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Authorized by Big Data Digest to reprint from academic headlines Author: Zhu Hengheng Editor: Wang Haha Typesetting: Li Xuewei According to the official website of the US FDA, Pfizer’s oral anti-coronavirus drug Paxlovid has received emergency use authorization for the treatment of mild to moderate COVID-19 over the age of 12 Pneumonia patients (the new coronavirus test result is positive, there is a risk of developing severe new coronavirus, including hospitalization or death)
.
According to previous clinical research data, Paxlovid can reduce the risk of hospitalization and death of patients with this type of new coronary pneumonia by 88%
.
Currently, Paxlovid is only available through prescription and needs to be used within 5 days of the onset of symptoms
.
In this regard, Dr.
Patrizia Cavazzoni, Director of the FDA’s Center for Drug Evaluation, said, “The first oral treatment for new coronary pneumonia authorized to be introduced today is an important measure to combat the global spread of new crowns
.
With the emergence of new variants, this emergency authorization is a major cause of the new crown virus.
During the epidemic, it provides a new method to fight against the new crown virus, which is expected to reduce the risk of death of patients who may develop a serious new crown infection
.
"About Paxlovid After the emergence of the new crown virus, scientists have analyzed the gene sequence and structure of the virus at a very fast speed, for the follow-up The design of vaccines and the development of antiviral drugs have laid a solid foundation
.
Now we know that the new coronavirus is a single positive-stranded RNA virus with an envelope
.
After the virus enters the host cell, it will decompose and release the viral RNA.
The viral RNA is translated into two polyproteins pp1a and pp1ab by the ribosome in the host cell.
These two polyproteins are like a puzzle packaged in a box.
, It still can't work, it needs to be disassembled and reorganized under the action of 3CL protease and PL protease to form a functional structural protein
.
In this process, 3CL protease (3C-like protease) is responsible for the cleavage of 11 sites of polyprotein to produce structural proteins that are very important for virus survival and reproduction, so it is also called the main protease
.
Obviously, if it can interfere with the activity of 3CL protease, it can effectively inhibit virus replication
.
Paxlovid under Pfizer is composed of two drugs, Nimarevir and Ritonavir.
Nimarevir is officially a new coronavirus protease inhibitor, which can target 3CL protease to prevent the replication of new coronavirus, while ritonavir can Inhibit the decomposition and metabolism of Nimanavir, thereby increasing its concentration in the body
.
Paxlovid is administered twice a day, two tablets of nimarevir and one tablet of ritonavir orally each time, and the use time should not exceed 5 days
.
The evidence supporting Paxlovid's emergency use authorization mainly comes from the EPIC-HR study, which is a randomized, double-blind, placebo-controlled clinical study that mainly enrolls patients over 18 years of age with mild to moderate neocoronavirus infection, and patients who have progressed to serious diseases Risk factors, or age greater than 60 years old
.
These patients have not previously been vaccinated against the new crown virus, nor have they been infected with the new crown virus
.
The primary endpoint of the study was the risk of hospitalization or death from the new crown during the 28-day follow-up period
.
In this study, 1,039 patients received Paxlovid treatment, and 1,046 control patients received placebo treatment
.
In the end, patients treated with Paxlovid had a hospitalization or mortality rate of 0.
8% within 28 days, compared with 6% in the placebo group
.
This means that Paxlovid can reduce the risk of hospitalization or death by 88% of patients with new coronary pneumonia, and the effect is significant
.
Of course, Paxlovid also has side effects, including impaired taste, diarrhea, high blood pressure, and muscle aches
.
At the same time, Paxlovid is mainly metabolized by the liver CYP3A enzyme in the body, so it cannot be used in combination with drugs that are highly dependent on this enzyme metabolism at the same time to avoid life-threatening adverse reactions
.
Similarly, some drugs that can induce CYP3A enzyme activity cannot be used in combination, which will cause Paxlovid to rapidly decompose and fail, and induce drug resistance
.
In addition, some special groups also need to pay attention when using Paxlovid
.
For example, for AIDS patients, Paxlovid can lead to drug resistance against HIV; for patients with severe liver and kidney dysfunction, Paxlovid is not recommended because it cannot be metabolized; and for patients with moderate liver and kidney insufficiency, the Paxlovid dose needs to be reduced, or with After discussion, professional doctors formulate appropriate treatment strategies
.
It should be noted that this Paxlovid emergency authorization is only applicable to the treatment of patients with mild to moderate COVID-19 infection, and cannot be used for the treatment of patients with severe COVID-19 infection, nor can it be used for the prevention of patients who are not infected with COVID-19
.
Therefore, Paxlovid cannot replace the new crown vaccine.
After all, the new crown vaccine or booster injection has been proven to significantly reduce the risk of hospitalization or death of new crown virus infection, and the market of Paxlovid is only for the treatment of patients with mild to moderate new coronary pneumonia
.
According to previous reports, in November, the US government had announced that it would spend US$5.
295 billion to purchase 10 million standard courses of Paxlovid for the treatment of domestic patients with new coronary pneumonia
.
At the same time, the Biden administration stated, “Although Paxlovid is a powerful tool for us to fight against the new coronavirus, actively receiving vaccines and booster injections are also important tools for us to save lives
.
” Paxlovid’s impact on China is currently benefited from China’s active epidemic prevention and control.
Policy, the overall domestic epidemic situation remains stable and controllable
.
Although there has been a small-scale outbreak in the recent past, the government responded quickly and curbed the possibility of the spread of the new coronavirus from the source
.
As of today, there are 4222 confirmed cases of COVID-19 in China, while the number of COVID-19 patients in the United States is as high as 10,765,115
.
Therefore, the listing of Paxlovid is very urgent for the United States, but the domestic impact is very limited
.
On the evening of December 8, the team of Professor Zhang Linqi of Tsinghua University, the team of Professor Wang Xinquan of the School of Life Sciences, the team of Professor Zhang Zheng of Shenzhen Third People’s Hospital, and Tengsheng Huachuang Medical Technology (Beijing) Co.
, Ltd.
jointly developed an anti-coronavirus antibody combination Drugs-Ambavirimab Injection (BRII-196) and Romisvirimab Injection (BRII-198) were officially approved by the China Food and Drug Administration, becoming China’s first self-developed anti-coronavirus antibody Drugs
.
The listing of this drug means that new coronary pneumonia is a preventable and curable disease in China, which will greatly reduce public panic
.
At the same time, Junshi Bio's JS026 clinical trial application was also accepted by the State Food and Drug Administration of China in October.
Another neutralizing antibody, esvirizumab (JS016), includes international multi-center phase Ib/II clinical trials including China.
The test is complete
.
Eli Lilly is responsible for the overseas production and supply of Etesvir.
The combination of this drug and banivirimab has been approved for emergency use in 15 countries including the United States and Italy
.
In addition, on October 30, China Biosciences also announced its two new crown-specific drugs under development-new crown-specific immunoglobulin and anti-new crown virus monoclonal antibodies
.
Luye Pharmaceuticals subsidiary Boan Bio's new crown innovative neutralizing antibody LY-CovMab, and Shanghai Zhijiang Bio's new crown bispecific antibody are also in progress
.
In general, many countries around the world have made great efforts to combat the new crown epidemic, and have achieved initial results.
The launch of various new crown drugs will further improve the survival of patients with new crown pneumonia and provide humans with better response to the new crown epidemic.
It's possible
.
Reference: https:// .
com/world/live-news/omicron-variant-coronavirus-news-12-22-21-intl People who click "Watching" will look better!
.
According to previous clinical research data, Paxlovid can reduce the risk of hospitalization and death of patients with this type of new coronary pneumonia by 88%
.
Currently, Paxlovid is only available through prescription and needs to be used within 5 days of the onset of symptoms
.
In this regard, Dr.
Patrizia Cavazzoni, Director of the FDA’s Center for Drug Evaluation, said, “The first oral treatment for new coronary pneumonia authorized to be introduced today is an important measure to combat the global spread of new crowns
.
With the emergence of new variants, this emergency authorization is a major cause of the new crown virus.
During the epidemic, it provides a new method to fight against the new crown virus, which is expected to reduce the risk of death of patients who may develop a serious new crown infection
.
"About Paxlovid After the emergence of the new crown virus, scientists have analyzed the gene sequence and structure of the virus at a very fast speed, for the follow-up The design of vaccines and the development of antiviral drugs have laid a solid foundation
.
Now we know that the new coronavirus is a single positive-stranded RNA virus with an envelope
.
After the virus enters the host cell, it will decompose and release the viral RNA.
The viral RNA is translated into two polyproteins pp1a and pp1ab by the ribosome in the host cell.
These two polyproteins are like a puzzle packaged in a box.
, It still can't work, it needs to be disassembled and reorganized under the action of 3CL protease and PL protease to form a functional structural protein
.
In this process, 3CL protease (3C-like protease) is responsible for the cleavage of 11 sites of polyprotein to produce structural proteins that are very important for virus survival and reproduction, so it is also called the main protease
.
Obviously, if it can interfere with the activity of 3CL protease, it can effectively inhibit virus replication
.
Paxlovid under Pfizer is composed of two drugs, Nimarevir and Ritonavir.
Nimarevir is officially a new coronavirus protease inhibitor, which can target 3CL protease to prevent the replication of new coronavirus, while ritonavir can Inhibit the decomposition and metabolism of Nimanavir, thereby increasing its concentration in the body
.
Paxlovid is administered twice a day, two tablets of nimarevir and one tablet of ritonavir orally each time, and the use time should not exceed 5 days
.
The evidence supporting Paxlovid's emergency use authorization mainly comes from the EPIC-HR study, which is a randomized, double-blind, placebo-controlled clinical study that mainly enrolls patients over 18 years of age with mild to moderate neocoronavirus infection, and patients who have progressed to serious diseases Risk factors, or age greater than 60 years old
.
These patients have not previously been vaccinated against the new crown virus, nor have they been infected with the new crown virus
.
The primary endpoint of the study was the risk of hospitalization or death from the new crown during the 28-day follow-up period
.
In this study, 1,039 patients received Paxlovid treatment, and 1,046 control patients received placebo treatment
.
In the end, patients treated with Paxlovid had a hospitalization or mortality rate of 0.
8% within 28 days, compared with 6% in the placebo group
.
This means that Paxlovid can reduce the risk of hospitalization or death by 88% of patients with new coronary pneumonia, and the effect is significant
.
Of course, Paxlovid also has side effects, including impaired taste, diarrhea, high blood pressure, and muscle aches
.
At the same time, Paxlovid is mainly metabolized by the liver CYP3A enzyme in the body, so it cannot be used in combination with drugs that are highly dependent on this enzyme metabolism at the same time to avoid life-threatening adverse reactions
.
Similarly, some drugs that can induce CYP3A enzyme activity cannot be used in combination, which will cause Paxlovid to rapidly decompose and fail, and induce drug resistance
.
In addition, some special groups also need to pay attention when using Paxlovid
.
For example, for AIDS patients, Paxlovid can lead to drug resistance against HIV; for patients with severe liver and kidney dysfunction, Paxlovid is not recommended because it cannot be metabolized; and for patients with moderate liver and kidney insufficiency, the Paxlovid dose needs to be reduced, or with After discussion, professional doctors formulate appropriate treatment strategies
.
It should be noted that this Paxlovid emergency authorization is only applicable to the treatment of patients with mild to moderate COVID-19 infection, and cannot be used for the treatment of patients with severe COVID-19 infection, nor can it be used for the prevention of patients who are not infected with COVID-19
.
Therefore, Paxlovid cannot replace the new crown vaccine.
After all, the new crown vaccine or booster injection has been proven to significantly reduce the risk of hospitalization or death of new crown virus infection, and the market of Paxlovid is only for the treatment of patients with mild to moderate new coronary pneumonia
.
According to previous reports, in November, the US government had announced that it would spend US$5.
295 billion to purchase 10 million standard courses of Paxlovid for the treatment of domestic patients with new coronary pneumonia
.
At the same time, the Biden administration stated, “Although Paxlovid is a powerful tool for us to fight against the new coronavirus, actively receiving vaccines and booster injections are also important tools for us to save lives
.
” Paxlovid’s impact on China is currently benefited from China’s active epidemic prevention and control.
Policy, the overall domestic epidemic situation remains stable and controllable
.
Although there has been a small-scale outbreak in the recent past, the government responded quickly and curbed the possibility of the spread of the new coronavirus from the source
.
As of today, there are 4222 confirmed cases of COVID-19 in China, while the number of COVID-19 patients in the United States is as high as 10,765,115
.
Therefore, the listing of Paxlovid is very urgent for the United States, but the domestic impact is very limited
.
On the evening of December 8, the team of Professor Zhang Linqi of Tsinghua University, the team of Professor Wang Xinquan of the School of Life Sciences, the team of Professor Zhang Zheng of Shenzhen Third People’s Hospital, and Tengsheng Huachuang Medical Technology (Beijing) Co.
, Ltd.
jointly developed an anti-coronavirus antibody combination Drugs-Ambavirimab Injection (BRII-196) and Romisvirimab Injection (BRII-198) were officially approved by the China Food and Drug Administration, becoming China’s first self-developed anti-coronavirus antibody Drugs
.
The listing of this drug means that new coronary pneumonia is a preventable and curable disease in China, which will greatly reduce public panic
.
At the same time, Junshi Bio's JS026 clinical trial application was also accepted by the State Food and Drug Administration of China in October.
Another neutralizing antibody, esvirizumab (JS016), includes international multi-center phase Ib/II clinical trials including China.
The test is complete
.
Eli Lilly is responsible for the overseas production and supply of Etesvir.
The combination of this drug and banivirimab has been approved for emergency use in 15 countries including the United States and Italy
.
In addition, on October 30, China Biosciences also announced its two new crown-specific drugs under development-new crown-specific immunoglobulin and anti-new crown virus monoclonal antibodies
.
Luye Pharmaceuticals subsidiary Boan Bio's new crown innovative neutralizing antibody LY-CovMab, and Shanghai Zhijiang Bio's new crown bispecific antibody are also in progress
.
In general, many countries around the world have made great efforts to combat the new crown epidemic, and have achieved initial results.
The launch of various new crown drugs will further improve the survival of patients with new crown pneumonia and provide humans with better response to the new crown epidemic.
It's possible
.
Reference: https:// .
com/world/live-news/omicron-variant-coronavirus-news-12-22-21-intl People who click "Watching" will look better!
