July 9, 2024 Source: drugdu 126
Recently, the State Drug Administration website announced that it agreed to accept OLYMVAX's application for clinical trials of trivalent influenza virus lysate vaccine (MDCK cells), which is also the first cell-based trivalent influenza vaccine to be declared for clinical use in China.
Influenza vaccination is an effective means of preventing influenza and reducing the burden of influenza-associated severe illness and death. Divided from the components of the vaccine and the types of preventive viruses, the influenza vaccines currently available in China include trivalent influenza vaccine and tetravalent influenza vaccine. Trivalent influenza vaccine mainly prevents H1N1 and H3N2 subtypes of Influenza A, as well as Influenza B Victoria lineage viruses, while tetravalent influenza vaccine is based on trivalent influenza vaccine, with added prevention against Influenza B Yamagata lineage viruses.
OLYMVAX's quadrivalent influenza virus lysate vaccine (MDCK cells) has been approved by the State Drug Administration for the issuance of the Notice of Approval for Clinical Trial of Drugs, and the acceptance of the application for clinical trial of the trivalent influenza virus lysate vaccine (MDCK cells) is a powerful supplement to the Company's influenza vaccine series, marking the initial formation of the Company's influenza series of vaccine portfolios, which is conducive to the enrichment of the Company's product layout, and to meet the market's needs. It is conducive to enriching the product layout of the Company, providing more diversified products to meet the market demand, and further improving the competitiveness of the Company in the market.
The cell-based influenza vaccine series developed by OLYMVAX can realize the effect of higher production yield, more stable product quality and lower production cost through large-scale cultivation in bioreactors. Cell-based influenza vaccines of CSL Behring, GSK, SK Bioscience and other manufacturers have been listed on the market abroad, and there is no cell-based influenza vaccine listed on the market domestically for the time being.
OLYMVAX specializes in the research and development, production and sales of human vaccines, and is committed to developing upgraded products of traditional vaccines and innovative vaccine products to fill the gaps in the market for the purpose of improving the quality of life of the people, and possesses outstanding R&D achievement transformation capability. The Company will continue to promote the clinical trial program of influenza vaccine series and strive to complete the relevant research as soon as possible, so as to provide more safe, effective and high-quality human vaccine products for the market.
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