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The first and only fully dosed, fully population-coverage quadrivalent influenza virus subunit vaccine in China has been approved for market
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- Time of issue:2025-09-03
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(Summary description)Recently, Ab&B Bio-Tech Co., Ltd. (hereinafter referred to as "Ab&B Bio") achieved a significant milestone—the supplementary application for its new Class I drug, the tetravalent influenza virus subunit vaccine ( HRK-X®), was approved by the National Medical Products Administration (NMPA) of China. The approved population now includes infants aged 6 to 35 months, making it the first and only tetravalent influenza virus subunit vaccine approved for the full population and full dosage in China. This advancement provides a safer and higher-quality new option for influenza prevention and control in the country, further aiding Ab&B Bio in expanding its market presence and making greater contributions to strengthening public health defenses and safeguarding public health.
The first and only fully dosed, fully population-coverage quadrivalent influenza virus subunit vaccine in China has been approved for market
(Summary description)Recently, Ab&B Bio-Tech Co., Ltd. (hereinafter referred to as "Ab&B Bio") achieved a significant milestone—the supplementary application for its new Class I drug, the tetravalent influenza virus subunit vaccine ( HRK-X®), was approved by the National Medical Products Administration (NMPA) of China. The approved population now includes infants aged 6 to 35 months, making it the first and only tetravalent influenza virus subunit vaccine approved for the full population and full dosage in China. This advancement provides a safer and higher-quality new option for influenza prevention and control in the country, further aiding Ab&B Bio in expanding its market presence and making greater contributions to strengthening public health defenses and safeguarding public health.
- Categories:Company news
- Author:
- Origin:
- Time of issue:2025-09-03 08:54
- Views:
Recently, Ab&B Bio-Tech Co., Ltd. (hereinafter referred to as "Ab&B Bio") achieved a significant milestone—the supplementary application for its new Class I drug, the tetravalent influenza virus subunit vaccine ( HRK-X®), was approved by the National Medical Products Administration (NMPA) of China. The approved population now includes infants aged 6 to 35 months, making it the first and only tetravalent influenza virus subunit vaccine approved for the full population and full dosage in China. This advancement provides a safer and higher-quality new option for influenza prevention and control in the country, further aiding Ab&B Bio in expanding its market presence and making greater contributions to strengthening public health defenses and safeguarding public health.
Source: State Drug Administration Government Service Portal Website
Currently, the influenza virus remains one of the significant respiratory pathogens threatening public health. Seasonal flu outbreaks, sporadic cross-species transmission of influenza viruses, and pandemics have profound impacts on human health and socio-economics. Particularly for infants, the elderly, and patients with underlying cardiopulmonary conditions, infection with the influenza virus may lead to severe complications such as pneumonia, resulting in critical illness or death. At present, vaccination against influenza is the most effective measure to prevent the disease and its large-scale outbreaks.
The approval of the marketing application for the quadrivalent influenza virus subunit vaccine for children aged 6-35 months marks another significant milestone in Ab&B Bio's subunit influenza vaccine family. This high-quality vaccine, featuring high purity, low reactogenicity, excellent safety, and comprehensive protection, aligns with global vaccine development trends. It unifies the vaccine formulation for all individuals aged 6 months and above, greatly enhancing the convenience of administration and management, while providing broader population coverage, greater peace of mind, and more effective immune protection for influenza prevention and control in China.
Relevant information
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Ab&B Bio-Tech Co., Ltd. collaborates with Walvax Biotechnology Co., Ltd. to seamlessly connect the third-generation subunit influenza vaccine and embark on a new journey of going globalOn March 13, 2026, Ab&B Bio-Tech Co., Ltd. (hereinafter referred to as "Ab&B Bio") and Walvax Biotechnology Co., Ltd. (hereinafter referred to as "Walvax") officially signed a strategic cooperation agreement for the overseas market of influenza virus subunit vaccines in Taizhou. Both parties announced that they will jointly promote the development of the influenza virus subunit vaccine independently developed by Ab&B Bio and set sail to the sea. This is not only a milestone moment for Chinese vaccine companies to cooperate and build a healthy industry ecosystem, but also signifies that China will bring safer and more effective solutions to the global influenza prevention and control field. - Monkeypox mRNA Vaccine Secures FDA Clinical Approval, Trivalent Influenza Virus Subunit Vaccine Wins First Bid in Shanxi 03-04
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