Interview with the first R & D team of new crown antibody combination therapy in China! How effective is the response to Omicron?

The worldwide COVID-19 pandemic has, to a certain extent, made the world more aware of and understanding of China, and the world people have seen the achievements and the national spirit reflected in China’s struggle against COVID-19. Moreover, COVID-19 has also accelerated the R & D Progress of China’s pharmaceutical enterprises and promoted the development of the national pharmaceutical industry. This exclusive interview mainly visited the R & D team of China’s first new crown antibody combination therapy.

Interview with the first R & D team of new crown antibody combination therapy in China! How effective is the response to Omicron?

On December 8, 2021, the new crown monoclonal neutralizing antibody ambacizumab / romistimab combination therapy (previously known as brii-196 / brii-198 combination therapy) was approved by the China Drug Administration for listing in an emergency manner for adults and adolescents with positive new crown test and severe high-risk (among them, the adolescent indication population is conditionally approved). The approval marks China’s first fully developed and proven randomized, double-blind, placebo-controlled study to prove effective anti COVID-19.

What is the effect of the new drug approved this time? Can we respond to the constantly updated COVID-19 variants?

Novel coronavirus pneumonia was introduced by Professor Zhang Linqi, director of the global health and infectious disease research center of Tsinghua University. In March 2020, the team worked with the third people’s Hospital of Shenzhen to study a pair of neutralizing antibodies which were highly active in the plasma of the newly diagnosed pneumonia patients. After antibody screening and a series of production, evaluation and industrial processing, strictly randomized, double-blind, placebo-controlled studies, clinical phase I trials, phase II trials and phase III trials have been carried out in many clinical trial centers around the world.

The marketing approval of ambacizumab / romistuzumab combination therapy by the national drug administration is based on the interim and final results of phase 3 of activ-2 trial supported by the National Institutes of health. Novel coronavirus pneumonia treatment showed that the combined end point of hospitalization and death of the new crown pneumonia outpatient clinic decreased by 80%, which was statistically significant. As of the 28 day clinical end point, there were no deaths in the treatment group, while 9 deaths in the placebo group, and no new safety hazards were observed.

Since May this year, there have been successive outbreaks in Guangzhou, Shenzhen, Nanjing, Yangzhou, Zhengzhou and Northeast China, including Manzhouli and Hailar recently. Tengsheng Huachuang donated antibody drugs to treat nearly 900 patients. Clinicians gave positive feedback, patients’ symptoms were relieved, virus load decreased and safety was good.

At the same time, Omicron with more than 50 mutations appears in many countries, which may pose a risk of escape for current vaccines and monoclonal antibody drugs. Therefore, it is defined by who as a mutant strain “requiring attention”. Can the newly approved antibody combination therapy deal with the threat of new variants?

In an exclusive interview with Sohu Health, Mr. Luo Yongqing, CEO of Tengsheng Huachuang, introduced that in fact, when starting antibody R & D last year, researchers had taken into account the risk of virus mutation, so the strategy adopted was to select “one pair” rather than “one” antibody.

The characteristics of anuwei monoclonal antibody are the different epitopes binding to the binding domain of COVID-19 spike protein (RBD). This is a highly conservative region. It is not easy to cause mutation and escape. However, the binding site of the combination of ROMI and McAb does not coincide with anbarb, which further reduces the risk of immune escape.

The virus needs to bind spike protein to ACE2 of human cells and fuse on the cell surface before infection. The antibody combination therapy can not only prevent the virus spike protein from binding to the receptor, but also prevent the cell membrane fusion after the receptor binding, so as to avoid the escape of the mutant to the neutralizing antibody as much as possible.

From January to July this year, a variety of mutated viruses appeared in the world, such as alpha, beta, Delta, etc. according to the results of third-party trials, antibody combination therapy can maintain activity against various variants. At present, Tengsheng Huachuang has conducted experiments on Omicron mutant in four laboratories around the world to identify whether it will affect the antibody. The test results are expected to be available in about two weeks.

Looking back on the Lambda and Mu COVID-19 variants that appeared in 8 and September this year, it was also known as “high threat” at that time, and the combined antibody drug test showed that it was effective. It is worth looking forward to whether there will be consistent results after the emergence of Omicron this time.

According to Mr. Li Ankang, chief financial officer of tengshengbo pharmaceutical, antibody combination therapy was submitted to the United States for emergency use authorization in October this year. At present, the approval process is in progress as planned. After applying for listing in China and the United States, it will be registered in other regions as soon as possible, including South Africa and Mexico. At present, the company is building a commercial team and discussing further production plans. It is promoting the process as soon as possible so that patients can use drugs as soon as possible.

The novel coronavirus pneumonia is a government procurement form in the United States, and it may also be a different form of government procurement in the future. But government procurement is definitely the most important form. At present, the government procurement price of similar antibody drugs in the United States is US $2100 per person. The price of the antibody combination therapy is also under further negotiation, and the specific price has not been released yet.

Can the new crown monoclonal neutralizing antibody ambacizumab / romisvir combination therapy replace the current vaccine immunization strategy after it is approved for marketing? Luo Yongqing explained that, first of all, the vaccine is used for the general population to prevent virus infection and turn into severe disease. The novel coronavirus pneumonia is treated by antibodies.

Therefore, antibody therapy and vaccine are complementary rather than alternative. Vaccine is a first-line prevention means, its use cost is low, and it is suitable for large-scale population to establish immunity. However, the vaccine can not achieve 100% of the effect, the elderly, chronic disease, AIDS, cancer patients and other low immunity crowd after vaccination has a high probability of not able to establish enough immunity, infection is easy to turn to severe. At this time, targeted vaccination of antibodies to produce passive immunity will help to reduce the risk of infection.

At present, two kinds of antibody therapy have obtained post exposure prevention, one of which has obtained the indication of pre exposure prevention. Further research is being carried out on the prevention indications of antibody combination therapy, which can provide more clinical prevention evidence in the future


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