Chinanews client, Beijing, December 17 (Reporter Zhang Ni Ren Jing) Recently, the State Food and Drug Administration announced emergency approval of Tengsheng Biopharma’s holding subsidiary Tengshenghua's innovative coronavirus neutralizing antibody combination therapy drug Ambavirin Registration application for anti-injection and Romisvirimab injection.

  The domestically produced new crown "special effect medicine" came out and attracted much attention from the outside world.

In the face of the "Omi Keron" mutant, can this medicine effectively deal with it?

Will the future production capacity be guaranteed?

In this regard, Li Ankang, Chief Financial Officer of Tengsheng Biopharmaceuticals and PhD in Biomedicine, accepted an exclusive interview on the "China New Observation" column of Chinanews.com for an exclusive interpretation.

Drawing: Zhang Jianyuan

Chinanews.com: As a new coronavirus neutralizing antibody combination therapy, what is the difference between the new drug approved this time and other drugs currently under research in the technical route?

What are the advantages?

Li Ankang: Neutralizing

antibody combination therapy is to find a neutralizing antibody specifically against the new

coronavirus

from the human body, further optimize it, and select a pair of neutralizing antibodies that bind to different parts of the new coronavirus for large-scale production. Stable, controllable medicine.

  The main advantages of our neutralizing antibody are: first, it is a pair of long-acting antibodies, modified by genetic engineering, it exists and is active in the human body for a longer time than ordinary antibodies.

Generally, the half-life of antibodies is only 2 to 3 weeks, and the half-life of this pair of antibodies in the human body can reach 3 months, providing the human body with 6 to 9 months or even longer protection.

  Second, in terms of safety, it comes from the human body. In Phase III clinical data, it performs better on the safety system than the placebo in the control group.

  Third, in terms of effectiveness, it can reduce the risk of death and hospitalization by 80% in Phase III clinical trials.

  Fourth, it is a combination therapy that has two antibodies at the same time, and has a high coverage of various mutant strains. The new coronavirus may escape from one antibody through mutation, and is not attacked by one antibody, but at the same time. The possibility of the action of the two antibodies is very low.

Chinanews.com: Who are the indications for ambavirumab injection and romisvirimab injection?

Li Ankang: The

currently approved indication for antibodies is for the treatment of mild and common types with high risk factors for progression to severe.

Approved ages above 12 years old,

12 to 17 years old people are subject to conditional approval, and adults over 18 years old are directly approved

.

  For the mild and general population, the earlier the use of antiviral drugs, the better.

Because the virus is in the stage of reproduction and amplification in the early stage of infection with the new crown, it can be stifled by drugs in time.

In the late and more severe stages, not only the virus harms the human body, but more importantly, the human body's own immune system produces an immune response to the human body.

  Therefore, if neutralizing antibody treatment is used in the later stage, 100% efficiency cannot be achieved.

In terms of the risk of severe illness, some patients have underlying diseases or are older, and are more likely to develop severe illness after being infected with the new crown. Therefore, the risk of these people without treatment is very high.

Therefore, we

give priority to the use of new crown antibodies for treatment in this part of the population who are at high risk of progressing to severe illness

.

China's first approved new coronavirus neutralizing antibody combination therapy with independent intellectual property rights, Ambavirimab Injection and Romisvirimab Injection.

Photo by Ying Ni

Chinanews.com: Recently, the "Omi Keron" mutant strain has attracted attention. Countries have also accelerated the 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 one antibody maintains its neutralizing activity against the virus, it can be used for treatment.

The laboratory results have shown that this antibody remains effective against "

Omi Keron

". Sex

.

  So far, it has maintained neutralizing activity against all major mutations, including "Alpha", "Beta", "Gamma", and "Delta", including the latest "Omi Keron" mutant.

Chinanews.com: Will the approved neutralizing antibody combination therapy be expected to provide preventive vaccination to healthy people in the later stage?

Li Ankang:

Currently in research, we can extend it to preventive applications when we have further data.

But from the perspective of large-scale prevention, the first step to establish a line of defense should be through mass vaccination, and then focus on people who cannot be fully protected or not suitable for vaccines, and use neutralizing antibodies for prevention.

  Because the neutralizing antibody can directly achieve the preventive effect, it does not depend on the person's own immune system, so for those whose immune system itself is not perfect or defective, the neutralizing antibody can directly complete the protection.

For example, people who are very old and have a weak immune system, or people who have some underlying diseases or have a defective immune system, including people like AIDS, can use Chinese antibodies for immune protection.

  However, further research is still being laid out and planned, so it is still unclear when the healthy population can be vaccinated.

Data map: Citizens accept nucleic acid testing.

Photo by Qian Chenfei

Chinanews: What is the current domestic price and capacity deployment of new drugs?

Li Ankang: For the

previous neutralizing antibody drugs approved in the United States, the purchase price given by the U.S. government is US$2,100. The domestic pricing is still under negotiation with relevant departments and

pricing is being calculated

.

From the production of antibody drugs, the production cost is related to the scale of production. The larger the scale of production, the lower the cost. Therefore, in the

future, pricing will be based on the order volume, including demand and market response

.

  The production capacity of medicines will not be a big bottleneck. The company is currently cooperating with manufacturers that specialize in outsourcing production.

In the future, production capacity and production scale will be arranged according to the order volume.

The batch of pharmaceutical stocks we have produced before can meet current demand.

Chinanews.com: Are there

any plans

to

"

go out

"

for

ambavirumab injection and romisvirimab injection

?

Lian Kang:

In October this year, after Phase III clinical complete data out, we have also submit to the Chinese Food and Drug Administration and the US Food and Drug Administration data, and

submit the application materials Emergency Use Authorization to the United States

, in keeping with the current regulatory Communicate and hope to be approved as soon as possible.

  In the third phase of clinical trials, in addition to the United States, Brazil, South Africa, Argentina and other countries have also participated in clinical trials, and we will also work hard to promote registration in these places.

In addition, we are also discussing with potential partners in different regions, hoping that more patients can benefit from neutralizing antibodies.

Li Ankang, Chief Financial Officer of Tengsheng Biopharmaceuticals and Ph.D. of Biomedicine, accepted an exclusive interview with the "China New Observation" column of Chinanews.com.

Photo courtesy of the interviewee

Chinanews: At present, the epidemic is still raging around the world, and domestic and foreign pharmaceutical companies are speeding up the research and development of new crown specific drugs. What is the position of 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 with

COVID-19

and enter clinical trials.

From the past period of time, Chinese pharmaceutical companies have also made considerable progress in drug research and development.

  From the perspective of new crown drug development, due to the relatively good control of the domestic epidemic situation, it will be difficult to find enough patients to conduct large-scale phase III clinical research after we complete the first phase of clinical trials, so we chose to conduct international cooperation. Through the third phase of the international multi-center to verify the effectiveness of our antibody drugs.

  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 later drug development.

Chinanews.com: Can human beings use special drugs or vaccines to completely contain or block the spread of the new crown epidemic?

Li Ankang: It

is more difficult to accurately predict how the epidemic will develop in the future, because the virus is indeed constantly mutating, and countries are also adopting different methods and policies to control the epidemic.

  It is not clear whether the epidemic can be cleared.

However, judging from the prevention and treatment of various aspects of fighting the epidemic and conducting drug research and development in the past, as long as scientific attitudes and methods are adopted to research, innovate, and develop treatment and prevention methods, the virus can be controlled and will not cause fundamental damage to human health. Sexual threats.

(Finish)

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