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    Home > Medical News > Latest Medical News > Shanghai completed the first case of new coronavirus and antibody subjects

    Shanghai completed the first case of new coronavirus and antibody subjects

    • Last Update: 2020-11-25
    • Source: Internet
    • Author: User
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    People's Network Shanghai, June 7 (Ge Junjun) June 5, Shanghai Junshi Biopharmaceutical Technology Co., Ltd. and China
    Microbiology Research Institute and other units jointly developed the reorganization of the whole human source anti-neo-coronavirus monoclonal antibody injection (hereinafter referred to as "JS016") was approved by the State Drug Administration, into phase I clinical trial stage. This morning, Huashan Hospital, affiliated with Fudan University, completed the first case of the subject's medication. This is the world's first non-human primate experiments, in a healthy population of the new coronary pneumonia therapeutic antibody clinical trials, marking China's independent intellectual property rights of the new coronavirus-specific antibody drugs successfully entered the human clinical evaluation stage.
    The clinical trial, using a randomized, double-blind, placebo-controlled study, was co-chaired by Professor Zhang Wei and Professor Zhang Wenhong of Huashan Hospital to evaluate the tolerance, safety, pharmacogenic characteristics and immunogenicity of JS016 intravenous infusions in Chinese health volunteers.
    Zhang Wei, the first dose group of 4 healthy subjects in good condition in the morning, the follow-up will be strictly in accordance with the test program to continue to advance. Safety tolerance data for all healthy subjects obtained will support the selection of appropriate doses for subsequent clinical trials in patients with new coronavirus infections.
    Feng Hui, chief operating officer of Junshi Bio, said that the antibody is produced by human B lymphocytes, and when the virus invades the cells, the antibody can preemptively bind to the antigens on the surface of the virus and "mesitive" them. As a "foreign aid" expressed in genetic engineering recombination, the antibody drug can be injected into the human body, can preempt the new coronavirus prickly protein (S protein) binding, so that the virus can not infect human cells, and thus be eliminated by the immune system. Previous clinical trials have shown that monoclonal and antibodies can reduce the level of virus in Ebola patients, play an effective role in normally memorized viral virology, substantially improve clinical symptoms, reduce the mortality rate of infected people and so on.Professor Zhang Wenhong,
    , said: "Neutral antibodies can attack the new coronavirus with precision, with a unique targeting, can prevent the virus from replicating in the human body, quickly produce effects." We want to demonstrate the good safety and todgability of JS016 in Phase I. to provide data support for follow-up clinical programs. The antibody therapy is expected to be the first treatment option to combat the new coronavirus. In
    potential therapeutic effects, previous studies have shown that antibody drugs have the effect of preventing viral infections. Unlike vaccines, the drug is more suitable for the prevention of key population groups such as health care workers and the elderly in intensive care units in emergency situations, and is complementary to vaccines.
    , a researcher at the Institute of Microbiology, said: "Preclinical studies have shown that JS016 has a strong ability to meso-active and block, as well as the prevention and treatment of new coronavirus. We look forward to further clinical validation. According
    , JS016 originated in patients recovering from neo-coronary pneumonia.Using single-cell sequencing technology, researchers at the
    Institute of Microbiology isolated the neutral monoclonal antibodies of the new coronavirus from a single nucleus of the patient's exost blood, and then used fluid cell technology to conduct blocking test analysis, screening out neutral and highly active antibodies and recombining them in-body recombination. In the Ministry of Science and Technology, Shanghai Science and Technology Commission emergency science and technology project support, Junshi biological
    microorganisms screened antibodies for multiple parallel development, completed protein expression, immune
    Fc segment (crystallization segment) engineering transformation, cell plant construction and other antibody process development and large-scale production of key steps, the original need for 4 to 6 months to prepare a stable cell strain shortened to 3 months.
    Under the overall promotion of the
    joint prevention and control mechanism, antibody research and development has been the Ministry of Science and Technology, the National Health And Safety Commission, the State Drug Administration,
    , Shanghai, Beijing, the strong support, up and down linkage, collaborative attack, reflecting the new national system in major drug research and development of great advantages.
    preclinical studies have shown that the subject binding region (RBD) of JS016 to the new coronavirus S protein exhibits a very specific affinity, reaching the namor level and being able to preemptively bind to the virus and block the virus from invading the host cells at the source.
    In terms of effectiveness, the rhesus monkey animal infection experiment showed the therapeutic and preventive effect of JS016, and the results showed that the medium antibody effectively blocked the infection of the new coronavirus, significantly reduced the load of the new coronavirus in the rhesus monkey respiratory tract, and protected the lung damage caused by the viral infection. The data has been published online in Nature, the world's top science and technology journal.
    in terms of safety, the JS016 antibody gene is derived from a single B cell in a recovered patient and is an all-human natural antibody, which is expected to have better safety. In addition, in order to reduce the risk of acute lung injury mediated by antibodies and ensure safety in clinical applications, the team modified the Fc segment of JS016 to effectively reduce the possible antibody-dependent enhancement effect (ADE), antibody-mediated cytotoxic effects, and cell phagocytospheric effects. In preclinical crab-eating monkey toxicology studies, the maximum to-to-do dose and the dose of no significant toxic reaction observed were dozens of times the recommended starting dose in human clinical trials, meaning that there was a large safety window.
    experts say there is still a long way to go from entering the human clinical trial phase to the eventual use of antibody drugs, and that the results are hard-won and there is still a long way to go.
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