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The latest news, the new crown drug BRII-196 and BRII-198 jointly developed by Tsinghua University, Shenzhen Third People’s Hospital and Tengshengbo Pharmaceutical have been unblinded in clinical phase III.
The drug delivery group achieved zero deaths after 28 days of treatment.
There were 8 deaths in the group, and the detailed results will be announced in the near future
.
This is also the fastest-growing antibody drug in China, and it is expected to be approved for conditional listing before the end of December
.
Compared with the new coronavirus antibody drug that has been approved for emergency use in Europe and the United States, this drug is the only one that has evaluated and obtained data on the treatment effect of patients infected with variant strains
.
Since the outbreak of the new crown epidemic in early 2020, preventive vaccines + specific therapeutic drugs have always been regarded as important means of epidemic prevention and control, and the two are also playing a "complementary" role in prevention and control
.
In terms of new crown vaccines, many vaccines around the world have been approved or authorized to varying degrees, involving multiple technical routes such as mRNA, inactivation, and adenovirus vectors
.
In contrast, most of the new crown treatment drugs are in the research and development stage
.
But with the unremitting efforts of Chinese and foreign scientists, the good news continues! The antibodies and drugs approved successively in November seem to have given the world hope of overcoming the epidemic
.
At present, a number of different types of new coronavirus treatment drugs have entered the late stage of development around the world, such as new coronavirus neutralizing antibodies mainly for mild and moderate patients, anti-cytokine receptor/neutralizing antibodies mainly for severe patients, and small molecule new drugs in patients with severe crown (including RNA polymerase inhibitor, JAK inhibitor, AR antagonists, 3CL protease inhibitors, etc.
) and the like
.
Multinational pharmaceutical companies are the first to hit the line, and Chinese scientists are struggling to catch up
.
How is the progress of new crown treatment drugs at home and abroad? 1.
The neutralizing antibody Ronapreve was jointly developed by Roche and Regeneron.
It is a combination therapy consisting of two neutralizing antibodies targeting different epitopes of the new coronavirus spike protein.
It is used to treat the risk of disease deterioration without the need for supplemental oxygen.
Increasing adult and adolescent patients (over 12 years old, weighing at least 40 kg), it is approved for the prevention of COVID-19 in adolescents and adults at the same time
.
Phase III clinical trial results showed that compared with placebo, patients who received intravenous Ronapreve had a 70% lower risk of hospitalization or death.
This combination also shortened the duration of symptoms in patients by 4 days
.
In addition, Ronapreve has also achieved good results in preventing new coronavirus infections.
In the phase III clinical trial, volunteers who received a subcutaneous injection had a 81% reduction in the risk of developing symptomatic COVID-19
.
Regkirona Regkirona is developed by South Korea's Celltrion company
.
Celltrion's Regkirona global phase III clinical trial data showed that compared with placebo, patients treated with Regkirona have a 70% lower risk of hospitalization or death
.
Among patients with an increased risk of deterioration, 3.
1% (14/446) of patients treated with Regkirona were hospitalized, oxygenated or died within 28 days after treatment, compared with 11.
1% (48/434) in the placebo group )
.
In addition to the above two neutralizing antibodies approved in the European Union, there are currently several neutralizing antibodies that have been authorized by the FDA for emergency use (EUA) or have submitted EUA, including Eli Lilly’s Etesevimab and Bamlanivimab double antibody therapy, GlaxoSmithKline Sotrovimab, Tengshengbo’s BRII-196/BRII-198 combination therapy, AstraZeneca’s AZD7442
.
Eli Lilly's Etesevimab and Bamlanivimab dual antibody therapy was authorized by the FDA for emergency use in February this year.
Data shows that Etesevimab and Bamlanivimab dual antibody therapy can reduce the risk of hospitalization and death from COVID-19 by 70%
.
However, the dual-antibody therapy is not effective against the Gamma and Delta mutant strains this spring.
It was stopped by the US regulatory agency in June and was authorized again in August this year
.
GlaxoSmithKline’s Sotrovimab was authorized by the FDA for emergency use in May of this year.
According to interim data from a phase III trial, Sotrovimab treatment reduces the risk of hospitalization or death in high-risk outpatient COVID-19 adult patients by 85% compared with placebo.
.
In addition, in vitro data also indicate that Sotrovimab maintains activity against all known virus variants, including variants from India
.
Tengshengbo Pharmaceutical's BRII-196/BRII-198 combination therapy has been submitted to the FDA for emergency use authorization in October
.
This combination therapy from China was jointly developed by Tsinghua University and Shenzhen Third People's Hospital
.
The EUA application submitted is based on the positive results of a phase III clinical trial supported by the National Institutes of Health (NIH)
.
The results showed that, compared with placebo, the BRII-196/BRII-198 combination therapy reduced the risk of hospitalization and death of COVID-19 outpatients with a high risk of clinical progression to severe disease by 78%
.
The trial is currently the only large-scale Phase III trial in progress for a Chinese company in the United States
.
The combination therapy is expected to become the first approved new crown neutralizing antibody drug in China
.
AstraZeneca's AZD7442AZD7442 is a combination of two long-acting antibodies Tixagevimab (AZD8895) and Cilgavimab (AZD1061), which are extracted from B cells of convalescent patients infected with the new coronavirus
.
According to the results of the phase III clinical trial of AZD7442 published in October, compared with placebo, mild non-hospital patients received a 50% reduction in the risk of severe illness or death by intramuscular injection of AZD7442 at a dose of 600 mg compared with placebo; received within five days of the onset of symptoms Pre-analysis conducted by the treated participants showed that compared with placebo, AZD7442 reduced the risk of severe illness or death by 67%
.
In addition to the above neutralizing antibodies, products under clinical phase III or phase II research include Tychan’s TY027, Abpro’s ABP-300, BMS’s BMS-986414/BMS-986413, SAB’s SAB-185, and Shenzhou’s SCTA01.
, Pok biological LY-CovMab, Jimin credible JMB-2002 and so on
.
2.
Small molecule oral drugs On November 4, the US pharmaceutical company Merck announced that its small molecule drug Molnupiravir has been approved by the UK Food and Drug Administration, becoming the world's first oral drug approved for the treatment of mild to moderate neocorona infections in adults Drugs
.
Only one day later, Pfizer Pharmaceuticals of the United States disclosed the results of the clinical trial of Paxlovid, an oral drug for new crowns it developed.
Taking the drug in the early stages of symptoms can reduce the risk of hospitalization or death by 89% of patients with new crowns
.
Molnupiravir Molnupiravir is an oral ribonucleoside analog developed by Merck and Ridgeback Biotherapeutics.
It can inhibit the replication of a variety of RNA viruses, including SARS-CoV-2 (the causative agent of the new coronavirus), and is used to treat mild to mild Moderate new coronary pneumonia
.
According to the Phase III clinical interim data released by Merck on October 1, the hospitalization or mortality rate of the Molnupiravir treatment group was 7.
3% (28/385), and the hospitalization or mortality rate of the control group was 14.
1% (53/377).
Molnupiravir will The risk of hospitalization or death is reduced by approximately 50%
.
In terms of mortality, there were no deaths in the treatment group and 8 deaths in the control group
.
Paxlovid Paxlovid was developed by Pfizer and is a specially designed SARS-CoV-2-3CL protease inhibitor
.
Unlike Merck’s Molnupiravi, Paxlovid is a compound medicine that contains PF-07321332 and ritonavir
.
On November 5, Pfizer announced an interim analysis based on a randomized, double-blind, phase 2/3 EPIC-HR trial.
The results showed that Paxlovid reduced the risk of hospitalization or death by 89% compared with the placebo group
.
Pfizer has submitted an emergency use authorization for Paxlovid to the FDA on the 16th
.
In addition to the above two, procrulamide from China is also a promising oral anti-coronavirus drug
.
Prokramide Prokramide is a new class 1.
1 anti-prostate cancer drug developed by Pioneer Pharmaceuticals
.
It has higher targeting activity than enzalutamide and is expected to become the best drug for the second generation of anti-prostate cancer clinical drugs targeting the androgen receptor
.
In March of this year, Pioneer Pharmaceuticals announced that the clinical trial of Prokalamide in Brazil for the treatment of severely ill patients with COVID-19 reached the primary end point.
Prokruline can reduce the risk of death of patients with severe COVID-19 by 92% and shorten the average length of hospital stay9 Days
.
AT-527 AT-527 was developed by Atea Company.
It is an RNA polymerase inhibitor.
After entering the human body, it can be converted into free base AT-511, and then produce the triphosphate metabolite AT-9010 with higher anti-coronavirus activity.
The activity of the new coronavirus is 5-8 times higher than that of Merck’s Molnupiravir
.
Unfortunately, on October 19, Roche announced the latest phase II clinical data of AT-527.
The results showed that the SARS-CoV-2 viral load on the 29th day of the AT-527 treatment group (550mg, bid) was lower than that of the baseline.
Compared with the placebo group, the change was not significantly reduced, and about two-thirds of patients still belonged to low-risk hospitalization patients with symptoms, and failed to reach the primary endpoint of the study
.
In addition to the above-mentioned products, the small-molecule oral drugs under development for anti-coronaviruses that have received attention include S217622 from Shiono Yoshihide, RHB-107 from Red Hill, VV116 from Junshi Biologics, EDP-235 from Enanta, etc.
, related clinical trial data Still to be disclosed
.
Source | Bio Valley Editor | Swagpp Click "Read the original text" below to download Metz Medical APP
The drug delivery group achieved zero deaths after 28 days of treatment.
There were 8 deaths in the group, and the detailed results will be announced in the near future
.
This is also the fastest-growing antibody drug in China, and it is expected to be approved for conditional listing before the end of December
.
Compared with the new coronavirus antibody drug that has been approved for emergency use in Europe and the United States, this drug is the only one that has evaluated and obtained data on the treatment effect of patients infected with variant strains
.
Since the outbreak of the new crown epidemic in early 2020, preventive vaccines + specific therapeutic drugs have always been regarded as important means of epidemic prevention and control, and the two are also playing a "complementary" role in prevention and control
.
In terms of new crown vaccines, many vaccines around the world have been approved or authorized to varying degrees, involving multiple technical routes such as mRNA, inactivation, and adenovirus vectors
.
In contrast, most of the new crown treatment drugs are in the research and development stage
.
But with the unremitting efforts of Chinese and foreign scientists, the good news continues! The antibodies and drugs approved successively in November seem to have given the world hope of overcoming the epidemic
.
At present, a number of different types of new coronavirus treatment drugs have entered the late stage of development around the world, such as new coronavirus neutralizing antibodies mainly for mild and moderate patients, anti-cytokine receptor/neutralizing antibodies mainly for severe patients, and small molecule new drugs in patients with severe crown (including RNA polymerase inhibitor, JAK inhibitor, AR antagonists, 3CL protease inhibitors, etc.
) and the like
.
Multinational pharmaceutical companies are the first to hit the line, and Chinese scientists are struggling to catch up
.
How is the progress of new crown treatment drugs at home and abroad? 1.
The neutralizing antibody Ronapreve was jointly developed by Roche and Regeneron.
It is a combination therapy consisting of two neutralizing antibodies targeting different epitopes of the new coronavirus spike protein.
It is used to treat the risk of disease deterioration without the need for supplemental oxygen.
Increasing adult and adolescent patients (over 12 years old, weighing at least 40 kg), it is approved for the prevention of COVID-19 in adolescents and adults at the same time
.
Phase III clinical trial results showed that compared with placebo, patients who received intravenous Ronapreve had a 70% lower risk of hospitalization or death.
This combination also shortened the duration of symptoms in patients by 4 days
.
In addition, Ronapreve has also achieved good results in preventing new coronavirus infections.
In the phase III clinical trial, volunteers who received a subcutaneous injection had a 81% reduction in the risk of developing symptomatic COVID-19
.
Regkirona Regkirona is developed by South Korea's Celltrion company
.
Celltrion's Regkirona global phase III clinical trial data showed that compared with placebo, patients treated with Regkirona have a 70% lower risk of hospitalization or death
.
Among patients with an increased risk of deterioration, 3.
1% (14/446) of patients treated with Regkirona were hospitalized, oxygenated or died within 28 days after treatment, compared with 11.
1% (48/434) in the placebo group )
.
In addition to the above two neutralizing antibodies approved in the European Union, there are currently several neutralizing antibodies that have been authorized by the FDA for emergency use (EUA) or have submitted EUA, including Eli Lilly’s Etesevimab and Bamlanivimab double antibody therapy, GlaxoSmithKline Sotrovimab, Tengshengbo’s BRII-196/BRII-198 combination therapy, AstraZeneca’s AZD7442
.
Eli Lilly's Etesevimab and Bamlanivimab dual antibody therapy was authorized by the FDA for emergency use in February this year.
Data shows that Etesevimab and Bamlanivimab dual antibody therapy can reduce the risk of hospitalization and death from COVID-19 by 70%
.
However, the dual-antibody therapy is not effective against the Gamma and Delta mutant strains this spring.
It was stopped by the US regulatory agency in June and was authorized again in August this year
.
GlaxoSmithKline’s Sotrovimab was authorized by the FDA for emergency use in May of this year.
According to interim data from a phase III trial, Sotrovimab treatment reduces the risk of hospitalization or death in high-risk outpatient COVID-19 adult patients by 85% compared with placebo.
.
In addition, in vitro data also indicate that Sotrovimab maintains activity against all known virus variants, including variants from India
.
Tengshengbo Pharmaceutical's BRII-196/BRII-198 combination therapy has been submitted to the FDA for emergency use authorization in October
.
This combination therapy from China was jointly developed by Tsinghua University and Shenzhen Third People's Hospital
.
The EUA application submitted is based on the positive results of a phase III clinical trial supported by the National Institutes of Health (NIH)
.
The results showed that, compared with placebo, the BRII-196/BRII-198 combination therapy reduced the risk of hospitalization and death of COVID-19 outpatients with a high risk of clinical progression to severe disease by 78%
.
The trial is currently the only large-scale Phase III trial in progress for a Chinese company in the United States
.
The combination therapy is expected to become the first approved new crown neutralizing antibody drug in China
.
AstraZeneca's AZD7442AZD7442 is a combination of two long-acting antibodies Tixagevimab (AZD8895) and Cilgavimab (AZD1061), which are extracted from B cells of convalescent patients infected with the new coronavirus
.
According to the results of the phase III clinical trial of AZD7442 published in October, compared with placebo, mild non-hospital patients received a 50% reduction in the risk of severe illness or death by intramuscular injection of AZD7442 at a dose of 600 mg compared with placebo; received within five days of the onset of symptoms Pre-analysis conducted by the treated participants showed that compared with placebo, AZD7442 reduced the risk of severe illness or death by 67%
.
In addition to the above neutralizing antibodies, products under clinical phase III or phase II research include Tychan’s TY027, Abpro’s ABP-300, BMS’s BMS-986414/BMS-986413, SAB’s SAB-185, and Shenzhou’s SCTA01.
, Pok biological LY-CovMab, Jimin credible JMB-2002 and so on
.
2.
Small molecule oral drugs On November 4, the US pharmaceutical company Merck announced that its small molecule drug Molnupiravir has been approved by the UK Food and Drug Administration, becoming the world's first oral drug approved for the treatment of mild to moderate neocorona infections in adults Drugs
.
Only one day later, Pfizer Pharmaceuticals of the United States disclosed the results of the clinical trial of Paxlovid, an oral drug for new crowns it developed.
Taking the drug in the early stages of symptoms can reduce the risk of hospitalization or death by 89% of patients with new crowns
.
Molnupiravir Molnupiravir is an oral ribonucleoside analog developed by Merck and Ridgeback Biotherapeutics.
It can inhibit the replication of a variety of RNA viruses, including SARS-CoV-2 (the causative agent of the new coronavirus), and is used to treat mild to mild Moderate new coronary pneumonia
.
According to the Phase III clinical interim data released by Merck on October 1, the hospitalization or mortality rate of the Molnupiravir treatment group was 7.
3% (28/385), and the hospitalization or mortality rate of the control group was 14.
1% (53/377).
Molnupiravir will The risk of hospitalization or death is reduced by approximately 50%
.
In terms of mortality, there were no deaths in the treatment group and 8 deaths in the control group
.
Paxlovid Paxlovid was developed by Pfizer and is a specially designed SARS-CoV-2-3CL protease inhibitor
.
Unlike Merck’s Molnupiravi, Paxlovid is a compound medicine that contains PF-07321332 and ritonavir
.
On November 5, Pfizer announced an interim analysis based on a randomized, double-blind, phase 2/3 EPIC-HR trial.
The results showed that Paxlovid reduced the risk of hospitalization or death by 89% compared with the placebo group
.
Pfizer has submitted an emergency use authorization for Paxlovid to the FDA on the 16th
.
In addition to the above two, procrulamide from China is also a promising oral anti-coronavirus drug
.
Prokramide Prokramide is a new class 1.
1 anti-prostate cancer drug developed by Pioneer Pharmaceuticals
.
It has higher targeting activity than enzalutamide and is expected to become the best drug for the second generation of anti-prostate cancer clinical drugs targeting the androgen receptor
.
In March of this year, Pioneer Pharmaceuticals announced that the clinical trial of Prokalamide in Brazil for the treatment of severely ill patients with COVID-19 reached the primary end point.
Prokruline can reduce the risk of death of patients with severe COVID-19 by 92% and shorten the average length of hospital stay9 Days
.
AT-527 AT-527 was developed by Atea Company.
It is an RNA polymerase inhibitor.
After entering the human body, it can be converted into free base AT-511, and then produce the triphosphate metabolite AT-9010 with higher anti-coronavirus activity.
The activity of the new coronavirus is 5-8 times higher than that of Merck’s Molnupiravir
.
Unfortunately, on October 19, Roche announced the latest phase II clinical data of AT-527.
The results showed that the SARS-CoV-2 viral load on the 29th day of the AT-527 treatment group (550mg, bid) was lower than that of the baseline.
Compared with the placebo group, the change was not significantly reduced, and about two-thirds of patients still belonged to low-risk hospitalization patients with symptoms, and failed to reach the primary endpoint of the study
.
In addition to the above-mentioned products, the small-molecule oral drugs under development for anti-coronaviruses that have received attention include S217622 from Shiono Yoshihide, RHB-107 from Red Hill, VV116 from Junshi Biologics, EDP-235 from Enanta, etc.
, related clinical trial data Still to be disclosed
.
Source | Bio Valley Editor | Swagpp Click "Read the original text" below to download Metz Medical APP
