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On October 11, local time, Merck announced that it was seeking an emergency use authorization (EUA) from the U.
S.
Food and Drug Administration (FDA) for its oral antiviral drug Molnupiravir under development
.
If approved, Molnupiravir will become the world's first oral small molecule new crown specific drug to be marketed
.
Molnupiravir is a bioavailable form of oral ribonucleoside analog developed by Merck and its partner Ridgeback Biotherapeutics, which can inhibit the replication of SARS-CoV-2
.
Preclinical studies have shown that Molnupiravir is active against the most common variant of SARS-CoV-2
.
It is reported that the submission of the EUA application is based on the interim analysis data of a global phase 3, randomized, placebo-controlled, double-blind, multi-center MOVe-OUT clinical trial.
This trial evaluates the potential development of Molnupiravir into severe COVID- 19 Therapeutic effect among hospitalized adult patients and/or non-hospitalized adult patients with mild to moderate COVID-19
.
The results of the analysis showed that on the 29th day after randomization, 7.
3% (28) of the 385 patients treated with monoprevir were hospitalized or died, compared with 14.
1% (53/ 377).
Overall, Molnupiravir reduced the risk of hospitalization or death by approximately 50%, and no deaths were reported in the treatment group during the trial, while 8 patients in the placebo group died
.
In terms of adverse reactions, the data in the Molnupiravir treatment group and the placebo group were comparable, with any adverse event rates of 35% and 40%, and drug-related adverse events of 12% and 11%, respectively
.
Merck announced the positive data of Molnupiravir on October 1.
As soon as the news came out, the anti-epidemic stocks of Hong Kong stocks plummeted almost across the board, which also confirmed the market's expectations for Molnupiravir
.
At the same time, the production cost of Molnupiravir is relatively low, so some insiders speculate that if the product is authorized for use, it will reconstruct the existing market structure of related new crown drugs
.
According to information released by Merck, based on confidence in the research results, the company has ventured to produce Molnupiravir in advance, and is expected to produce 10 million treatment courses by the end of 2021, and will continue to increase the supply next year
.
On the same day that Merck announced the submission of the Molnupiravirde EUA application, AstraZeneca also brought good news about its new crown neutralizing antibody AZD7442
.
Compared with placebo, 407 patients received the antibody treatment within 7 days after the onset of symptoms, and the risk of developing severe disease or death from the new coronary disease was reduced by 50%
.
Another set of data shows that if you receive AZD7442 treatment within 5 days after the onset of symptoms, the patient's risk of developing serious illness and death will be reduced by 67%
.
At present, AstraZeneca has submitted AZD7442 to the FDA on October 5 as an EUA for the new crown preventive drug
.
In terms of anti-coronavirus drugs, in addition to products developed by foreign companies, local pharmaceutical companies have also brought some good news recently
.
For example, on October 9th, the first native new crown neutralizing antibody combination therapy BRII-196/BRII-198 developed by Tengshengbo Pharmaceutical also submitted an EUA application to the FDA
.
If it goes well, the BRII-196/BRII-198 combination therapy is expected to be approved by the FDA within this year
.
End reference materials: [1] Merck's official website [2] AstraZeneca's official website [3] Merck's new crown oral drug still can not replace the role of the vaccine, the anti-epidemic stock was wrongly killed?
S.
Food and Drug Administration (FDA) for its oral antiviral drug Molnupiravir under development
.
If approved, Molnupiravir will become the world's first oral small molecule new crown specific drug to be marketed
.
Molnupiravir is a bioavailable form of oral ribonucleoside analog developed by Merck and its partner Ridgeback Biotherapeutics, which can inhibit the replication of SARS-CoV-2
.
Preclinical studies have shown that Molnupiravir is active against the most common variant of SARS-CoV-2
.
It is reported that the submission of the EUA application is based on the interim analysis data of a global phase 3, randomized, placebo-controlled, double-blind, multi-center MOVe-OUT clinical trial.
This trial evaluates the potential development of Molnupiravir into severe COVID- 19 Therapeutic effect among hospitalized adult patients and/or non-hospitalized adult patients with mild to moderate COVID-19
.
The results of the analysis showed that on the 29th day after randomization, 7.
3% (28) of the 385 patients treated with monoprevir were hospitalized or died, compared with 14.
1% (53/ 377).
Overall, Molnupiravir reduced the risk of hospitalization or death by approximately 50%, and no deaths were reported in the treatment group during the trial, while 8 patients in the placebo group died
.
In terms of adverse reactions, the data in the Molnupiravir treatment group and the placebo group were comparable, with any adverse event rates of 35% and 40%, and drug-related adverse events of 12% and 11%, respectively
.
Merck announced the positive data of Molnupiravir on October 1.
As soon as the news came out, the anti-epidemic stocks of Hong Kong stocks plummeted almost across the board, which also confirmed the market's expectations for Molnupiravir
.
At the same time, the production cost of Molnupiravir is relatively low, so some insiders speculate that if the product is authorized for use, it will reconstruct the existing market structure of related new crown drugs
.
According to information released by Merck, based on confidence in the research results, the company has ventured to produce Molnupiravir in advance, and is expected to produce 10 million treatment courses by the end of 2021, and will continue to increase the supply next year
.
On the same day that Merck announced the submission of the Molnupiravirde EUA application, AstraZeneca also brought good news about its new crown neutralizing antibody AZD7442
.
Compared with placebo, 407 patients received the antibody treatment within 7 days after the onset of symptoms, and the risk of developing severe disease or death from the new coronary disease was reduced by 50%
.
Another set of data shows that if you receive AZD7442 treatment within 5 days after the onset of symptoms, the patient's risk of developing serious illness and death will be reduced by 67%
.
At present, AstraZeneca has submitted AZD7442 to the FDA on October 5 as an EUA for the new crown preventive drug
.
In terms of anti-coronavirus drugs, in addition to products developed by foreign companies, local pharmaceutical companies have also brought some good news recently
.
For example, on October 9th, the first native new crown neutralizing antibody combination therapy BRII-196/BRII-198 developed by Tengshengbo Pharmaceutical also submitted an EUA application to the FDA
.
If it goes well, the BRII-196/BRII-198 combination therapy is expected to be approved by the FDA within this year
.
End reference materials: [1] Merck's official website [2] AstraZeneca's official website [3] Merck's new crown oral drug still can not replace the role of the vaccine, the anti-epidemic stock was wrongly killed?