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Introduction: The detailed data of the first and second phases will be officially released or will be released in the near future.
The third phase of the trial is still in progress and is expected to end in April.
The Ministry of Innovation of Uzbekistan said on Monday that the Uzbek government has approved the new crown vaccine (CHO cell) developed by Anhui Zhifeilongkoma Biopharmaceutical Co.
, Ltd.
for use in Uzbekistan.
Officials in Uzbekistan recently stated that it will implement voluntary vaccination from March.
The Deputy Prime Minister of Uzbekistan Behzod Musayev (Behzod Musayev) said at a meeting: "In our country, vaccination will be voluntary.
If a person refuses to be vaccinated, it will not be taken against him or her.
Any measures.
" Uzbekistan officials said that the first phase of the mass vaccination campaign will cover 4.
1 million people.
The key population will be the elderly and disabled, employees of the health care and education system, and members of law enforcement agencies.
Uzbekistan participated in the international multi-center phase III clinical trial of the vaccine named ZF2001 in late December last year.
This recombinant new crown vaccine was launched in China's domestic Phase III clinical trial on November 18 last year.
This clinical trial will be carried out in people 18 years of age and above.
It will be a randomized, double-blind, placebo-controlled international multi-center clinical trial.
A total of 29,000 people are planned to be recruited worldwide.
Uzbekistan is the first overseas clinical trial site for this vaccine.
This is also the first domestic recombinant subunit COVID-19 vaccine that has launched a phase III clinical trial abroad.
Uzbekistan plans to have 5,000 volunteers participating in the trial.
ZF2001 is a new coronavirus recombinant protein subunit vaccine jointly developed by the Gaofu team of the Institute of Microbiology of the Chinese Academy of Sciences and Anhui Zhifeilongkema Biopharmaceutical Co.
, Ltd.
The key antigen protein of the virus is expressed by in vitro recombination to prepare a vaccine.It is mainly for the development of vaccines against the receptor binding domain (RBD region) on the S protein of the new coronavirus.
Under the leadership of the team of Academician Gao Fu, the two new coronavirus RBDs were tandemly expressed as a dimer protein to prepare a recombinant protein subunit vaccine.
As one of the five major vaccine routes in my country, the recombinant subunit new crown vaccine has independent knowledge The property rights were developed by the team of academician Gao Fu and researcher Yan Jinghua of the Institute of Microbiology.
Researcher Dai Lianpan is one of the main accomplishers of the results.
On October 30 last year, the Institute of Microbiology of the Chinese Academy of Sciences successfully completed the unblinding of phase I/II clinical trials.
The unblinding data showed that the clinical trial results were in line with expectations, and the vaccine showed good safety and immunogenicity.
Safety and immunogenicity of a recombinant tandem-repeat dimeric RBD protein vaccine against COVID-19 in adults: pooled analysis of two randomized, double-blind, placebo-controlled, phase 1 and 2 trials, doi: https://doi.
org/ 10.
1101/2020.
12.
20.
20248602 At the end of December last year, the Institute of Microbiology of the Chinese Academy of Sciences and Anhui Zhifeilongkoma Biopharmaceutical jointly published online in MedRxiv Phase I and II clinical trial data, showing that between June 22 and September 15, 2020, a total of 50 Participants participated in the Phase 1 study (mean age 32.
6 years), and 900 participants entered the Phase 2 study (mean age 43.
5 years) to receive a two-dose vaccine or a placebo or three-dose schedule.
For these two trials, there were no local or systemic adverse reactions or mild symptoms in most participants.
Neither trial found serious adverse events related to the vaccine.
After three doses, neutralizing antibodies were detected in all participants who received 25μg or 50μg doses of vaccine and 97% (25μg group) and 93% (50μg group) participants in the phase 1 study.
In the second phase of the study. The SARS-CoV-2 neutralization geometric mean titer (GMT) of the 25μg group in the first stage was 94.
5 in the first stage, 117.
8 in the 50μg group, and 102.
5 in the 25μg group in the second stage, and 102.
5 in the 50μg group Is 69.
1.
Exceed the level of a set of COVID-19 rehabilitation samples (GMT, 51).
The vaccine induced a balanced response between TH1 and TH2.
Compared with the 25 μg group, the 50 μg group did not show enhanced immunogenicity.
Humoral immune response in phase 1 and phase 2 trials, doi: https://doi.
org/10.
1101/2020.
12.
20.
20248602 In short, ZF2001 is well tolerated and there are no serious adverse events related to the vaccine.
On the 0th, 30th, and 60th day of the immune activity test, the seroconversion rate of neutralizing antibody was 93-100%, and the GMT exceeded the size of the serum sample in the recovery period.
Similarly, this vaccine caused a moderate cellular immune response, which was detected as a balanced production of cytokines related to TH1/TH2 cells.
Neutralization of SARS-CoV-2 VOC 501Y.
V2 by human antisera elicited by both inactivated BBIBP-CorV and recombinant dimeric RBD ZF2001 vaccines, doi: https://doi.
org/10.
1101/2021.
02.
01.
429069 In early February this year, China Disease Prevention The Gaofu team of the control center released the domestically-made recombinant protein subunit new crown vaccine that is undergoing phase 3 clinical trials and the domestically-made inactivated new crown vaccine (the BBIBP-CorV inactivated new crown vaccine jointly developed by Beijing Institute of Biological Products and others) on bioRxiv.
The protective effect of the new South African variant (501Y.
V2). The results showed that although the neutralizing effect of the sera of these two vaccines against the new South African variant slightly decreased, it still retained most of the neutralizing activity, suggesting that the two vaccines still have a protective effect on the new South African variant.
doi: https://doi.
org/10.
1101/2021.
02.
01.
429069 The article stated that the researchers selected 12 serum samples from clinical trial participants for each vaccine, whether it was ZF2001 or 12 of BBIBP-corV subjects The serum samples basically retained the neutralizing effect of the South African mutant strain.
Compared with the titers of the new coronavirus strain WT or D614G, the geometric mean titers (GMTs) decreased by 1.
6 times.
Encouragingly, the reduction is significantly less than previously reported reductions in serum from recovered patients (more than 10 times) or antibody serum from mRNA vaccine recipients (more than 6 times).
Group A (Zhifei Recombinant Protein Vaccine): Compared with the original strain, the geometric mean titer (GMT) of the South African mutant strain dropped from 106.
1 to 66.
6, a decrease of 1.
6 times; relative to the epidemic strain, GMT dropped from 93.
2 to 66.
6.
However, the sample size of this study is too small and it is only an in vitro serum test.
It is not the true phase III protection rate (the actual phase III clinical protection rate disclosed abroad).
In addition, Zhifei recombinant protein and Sinopharm inactivated serum against the South African strain The neutralization titer decreased by 1.
6 times.
This figure is very accurate and requires further study.
At present, the Institute of Microbiology of the Chinese Academy of Sciences and Zhifei Biology are actively promoting the Phase III clinical trials of the vaccine in Uzbekistan, Indonesia, Pakistan, and Ecuador.
According to people familiar with the matter, the detailed data of the first and second phases will be officially released or will be released in the near future.
The third phase of the trial is still in progress and is expected to end in April.
Recently, according to the China Economic Herald, the seventh production workshop of Anhui Zhifeilongkoma Biopharmaceutical Co.
, Ltd.
, located in Hefei High-tech Zone, has begun trial production of recombinant protein COVID-19 vaccine. Reference: Safety and immunogenicity of a recombinant tandem-repeat dimeric RBD protein vaccine against COVID-19 in adults: pooled analysis of two randomized, double-blind, placebo-controlled, phase 1 and 2 trials, doi: https://doi .
org/10.
1101/2020.
12.
20.
20248602 Neutralization of SARS-CoV-2 VOC 501Y.
V2 by human antisera elicited by both inactivated BBIBP-CorV and recombinant dimeric RBD ZF2001 vaccines, doi: https://doi.
org/10.
1101/2021.
02.
01.
429069
The third phase of the trial is still in progress and is expected to end in April.
The Ministry of Innovation of Uzbekistan said on Monday that the Uzbek government has approved the new crown vaccine (CHO cell) developed by Anhui Zhifeilongkoma Biopharmaceutical Co.
, Ltd.
for use in Uzbekistan.
Officials in Uzbekistan recently stated that it will implement voluntary vaccination from March.
The Deputy Prime Minister of Uzbekistan Behzod Musayev (Behzod Musayev) said at a meeting: "In our country, vaccination will be voluntary.
If a person refuses to be vaccinated, it will not be taken against him or her.
Any measures.
" Uzbekistan officials said that the first phase of the mass vaccination campaign will cover 4.
1 million people.
The key population will be the elderly and disabled, employees of the health care and education system, and members of law enforcement agencies.
Uzbekistan participated in the international multi-center phase III clinical trial of the vaccine named ZF2001 in late December last year.
This recombinant new crown vaccine was launched in China's domestic Phase III clinical trial on November 18 last year.
This clinical trial will be carried out in people 18 years of age and above.
It will be a randomized, double-blind, placebo-controlled international multi-center clinical trial.
A total of 29,000 people are planned to be recruited worldwide.
Uzbekistan is the first overseas clinical trial site for this vaccine.
This is also the first domestic recombinant subunit COVID-19 vaccine that has launched a phase III clinical trial abroad.
Uzbekistan plans to have 5,000 volunteers participating in the trial.
ZF2001 is a new coronavirus recombinant protein subunit vaccine jointly developed by the Gaofu team of the Institute of Microbiology of the Chinese Academy of Sciences and Anhui Zhifeilongkema Biopharmaceutical Co.
, Ltd.
The key antigen protein of the virus is expressed by in vitro recombination to prepare a vaccine.It is mainly for the development of vaccines against the receptor binding domain (RBD region) on the S protein of the new coronavirus.
Under the leadership of the team of Academician Gao Fu, the two new coronavirus RBDs were tandemly expressed as a dimer protein to prepare a recombinant protein subunit vaccine.
As one of the five major vaccine routes in my country, the recombinant subunit new crown vaccine has independent knowledge The property rights were developed by the team of academician Gao Fu and researcher Yan Jinghua of the Institute of Microbiology.
Researcher Dai Lianpan is one of the main accomplishers of the results.
On October 30 last year, the Institute of Microbiology of the Chinese Academy of Sciences successfully completed the unblinding of phase I/II clinical trials.
The unblinding data showed that the clinical trial results were in line with expectations, and the vaccine showed good safety and immunogenicity.
Safety and immunogenicity of a recombinant tandem-repeat dimeric RBD protein vaccine against COVID-19 in adults: pooled analysis of two randomized, double-blind, placebo-controlled, phase 1 and 2 trials, doi: https://doi.
org/ 10.
1101/2020.
12.
20.
20248602 At the end of December last year, the Institute of Microbiology of the Chinese Academy of Sciences and Anhui Zhifeilongkoma Biopharmaceutical jointly published online in MedRxiv Phase I and II clinical trial data, showing that between June 22 and September 15, 2020, a total of 50 Participants participated in the Phase 1 study (mean age 32.
6 years), and 900 participants entered the Phase 2 study (mean age 43.
5 years) to receive a two-dose vaccine or a placebo or three-dose schedule.
For these two trials, there were no local or systemic adverse reactions or mild symptoms in most participants.
Neither trial found serious adverse events related to the vaccine.
After three doses, neutralizing antibodies were detected in all participants who received 25μg or 50μg doses of vaccine and 97% (25μg group) and 93% (50μg group) participants in the phase 1 study.
In the second phase of the study. The SARS-CoV-2 neutralization geometric mean titer (GMT) of the 25μg group in the first stage was 94.
5 in the first stage, 117.
8 in the 50μg group, and 102.
5 in the 25μg group in the second stage, and 102.
5 in the 50μg group Is 69.
1.
Exceed the level of a set of COVID-19 rehabilitation samples (GMT, 51).
The vaccine induced a balanced response between TH1 and TH2.
Compared with the 25 μg group, the 50 μg group did not show enhanced immunogenicity.
Humoral immune response in phase 1 and phase 2 trials, doi: https://doi.
org/10.
1101/2020.
12.
20.
20248602 In short, ZF2001 is well tolerated and there are no serious adverse events related to the vaccine.
On the 0th, 30th, and 60th day of the immune activity test, the seroconversion rate of neutralizing antibody was 93-100%, and the GMT exceeded the size of the serum sample in the recovery period.
Similarly, this vaccine caused a moderate cellular immune response, which was detected as a balanced production of cytokines related to TH1/TH2 cells.
Neutralization of SARS-CoV-2 VOC 501Y.
V2 by human antisera elicited by both inactivated BBIBP-CorV and recombinant dimeric RBD ZF2001 vaccines, doi: https://doi.
org/10.
1101/2021.
02.
01.
429069 In early February this year, China Disease Prevention The Gaofu team of the control center released the domestically-made recombinant protein subunit new crown vaccine that is undergoing phase 3 clinical trials and the domestically-made inactivated new crown vaccine (the BBIBP-CorV inactivated new crown vaccine jointly developed by Beijing Institute of Biological Products and others) on bioRxiv.
The protective effect of the new South African variant (501Y.
V2). The results showed that although the neutralizing effect of the sera of these two vaccines against the new South African variant slightly decreased, it still retained most of the neutralizing activity, suggesting that the two vaccines still have a protective effect on the new South African variant.
doi: https://doi.
org/10.
1101/2021.
02.
01.
429069 The article stated that the researchers selected 12 serum samples from clinical trial participants for each vaccine, whether it was ZF2001 or 12 of BBIBP-corV subjects The serum samples basically retained the neutralizing effect of the South African mutant strain.
Compared with the titers of the new coronavirus strain WT or D614G, the geometric mean titers (GMTs) decreased by 1.
6 times.
Encouragingly, the reduction is significantly less than previously reported reductions in serum from recovered patients (more than 10 times) or antibody serum from mRNA vaccine recipients (more than 6 times).
Group A (Zhifei Recombinant Protein Vaccine): Compared with the original strain, the geometric mean titer (GMT) of the South African mutant strain dropped from 106.
1 to 66.
6, a decrease of 1.
6 times; relative to the epidemic strain, GMT dropped from 93.
2 to 66.
6.
However, the sample size of this study is too small and it is only an in vitro serum test.
It is not the true phase III protection rate (the actual phase III clinical protection rate disclosed abroad).
In addition, Zhifei recombinant protein and Sinopharm inactivated serum against the South African strain The neutralization titer decreased by 1.
6 times.
This figure is very accurate and requires further study.
At present, the Institute of Microbiology of the Chinese Academy of Sciences and Zhifei Biology are actively promoting the Phase III clinical trials of the vaccine in Uzbekistan, Indonesia, Pakistan, and Ecuador.
According to people familiar with the matter, the detailed data of the first and second phases will be officially released or will be released in the near future.
The third phase of the trial is still in progress and is expected to end in April.
Recently, according to the China Economic Herald, the seventh production workshop of Anhui Zhifeilongkoma Biopharmaceutical Co.
, Ltd.
, located in Hefei High-tech Zone, has begun trial production of recombinant protein COVID-19 vaccine. Reference: Safety and immunogenicity of a recombinant tandem-repeat dimeric RBD protein vaccine against COVID-19 in adults: pooled analysis of two randomized, double-blind, placebo-controlled, phase 1 and 2 trials, doi: https://doi .
org/10.
1101/2020.
12.
20.
20248602 Neutralization of SARS-CoV-2 VOC 501Y.
V2 by human antisera elicited by both inactivated BBIBP-CorV and recombinant dimeric RBD ZF2001 vaccines, doi: https://doi.
org/10.
1101/2021.
02.
01.
429069
