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HRK-X Receives Registration Approval from the Drug Administration of Macau

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Time of issue:2024-05-17
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(Summary description)On May 10, 2024, Ab&B Bio-Tech CO.,LTD.JS (hereinafter referred to as “Ab&B Bio”) received registration approval from the Drug Administration of the Government of the Macao Special Administrative Region (Macao SAR) for its full-dose, adjuvant-free quadrivalent influenza virus subunit vaccine (HRK-X®), which is intended for use in people 3 years of age and older.

HRK-X Receives Registration Approval from the Drug Administration of Macau

Categories:Company news
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Time of issue:2024-05-17 10:29
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　　On May 10, 2024, Ab&B Bio-Tech CO.,LTD.JS (hereinafter referred to as “Ab&B Bio”) received registration approval from the Drug Administration of the Government of the Macao Special Administrative Region (Macao SAR) for its full-dose, adjuvant-free quadrivalent influenza virus subunit vaccine (HRK-X®), which is intended for use in people 3 years of age and older.

　　Source: Portal of the Drug Administration of the Government of the Macao Special Administrative Region.

　　With its unique extraction process of influenza virus subunits (HA: hemagglutinin and NA: neuraminidase), WiseCare ensures the high purity (over 85%) of HA and NA content of the four vaccine strains (including H1N1, H3N2, BV, and BY) and the safety of the vaccines, while at the same time exerting good immunogenicity. Many of the quality standards of the product are higher than the standards of Chinese and EU Pharmacopoeia, reaching the international advanced level.

　　According to the Technical Guidelines for Influenza Vaccination in China (2023-2024), from the point of view of vaccine preparation process, subunit vaccine removes the internal proteins of the virus and only retains the HA and NA antigenic components with higher purity, which has better safety compared with the cracked vaccine. In a phase III RCT, the overall incidence of adverse events for the quadrivalent influenza virus subunit vaccine was lower than that for the quadrivalent lysed vaccine in the 18-64 year age group. Stronger immune responses were induced against all four vaccine strains, with statistically significant higher GMT (geometric mean titer of antibodies) than the cracked vaccine.

　　The successful registration of HRK-X in Macau will bring more advanced, safer and more effective influenza vaccination options to Macau, guarding the lives and health of the Macau people and contributing to the prevention and control of influenza in Macau! At the same time, it also fully reflects the affirmation of the quality of the product by the drug regulatory authorities of the Macao SAR government, and China Wise Biologics will continue to work hard to produce more innovative and high-quality vaccines to care for life and protect health!