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    Home > Biochemistry News > Biotechnology News > After the vaccine, China's new crown neutral antibody research also ranks among the world's leading level

    After the vaccine, China's new crown neutral antibody research also ranks among the world's leading level

    • Last Update: 2020-06-17
    • Source: Internet
    • Author: User
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    It is reported that the trial is a random, double-blind, placebo-controlled study, co-chaired by Professor Zhang Wei and Professor Zhang Wenhong of Huashan Hospital affiliated with Fudan University, to evaluate the tolerance, safety and pharmacokinetic characteristics and immunogenicity of JS016 intravenous infusion drugs in Chinese health volunteers, to provide a basis for exploring the treatment and prevention of JS016 anti-new coronavirus in human sinIt is worth mentioning thatthis is the world's first new coronavirus neutralizing antibody clinical trials in healthy subjects, and the first in China to enter the clinical phase of the new coronavirus neutralizing antibodyprevious clinical trials have shown that single-clone neutralizing antibodies can reduce the level of Ebola patients, effectively neutralizing virus toxicity, substantially improving clinical symptoms, and reducing the mortality rate of infected peopleJS016 is a human-sourced monoclonal antibody that is rapidly screened in patients during rehabilitation and recombined in vitro to express a high degree of virus and abilityPreclinical studies have shown that JS016's receptor binding region (RBD) of the ncytovirus sting protein (S protein) exhibits a high degree of specific affinity, reaching nM levels, and is able to preemptively bind to the virus, thus blocking the virus from invading host cells from the sourcein terms of effectiveness, rhesus monkey animal infection experiments showed JS016 to show therapeutic and preventive results, and the data were published online in the international authoritative journal Nature (IF 43.070), the first non-human primate experiment to report anti-new coronavirus neutralizing antibodiesin terms of safety, JS016 antibody gene comes from a single B-cell in a rehabilitation patient, is an all-human natural antibody, screened by the human immune system, does not bind to the human body's own antigen, is expected to have better safetyIn addition, in order to reduce the risk of antibody-mediated acute lung injury and ensure safety in clinical applications, the team modified The Fc region of JS016 to effectively reduce possible antibody dependence enhancement effects (ADE), antibody-mediated cytotoxic effects (ADCC), and cell phagocytosis (ADCP)In the toxicology of preclinical crab monkeys, the maximum tolerable dose (MTD) and the unobserved apparent toxic reaction dose (NOAEL) are dozens of times the recommended starting dose in human clinical trials, suggesting that there are large safety windows and providing a reliable scientific basis for JS016 clinical trials to play a safe, stable and effective rolefor the new coronavirus, neutralizing antibody drugs may be one of the effective responsesFrom February 2020 to the present, many pharmaceutical companies, including Regenerative Yuan, Lilly, AstraZeneca and Celltrion, are in ongoing research and developmentSo far, two companies have announced that they have been approved for human clinical practice, and the other is the Canadian drug maker AbCellera and Lilly's LYCoV555, which entered Phase I clinical on June 1and for JS016, Lilly is also "a part of it." On May 4, Junshi Bio announced a cooperation agreement with Lilly on the development and development of new crown neutralizing antibody drugs, which mainly includes:(1) authorize Lilly to conduct exclusive licenses for research and development, production and sales of Junshi New Crown Antibodies outside Greater China; Pay a down payment of $10 million and pay the company up to $245 million in milestones, plus a double-digit percentage of the net sales of the product, after each of the required milestones is achieved by the new crown antibodies (single-use or combination)(2) the two sides will promote clinical trials and commercialization of the new new crown antibody drug, and Lilly will subscribe for a new H-share (potential subscription) of Junshi Bio for $75 million under a mutually agreed terms and conditionsa global multi-pronged approach to find the "antidote" to the new coronavirus as soon as possibleOn vaccines, according to the United Nations Health Organization, there are 133 candidate sin-based vaccine programmes for the new coronavirus worldwide, Chinese mainland six are in clinical trialsAntibody drugs, according to the latest statistics of The evaluate website on June 4, the global anti-new crown virus antibodies and protein research and development projects up to 18, regenerative yuan, AstraZeneca and other international giants such projects will be in June and beyond will gradually enter the human clinicalSource: Pharmaceutical MingkangReferences:1, Junshi Bio announcement2, Guojin Securities: China's first new crown neutralizing antibody approved IND completed the first injection
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