NEWS
PRE-APPLICATION FOR CLINICAL TRIALS FOR QUADRIVALENT INFLUENZA VIRUS VACCINE (MDCK CELLS) SUBMITTED
The board of directors of the Company (the “Board”) is pleased to announce that the Group has submitted the pre-application for clinical trials for quadrivalent influenza virus vaccine (MDCK Cells) on March 27, 2024. Currently, all influenza vaccines available on the domestic market are produced using chicken embryo technology. There have not been cell-based influenza vaccines approved for marketing. Organizations such as the World Health Organization, the U.S. Food and
Drug Administration, and governments of several countries worldwide advocate for the adoption of animal cell culture technology to replace the traditional chicken embryo technology in production of influenza vaccines.
Due to the high variability of the influenza virus, the World Health Organization annually announces the candidate strains for seasonal influenza vaccines in the northern and southern hemispheres for the upcoming season to guide countries in researching and developing and producing influenza vaccines to address the upcoming season’s pandemic. The influenza virus vaccine developed by the Company utilizes MDCK cells instead of chicken embryos for cultivation. This vaccine has a shorter production cycle, does not face concerns regarding unstable raw material supply, has robust capability to withstand virus mutations, can be cultivated
automatically in bioreactors at scale with low contamination risks and is conducive to large-scale industrial production. Consequently, the vaccine can be tailored to produce products targeting the seasonal strains in accordance with the candidate strains announced by the World Health Organization each season, better meeting public health needs. Furthermore, the influenza vaccine (MDCK Cells) developed by the Company has a low probability of virus mutation during passage, and does not contain ovalbumin, significantly reducing the risk of allergic reactions.
The quadrivalent influenza virus vaccine (MDCK Cells) developed by the Group is made from the influenza A and B virus strains recommended by the World Health Organization. It is indicated for people aged 6 months and above, especially those who are susceptible and prone to related complications, including children, the elderly, the infirm and people in the influenza-endemic areas. After vaccination, specific humoral immunity and cellular immunity will be generated. Anti-HA is a neutralizing antibody that resists infection, while anti-NA antibodies are associated with alleviating diseases and preventing virus transmission. The main role of cellular immune response is that specific CD4+ T lymphocytes can help B-lymphocytes produce antibodies and CD8+ T cells
will kill the infected cells, effectively preventing influenza.
Acute respiratory infectious diseases caused by influenza viruses are highly contagious and have the potential to cause large-scale pandemics. These diseases can result in complications such as pneumonia, bronchitis and myocarditis and exacerbate pre-existing conditions in high-risk groups such as the elderly and those who are physically weak, increasing the disease burden and posing a threat to human health. According to the estimation of the World Health Organization, influenza causes 3 to 5 million cases of severe illnesses and 290,000 to 650,000 respiratory diseases-related deaths a year globally. Influenza vaccination is the most cost-effective and efficient measure to prevent influenza diseases and pandemic outbreaks. In 2019, the approved lot release volume of influenza vaccines was approximately 22.67 million doses in China, and it is estimated that the approved lot release volume was 76.69 million doses in 2023. China Insights Industry Consultancy Limited, an industry consultant, predicts that China’s influenza vaccine market will reach approximately RMB20 billion in 2030.
Drug Administration, and governments of several countries worldwide advocate for the adoption of animal cell culture technology to replace the traditional chicken embryo technology in production of influenza vaccines.
Due to the high variability of the influenza virus, the World Health Organization annually announces the candidate strains for seasonal influenza vaccines in the northern and southern hemispheres for the upcoming season to guide countries in researching and developing and producing influenza vaccines to address the upcoming season’s pandemic. The influenza virus vaccine developed by the Company utilizes MDCK cells instead of chicken embryos for cultivation. This vaccine has a shorter production cycle, does not face concerns regarding unstable raw material supply, has robust capability to withstand virus mutations, can be cultivated
automatically in bioreactors at scale with low contamination risks and is conducive to large-scale industrial production. Consequently, the vaccine can be tailored to produce products targeting the seasonal strains in accordance with the candidate strains announced by the World Health Organization each season, better meeting public health needs. Furthermore, the influenza vaccine (MDCK Cells) developed by the Company has a low probability of virus mutation during passage, and does not contain ovalbumin, significantly reducing the risk of allergic reactions.
The quadrivalent influenza virus vaccine (MDCK Cells) developed by the Group is made from the influenza A and B virus strains recommended by the World Health Organization. It is indicated for people aged 6 months and above, especially those who are susceptible and prone to related complications, including children, the elderly, the infirm and people in the influenza-endemic areas. After vaccination, specific humoral immunity and cellular immunity will be generated. Anti-HA is a neutralizing antibody that resists infection, while anti-NA antibodies are associated with alleviating diseases and preventing virus transmission. The main role of cellular immune response is that specific CD4+ T lymphocytes can help B-lymphocytes produce antibodies and CD8+ T cells
will kill the infected cells, effectively preventing influenza.
Acute respiratory infectious diseases caused by influenza viruses are highly contagious and have the potential to cause large-scale pandemics. These diseases can result in complications such as pneumonia, bronchitis and myocarditis and exacerbate pre-existing conditions in high-risk groups such as the elderly and those who are physically weak, increasing the disease burden and posing a threat to human health. According to the estimation of the World Health Organization, influenza causes 3 to 5 million cases of severe illnesses and 290,000 to 650,000 respiratory diseases-related deaths a year globally. Influenza vaccination is the most cost-effective and efficient measure to prevent influenza diseases and pandemic outbreaks. In 2019, the approved lot release volume of influenza vaccines was approximately 22.67 million doses in China, and it is estimated that the approved lot release volume was 76.69 million doses in 2023. China Insights Industry Consultancy Limited, an industry consultant, predicts that China’s influenza vaccine market will reach approximately RMB20 billion in 2030.
