It took 20 months to reveal the birth process of China's first COVID-19 treatment

On December 9, an announcement by Tengsheng Bo Pharmaceutical triggered public opinion.

According to the announcement, the State Drug Administration has approved the listing application of the combination therapy of monoclonal neutralizing antibody amphavir monoclonal antibody ampavirus/romizumab, a holding company of Tengsheng Bo Pharmaceuticals, for the treatment of mild and ordinary adults and adolescents (12-17 years old, weighing ≥40 kg) with severe high-risk factors (12-17 years old, weight ≥40 kg) patients infected with the new coronavirus.

This means that China's first approved drug for the treatment of new crown pneumonia is coming!

It is understood that the neutralizing antibodies produced by the drug can produce effective protection against the body like vaccines, but it is more focused on the therapeutic function, and for new crown patients who have already developed symptoms, "the earlier they are used, the better the treatment effect." International Phase III clinical final data show that this combination therapy can reduce the risk of hospitalization and death by 80% and has a good safety profile.

On December 10, Dr. Li Ankang, chief financial officer of Tengsheng Bo Pharmaceutical, was interviewed by the Beijing News Shell Financial Reporter, who not only introduced the dosage of combination therapy, explained in detail the suitable population, but also exclusively revealed the research and development process.

It took 20 months for Tengsheng BoYao and his partners to create The Speed of China, during which time they crossed several mountains and crossed what hurdles?

Dr. Ankang Li, Chief Financial Officer of Tengsheng Bo Pharmaceutical, courtesy of the interviewee

Beijing News Shell Financial Reporter: What is the use, dosage and treatment cycle of the combination therapy of monoclonal neutralizing antibody amphavir monoclonal antibody / romizumab? The combination of these two drugs produces antibodies, what is the biggest difference from vaccines?

Ankang Li: This pair of neutralizing antibodies is used to treat new crown pneumonia. In the treatment process, mainly through intravenous injection, the two drugs are injected successively with 1g each, the whole process is less than one hour, and only one time can be completed.

We expect that after injection, it can provide effective protection for the human body for more than 6-9 months.

From a cost perspective, our combination therapy approvals are for treatment. From a scientific point of view, neutralizing antibodies definitely have a preventive effect, and vaccines can be said to be complementary, after people inject vaccines, we will then targeted to protect key populations.

Beijing News Shell Financial Reporter: In the treatment of new crown pneumonia, what effect will this combination therapy have on the treatment of mild and moderately ill patients?

Li Ankang: The mechanism of action of antibodies is to be able to bind to the virus, on the one hand, it can prevent the virus from entering the human cells, on the other hand, it can remove the virus.

In terms of use, it is certainly the sooner the better, because when the virus first invades the human body, the number of people entering the human body is relatively small, and the use of our combination therapy to produce neutralizing antibodies can make the patient heal faster.

As for severely ill patients, at this time they are not just fighting the virus, because after the human body is invaded by the virus, there will be an immune response, and at this time, only the neutralizing antibodies against the new crown are used to treat, and the effect cannot be 100%.

So we are approved for the treatment of adults and adolescents (12-17 years, weighing ≥40 kg) with mild and normal types who are associated with high-risk factors for progression to severe (including hospitalization or death) with COVID-19 patients.

Beijing News Shell Financial Reporter: Compared with similar products of other pharmaceutical companies, what is the main advantage of tengsheng bo medicine, which is a combination therapy?

Li Ankang: Our neutralizing antibody is China's first approved drug for the treatment of new crown pneumonia, which can be said to fill the gap in china and make a breakthrough of zero.

Compared with several foreign COVID-19 treatments, our approval is based on phase III clinical data from international multicentre, and through this data, it can be seen that the risk of death and hospitalization can be reduced by 80%.

We have several significant advantages in phase III clinical practice, first, after the patient develops symptoms, patients within 10 days can come to participate in clinical trials. The earlier this drug is used, the better the effect, other families are required to be within 3 days, 5 days or 7 days, we are asking for 10 days, still have very good data.

Second, our clinical trials are closer to reality. Because many patients from the appearance of symptoms to the examination, diagnosis, the beginning of treatment is already 7 days later, so other neutralizing antibodies in the real world is difficult to achieve, patients are difficult to use in time.

Third, the clinical trial was conducted from January to July this year, and more than half of it was completed in June and July. This period coincides with the period of global mutant outbreaks, so clinical data can also show whether the mutant strains can remain effective.

Beijing News Shell Financial Reporter: From the beginning of research and development to approval, how long does it take? In the process of research and development, how much manpower, material and financial resources have been invested?

Li Ankang: From the time when the new crown epidemic first appeared, we began to cooperate with Tsinghua University and the Third People's Hospital of Shenzhen to start research and development, and the whole process took about 20 months, which is very rare in pharmaceuticals, because generally a drug takes almost 10 years of research and development time. The time from research and development to approval is so short, it is inseparable from the help and support of each of our partners.

In terms of funds, our company's own investment exceeds 1 billion yuan.

Beijing News Shell Financial Reporter: In the process of research and development, what roles do Tengsheng Bo Pharmaceutical, Tsinghua University and the Third People's Hospital of Shenzhen play?

Li Ankang: This antibody was isolated from Chinese COVID-19 patients, patients in the recovery period, and this isolation work was completed by the Third People's Hospital of Shenzhen. Then Tsinghua went to clone it, and then found its sequence, at that time there were more than 200 antibodies isolated, tengsheng Bo medicine from which to find the most suitable and most effective antibody to develop.

Beijing News Shell Financial Reporter: What is the pricing of these two drugs? What are the company's expectations for their sales in the country? Has the company calculated how much the drug will affect the performance of Temsex?

Li Ankang: Our pricing is still under discussion, and there are no accurate figures to share with you.

There are many uncertainties in the COVID-19 epidemic itself, such as how long the epidemic will last and what the future prevention and control policies will be, which will have an impact on the market for COVID-19 therapeutic drugs.

From the current situation, the new crown may be a long-term disease, then our drug after the market, should be able to have a positive impact on the company's performance.

In fact, for investors who invest in biotech (biotechnology), they do not value whether the company can generate profits in the short term or whether it can have more income. We ourselves don't pay too much attention to how much profit a product can bring to the company in the short term.

Beijing News Shell Financial Reporter: After the drug was approved, the public is also very concerned about the production capacity problem, in this regard, how does the company plan?

Li Ankang: In terms of production, it is our partner WuXi Biologics, which ranks among the top in the world in terms of production capacity, and we are not worried about capacity supply and yield problems.

Beijing News Shell Financial Reporter: What is the original intention of Tengsheng Bo Pharmaceutical to list in Hong Kong stocks?

Li Ankang: The biggest role of listing is to provide a financing channel for the company to support our subsequent development.

The reason for choosing Hong Kong stocks is because we have many projects with global international interests, many international investors are very concerned, and at the same time, it also provides a certain operating space for international cooperation that may occur in the future.

Recently, we have just entered the Hong Kong Stock Connect, so that in the future, we can not only dock with international capital, but also have further interaction with domestic investors and expand financing channels.

Beijing News Shell Financial Reporter: Tengsheng Bo Pharmaceutical operates in China and the United States, listed on the Hong Kong stock market in July 2021, and has conducted many studies in the field of major infectious diseases. According to your observation, what is the current status of innovative drug research and development for infectious diseases in China, and what are the differences compared with the United States?

Li Ankang: From the perspective of drug research and development against infectious diseases, in fact, the entire international investment is insufficient. Why is there insufficient investment? Because many infectious diseases erupt suddenly, it is difficult to predict when they will erupt. Many infectious diseases disappear quickly, and there may be no market for your drug development.

In order to deal with these problems, there needs to be a group of companies that can take root in this area. At the beginning of its establishment, Tengsheng Bo Pharmaceutical was based on the positioning of public health to solve these problems, and our mission is to respond to the most severe public health challenges with breakthrough innovation and insight. We have established a pipeline of more than 10 innovative candidates for infectious and CNS diseases.

Beijing News Shell Financial Reporter Yan Xia Li Yunqi Editor Xu Chao Proofreader Liu Baoqing