Beijing, December 17 (Reporter Zhang Ni Ren Jing) Recently, the State Food and Drug Administration announced the emergency approval of Tengsheng Huachuang, a holding subsidiary of Tengsheng Bo Pharmaceutical, for the registration of the new coronavirus neutralization antibody combination treatment drugs ampavirine monoclonal antibody injection and romizumvir monoclonal antibody injection.
The domestic new crown "special drug" came out, and the outside world paid a lot of attention. In the face of the "Omi kerong" variant strain, can this drug be effectively dealt with? Is the future production capacity guaranteed? In this regard, Li Ankang, chief financial officer of Tengsheng Bo Pharmaceutical and doctor of biomedicine, was interviewed by China News Network "China New Observation" column for exclusive interpretation.
Draft: Zhang Jianyuan
China News Network: As a combination therapy drug for neutralizing antibodies of the new coronavirus, what is the difference between the new drug approved this time and the technical route of other drugs currently under development? What are the advantages?
Li Ankang: Neutralizing antibody combination therapy is to find a neutralizing antibody specifically for the new crown virus from the human body, further optimize it, and select a pair of neutralizing antibodies that bind to different parts of the new crown virus for large-scale production to make a stable and controllable drug.
The main advantage of our neutralizing antibody is that, first, it is a pair of long-acting antibodies, through genetic engineering modification, it is present and active in the human body for a longer time than the general antibody. The general antibody half-life is only 2 to 3 weeks, and this pair of antibodies can reach 3 months in the human body, providing protection for 6 to 9 months or even longer.
Second, in terms of safety, it comes from the human body, and in the phase III clinical data, it performed better on the safety system than the control group placebo.
Third, in terms of effectiveness, it reduces the risk of death and hospitalization by 80% in phase III clinical trials.
Fourth, it is a combination of therapies, with two antibodies at the same time, and the coverage of various mutant strains is high, and the new crown virus may escape from one antibody through mutations and not be attacked by one antibody, but the possibility of not being affected by two antibodies at the same time is very low.
China News Network: What are the indications for ambavir monoclonal antibody injection and romizumab injection?
Ankang Li: The indications for antibodies are now approved for the treatment of mild and ordinary types with high-risk factors that progress to severe. Approvals are for those aged 12 or over, for those aged 12 to 17 years, and for adults over the age of 18.
For both mild and general populations, the sooner antivirals are used, the better. Because of the early stage of infection with the new crown, the virus is in the stage of reproduction and amplification, and it can be killed by drugs in time. In the advanced and more severe stages, not only the damage of the virus to the human body, but also the damage to the human body after the immune response of the person's own immune system.
Therefore, if the treatment with neutralizing antibodies is used in the later stage, it is not possible to achieve 100% efficiency. In terms of the risk of severe illness, some patients have underlying diseases, or are older, and are more likely to develop severe disease after infection with the new crown, so the risk of this part of the population not being treated will be very high. Therefore, we prioritize the use of COVID-19 antibodies in this segment of the population with high risk of progressing to severe disease.
The first approved independent intellectual property rights in China for the new crown virus neutralization antibody combination treatment drug amphavir monoclonal antibody injection and romimab injection. Photo by Ying Ni
China News Network: Recently, the "Omikejong" variant has attracted attention, and countries have also accelerated the research and development of corresponding vaccines and drugs, can the drug cope with the current virus mutation?
Li Ankang: Because this is a pair of antibodies, as long as there is an antibody to maintain neutral activity against the virus, it can be used for treatment, and the current laboratory results have shown that this antibody maintains its effectiveness against "Omi Kerong".
So far, it has neutralized all of these major mutations, including Alpha, Beta, Gamma, Delta, including the latest Omikejong strain.
China News Network: Is the approved neutralizing antibody combination therapy drug expected to be vaccinated for healthy people in the later stage?
Li Ankang: At present, in the study, there are further data that can be generalized to the prevention and application. However, from the perspective of large-scale prevention, the first step in the establishment of a line of defense should be through mass vaccination, and then focus on the use of neutralizing antibodies for prevention in populations that cannot be completely protected or suitable for vaccines.
Because neutralizing antibodies can directly achieve a preventive effect, it does not rely on the person's own immune system, so for those whose immune system itself is not perfect or defective, protection can be directly completed through neutralizing antibodies. For example, people who are particularly old and have a weak immune system, or people with some underlying diseases and defective immune systems, including people like AIDS, can use zygote antibodies for immune protection.
However, further research is still being laid out and planned, so it is not yet clear when healthy people will be vaccinated.
Infographic: Citizens receive nucleic acid testing. Photo by Qian Chenfei
China News Network: What is the current price of new drugs in China and the deployment of production capacity?
Li Ankang: Before the approval of the United States neutralizing antibody drugs, the U.S. government gave the purchase price of 2100 US dollars, the domestic pricing is still in discussion with the relevant departments, is measuring the pricing. From the production of antibody drugs, the production cost is related to the production scale, and the larger the production scale, the lower the cost, so the future will be priced according to the order volume, including demand and market response.
Pharmaceutical capacity will not be a big bottleneck, and the company is currently working with manufacturers who specialize in outsourced production. In the future, the production capacity and production scale will be arranged according to the order volume. We previously produced a stockpile of medicines that meet current needs.
China News Network: Is there a plan to "go out" with ambavir monoclonal antibody injection and romizumab injection?
Li Ankang: In October this year, after the release of the phase III clinical complete data, we have submitted data to the China Food and Drug Administration and the United States Food and Drug Administration at the same time, and submitted emergency use authorization application materials to the United States, and we are currently communicating with the regulatory authorities, hoping to be approved as soon as possible.
In the phase III clinical trial, in addition to the United States, Brazil, South Africa, Argentina and other countries have also participated in clinical trials, and we will also strive to promote registration in these places. In addition, we are also discussing with potential partners in different regions, hoping that more patients will benefit from neutralizing antibodies.
Li Ankang, Chief Financial Officer of Tengsheng Bo Pharmaceutical and Doctor of Biomedicine, was interviewed by China News Network 'China New Observation'. Courtesy of respondents
China News Network: At present, the epidemic is still raging around the world, and domestic and foreign pharmaceutical companies are accelerating the research and development of new crown special drugs, what position are domestic pharmaceutical companies in research and development? What problems will be solved in the future?
Li Ankang: We should be one of the first pharmaceutical companies to isolate neutralizing antibodies from the serum of patients who have recovered from the new crown and enter clinical trials. From the past period of time, Chinese pharmaceutical companies have also made great progress in drug research and development.
From the perspective of new crown drug development, due to the relatively good control of the epidemic in China, it is difficult to find enough patients to carry out large-scale phase III clinical research after we complete the phase I clinic, so we choose to carry out international cooperation to verify the effectiveness of our antibody drugs through the international multi-center phase III.
From the perspective of domestic drug development, especially drug development such as the new crown, it is necessary to go out and use international clinical resources to support the development of drugs in the later stage.
China News Network: Can humans use specific drugs or vaccines to completely contain or block the spread of the new crown epidemic?
Li Ankang: It is difficult to accurately predict how the epidemic will develop in the future, because the virus is indeed constantly mutating, and countries are also using different means and policies to control the epidemic.
It is unclear whether the outbreak can be cleared. However, from the perspective of the prevention and control work in all aspects of fighting the epidemic and carrying out drug research and development in the past, as long as scientific attitudes and means are adopted to research, innovate, develop treatment and prevention methods, the virus can be controlled and will not pose a fundamental threat to human health. (End)