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The first domestic new crown specific drug approved: how effective is it on mutant strains?

Share the QR code < / P > < p > with wechat scanning code to friends and circle of friends < / P > < p > the new crown neutralizing antibody therapy of tengshengbo medicine has obtained emergency approval in China

12 8, the official website of the State Administration of drug administration announced that emergency approval of Tengsheng Huachang Pharmaceutical Technology (Beijing) Co., Ltd. (Tengsheng Huachang), COVID-19 neutralizing antibody combination therapy, BRII-196 and romicwell monoclonal antibody injection (BRII-198) registration application. The above two drugs are approved for the treatment of light and ordinary New Coronavirus and COVID-19 patients with adult and adolescent (12 to 17 years old, weight over 40kg) who are highly risk factors (including hospitalization or death). Among them, adolescents (12-17 years old, weight ≥ 40kg) with indications are subject to conditional approval < p > the State Food and Drug Administration said that the drug was subject to emergency review and approval by the State Food and Drug Administration in accordance with the relevant provisions of the drug administration law and the special drug approval procedures. It is the first Chinese self approved intellectual property COVID-19 neutralizing antibody combination therapy. p> < p > from the perspective of industry, the approved combination therapy is also the first approved new crown neutralizing antibody combination therapy in China < p > who is Tengsheng Huachuang < p > the company behind the above new crown neutralizing antibody combination therapy is Tengsheng Huachuang, a subsidiary of Tengsheng boyao (02137. HK), a Hong Kong listed company

2020, Tengsheng pharmaceutical and Tsinghua University and Shenzhen Third People's Hospital reached a joint venture to announce the joint efforts to promote the research, transformation, production and commercialization of monoclonal antibody neutralizing antibodies against COVID-19. After that, the three parties set up joint venture Tengsheng Huachang to jointly develop neutralizing antibodies against BRII-196 and BRII-198. p> < p > at the end of November this year, public information showed that the new crown neutralizing antibodies of brii-196 and brii-198 are expected to be approved for listing by the end of December

Tengsheng pharmaceutical was founded in 2017 and listed on the HKEx in July this year. Its main business areas are targeted at major infectious diseases in China and the world (such as hepatitis B, COVID-19, human immunodeficiency virus (HIV) infection, multiple drug resistance (MDR) or extensively drug-resistant (XDR) gram negative bacterial infections) and other diseases with significant public health burden. (e.g. central nervous system diseases) Develop innovative therapies. < / P > < p > affected by the good news of neutralizing antibody combination therapy, the share price of tengshengbo pharmaceutical has risen steadily since November 9, with a cumulative increase of more than 130%. As of the closing of December 8, tengshengbo pharmaceutical reported HK $42.8/share, up 0.59%, with a market value of HK $30.83 billion. < / P > < p > how is the effect of Zhonghe antibody therapy on mutant strains? < / P > < p > according to the report of science and Technology Daily on November 22, tengshengbo The novel coronavirus pneumonia antibody therapy in 4 continents, 6 countries and 111 clinical trial institutions, 837 clinical trials of new crown pneumonia patients showed that the combined drug could reduce 78% hospitalization and mortality rate, and the drug delivery group achieved zero death after 28 days of treatment, while 8 cases died in the control group.

in addition to the positive results of clinical research, in fact, before the emergency response was approved, the drug delivery system was effective in treating the patients with severe acute respiratory syndrome. The above neutralizing antibody therapy has played a role in clinical treatment. Previously, the surging reporter learned from the Ministry of science and technology that more than 800 patients were treated with the combination of brii-196 and brii-198. Preliminary clinical observation showed that the combination of brii-196 and brii-198 had good safety and antiviral efficacy. < / P > < P > after the drug was approved, tengshengbo drug president and greater China Luo Yongqing, general manager of the District, wrote in the circle of friends: "zero breakthrough of anti Xinguan special drug! Today, with a long tassel in hand, when to bind the Canglong!" < / P > < p > at present, tengshengbo medicine has not released relevant information on whether the Omicron variant that has attracted much attention affects the effect of neutralizing antibody therapy. < / P > < p > however, Zhang Linqi, a professor of Tsinghua University who participated in the study of brii-196 and brii-198 combination therapy, once told surging news reporters: in the process of promoting global multicenter clinical trials, especially from May to August this year , delta was the main epidemic strain in the country Virus dominated. The blinded phase III clinical trial showed the effectiveness of reducing the death and hospitalization rate by 78%, and also proved that it maintained good activity against these mutants, and the broad-spectrum of the drug was also demonstrated in the antiviral experiment in vitro. < / P > < p > for the research direction of the above neutralizing antibody combination therapy in the future, Zhang Linqi revealed that the clinical research includes Basic research and clinical trials should cooperate with each other. Basic research will continue to be carried out mainly from the aspects of the mechanism of antibody inhibiting virus, how to give greater play to the antiviral activity of drugs, the long-term effect in vivo, and the broad spectrum of different mutant strains. Corresponding work will also be carried out for the application of the above combination therapy in prevention in the future. < / P > < p > The novel coronavirus pneumonia in China is also mainly focused on 3 technical routes, including BRII-196 replication, neutralization antibody combination therapy, BRII-196, BRII-198, BDB-001, JS016, neutralizing antibody DXP604, and so on. The following are the main technical routes to inhibit the replication of virus, block the entry of virus into the cell and regulate the immune system of

. Among them, there are many new advances in the treatment of drugs. Neutralizing antibody therapy JS016, developed by

and the Jun Shi biological team, is also a neutralizing antibody. After the completion of the international multicenter Ib/II clinical trial in mainland China, Hongkong, Chinese mainland, Philippines and Ukraine, all the patients in the JS016 and all clinical data were included. It is expected that the clinical trial conclusion will be drawn in December. < / P > < p > azvudine developed by Henan Normal University is an oral new crown treatment drug, and phase III clinical trials are being carried out in China, Brazil and Russia. Surging news previously learned from the Ministry of science and technology that the drug is striving to apply for domestic conditional approval for listing in December. < / P > < p > prochloramide, which develops the pharmaceutical industry, is another oral new crown treatment drug At present, three international multicenter phase III clinical trials are being carried out in China, the United States, Brazil and other countries. The enrollment work is being carried out in an orderly manner for patients with mild and moderate new crowns and patients with severe new crowns. The fastest progress is the phase III clinical trial for patients with mild and moderate new crowns carried out in the United States and other countries. The interim data are expected to be released in December. < / P > < p > there is a Will the new crown therapeutic drugs and the new crown vaccine still be used? < / P > < p > the emergence of the new crown therapeutic drugs gives people a new hope of global anti epidemic. With therapeutic drugs, will the people's demand for the new crown vaccine decrease? How to invest in the new crown vaccine market? < / P > < p > for the new crown therapeutic drugs and ?
2023-03-22 10:04:47

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