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On October 9, Tengsheng Biopharma announced that it had submitted an emergency use authorization (EUA) application to the US Food and Drug Administration (FDA) for its SARS-CoV-2 combination therapy BRII-196/BRII-198 .
Emergency use authorization application for Tengshengbo medicine BRII-196/BRII-198This is the fourth company after Regeneron, Eli Lilly, and Vir Bio to submit an EUA application to the FDA for a new crown neutralizing antibody.
It is also the first domestic company to submit an EUA application to the FDA
The first domestic company to submit an EUA application to the FDA
It is reported that BRII-196 and BRII-198 are non-competitive new severe acute respiratory systems obtained by Tengsheng Bo Pharmaceutical in cooperation with Tsinghua University and Shenzhen Third People’s Hospital from patients with new coronavirus pneumonia (COVID-19) during the convalescence period.
SARS-CoV-2 monoclonal neutralizing antibody, especially genetic engineering technology is applied to reduce the risk of antibody-mediated dependent enhancement, and to extend the plasma half-life to obtain a more lasting therapeutic effect
.
Their non-overlapping epitope binding regions provide a high degree of neutralizing activity against SARS-CoV-2
The EUA application is based on the positive results of the Phase 3 clinical trial of ACTIV-2 supported by the National Institutes of Health (NIH).
The results show that compared with placebo, the BRII-196/BRII-198 combination therapy makes clinical progress to be severe Outpatients with COVID-19 at high risk of disease have a 78% reduction in the risk of hospitalization and death, which is statistically significant, and its safety is better than placebo
.
For subjects who started treatment early (within 5 days after the onset of symptoms), compared with subjects who started treatment late (within 6 to 10 days after the onset of symptoms), significant reductions in hospitalization and mortality were observed
In terms of safety, there were no deaths in the treatment group within 28 days, while there were 8 deaths in the placebo group
.
During the 28-day follow-up after treatment, one death was found in each group
Dr.
Hong Zhi, Chairman and CEO of Tengshengbo Pharmaceutical, said: “We are very pleased to observe continuous positive clinical results and good safety throughout the development process of BRII-196/BRII-198, a well-designed global clinical trial.
sex
.
at the same time, we will be in these strong clinical evidence to support the potential of this new therapeutic option to bring more high risk of clinical progression of COVID-19 outpatients
In addition, Tengshengbo Pharmaceutical is actively promoting the registration application of BRII-196/BRII-198 combination therapy in other mature and emerging markets around the world.
And the Hong Kong Department of Health of China submitted and approved a new drug clinical trial application (IND) for the BRII-196/BRII-198 combination therapy
.
Tengshengbo Pharmaceutical has also carried out further studies in China to evaluate the pharmacokinetics and safety of the BRII-196/BRII-198 combination therapy, and evaluate the lower-dose BRII-196/BRII-198 combination in a phase 2 study Effectiveness of therapies to treat COVID-19
Reference materials:
Reference materials:[1]https://mp.
[1]https://mp.
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