CCTV News:The combination therapy of COVID-19 monoclonal neutralizing antibody "Anbavir monoclonal antibody/Romisvir monoclonal antibody" developed by Tsinghua University was approved by China Drug Administration on December 8, which is the first anti-Covid-19 drug independently developed in China and proved to be effective through strict randomized, double-blind and placebo-controlled research. At present, this domestic new drug has been approved for more than 10 days. What is its safety and effectiveness? Let’s look at the introduction of Professor Zhang Linqi who leads the R&D team.
Professor Zhang Linqi of Tsinghua University Medical College:The clinical trial was carried out in 111 clinical trial bases in six countries on four continents, so it is a multi-national and multi-center clinical trial at home and abroad, which has shown very good safety and effectiveness in the whole process and can reduce the hospitalization rate and mortality rate by more than 80%.
It is understood that the average age of the R&D team, which is the main force behind the scenes, is less than 30 years old, and it consists of 4 teachers and 11 doctors and postdoctoral students. Under the leadership of Professor Zhang Linqi, they fought for more than 600 days and nights, from the initial isolation and screening of neutralizing antibodies to the international phase III clinical trial, and finally obtained the listing approval of China.
Professor Zhang Linqi of Tsinghua University Medical College, team member Zhang Qi:I think the laboratory can make such great achievements in this project because it has accumulated many technologies and methods in the field of fighting against emerging infectious diseases for a long time. For example, we did MERS Middle East Respiratory Syndrome, SARS virus, Zika virus and Ebola virus before, and we directly applied these technologies and methods to the research against Covid-19 when we were in COVID-19 this time.
Domestic new drugs block the cell surface.
According to reports, Covid-19’s invasion into the human body needs to enter the cell through spike protein to complete the infection. It is in this link that COVID-19 monoclonal neutralizing antibody, which was approved for emergency marketing in China more than 10 days ago, blocks the virus.
Professor Zhang Linqi of Tsinghua University Medical College:What I’m holding in my hand is actually a protein on the surface of a virus. The function of the protein is to open the lock on the cell. Because the virus must go into the cell to replicate itself and produce generations. How the antibody works is basically to block things on the surface, and there is a way of fighting in groups. In this case, its key can’t contact the lock at all.
Domestic new drugs are effective against Omicron mutant.
The emergence of Covid-19 Omicron mutant is really a big test for all the listed "anti-COVID-19 weapons". The COVID-19 monoclonal neutralizing antibody Ambavavir monoclonal antibody Romisevir, which was approved for marketing more than 10 days ago in China, is also facing the same problem, because the Omicron mutant in Covid-19 only appeared after the research and development of this combination therapy drug was completed. So, is this combination therapy effective for Covid-19 Omicron mutant?
Professor Zhang Linqi introduced that mutation is actually a strategy for the survival of coronavirus. Studies have shown that Covid-19 mutates almost once a week, and they have experienced dominant strains such as Alpha, Beta, Gamma and Delta in the process of developing this drug. Therefore, the team must fully consider the possibility of Covid-19 mutating again when designing the drug.
Professor Zhang Linqi of Tsinghua University Medical College:Because the mutation of the virus does not occur at every point, only some of them are prone to mutation, so we will try our best to select virus targets in the whole analysis of virus changes and antibody recognition sites, and those that do not change a lot can maintain the effectiveness of our weapons.
Zhang Linqi said that drug research and development is like a competition with Covid-19’s mutation. Although the effectiveness and broad spectrum of the drug were fully considered in the development process, every time a new mutant appeared, they would break out in a cold sweat and reconfirm whether their selected antibody would be affected.
Professor Zhang Linqi of Tsinghua University Medical College:Fortunately, because we considered the possibility of mutation in the whole selection and evaluation process, especially the improvement of the interaction and joint efforts of two antibodies, we still maintained our ability in effectiveness and broad spectrum. For Omicron, the initial results showed that our antibody combination still maintained its binding ability and neutralizing ability to Omicron, and it was effective, so I was very pleased.
With domestic new drugs, we still need to vaccinate, and the two complement each other.
So, with this new domestic drug, do you still need to get Covid-19 vaccine?
According to experts, vaccines and drugs are complementary and cannot replace each other. Vaccine is the first line of defense, and antibodies provided by drugs are the key protection. The two cannot be equated.