Tengshengbo Pharmaceutical submitted an emergency use authorization application for the new crown neutralizing antibody to the FDA, which has better efficacy than small molecule drugs

Recent popular reports from Yimaike ★ Dr.
Qing Zhu of Tengshengbo Medicine: The "cocktail" therapy of the new crown neutralizing antibody has begun to show its therapeutic potential, which is not an unexpected "surprise"! Yi Mai Meng broke the news★Academician Zhong Nanshan led research! Tengshengbo Pharmaceutical's new crown neutralizing antibody is in phase 2 clinical trials in ChinaMedMeng broke the news October 11, 2021/eMedClub News/--Neutralizing antibodies are currently mostly screened from patients in the recovery period It can also be screened from the antibody library, which can bind to the neutralizing epitope of the virus, thereby preventing the virus from infecting cells
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Different from the monoclonal antibody that is designed to bind to the target artificially, and the mRNA vaccine that is designed in advance for a specific gene site, the neutralizing antibody is derived from the natural humoral immune response in the patient after the actual infection
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Therefore, neutralizing antibodies have dual effects of prevention and treatment, and their effects are predictable
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Recently (October 9, 2021), Brii Biosciences (hereinafter referred to as "Tengsheng Biosciences") announced to the US FDA to submit its new crown neutralizing antibody combination therapy BRII-196/BRII-198 to the US FDA.
Emergency Use Authorization (EUA) application for the treatment of COVID-19 outpatients with high risk of severe disease
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BRII-196 and BRII-198 are non-competitive new severe acute respiratory syndrome virus 2 (SARS-CoV-2) monoclonal neutralizing antibodies obtained from patients with new coronavirus pneumonia (COVID-19) during the convalescence period.
In particular, genetic engineering technology is used to reduce the risk of antibody-mediated dependent enhancement, and to extend the plasma half-life to obtain a longer-lasting therapeutic effect
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Their non-overlapping epitope binding regions provide a high degree of neutralizing activity against SARS-CoV-2 and reduce the risk of inactivation due to virus mutation
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Tengshengbo Pharmaceutical became the fourth pharmaceutical company to submit an EUA application for the new crown neutralizing antibody to the FDA after Regeneron, Eli Lilly, and Vir Bio
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Currently, the new crown neutralizing antibody BRII-196/BRII-198 "cocktail" therapy is undergoing phase 3 clinical trials in multiple centers around the world
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This is also one of the first new coronavirus neutralizing antibodies developed by Chinese local companies to enter Phase 3 clinical trials
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The EUA application is based on the positive results of the ACTIV-2 Phase 3 clinical trial supported by the National Institutes of Health (NIH)
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The results showed that compared with placebo, the BRII-196/BRII-198 combination therapy reduced the risk of hospitalization and death by 78% for outpatients with high-risk COVID-19 clinical progression to severe disease
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Some time ago, the phase 3 clinical success of Merck's small molecule drug Molnupiravir has attracted the attention of the industry
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However, from the perspective of efficacy, neutralizing antibodies seem to be more advantageous, and Molnupiravir can only reduce the risk of hospitalization or death by 50%
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After completing the EUA submission, review and approval, Tengshengbo Pharmaceutical plans to work closely with the FDA to further promote the follow-up registration and approval of the BRII-196/BRII-198 combination therapy
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At the same time, the company is actively advancing the registration application of BRII-196/BRII-198 combination therapy in other mature and emerging markets around the world.
The initial focus is to ensure that countries where clinical trials are conducted and countries that have significant gaps in access to efficient treatments promote market standards.
Into
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In addition, Tengshengbo Pharmaceutical already has some stocks in WuXi Biologics, and if it is urgent, it can be shipped to the place where the market needs it immediately
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Regarding the future commercialization layout, because the new crown is a public health issue, it is not the same as the ordinary drug commercialization model.
This is a strategic reserve, so it may be more of cooperation with the government
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The rapid advancement of domestic research In July 2020, the Center for Drug Evaluation (CDE) of the State Food and Drug Administration of China approved the clinical trial application for the BRII-196/BRII-198 combination therapy.
One of several companies involved in clinical trials of the Neutralizing Antibody
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At present, the phase 2 clinical study of BRII-196/BRII-198 "cocktail" therapy in China is nearing completion
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This study (NCT04787211) was led by Academician Zhong Nanshan, Academician of the Chinese Academy of Engineering and Director of the National Respiratory Disease Clinical Medicine Research Center of the First Affiliated Hospital of Guangzhou Medical University.
The treatment and protection effect
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According to reports, the neutralizing antibody project from the discovery of antibodies, to the start of production, pharmacological and toxicological evaluations, to the clinical trials of the first dose of drugs in humans, the process of research, transformation, and production only took about three or four.
Time of month
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In addition, the BRII-196/BRII-198 "cocktail" therapy is one of the few in the world that has a neutralizing antibody "cocktail" therapy for real-world cases of patients infected with the "delta" variant of the new coronavirus
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In the case of the variant new crown epidemic that broke out in Guangzhou and Shenzhen in May of this year, the BRII-196 and BRII-198 cocktail combination played an active role in the treatment of patients
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Considering that some of the new crown patients in Guangzhou and Shenzhen were infected with the mutant strains that were first discovered in India and the United Kingdom.
In an emergency, after rigorous evaluation by experts from all parties, some hospitals in Guangzhou and Shenzhen Third People’s Hospital began to Patients use this cocktail combination therapy
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In the end, with the joint efforts of many parties, the patient's condition gradually improved.
Many critically ill patients took off the ventilator, and the patient's lesions also significantly subsided, and no obvious side effects were found
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At the moment, the struggle between humans and the new coronavirus is continuing, and the research and development of drugs is also continuing
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Against the new coronavirus, the development of neutralizing antibodies has become a new hope besides vaccines; in addition, neutralizing antibody technology has been used in the prevention and treatment of sudden infectious diseases (such as Ebola virus, MERS, influenza virus, etc.
) The good application precedent also prepares for the prevention and control of other possible pandemics in the future
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