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Long press the two-dimensional code to receive on May 26, the US FDA granted emergency use authorization (EUA) for the COVID-19 monoclonal antibody drug sotrovimab, which is used to test positive for the virus and have a high risk of developing severe COVID-19 (including hospitalization and death) Of mild to moderate adults and adolescents (12 years and older, weighing at least 40 kg) patients [1].
Sotrovimab is a neutralizing antibody developed by GlaxoSmithKline (GSK) and Vir Biotechnology (hereinafter referred to as Vir).
This approval will provide another effective treatment plan for the fight against the COVID-19 pandemic.
//Neutralizing antibodies-a "new weapon" to fight the new crown //In terms of the development of therapies to fight the new crown epidemic, the development of neutralizing antibodies has always been one of the focuses of research and development [2].
Neutralizing antibodies can prevent the new coronavirus from infecting cells by binding to the spike protein of the new coronavirus.
They can not only be used to treat patients infected by the new coronavirus, but also can be used as a preventive therapy to provide passive immunity to high-risk populations who are vulnerable to infection.
Compared with the vaccine, its advantage is that it can take effect immediately after receiving the injection, and it is equally effective for people who may not be able to produce an adequate immune response to the vaccine (including some elderly people and patients with suppressed immune systems).
//The discovery of Sotrovimab neutralizing antibody//Sotrovimab is a new type of coronavirus (SARS-CoV-2) monoclonal antibody with dual effects.
In 2003, scientists discovered a neutralizing antibody called S309 when analyzing the memory B cells of a recovered patient infected with SARS-CoV-1.
It binds to a highly conserved epitope on the antibody binding domain (RBD) of the spike protein, not only has the activity of neutralizing SARS-CoV-1, but also has the ability to neutralize the new coronavirus and other coronaviruses.
S309 is the predecessor of sotrovimab, which is now urgently authorized by the FDA.
//Highly conserved epitopes are used as targets for the development of neutralizing antibodies.
//Researchers have found that the epitopes bound by S309 to the new coronavirus S protein (the S protein helps the virus enter human cells) are very conserved in the new coronavirus.
Only 4 of the 11839 new coronavirus isolates reported so far have mutations in this epitope.
Studies believe that the mutations in these four virus strains do not affect the binding of S309 to the S protein.
Moreover, the amino acids bound by the S309 antibody are also highly conserved in other coronavirus families.
S309 may cover all related coronavirus families, which means that even if the new coronavirus continues to evolve, it will be difficult to overcome the neutralizing activity of S309.
With the continuous emergence of new coronaviruses, a neutralizing antibody with "broad-spectrum" efficacy undoubtedly adds a powerful tool for the treatment of COVID-19.
//By optimizing the Fc terminal, prolonging the half-life, and enhancing active immunity//Vaccines stimulate the body's adaptive immune response, allowing the body to produce antibodies and immune cell responses against the new coronavirus, which we call "active immunity".
Neutralizing antibodies can prevent them from entering and infecting cells by binding to viruses, which we call "passive immunity".
The process of active immunity is slower, but it may be longer, and passive immunity is faster, but it may last for a shorter time.
In order to overcome the short-duration problem, in the development process of sotrovimab, the Fc end of the sotrovimab monoclonal antibody was further optimized by using XmAb antibody engineering technology, which not only prolonged the half-life of the neutralizing antibody, but also gave sotrovimab promotion The ability of dendritic cells to mature and activate CD8-positive T cells.
This gives these antibodies the potential to enhance the active immune response similar to vaccines, which may further extend the protection against pathogens [3].
Schematic diagram of sotrovimab activation of innate immune cells (Source: Vir Biotechnology official website) // Because of its good efficacy, the phase III clinical trial was terminated early // In March this year, Vir and GlaxoSmithKline jointly announced that based on the use of sotrovimab (VIR-7831) ) As a result of the positive interim analysis, the Independent Data Monitoring Committee (IDMC) recommended the early termination of the phase III clinical trial of sotrovimab for the treatment of high-risk COVID-19 patients.
In this clinical trial, a total of 583 patients received sotrovimab monotherapy or placebo.
The risk of hospitalization for these patients is 3 times the average, and the risk of death is 2 times the average.
The results of the interim analysis showed that in the 29 days after receiving treatment, the risk of hospitalization or death in the sotrovimab group was reduced by 85% compared with the control group (p=0.
002) [4].
//"Broad-spectrum anti-virus", maintaining activity against a variety of new crown variants//As the COVID-19 epidemic continues, the new crown virus continues to produce new mutant strains, and CHMP (Committee on Medicinal Products for Human Use) also reviewed several items Data from in vitro studies, live virus and pseudovirus in vitro testing data show that sotrovimab maintains activity against a number of epidemic mutants of concern, including the P.
1 variant originally found in Brazil and B.
1.
427/B found in California, USA .
1.
429 variants, B.
1.
351 variants found in South Africa, B.
1.
1.
7 variants found in the UK, B.
1.
526 variants found in New York, and B.
1.
617 variants found in India [5].
At present, the genetic mutations carried by a variety of mutant virus strains that have received attention have shown the potential to evade the neutralizing activity of antibodies.
Therefore, tracking the immune escape ability of mutant virus strains is very important for the development of neutralizing antibody therapy, and sotrovimab has selected a highly conserved epitope as the target for the development of neutralizing antibody to avoid the immune escape of the mutant.
The rapid success of neutralizing antibodies in the treatment of early-stage COVID-19 patients and post-exposure prevention environments benefited from the accumulated experience of rapid isolation of human monoclonal antibodies, a variety of methods to optimize the Fc-terminus of antibodies, and the development of antibody production processes.
progress.
At the time of the COVID-19 pandemic, we hope that more new crown vaccines and therapies will receive good news, and help control the epidemic as soon as possible, so that the people of the world can return to their normal lives.
com/en-gb/media/press-releases/vir-biotechnology-and-gsk-announce-vir-7831-reduces-hospitalisation-and-risk-of-death-in-early-treatment-of-adults-with- covid-19/; 5.
Vir Biotechnology and GSK announce VIR-7831 reduces hospitalisation and risk of death in early treatment of adults with COVID-19.
Retrieved March 11, 2021, from https:// gb/media/press-releases/vir-biotechnology-and-gsk-announce-vir-7831-reduces-hospitalisation-and-risk-of-death-in-early-treatment-of-adults-with-covid-19/ .
Yaodu APP "points new gameplay" company enjoys the database super-value permission dry granulation technology to discuss the ups and downs of 20 years, where is the future of kinase inhibitors? Amgen's new generation of calcimimetic Etecartide will soon be approved for marketing in China, and the curative effect will not lose cinacalcet.
Click "read original text" to keep abreast of industry trends com/en-gb/media/press-releases/vir-biotechnology-and-gsk-announce-vir-7831-reduces-hospitalisation-and-risk-of-death-in-early-treatment-of-adults-with- covid-19/.
Yaodu APP "Points New Game" company enjoys the database super-value permission dry granulation technology to discuss the ups and downs of 20 years, where is the future of kinase inhibitors? Amgen's new generation of calcimimetic Etecartide will soon be approved for marketing in China, and the curative effect will not lose cinacalcet.
Click "read original text" to keep abreast of industry trends com/en-gb/media/press-releases/vir-biotechnology-and-gsk-announce-vir-7831-reduces-hospitalisation-and-risk-of-death-in-early-treatment-of-adults-with- covid-19/.
Yaodu APP "Points New Game" company enjoys the database super-value permission dry granulation technology to discuss the ups and downs of 20 years, where is the future of kinase inhibitors? Amgen's new generation of calcimimetic Etecartide will soon be approved for marketing in China, and the curative effect will not lose cinacalcet.
Click "read original text" to keep abreast of industry trends
Sotrovimab is a neutralizing antibody developed by GlaxoSmithKline (GSK) and Vir Biotechnology (hereinafter referred to as Vir).
This approval will provide another effective treatment plan for the fight against the COVID-19 pandemic.
//Neutralizing antibodies-a "new weapon" to fight the new crown //In terms of the development of therapies to fight the new crown epidemic, the development of neutralizing antibodies has always been one of the focuses of research and development [2].
Neutralizing antibodies can prevent the new coronavirus from infecting cells by binding to the spike protein of the new coronavirus.
They can not only be used to treat patients infected by the new coronavirus, but also can be used as a preventive therapy to provide passive immunity to high-risk populations who are vulnerable to infection.
Compared with the vaccine, its advantage is that it can take effect immediately after receiving the injection, and it is equally effective for people who may not be able to produce an adequate immune response to the vaccine (including some elderly people and patients with suppressed immune systems).
//The discovery of Sotrovimab neutralizing antibody//Sotrovimab is a new type of coronavirus (SARS-CoV-2) monoclonal antibody with dual effects.
In 2003, scientists discovered a neutralizing antibody called S309 when analyzing the memory B cells of a recovered patient infected with SARS-CoV-1.
It binds to a highly conserved epitope on the antibody binding domain (RBD) of the spike protein, not only has the activity of neutralizing SARS-CoV-1, but also has the ability to neutralize the new coronavirus and other coronaviruses.
S309 is the predecessor of sotrovimab, which is now urgently authorized by the FDA.
//Highly conserved epitopes are used as targets for the development of neutralizing antibodies.
//Researchers have found that the epitopes bound by S309 to the new coronavirus S protein (the S protein helps the virus enter human cells) are very conserved in the new coronavirus.
Only 4 of the 11839 new coronavirus isolates reported so far have mutations in this epitope.
Studies believe that the mutations in these four virus strains do not affect the binding of S309 to the S protein.
Moreover, the amino acids bound by the S309 antibody are also highly conserved in other coronavirus families.
S309 may cover all related coronavirus families, which means that even if the new coronavirus continues to evolve, it will be difficult to overcome the neutralizing activity of S309.
With the continuous emergence of new coronaviruses, a neutralizing antibody with "broad-spectrum" efficacy undoubtedly adds a powerful tool for the treatment of COVID-19.
//By optimizing the Fc terminal, prolonging the half-life, and enhancing active immunity//Vaccines stimulate the body's adaptive immune response, allowing the body to produce antibodies and immune cell responses against the new coronavirus, which we call "active immunity".
Neutralizing antibodies can prevent them from entering and infecting cells by binding to viruses, which we call "passive immunity".
The process of active immunity is slower, but it may be longer, and passive immunity is faster, but it may last for a shorter time.
In order to overcome the short-duration problem, in the development process of sotrovimab, the Fc end of the sotrovimab monoclonal antibody was further optimized by using XmAb antibody engineering technology, which not only prolonged the half-life of the neutralizing antibody, but also gave sotrovimab promotion The ability of dendritic cells to mature and activate CD8-positive T cells.
This gives these antibodies the potential to enhance the active immune response similar to vaccines, which may further extend the protection against pathogens [3].
Schematic diagram of sotrovimab activation of innate immune cells (Source: Vir Biotechnology official website) // Because of its good efficacy, the phase III clinical trial was terminated early // In March this year, Vir and GlaxoSmithKline jointly announced that based on the use of sotrovimab (VIR-7831) ) As a result of the positive interim analysis, the Independent Data Monitoring Committee (IDMC) recommended the early termination of the phase III clinical trial of sotrovimab for the treatment of high-risk COVID-19 patients.
In this clinical trial, a total of 583 patients received sotrovimab monotherapy or placebo.
The risk of hospitalization for these patients is 3 times the average, and the risk of death is 2 times the average.
The results of the interim analysis showed that in the 29 days after receiving treatment, the risk of hospitalization or death in the sotrovimab group was reduced by 85% compared with the control group (p=0.
002) [4].
//"Broad-spectrum anti-virus", maintaining activity against a variety of new crown variants//As the COVID-19 epidemic continues, the new crown virus continues to produce new mutant strains, and CHMP (Committee on Medicinal Products for Human Use) also reviewed several items Data from in vitro studies, live virus and pseudovirus in vitro testing data show that sotrovimab maintains activity against a number of epidemic mutants of concern, including the P.
1 variant originally found in Brazil and B.
1.
427/B found in California, USA .
1.
429 variants, B.
1.
351 variants found in South Africa, B.
1.
1.
7 variants found in the UK, B.
1.
526 variants found in New York, and B.
1.
617 variants found in India [5].
At present, the genetic mutations carried by a variety of mutant virus strains that have received attention have shown the potential to evade the neutralizing activity of antibodies.
Therefore, tracking the immune escape ability of mutant virus strains is very important for the development of neutralizing antibody therapy, and sotrovimab has selected a highly conserved epitope as the target for the development of neutralizing antibody to avoid the immune escape of the mutant.
The rapid success of neutralizing antibodies in the treatment of early-stage COVID-19 patients and post-exposure prevention environments benefited from the accumulated experience of rapid isolation of human monoclonal antibodies, a variety of methods to optimize the Fc-terminus of antibodies, and the development of antibody production processes.
progress.
At the time of the COVID-19 pandemic, we hope that more new crown vaccines and therapies will receive good news, and help control the epidemic as soon as possible, so that the people of the world can return to their normal lives.
com/en-gb/media/press-releases/vir-biotechnology-and-gsk-announce-vir-7831-reduces-hospitalisation-and-risk-of-death-in-early-treatment-of-adults-with- covid-19/; 5.
Vir Biotechnology and GSK announce VIR-7831 reduces hospitalisation and risk of death in early treatment of adults with COVID-19.
Retrieved March 11, 2021, from https:// gb/media/press-releases/vir-biotechnology-and-gsk-announce-vir-7831-reduces-hospitalisation-and-risk-of-death-in-early-treatment-of-adults-with-covid-19/ .
Yaodu APP "points new gameplay" company enjoys the database super-value permission dry granulation technology to discuss the ups and downs of 20 years, where is the future of kinase inhibitors? Amgen's new generation of calcimimetic Etecartide will soon be approved for marketing in China, and the curative effect will not lose cinacalcet.
Click "read original text" to keep abreast of industry trends com/en-gb/media/press-releases/vir-biotechnology-and-gsk-announce-vir-7831-reduces-hospitalisation-and-risk-of-death-in-early-treatment-of-adults-with- covid-19/.
Yaodu APP "Points New Game" company enjoys the database super-value permission dry granulation technology to discuss the ups and downs of 20 years, where is the future of kinase inhibitors? Amgen's new generation of calcimimetic Etecartide will soon be approved for marketing in China, and the curative effect will not lose cinacalcet.
Click "read original text" to keep abreast of industry trends com/en-gb/media/press-releases/vir-biotechnology-and-gsk-announce-vir-7831-reduces-hospitalisation-and-risk-of-death-in-early-treatment-of-adults-with- covid-19/.
Yaodu APP "Points New Game" company enjoys the database super-value permission dry granulation technology to discuss the ups and downs of 20 years, where is the future of kinase inhibitors? Amgen's new generation of calcimimetic Etecartide will soon be approved for marketing in China, and the curative effect will not lose cinacalcet.
Click "read original text" to keep abreast of industry trends
