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IND Application for Quadrivalent Influenza Virus Subunit Vaccine (Adjuvant) Approved
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- Time of issue:2024-07-30
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(Summary description)Recently, the IND application for a Class I new drug "Quadrivalent Influenza Virus Subunit Vaccine (Adjuvant)" jointly submitted by Ab&B Bio-Tech Co., Ltd. (Ab&B Bio-Tech Co., Ltd.) and its subsidiary Yither Biotech (Shanghai) Co., Ltd. (Yither Bio) was approved by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA).
IND Application for Quadrivalent Influenza Virus Subunit Vaccine (Adjuvant) Approved
(Summary description)Recently, the IND application for a Class I new drug "Quadrivalent Influenza Virus Subunit Vaccine (Adjuvant)" jointly submitted by Ab&B Bio-Tech Co., Ltd. (Ab&B Bio-Tech Co., Ltd.) and its subsidiary Yither Biotech (Shanghai) Co., Ltd. (Yither Bio) was approved by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA).
- Categories:Company news
- Author:
- Origin:
- Time of issue:2024-07-30 11:57
- Views:
Recently, the IND application for a Class I new drug "Quadrivalent Influenza Virus Subunit Vaccine (Adjuvant)"jointly submitted by Ab&B Bio-Tech Co., Ltd. (Ab&B Bio-Tech Co., Ltd.) and its subsidiary Yither Biotech (Shanghai) Co., Ltd. (Yither Bio) was approved by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA).
Source: Website of the Center for Drug Evaluation of the National Medical Products Administration
At present, influenza virus is still one of the most important respiratory pathogens threatening human public health. Seasonal influenza outbreaks or occasional cross-species transmission and pandemics of influenza viruses have a significant impact on human health and the social economy. Compared with other age groups, the infection rate among the elderly is higher, and the risk of severe illness and death after contracting influenza is greater, with this risk increasing with age. Both the WHO and the Chinese Center for Disease Control and Prevention recommend that the elderly be one of the priority groups for influenza vaccination.
The "quadrivalent influenza virus subunit vaccine (adjuvant)" approved this time is the first adjuvanted influenza vaccine in China designed specifically to protect elderly individuals aged 65 and above against four seasonal influenza virus strains. It utilizes the company's independently innovated subunit influenza antigens and novel adjuvants; preclinical studies have shown that the vaccine can significantly increase the body's antibody levels and neutralizing antibody titers, demonstrating notable advantages in enhancing immune response capabilities.
On July 29, Ab&B Bio-Tech Co., Ltd. (Ab&B Bio-Tech Co., Ltd.) and its subsidiary Yither Biotech (Shanghai) Co., Ltd. (Yither Bio) jointly submitted another Class I new drug trivalent "Influenza virus subunit vaccine (adjuvant)" IND application, which was also accepted by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration. This marks the expansion of the company's influenza virus vaccine portfolio, with increasingly comprehensive coverage and selection options.
Source: Website of the Center for Drug Evaluation of the National Medical Products Administration
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