CCTV news: The new crown monoclonal neutralizing antibody "amphavir monoclonal antibody "amphavir monoclonal antibody / romimab" combined therapy developed by Tsinghua University was approved for listing by the China Drug Administration on December 8, which is the first anti-new coronavirus drug fully independently developed in China and proven effective through strict randomized, double-blind and placebo-controlled studies. At present, this domestic new drug has been approved for more than 10 days, how safe and effective is it? Let's take a look at the introduction of Professor Zhang Linqi, who leads the R&D team.
Professor Zhang Linqi of Tsinghua University School of Medicine: Clinical trials are carried out in 111 clinical trial bases in six countries on four continents in the world, so it is a multi-center clinical trial in many countries and centers at home and abroad, which has demonstrated very good safety and efficacy in the whole process, and can reduce hospitalization rate and mortality rate by more than 80%.
It is understood that the average age of the R& D team as the main research and development behind the scenes is less than 30 years old, consisting of 4 teachers and 11 doctoral and postdoctoral students. Under the leadership of Professor Zhang Linqi, they worked for more than 600 days and nights continuously, from the initial neutralizing antibody isolation and screening to the international phase III clinical trial, and finally obtained marketing approval in China.
Zhang Qi, a member of the Team of Tsinghua University School of Medicine, Zhang Linqi: I think the laboratory can achieve so much in this project, because it has accumulated a lot of technologies and methods in the field of fighting new infectious diseases for a long time, such as we do MERS Middle East respiratory syndrome, do the previous SARS virus, do Zika virus, do Ebola virus, etc., this time when the new crown is the new crown, these technologies and methods are directly applied to the research of anti-new crown virus.
The new domestic drug is blocked on the cell surface
According to reports, the new crown virus invades the human body and needs to enter the cell through the spike protein to complete the infection, and the new crown monoclonal neutralizing antibody approved for listing more than 10 days ago in China is in this link to block the virus.
Professor Zhang Linqi of Tsinghua University School of Medicine: What I am holding in my hand is actually a protein on the surface of a virus, and the role of the protein is to open the lock on the cell. Because the virus must go inside the cell to replicate itself, giving rise to generations. How the antibody implements the effect, basically the surface of the thing is blocked, there is a way to fight in groups, in this case, its key can not contact the lock at all.
The domestic new drug is effective against the Ami Kerong variant strain
The emergence of the new coronavirus Olmikeron variant is indeed a big test of all the "anti-covid-19 weapons" that have been listed. China only more than 10 days ago emergency approval of the new crown monoclonal neutralizing antibody ampavivir monoclonal antibody romisvir also faces the same problem, because after the end of the development of this combination treatment drug, the new crown virus Omilcronn variant strain appeared. So, is this combination therapy drug effective against the Omiljung strain of the new coronavirus?
Professor Zhang Linqi introduced that mutation is actually a strategy for the survival of the coronavirus. Studies have shown that the new crown virus mutates almost once a week, and they have experienced alpha, beta, gamma, delta and other dominant strains in the process of developing this drug, so when designing the drug, the team must fully consider the possibility of the new crown virus mutating again.
Professor Zhang Linqi of Tsinghua University School of Medicine: Because virus mutations do not occur at every point, but only some of them are prone to mutations, we will certainly do our best to select virus targets in the whole analysis of virus changes and antibody recognition sites.
Zhang Linqi said that drug research and development is like a game with the mutation of the new crown virus. Although in the development process, the effectiveness and broad spectrum of the drug were fully considered, but every time a new variant appeared, they would also break out in a cold sweat, and once again confirmed whether the antibody they chose would be affected.
Professor Zhang Linqi of Tsinghua University School of Medicine: Fortunately, because we considered the possibility of mutation throughout the selection and evaluation process, especially the interaction of the two antibodies and the improvement of joint efforts, we still maintained our ability in terms of effectiveness and broad spectrum. For the initial indication of the results of the Aumechjong, our antibody combination still maintains the binding ability and neutralization ability of the Aumecreon, which is effective, so I am still very pleased.
With domestic new drugs, vaccines are still needed and the two complement each other
So, with this new domestic drug, is it still necessary to get a new coronavirus vaccine?
According to experts, vaccines and drugs are complementary and cannot be substituted for each other. Vaccines are the first line of defense, and the antibodies provided by drugs are key protection, and the two cannot be equated.
Source: CCTV