclusion of innovative drugs in the new medical insurance, as well as the support of a series of policies such as accelerated drug approval, patent protection, and tax reduction, it is bringing about While there are more opportunities, it will continue to increase the opportunities for patients to obtain new drugs
.
It is worth noting that in addition to the large number of clinical approvals of Class 1 new drugs, more patients will be benefited, and industry insiders also said that judging from the large number of domestic new drugs approved this time, domestic innovation strength is actually improving
.
It is understood that in recent years, with the advancement of sound pharmaceutical policies, the country has ushered in a major trend of innovation.
.
In the future, it is expected that with the support of a series of policies such as accelerated drug approval, patent protection, and tax reduction, the development of domestic innovative drugs will continue to heat up and begin to promote the growth of the domestic innovative drug market in the future
.
However, it should be noted that, although the domestic pharmaceutical industry has ushered in a strong trend of innovation under the promotion of sound pharmaceutical policies in recent years, the development of domestic innovative drugs still faces many difficulties, such as homogeneity.
Serious and so on
.
It is understood that in terms of PD-1 products, as of November 2021, 6 domestic PD-1 models have been approved for listing in China, and 4 models have already entered medical insurance
.
At the same time, there are 3 products in the production stage
.
In addition, there are currently 657 registrations of PD-1/PD-L1 clinical trials in China, involving more than 150 companies
.
Therefore, analysts said that in the future, domestic pharmaceutical companies need to pay more attention to clinical needs as the center, clinical value-oriented, and focus on the driving force of precise treatment in the development of new drugs; strengthen basic research, strengthen disease awareness, and improve drug innovation Ability; rationally choose fast channels and pay attention to new methods of using old drugs
.
.
According to data from the Center for Drug Evaluation (CDE) of the State Drug Administration of China, from December 6th to December 10th, 19 new class 1 new drugs (excluding supplementary applications) were added in China, involving Shuanglu Pharmaceutical and Zhengxiang Pharmaceutical , Simcere Pharmaceutical, and foreign-funded enterprises such as Biaoxin and BioInvent
.
From an overall point of view, analysts believe that a large number of domestic and foreign Class 1 new drugs are approved for clinical use, which will enable patients to usher in more drug treatment options
.
For example, Borui Medicine's BGC0228 for injection, the clinical research indication approved this time is advanced malignant solid tumor
.
Previously, its pre-clinical experiments proved that Borui Medicine's targeted polymer conjugated drugs can penetrate the blood-brain barrier and open a window for the treatment of glioma and tumor brain metastases
.
The Class 1 new drug approved by Shuanglu Pharmaceutical this time is a DT678 tablet jointly developed with Diapin Therapeutics
.
The drug can inhibit the binding of ADP to the receptor of platelet P2Y12, thereby inhibiting platelet aggregation and preventing thrombosis
.
The clinical research indications approved in China this time are: prevention and treatment of heart, brain and other arterial circulatory disorders caused by high platelet aggregation, and can be used to prevent and treat coronary heart disease, acute myocardial infarction, cerebral thrombosis, stroke and other thrombosis Sexual disease
.
In addition, it is also applicable to patients with CYP2C19 gene mutations in the P450 enzyme system
.
From an overall point of view, with the centralized procurement of generic drugs and the inclusion of innovative drugs in the new medical insurance, as well as the support of a series of policies such as accelerated drug approval, patent protection, and tax reduction, it is bringing about While there are more opportunities, it will continue to increase the opportunities for patients to obtain new drugs
.
It is worth noting that in addition to the large number of clinical approvals of Class 1 new drugs, more patients will be benefited, and industry insiders also said that judging from the large number of domestic new drugs approved this time, domestic innovation strength is actually improving
.
It is understood that in recent years, with the advancement of sound pharmaceutical policies, the country has ushered in a major trend of innovation.
.
In the future, it is expected that with the support of a series of policies such as accelerated drug approval, patent protection, and tax reduction, the development of domestic innovative drugs will continue to heat up and begin to promote the growth of the domestic innovative drug market in the future
.
However, it should be noted that, although the domestic pharmaceutical industry has ushered in a strong trend of innovation under the promotion of sound pharmaceutical policies in recent years, the development of domestic innovative drugs still faces many difficulties, such as homogeneity.
Serious and so on
.
It is understood that in terms of PD-1 products, as of November 2021, 6 domestic PD-1 models have been approved for listing in China, and 4 models have already entered medical insurance
.
At the same time, there are 3 products in the production stage
.
In addition, there are currently 657 registrations of PD-1/PD-L1 clinical trials in China, involving more than 150 companies
.
Therefore, analysts said that in the future, domestic pharmaceutical companies need to pay more attention to clinical needs as the center, clinical value-oriented, and focus on the driving force of precise treatment in the development of new drugs; strengthen basic research, strengthen disease awareness, and improve drug innovation Ability; rationally choose fast channels and pay attention to new methods of using old drugs
.
