Clicking on the novel coronavirus pneumonia is concerned about the high contagion of the delta strain.
The recent epidemic trend of overseas epidemic and the occasional outbreak in China have also attracted people’s attention to drugs that can cure novel coronavirus pneumonia.
On September 10, the Beijing Daily learned from tengshengbo Pharmaceutical Biotechnology Co., Ltd.
that in June this year, academician Zhong Nanshan led the company to launch the phase II clinical trial of the combination therapy of novel coronavirus neutralizing antibody brii-196 / brii-198 in China.
In August this year, the enrollment of patients in the international phase III clinical trial of this combination therapy was completed.
The interim results published at the end of August showed that this combination therapy reduced the composite end point of hospitalization and death by 78%, and was safe and well tolerated.
Novel coronavirus pneumonia is diagnosed in 223022538 cases and 4602882 cases died in Beijing, daylight saving time, according to the latest real-time statistics from the World Health Organization.
At 16:47 on September 10th (16:47 22:47 in September 10th), the total number of confirmed cases of novel coronavirus pneumonia was accumulated worldwide.
According to the official website of tengshengbo medicine, the company is a multinational biotechnology enterprise located in China and the United States.
At present, it is stepping up the research and development of novel coronavirus neutralizing antibodies brii-196 and brii-198 combined therapy.
In August this year, the enrollment of patients in the international phase III clinical trial of brii-196 / brii-198 combined therapy was completed.
On August 25, tengshengbo pharmaceutical announced that the company’s novel coronavirus neutralizing antibody brii-196 / brii-198 combination therapy reduced the composite end point of hospitalization and death by 78% compared with placebo in 837 patients at high risk of disease progression.
This means that the novel coronavirus drug may reduce the mortality of hospitalized patients by 78%.
BRII-196 and BRII-198 are the monoclonal neutralizing antibodies obtained from the body of New Coronavirus pneumonia patients in rehabilitative period by Tengsheng Bo medicine and the third people’s Hospital of Tsinghua University and Shenzhen people’s hospital.
The gene engineering technology is used to reduce the risk of mediating dependence enhancement, enhance the penetration of antibody to the lung, and extend the plasma half-life to achieve more lasting therapeutic effect.
It also has high neutralizing activity.
Photo source: tengshengbo official website at present, the application for new drug clinical trial of this combination therapy has been submitted to the U.S.
Food and drug administration, the State Drug Administration of China and the Department of health of Hong Kong, China.
Since May this year, tengshengbo pharmaceutical has assisted relevant government departments to urgently provide brii-196 / brii-198 neutralizing antibodies for clinical treatment in many outbreak areas in China, including Shenzhen, Guangzhou, Ruili, Nanjing, Yangzhou, Zhangjiajie and Zhengzhou.
The experimental data of in vitro chimeric virus showed that BRII-196/BRII-198 combination therapy maintained neutralization activity on the major COVID-19 mutant strains that were widely concerned, including “Alfa”, “beta”, “gamma”, “epsilon”, “delta”, “lambda” and “Miao”.
So far, only a few novel coronavirus antibody drugs such as regenerant, Lilly, GSK and vir have been authorized for emergency use worldwide.
In addition, according to Yan Li, chief medical officer of tengshengbo pharmaceutical, the phase II clinical trial of brii-196 / brii-198 combined therapy new drug in China (nct04787211) is under way, led by academician Zhong Nanshan, academician of the Chinese Academy of engineering and director of the National Clinical Medical Research Center for respiratory diseases of the First Affiliated Hospital of Guangzhou Medical University.
At present, the enrollment of patients has been completed, The relevant test results will be announced before the end of the year.
“We have just invested an additional US $100 million to further prepare for the registration and listing of brii-196 / brii-198 combination therapy.” Dr.
Li Ankang, chief financial officer of tengshengbo pharmaceutical, said: “this US $100 million will be mainly used for the preparation of global approval and listing, including China and the United States.” it is reported that, At present, brii-196 / brii-198 combination therapy has been used in more than 1500 patients.
At present, no serious adverse reactions have been observed, showing good safety and tolerance.
Two months after listing, the share price soared by 90%.
According to the data, tengshengbo pharmaceutical is a biotechnology enterprise focusing on the field of major infectious diseases and central nervous system diseases.
It focuses on the research and development of innovative drugs for infectious diseases.
The novel coronavirus monoclonal neutralizing antibody brii-196 / brii-198 combination therapy is the new drug with the fastest research progress of the company which has just been established for four years.
Tengsheng pharmaceutical has not been on the capital market for a long time.
It was listed on the Hong Kong Stock Exchange in July 13, 2021.
Due to the rapid development of the joint therapy of the novel coronavirus virus treatment drug BRII-196/BRII-198, it has entered the three phase of the international clinical research and is highly sought after by the capital.
In addition to neutralizing antibodies, tengshengbo pharmaceutical has 11 pipelines under research, of which 7 are imported projects.
Since July 13, the share price of Tengsheng Bo pharmaceutical has risen from the issue price of HK $22.25 to HK $42.2, with a cumulative increase of nearly 90%.
The latest total market value is HK $30.4 billion.
At present, tengshengbo pharmaceutical has no drug on the market, so the operating revenue is zero and the main expenditure is R & D expenses.
In 2019 and 2020, the R & D expenses were 83.785 million yuan and 876 million yuan respectively, so it has been in a state of loss.
The loss in the first half of this year was as high as 2.95 billion yuan, and the loss in 2019 and 2020 were 520 million yuan and 1.29 billion yuan respectively.
Pharmaceutical enterprises compete for the layout of neutralizing antibody drugs.
In the R & D of many novel coronavirus drugs for treatment, neutralizing antibody drugs are considered to be one of the biggest breakthroughs that are expected to become the “special drugs” of the novel coronavirus, and it is also the most sought after track, attracting a large number of Chinese and foreign pharmaceutical enterprises to compete for the layout.
Industrial Securities believes that the commercial market space of neutralizing antibody drugs can reach 44.4 billion to 93.9 billion yuan.
The so-called neutralizing antibody is a soluble protein secreted by B lymphocytes.
When the human body is attacked by a virus, immune cells will release neutralizing antibodies into the blood and combine the virus particles in the blood to prevent the virus from adhering to the target cell receptor and destroy the infection behavior of the virus, so as to “neutralize” the virus.
According to the securities times, at present, there are as many as 20 drugs related to the prevention / treatment of novel coronavirus disease approved by regulatory authorities, emergency use authorization (EUA) / temporary supply in China, the United States, Europe and Japan, including 11 vaccines, 3 neutralizing antibodies and 6 other products.
Photo source: Photo Network (irrelevant to pictures and texts) at present, there are at least 10 novel coronavirus neutralizing antibody drugs under research in China.
Among them, js016 jointly developed by Junshi biology and Institute of Microbiology of Chinese Academy of Sciences, two neutralizing antibodies brii-196 and briii-198 of tengshengbo medicine, mw33 of Maiwei biology, scta01 of Shenzhou cell, ly covmab of LVYE pharmaceutical, Fuhong Hanlin hlx70 and jiminxin jmb2002 have entered the stage of clinical trials.
In addition, Yang Xiaoming team of Sinopharm China biology also found monoclonal antibodies effective for a variety of novel coronavirus variants.
At present, the clinical application of 2B11 antibody is advancing in an orderly manner..