The first domestic new crown "special medicine" is coming. Novel coronavirus pneumonia was first approved by China's NMPA in December 8, 2021. It is estimated that the drug took less than 20 months from the beginning of laboratory research to its approval for marketing. Source: Official Website of the State Drug Administration Enjoy the "policy green light", but the price of 8000 yuan is to be determined This is a neutralizing antibody combination therapy drug, combined with ambacizumab (brii-196) and romisvir monoclonal antibody (brii-198) (commonly known as "cocktail therapy"), jointly developed by Tengsheng Huachuang, a subsidiary of Tengsheng Bo medicine, Shenzhen Third People's Hospital and Tsinghua University. It is suitable for treating light and common types of adults and adolescents with progression to heavy types (including hospitalization or death) high risk factors of COVID-19 infected patients. Among them, conditional approval is required for young people, and more clinical data need to be added to follow up. It is reported that the listing approval is based on the National Institutes of Health (NIH) Interim and final results of phase 3 of the supported activ-2 trial. The final results showed that compared with placebo, this combination therapy reduced the composite end point of hospitalization and death of covid-19 outpatients at high risk of clinical progression by 80%, which was statistically significant; as of the clinical end point of 28 days, there were no deaths in the treatment group and 9 deaths in the placebo group; no new safety hazards were observed. The newly approved "special effect medicine" (official picture provided by the enterprise) It is noteworthy that COVID-19 neutralizing antibody combination therapy can bring revenue to the first commercial product of Tengsheng Bo, but whether it can help to turn it around is still unknown. Therefore, commercialization and pricing have become the focus of attention. Previously, there was news that the combined therapy was priced at 8000 yuan. In this regard, Li Ankang, chief financial officer of tengshengbo medicine, pointed out that "it has not been determined. It is related to factors such as communication with the government, pricing and government procurement volume." Luo Yongqing, President of tengshengbo pharmaceutical and general manager of Greater China, told reporters, "this product is relatively special, and government procurement may be the main mode. During the phase II and III clinic, the company had close communication and exchange with relevant government departments of the country, and discussed the government's strategic reserve and strategic procurement, which is still being promoted." Luo Yongqing pointed out that at present, Yaoming biology is in production, "not worried about production capacity", and will adjust according to the supply, "relatively flexible"; the channels will be divided into two parts: national strategic reserve and daily consumption, that is, it will be managed according to the conventional prescription drug channels. It is noteworthy that the rapid approval of this "specific drug" also benefits from the "policy green light". According to Zhou Qian, vice president of Registration Affairs Department of tengshenghuachuang, the approval is based on a special approval procedure of the State Food and drug administration, that is, the so-called "research review linkage". "Whenever important time nodes and important data appear, we will hold a communication meeting with the drug evaluation center for the first time and get their help and guidance throughout the whole process. In the final stage of the research and review linkage, the FDA also determined to adopt the form of rolling submission of data, that is, we will continuously supplement the obtained data in the form of rolling submission to achieve All the pre-evaluation work and the backward schedule are in days, so the rapid evaluation can be carried out when the last clinical report comes out, and the product can be approved in an emergency. " As for overseas application, just in October this year, for this "specific drug", the developer also submitted an emergency use authorization application to the US FDA, which is currently in the process of approval. In view of the good control of the domestic epidemic, if it can be approved overseas, tengshengbo medicine will be able to expand the overseas market more quickly. Broaden indications and step up R & D competition In the global new crown drug R & D competition, neutralizing antibody is considered to be one of the biggest breakthroughs of new crown therapeutic drugs, which has also attracted Chinese and foreign pharmaceutical enterprises to bet. In addition to brii-196 and brii-198 neutralizing antibody combination therapy, domestic Xinguan drug treatment also involves dxp604, scta01, neutralizing antibody js016 and other drugs. Related enterprises also involve Sinopharm China biology, Junshi biology, Kaifa pharmaceutical, LVYE pharmaceutical, etc. As shown above, novel coronavirus pneumonia or Roche REGEN-COV, Jun Shi / Eli Lilly Bamlanivimab+etesevimab, Vir Biotechnology/ GlaxoSmithKline Sotrovimab, etc. have been obtained overseas, and they have been granted emergency use authorization in the United States for the treatment of mild to moderate new crown pneumonia patients or post exposure prevention. Source: Huasheng securities Before that, the government procurement price of bamlanivimab + etesevimab approved in the United States was US $2100, the average price of regeneration yuan per dose was more than US $2000, and the government procurement price of small molecule oral drugs for a course of treatment was US $712. In contrast, if the "rumored price of 8000 yuan" could be truly implemented, it would be much cheaper than the antibodies of several existing international giants. In addition, neutralizing antibodies can also be applied to the field of prevention, and the commercial space can continue to be expanded. It is reported that tengshengbo medicine will also carry out further research in China to evaluate the preventive and immune enhancement effect of ambavizumab / romistumab combination therapy in immunosuppressed people. Luo Yongqing pointed out to reporters that vaccination is active immunization, which produces a variety of antibodies with strong and weak abilities; in contrast, the neutralizing antibody provided by Tengsheng Huachuang is to select the two antibodies with the strongest antiviral ability among many antibodies, which can complement each other, so as not to produce drug resistance, and genetically modify this pair of antibodies by means of bioengineering to make their half-life Longer. "Generally, the antibody produced by the human body is about 21 days. After genetic function transformation, the neutralizing antibody of Tengsheng Huachuang can have a half-life of 76 days to about two or three months, which means that the retention time and effective concentration in the blood can be maintained for a long time." Therefore, there is a complementary relationship between neutralizing antibodies for injection and antibodies produced by injection vaccine. So far, three neutralizing antibodies for prevention indications have been approved overseas, of which two have obtained post exposure prevention and one has obtained exposure prevention. In addition, compared with competitive products, according to the previous interview with medtrend by Dr. Yan Li, chief medical officer of tengshengbo pharmaceutical, several highlights of brii-196 / brii-198 combination therapy are: First, the double antibody structure can bind different sites to form a superposition effect, which can better avoid the failure risk caused by mutant strains; Second, the team genetically modified antibodies, which can prolong their half-life, increase the blood concentration of the lungs, and better protect the patients, because the respiratory tract and lung are the main places for COVID-19 to invade. Third, reduce the risk of patient death, which is the only similar variety in research that has clinical data to prove. In addition, how to deal with the continuous mutation and upgrading of the virus is an issue that almost every new crown drug has to consider from the beginning of the project. Whether this drug can block Omicron, Luo Yongqing said, and further research results are expected within two weeks. After all in "new crown", can tengshengbo become an anti infection giant? Xinguan specific drug is a strategic drug, and its price and quantity are controlled by the state. Even though there is still some uncertainty in its commercialization, it must be very good for tengshengbo drug. Reflected in the capital level, affected by the good news of neutralizing antibody combination therapy, the share price of Tengsheng boyao has risen steadily in the past month, with a cumulative increase of more than 100%. As of the closing on December 9, the market value of Tengshi boyao has reached about HK $30.7 billion. In this regard, Shi lichen, head of Beijing Dingchen pharmaceutical management consulting center, previously pointed out in an interview that at present, the concept of new crown specific drugs is hot, and its real value is to prove that the enterprise has a very strong R & D strength and can share the R & D expenses, but it does not mean that the pharmaceutical enterprise will achieve great benefits. In fact, at the beginning of 2018, Tengsheng pharmaceutical mainly focused on studying the treatment plan for major infectious diseases. However, the sudden COVID-19 "disrupted" its rhythm -- in 2020, quickly invested all resources, all in "new crown" to promote neutralization antibody combination therapy. Tengshengbo pharmaceutical product line under development (prospectus version) By September 2020, Luo Yongqing, former global vice president of Geely de and general manager of China, announced to join tengshengbo pharmaceutical to steer the company's Greater China region. Under his leadership, Tengsheng pharmaceutical has established dozens of product lines for infectious diseases and CNS (central nervous system) diseases through internal research and development and "License in". In addition to anti crown drugs, most of the hepatitis B functional cure drugs and long-acting HIV therapies are aimed at infectious diseases with significant public health burden and have great potential for development. Taking hepatitis B new drug as an example, it is the most important direction of the development of antiviral drugs in China. A group of data can intuitively reflect that more than 200 million of all chronic hepatitis B virus (HBV) infections are expected worldwide. The industry generally believes that the number of patients with chronic hepatitis B in China is close to 75 million. The vast majority of patients with chronic hepatitis B need to receive lifelong treatment. More than 650 thousand people die from HBV related end-stage liver disease every year, including liver failure, cirrhosis and hepatocellular carcinoma (HCC). So far, there are not a few HBV drugs developed in the world. The drugs that have been listed are mainly interferon and nucleoside analogues (NA). However, interferon has gradually withdrawn from the HBV drug market due to its large side effects and poor patient tolerance for a long time. However, the therapeutic effect of Na is "very limited" and can not achieve functional cure. Therefore, Li Ankang believes that, "Hepatitis B research and development project is likely to bring great value to the company." In addition, from a macro perspective, according to the data provided by frost Sullivan, the market scale of global infectious disease drugs (including antiviral drugs, antibiotics, antifungal drugs and other infectious disease drugs) is expected to increase from US $128.2 billion in 2019 to US $19.6 billion in 2034, still the third largest treatment field in the world. Especially after COVID-19, the development of anti infective drugs has received unprecedented attention. Massive amounts of resources have been rapidly and continuously inflow. Whether VC/PE or two tier market funds, all kinds of funds are actively looking for high-quality investment targets for anti infective investment tracks, and the number of investment increases year by year (as shown below). Number of financing projects in anti infection field over the years (picture source: medicine cube) Under such a good development background, coupled with the fact that Hong Kong stock 18a company focuses on the research and development of new anti-tumor and autoimmune diseases, tengshengbo medicine can be called a unique, scarce and popular target, and the trend prospect is worth looking forward to. In the long run, enterprises with deep product layout in the anti infection track are very scarce even if they look at the world. Gilead, who came from the track of HIV-1, HBV and HCV infection, is now a multinational pharmaceutical giant. Can tengshengbo become the Chinese version of Gilead? This deserves our long-term attention. (Xinhua News Agency)