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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 individuals 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 individuals 3 years of age and older.

　　Source: Official 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), HRK-X ensures a 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 vaccine, while also demonstrating good immunogenicity. Many of the quality standards of the product are higher than the standards of the Chinese and EU Pharmacopoeia, reaching an international advanced level.

According to the Technical Guidelines for Influenza Vaccination in China (2023-2024), from the perspective of vaccine preparation technology, subunit vaccines remove the internal proteins of the virus and only retain the HA and NA antigenic components with higher purity, which provide better safety compared with split-virion vaccines. 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 split-virion vaccine in the 18-64 years age group. Stronger immune responses were induced against all four vaccine strains, with statistically significant higher GMT (geometric mean titer of antibodies) than the split-virion vaccine.

The successful registration of HRK-X in Macau will bring more advanced, safer, and more effective influenza vaccination options to the region, guarding the lives and health of residents and contributing to the prevention and control of influenza in Macau! At the same time, it also fully reflects the recognition of the product quality by the Macao SAR drug regulatory authorities, and Ab&B Bio will continue to strive to produce more innovative and high-quality vaccines to care for life and protect health!