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On February 11, the State Food and Drug Administration conducted emergency review and approval in accordance with the relevant provisions of the "Drug Administration Law" and in accordance with the special drug approval procedures, and approved Pfizer's new coronavirus treatment drug Nematicavir Tablets/Ritonavir Tablets with conditions.
Combination packaging (ie Paxlovid) import registration
.
This product is an oral small-molecule novel coronavirus treatment drug for the treatment of adults with mild to moderate novel coronavirus pneumonia (COVID-19) with high risk factors for progression to severe disease, such as advanced age, chronic kidney disease, diabetes, Patients with severe high-risk factors such as cardiovascular disease and chronic lung disease
.
Patients should strictly follow the instructions for medication under the guidance of physicians, and should pay close attention to the interaction information with other drugs listed in the instructions during use
The State Food and Drug Administration requires the marketing authorization holder to continue to carry out relevant research work, complete the conditional requirements within a time limit, and submit the follow-up research results in a timely manner
.
01.
What is Paxlovid?
Paxlovid is an oral antiviral drug developed by Pfizer that reduces the ability of the new coronavirus to reproduce in the body
.
The drug consists of small-molecule drugs nirmatrelvir and ritonavir, which are inhibitors of the main protease of the new coronavirus.
The drug consists of small-molecule drugs nirmatrelvir and ritonavir, which are inhibitors of the main protease of the new coronavirus.
Various results show that nelmatevir is a key protease inhibitor of SARS-Cov-2 that can be absorbed orally, with very good in vitro antiviral activity and excellent off-target selectivity, as well as extremely high safety.
Tolinavir showed excellent antiviral effect and clinical application prospect when co-administered!
On November 5, 2021, Pfizer announced the results of a Phase III clinical study of Paxlovid, which showed that patients with mild to moderate new crowns who took the drug within 3 days of diagnosis could reduce the risk of hospitalization and death by about 89%
.
The performance of Paxlovid is comparable to the therapeutic effect of the new crown neutralizing antibody, and it is also significantly better than the broad-spectrum antiviral drug Monlnupiravir developed by Merck &
On November 5, 2021, Pfizer announced the results of a Phase III clinical study of Paxlovid, which showed that patients with mild to moderate new crowns who took the drug within 3 days of diagnosis could reduce the risk of hospitalization and death by about 89%
On December 22, 2021, Paxlovid became the first oral drug approved by the FDA for emergency use in the treatment of new coronavirus infection , so that people around the world can see the dawn of ending the new crown
.
02.
Combined with China's new crown special medicine
On December 3, 2021, after a rigorous comparative test, the National Institutes of Health (NIH) released all clinical data on the combination therapy of ambavirumab/romisevirumab and the new coronavirus antibody
.
In a phase III clinical trial, compared with placebo, the combination therapy of ambavirumab The main role is to treat .
Ambavirumab /romisevirumab combination therapy can reduce the risk of hospitalization and death in high-risk new crown outpatients by 80%!
It is reported that the drug is administered intravenously, and the whole process only takes 40 minutes, and it can take effect immediately after entering the human body
.
On December 8, 2021, China's first anti-coronavirus specific drug, the combination therapy specific drug of ambavirumab/romisevirumab, was approved by the Food and Drug Administration, marking China's first fully independent research and development.
And it has been proved that an effective anti-new coronavirus antibody specific drug was officially launched
On December 8, 2021, China's first anti-coronavirus specific drug, the combination therapy specific drug of ambavirumab/romisevirumab, was approved by the Food and Drug Administration, marking China's first fully independent research and development.
And it has been proved that an effective anti-new coronavirus antibody specific drug was officially launched