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2024-2025 Flu Season HRK-X Approved for Market Launch
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- Time of issue:2024-06-12
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(Summary description)On June 12, 2024, China Wisdom Bio's quadrivalent influenza virus subunit vaccine HRK-X for the 2024-2025 influenza season received the Certificate of Approval for Biological Products issued by the National Medical Products Administration (NMPA). As China's only approved subunit influenza vaccine of its kind, it will be quickly distributed nationwide to safeguard the health of the Chinese people.
2024-2025 Flu Season HRK-X Approved for Market Launch
(Summary description)On June 12, 2024, China Wisdom Bio's quadrivalent influenza virus subunit vaccine HRK-X for the 2024-2025 influenza season received the Certificate of Approval for Biological Products issued by the National Medical Products Administration (NMPA). As China's only approved subunit influenza vaccine of its kind, it will be quickly distributed nationwide to safeguard the health of the Chinese people.
- Categories:Company news
- Author:
- Origin:
- Time of issue:2024-06-12 17:31
- Views:
On June 12, 2024, China Wisdom Bio's quadrivalent influenza virus subunit vaccine HRK-X for the 2024-2025 influenza season received the Certificate of Approval for Biological Products issued by the National Medical Products Administration (NMPA). As China's only approved subunit influenza vaccine of its kind, it will be quickly distributed nationwide to safeguard the health of the Chinese people.
As a third-generation influenza vaccine, the quadrivalent influenza virus subunit vaccine HRK-X utilizes a unique extraction process for influenza virus subunits (HA: hemagglutinin and NA: neuraminidase), which ensures both high purity of the vaccine strain's HA and NA content (over 85%) and vaccine safety, while delivering good immunogenicity. Many of the product's quality standards exceed those of the Chinese and EU Pharmacopoeias and have reached internationally advanced levels.
The approval of HRK-X will provide a better vaccination option for the 2024-2025 influenza season and support influenza prevention and control efforts.

According to statistics, China reported 12.52 million influenza cases in 2023, a 5.1-fold increase from 2022.
Influenza (commonly known as "flu") is an acute respiratory infectious disease caused by the influenza virus, posing a serious health risk to humans. Influenza viruses exhibit antigenic variability and spread rapidly, causing seasonal epidemics annually. Outbreaks frequently occur in crowded settings such as schools, childcare institutions, and nursing homes. The general population is susceptible to influenza virus, with high-risk groups (including pregnant women, infants, the elderly, and chronic disease patients) facing more severe consequences from infection.
According to China CDC's infectious disease surveillance data: in 2023, reported influenza cases surpassed 10 million, reaching 12.52 million cases - a 5.1-fold increase from 2022. The World Health Organization (WHO) Influenza Vaccine Position Paper (2022 Edition) and China's Influenza Vaccination Technical Guidelines (2023-2024) both recommend annual influenza vaccination as the most effective prevention method, which can significantly reduce the risk of influenza and serious complications among vaccine recipients.

Relevant information
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Influenza (commonly referred to as the flu) is an acute respiratory infectious disease caused by the influenza virus. Unlike the common cold, influenza is highly contagious and is characterized primarily by systemic symptoms. Elderly individuals, children under the age of 5, patients with chronic diseases, pregnant women, and individuals with compromised immune systems are all considered high-risk populations for severe influenza [1]. A study based on national influenza surveillance and cause-of-death surveillance data revealed that, on average, there are 88,000 excess deaths related to influenza-associated respiratory diseases annually across China [2]. The total economic burden on outpatient patients with influenza ranges from RMB 801 to RMB 1,320, while the total economic burden on hospitalized influenza patients ranges from RMB 9,832 to RMB 23,833 [1]. In the face of the significant challenge posed by influenza, influenza vaccination is currently recognized worldwide as the most cost-effective and effective means of preventing influenza [1]. - The leap in influenza vaccine technology: from split-virus vaccines to whole-population subunit vaccines – what are the key advancements in the third-generation vaccines? 08-19
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