my country's new crown specific drug "candidate seeds" Phase III clinical unblind

"Compared with the new crown antibody drugs that have been approved for emergency use in Europe and the United States, we are the only one that has evaluated the therapeutic effect of variant infections and obtained data

The research and development progress is rapid, the data quality is high, and the results are good.

According to the latest news obtained by a reporter from Science and Technology Daily, the third phase of the "seed medicine" has been unblinded.

R & D team: do not believe in shortcuts, research and develop from scratch

In the early stage of the new crown epidemic, effective drugs were scarce, and some drugs developed based on MERS (Middle East Respiratory Syndrome) and HIV have high hopes

In an academic exchange in April 2020, the project leader Zhang Linqi once said that, scientifically speaking, the possibility that drugs against other viruses will be effective against the new coronavirus is too small

The scientific spirit and attitude of "don't believe in shortcuts, research and develop from scratch" allowed the Tsinghua team not only to start early, but also to avoid detours

The world is looking for the most effective neutralizing antibody drugs.

"We not only look for active neutralizing antibodies in the immune system of infected persons, but also study

In addition, in response to virus mutations, the team is not only one step ahead of the virus, but also one step ahead of others——

Going ahead with the virus, the team used 28 mutant pseudoviruses to evaluate the neutralizing ability of 12 neutralizing antibodies based on the analysis of the fine structure, and obtained the virus mutation law that caused antibody failure before the mutation occurred

One step ahead, the team, with its rich experience in the development of antiviral drugs, evaluated the neutralizing activity of its candidate antibody combination BRII-196/BRII-198 against mutant strains in the early stages of clinical trials, effectively avoiding being "on the battlefield" but being infected by the virus.

In contrast, many neutralizing antibody candidate drugs in other R&D teams around the world have been proven to be ineffective against virus variants in Phase III clinical trials

Multi-department: rolling projects, initiating inspections, and coordinated advancement

Due to the good control of the new crown epidemic in China, the development of research and development is facing the dilemma of "not enough patients in the group and slow progress in clinical trials

On the one hand, the scientific research team actively promoted rolling support for the neutralizing antibody emergency project, and completed the rolling project support for the BRII-196 and BRII-198 neutralizing antibody combination therapy in a timely and efficient manner through the strict review and strong recommendation of experts.

On the other hand, Tsinghua University, Shenzhen Third People's Hospital and Tengshengbo Pharmaceutical started joint research and development

According to reports, the current combination of BRII-196 and BRII-198 is expected to achieve the synchronization of conditional approval for marketing in China and emergency use in the United States

High-scoring answer sheet: In the face of "procrastination" patients, the effect is still significant

The data provided by the project team showed that the clinical trial design was of high quality and difficulty, and verified that the combined drug can treat different regions (multi-center), different ethnic (multi-ethnic) populations, and multiple new coronavirus variants (multi-variable strains).

Internationally, the same type of antibody drugs have been approved for emergency use.
Regeneron’s neutralizing antibody reduced hospitalization and mortality by 70%, and GlaxoSmithKline/Vir Biotechnology’s neutralizing antibody reduced hospitalization and mortality.
A decrease of 79%, but the two neutralizing antibody clinical trials did not contain variant data, and the included subjects were patients within 5-7 days of the diagnosis
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In comparison, the subjects enrolled in BRII-196 and BRII-198 were within 10 days of onset, the condition developed in the body for a longer time, the treatment was more difficult, and the significant protection data of 78% was still obtained
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(Zhang Jiaxing)