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艾美疫苗(06660):四价MDCK细胞流感病毒疫苗提交临床试验预申请

Le Méridien vaccine (06660): quadrivalent MDCK cell influenza virus vaccine submitted for clinical trial pre-application

Zhitong Finance ·  Mar 28 08:13

Le Méridien Vaccine (06660) announced that the group submitted quadrivalent MDCK cells on March 27, 2024...

Zhitong Finance App News, Le Méridien Vaccine (06660) announced that the group submitted a pre-clinical trial application for the quadrivalent MDCK cell influenza virus vaccine on March 27, 2024. Currently, all influenza vaccines marketed in China are produced based on the chicken embryo process, and no influenza vaccine based on cellular matrices has been approved for marketing. Organizations such as the World Health Organization, the US Food and Drug Administration, and many governments encourage the use of animal cell culture technology to replace traditional chicken embryo processes to produce influenza vaccines.

Due to the high variability of the influenza virus, the World Health Organization announces candidate strains for seasonal influenza vaccines in the northern and southern hemispheres every year to guide countries in developing and producing influenza vaccines to cope with the next season's pandemic. The influenza virus vaccine developed by the company uses MDCK cells to replace chicken embryos for cultivation. The production cycle is short, there is no problem of unstable supply of raw materials, and it has a strong ability to cope with virus mutations. It can be automated and cultivated on a large scale in bioreactors. The risk of contamination is low, and it is easy to be industrialized on a large scale. Therefore, it can produce products that respond to popular seasonal strains announced by the World Health Organization to better meet public health needs. In addition, the MDCK cell influenza vaccine developed by the company has a low chance of virus mutation during transmission, contains no egg albumin, and the risk of allergies is significantly reduced.

The quadrivalent MDCK cell influenza vaccine developed by the group is made using influenza A and B influenza virus strains recommended by the World Health Organization. It is suitable for people aged 6 months and above. It is especially recommended for susceptible people and people prone to related complications, such as children, the elderly, the frail, and people in areas where influenza is prevalent. After receiving this vaccine, specific humoral immunity and cellular immunity can be produced. Anti-HA antibodies neutralize the occurrence of infections, while reducing the condition and stopping the spread of the virus are related to anti-NA antibodies. The cellular immune response is mainly that specific CD4+ T lymphocytes can help B lymphocytes produce antibodies, and CD8+ T cells can kill infected cells, effectively preventing influenza.

The influenza virus is an acute respiratory infectious disease that can cause large-scale epidemics. It is highly contagious. It can cause complications such as pneumonia, bronchitis, and myocarditis. It can exacerbate underlying diseases in high-risk groups such as the elderly and the infirm, increase the burden of disease, and endanger human health. The World Health Organization estimates that influenza can cause 3 to 5 million severe cases and 290,000 to 650,000 deaths related to respiratory diseases worldwide each year. Vaccination against influenza is the most economical and effective way to prevent influenza disease and influenza outbreaks. The number of influenza vaccine batches issued in China in 2019 was about 22.67 million, and the number of batches issued in 2023 is expected to be 76.69 million. Industry consultants' insight and consultation estimates that China's influenza vaccine market will be about 20 billion yuan in 2030.

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