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    Home > Active Ingredient News > Infection > mRNA vaccine ARCoV is about to start phase III clinical trials in Mexico | Yimai Meng broke the news

    mRNA vaccine ARCoV is about to start phase III clinical trials in Mexico | Yimai Meng broke the news

    • Last Update: 2021-05-21
    • Source: Internet
    • Author: User
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    Recent popular reports from Yimaike ★ Genxi Biotech appointed Dr.
    Ni Yajin, a senior expert in the field of gene and cell therapy, as the company's chief technology officer ★ Focusing on CAR-T cell transformation, where is the next generation of CAR-T therapy? MedClub News May 14, 2021/MedClub News/--On May 11, Mexican Foreign Minister Marcelo Ebrard announced that the new mRNA vaccine ARCoV developed by a Chinese company will be available on the 30th of this month.
    Mexico started a phase III trial, and it is expected that 6000 volunteers will participate.

    The ARCoV vaccine was jointly developed by Yunnan Watson Biotechnology Company (hereinafter referred to as Watson Bio), Suzhou Aibo Bio, and the Institute of Military Medicine of the Academy of Military Sciences.
    The overseas phase III clinical trials will be launched in May.

    According to Reuters, this is China's first mRNA vaccine to enter Phase III clinical trials.

    Hong Kong's "South China Morning Post" quoted data from the online database ClinicalTrials.
    gov on the 12th, showing that in the phase III clinical trial, Watson Bioplans to recruit about 28,000 volunteers over the age of 18 worldwide, of which at least 25% are volunteers The person is over 60 years old.

    These volunteers will be randomly assigned to the study group and the control group, and receive two doses of experimental vaccine or placebo, 28 days apart.

    The health of the volunteers will be monitored for 12 months.

    According to the report, the preliminary study of this clinical trial is expected to be completed by the end of October.

    According to public information, Watson Biosciences developed the ARCoV vaccine in 2020, and obtained the drug clinical trial approval from the National Medical Products Administration in June of that year, and then entered the phase II clinical trial phase.

    It is reported that the first two phases of clinical data are relatively satisfactory.

    ARCoV vaccine has independent intellectual property rights, and its core raw materials and key equipment have been localized.

    In December 2020, Watson built China's first mRNA COVID-19 vaccine production workshop.
    The ARCoV vaccine is expected to be completed and put into production within 8 months, with a production capacity of 120 million doses per year in the first phase.

    In March of this year, Huang Zhen, co-founder of Watson Biotech, said that the company has contacted Mexico, Colombia, Indonesia, Pakistan and Turkey and may start trials in the second half of this year.

    He also said that the interim analysis data of the trial will be available at the end of this year.

    In April this year, in an exclusive interview with CCTV, the founder of Aibo Biotech, Dr.
    InBev also revealed that the vaccine will officially start an overseas multi-center clinical trial as early as May, with the first choice or in South America, "will consider the local epidemic situation, Countries that lack research and development capabilities and vaccine supply are given priority considerations, so that they can effectively help local control the epidemic.
    "
    mRNA, or Messenger RNA (messenger ribonucleic acid), is a messenger that transfers genetic information from DNA to protein, and provides instructions for human cells to produce target proteins (antigens), thereby activating the human immune response and resisting the corresponding virus.

    Up to now, two mRNA vaccines have been approved globally, namely BNT162b2 jointly developed by Germany BioNTech, Pfizer and Fosun Pharma, and mRNA-1273 from Moderna of the United States.
    Both have demonstrated a protection rate of over 90% in clinical trials.
    , Is currently the new crown vaccine with the highest protection rate data in the world.

    However, the storage and transportation temperature conditions of the two are relatively high, requiring minus -70 degrees (BNT162b2) and -20 degrees (mRNA-1273) respectively.

    Aibo Biological is one of the earliest companies engaged in mRNA drug research and development in China.
    It was founded in Suzhou Industrial Park in early 2019.
    In 2020, the Joint Academy of Military Sciences Institute of Military Medicine and Yunnan Watson Biology successfully developed the first Chinese new crown ARCoV vaccine to enter the clinic.

    "Whether it is an in vivo animal experiment or a clinical experiment, from the results we got, the domestic ARCoV vaccine product is completely comparable to the two overseas mRNA vaccines," said InBev, the founder of Abbio.

     ▲ SARS-CoV-2 vaccine can cause a protective immune response in mice and non-human primates.
    Compared with other mRNA vaccines, ARCoV is different in that it can be stored at 2-8 degrees Celsius.

    In the animal test published in the medical journal Cell, in order to evaluate the thermal stability of ARCoV, the team of Professor Qin Chengfeng of the Academy of Military Medical Sciences stored the vaccine at room temperature for up to 7 days, and then injected it into mice to still be effective.

    This allows ARCoV to greatly reduce the challenges of cold chain transportation.

    Compared with other types of vaccines, the biggest advantage of mRNA vaccines lies in the short production links and R&D cycle, relatively simple process, and rapid production.

    According to news in December 2020, Watson Bio is mainly responsible for the industrialization of ARCoV.
    The production workshop of Watson Bio for the production of mRNA new crown vaccine was started in Yuxi, Yunnan, with an investment of 280 million yuan and an estimated production capacity of 120 million doses per year.

    It is worth mentioning that in April this year, Aibo Bio-Bio announced the formal completion of 600 million yuan in Series B financing.

    Recommended reading: Pharmaceutical financingAibo Biotech's B round financing of 600 million yuan, marching towards a new journey of RNA technology research and development! Reference materials: 1.
    Observer Network "Follow! Major Progress in China's mRNA Vaccines" Yimike has always been committed to original news reports on cutting-edge technologies, industry trends, and industry insights in bio-innovative drugs.
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