According to CCTV News, on December 8th, my country’s first anti -new coronal virus special medicine -Anbawei’s anti -anti -anti -anti -anti -anti -anti -anti -anti -combined therapy special drug was approved by the China Drug Administration, which marked China The first fully independent research and development and proved effective anti -new coronal virus antibody special effects of special effects were officially launched. Zhang Linqi, a professor at the School of Medicine of Tsinghua University and Director of the Global Health and Infectious Disease Research Center, is the leader of this R & D team.
How to use the first anti -new coronary virus antibody antibody medicine? What is the effect?
Zhang Linqi: We are intravenous. Put a bottle in the physiological salt water and hang a bag and a drop of injection. After losing a bottle, we lose another bottle. The whole process is 40 minutes before and after. After injection, it takes effect and can provide a strong protective effect on the body.
Clinical trial data show that this special effect medicine can reduce 80%of the hospitalization and mortality of 80%of patients with high -risk new crown clinics. The main role is mainly treatment. At the same time, antibodies can remain in the human body for 9 to 12 months, which also has a certain effect on preventing infection. This is currently the best treatment data of anti -new coronal virus specialty drugs around the world.
Active formation of team R & D Antibody Special Effectives
In January 2020, the new crown epidemic just broke out shortly. With the sensitivity of his occupation, Zhang Linqi led the research team of Tsinghua University School of Medicine and Professor Wang Xinquan of the School of Life Sciences of Tsinghua University and the team of Professor Zhang Zheng of Shenzhen Third People’s Hospital. The research consortium is very clear, that is, to develop antibody special medicine for anti -new coronal virus.
Zhang Linqi: The key part of the concentrated energy to study the virus is the structure and function of the spiny protein on the surface of the virus, because this spiny protein is very critical for the virus, like a thief entering a key to the family. This door lock is actually another protein on the surface of our cells. In fact, the relationship between this key and lock is the interaction between the two proteins. We see that the realization of many life phenomena interacts with protein and protein. The virus enters the cells, that is, the use of its own protein to enter the human cells, and use the cells as a channel and base that copy the cells as its descendants.
The basic principle of antibody special effects drugs
Antibodies are natural weapons in the human body. The goal of Zhang Linqi and his team is to find one or several super -strong antibodies that can accurately block the combination of viruses and human cells, and then inhibit the virus into human cells for replication and infection. Let the patient’s body recover quickly.
Zhang Linqi: After the body is infected by the virus, there is a lot of immune response. The human body has so many antibodies. Not every antibody has this function. A metaphor is a metaphor. The antibody of neutralization of the virus, or the special forces in a army have this function. Therefore, to screen these special soldiers, and choose the special forces as a seed to be zoomed in in vitro and then return to the patient, it can immediately take effect and can play the role of blocking the virus. This is the most basic principle of antibody drugs.
Reporter: This screening process is very complicated?
Zhang Linqi: The sea is used to pick a needle.
Zhang Linqi, 58, was famous in the international virus. He graduated from the Department of Biology, Beijing Normal University in the 1980s. He studied Ph.D. in the Department of Molecular Genetics at the University of Edinburgh in the UK to study the laws of mutation and escape from HIV in the body of HIV. In 1993, he went to New York University. He was Professor from He University and continued to participate in the research of AIDS virus. In 2007, Zhang Linqi returned to work at Tsinghua University and was mainly engaged in the research and development of AIDS drugs and vaccines. In addition to AIDS, Zhang Linqi also had high pathogenic virus such as Ebola virus, Zika virus, Sas and the Middle East respiratory virus virus research.
If you want to choose antibodies that can most accurately crack down on the new crown virus, and develop antibody special effects drugs, you must get a certain number of antibodies of infected people. On the shoulders. After the new crown epidemic was outbreak, the Shenzhen Third People’s Hospital had treated a group of new crown pneumonia patients and sequensed the antibody genes produced by the lymphocytes on the infected people. Genes, sent to Tsinghua Zhang Linqi research team.
Zhang Linqi: The screening process is a relatively complicated process. With the gene of antibodies, we must first go back to the protein, and then arrange them well to identify the virus surface protein. Sample. Not only must it be combined, but also depends on whether it can block the virus into human cells. Some antibodies may have the ability to combine, but they do not have the ability to block.
Why do two antibodies screen out?
After one and a half months of hard and meticulous experiments and screening, on March 5, 2020, Zhang Linqi and his team finally screened two antibodies that were very powerful to the new crown virus.
Zhang Linqi: Why the two antibodies at the time may have another deep reason. My background comes from the AIDS field, and my partner also comes from the AIDS field. We faintly feel that this virus will not stop here. Although this virus is not the same as AIDS virus, it is also a virus that belongs to RNA as a genetic material. The characteristic of RNA virus is a characteristic that it is easy to cause mutations. So we feel that to truly inhibit this virus, it may not work by single antibodies. Therefore, at that time, two antibodies were made to make decisions. These two antibodies must have the ability to combine, neutralize the ability, synergistic ability, and the ability to combine fist.
How to deal with new crown variants in the research and development process?
After the development of the Ambaleko monoclonal anti -anti -anti -anti -anti -anticipated therapy, after the research and development of the special drug of the anti -combination therapy, the safety and validity test were performed on animals. Since then, in September 2020, the first clinical study of the drug in the domestic human body ended and the safety was certified. But in December 2020, humans first discovered the mutant strains of the new coronary virus.
Zhang Linqi: At that time, we had a cold sweat, worried that the antibody lost its activity, and worried that the effect of our combination of fist was greatly discounted. When the first mutant strain appeared in the UK at the end of last year, we immediately conducted genetic mutations in our hands, completely imitating the way of virus mutation, a round of assessment of our antibody combination, neutralization, and combination capabilities. It is no problem, so my heart is very practical. Every time we have mutations, we will take the same process and path to evaluate whether the outside body is inactivated. Still, ability is still there, so confidence is gradually increasing.
Go abroad to receive global clinical trials
As Zhang Linqi wanted to further do the clinical study of the second and third phases, due to the proper epidemic prevention measures, it was difficult to find new crown patients in China. In December 2020, based on the results of the first phase of clinical research conducted in China, Zhang Linqi applied for a clinical trial led by the World Institute of Health (NIH) to lead the world.
Zhang Linqi: In fact, there are high requirements for clinical research entering the international stage. It is reflected in an open and transparent. It is a global comparison basis that can then enter the network of clinical research that can be entered worldwide. At that time, when we declared this project to the National Institute of Health, we showed our excellent and efficient inhibitory activity of the combination of boxing antibodies in vitro, and the safety of the first phase of the human body’s first clinical trial at the Tanni Hospital. In the process of competition and evaluation, we were recognized by the previous status of the United States National Health Research Institute, so we directly entered the second -phase test of the internationally clinical. After entering clinical trials, our main role is to test our medicines. We do not participate in the design of clinical trials, and we do not participate in the implementation of clinical trials. We can only conduct clinical design and clinical assessment by third parties.
According to international practice, the organizers divided the new crown virus patients into two groups. One group accepted the treatment of this Ambale monoclonal anti -anti -antibody anti -antibody special effect of special effects. In accordance with the principles of random, double -blindness, and control, this special effects drugs were conducted in international clinical trials. In 28 days, they compared the hospitalization and death of patients.
Zhang Linqi: What is the randomness, that is, these infected people meet the conditions of the group and will be divided into the treatment group or not the treatment group. This process is random. What does double blindness mean? The doctor gave you this medicine, and the doctor did not know whether it was a medicine or a placebo. The patient did not know whether it was a medicine or a placebo. What does the control mean? In contrast to each other, I have a medication that is compared with the use of no medication. So this is the most scientific and most objective test method in our clinical research, and there are no factors. Our drug provider and the National Institute of Health do not know all the data. Who knows? Only one organization knows that this organization is a data and security committee specially established for these clinical trials. In the process of execution, they will look at the results at a certain time node. For example, whether there is a certain difference between your two groups. If there is a certain difference, this clinical trial is worth continuing. For example The period becomes three periods. If there is no difference in the two groups, the mortality rate and hospitalization rate does not difference, you will go out.
After the strict comparison test, the National Institute of Health did not disclose the results of the second phase of clinical trials to the Zhang Linqi team, but the test did not stop. The National Institute of Health was presided over a large -scale clinical trial of the drug.
Zhang Linqi: During the clinical trials, these experiments carried out by 111 clinical trial bases in four countries and six countries around the world have invested a lot of manpower and material resources, so you can see that this process is international standard. In fact, it is the most stringent international standard for international standards.
Reporter: Before this data has not come out, what does your researcher feel in your heart?
Zhang Linqi: We are particularly confident that the antibodies that are picked out in the laboratory, the ability to display outside the body, but the things from the laboratory are only the first step of the Long March, and the real display effect is the gold standard. , So every step of walking will have extremely expectations, and at the same time, there is extremely anxious anxiety.
A year long waiting
As for life, the clinical trials before the listing of new drugs have always been a long waiting process.
Reporter: If the test terminates out, how do you face it?
Zhang Linqi: We particularly don’t want this situation, but once we occur, we must accept science. With this result, wherever you fall, there are no other choices.
Reporter: But this means clear zero, all your previous efforts have been used in vain?
Zhang Linqi: Zero is often happening in science. The quality of scientists is particularly different from ordinary people. It is to aim at cutting -edge problems. Under the premise of being hit and destroyed by countless times Basic quality.
On December 3, 2021, after the waiting time for nearly a year, the National Institute of Health (NIH) announced all the clinical data of the new crown antibody drugs for the Ambale Monopoly/Romi Siwei anti -antibodies. In the third phase of clinical trials, the active mid -term and final results of 847 patients with admission showed that compared with placebo, Ambale Monopoly/Romi Siwei’s anti -combination therapy can reduce the hospitalization and hospitalization of high -risk new crown outpatient patients and the hospitalization and hospitalization and hospitalization and hospitalization and hospitalization and hospitalization and hospitalization of new crown clinics. The risk of death is 80%. As of the clinical end of the 28 days, the treatment group was zero death, and nine deaths of the placebo groups died, and its clinical safety was better than the placebo group.
Zhang Linqi: The result of this day is actually very exciting, proves that the two seeds we picked out at the time were really two seeds that were really shining. How easy it is to achieve 80%of the effect when the plants are popular. So we are ecstatic and very excited and happy about this effect.
Can this special effect of this my country cope with “Omikon”?
With the development of global scientists special effects, the mutation of the new crown virus is also continuing. Since November this year, the new crown virus variants “Omikon” has attracted strong attention. At present, it is known that the virus has mutated 32 spiny protein, and WHO defines it as “the fifth kind of concern variable strain.” Faced with the aggressive “Omikon”, can this special effect of China be effective?
Zhang Linqi: Whenever there are new mutant plants, we have to follow the process of synthesis and assessment every time. We find that one of the antibodies of combination boxing is active, and the other antibody loses part of the activity, but because we are a combination boxing, we are a combination boxing. Two antibodies are added together, and we still maintain the neutralization of the “Omikon” mutation strain, so we have a great confidence in our antibody drugs for new viruses.
When will the special effect push to the market?
Although the new medicine has been approved to be listed, Zhang Linqi and his team are still in a state of high -speed operation.
Reporter: Is there a timetable, when will this special effect push to the market?
Zhang Linqi: There is no schedule, maybe it may occur within a few weeks or days. The government department, supervision department, and corresponding technical teams will promote the process every night.
Reporter: When this special effect medicine can fully push the market for the market, will there be a fundamental promotion and change of the entire country’s epidemic prevention policy?
Zhang Linqi: It must be very different from medicine and no medicine.
Subsidity Pharmaceutical R & D team subsequent plan
Reporter: What research plans do you have for this new crown special medicine?
Zhang Linqi: With the support of the Ministry of Science and Technology, the laboratory further taps the mechanism of interaction between the entire virus and antibody interaction and the law of virus mutation, so that we are still digging whether there are better antibodies and spare tire antibodies to prevent the cliffs in the future. Activation of the effect. We are still working hard to make it play its role in terms of effectiveness, broad -spectrum, and durability.
Edit Liu Jiani