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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 Drug Administration.
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 Drug Administration.
- 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 Drug Administration.
Source: Website of the Center for Drug Evaluation of the State Drug Administration
At present, influenza virus is still one of the 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 social economy. Compared with other age groups, the infection rate of the elderly is higher, and the risk of severe illness and death after contracting influenza is greater, and this risk increases with age. 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)" accepted this time is the first adjuvanted influenza vaccine in China to protect the elderly aged 65 and above from four seasonal influenza virus strains. It uses the company's independently innovated subunit influenza antigens and new adjuvants; preclinical studies have shown that the vaccine can significantly increase the body's antibody level and neutralizing antibody titer, and has significant advantages in improving 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 Drug Administration. This marks that the company's influenza virus vaccine family is growing, and the coverage and selection range are becoming more comprehensive.
Source: Website of the Center for Drug Evaluation of the State Drug Administration
Relevant information
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Ab&B Bio and Yither Bio have both obtained qualification certification!Recently, Ab&B Bio-Tech Co.,Ltd（Ab&B Bio） and its subsidiary Yither biotech (Shanghai) Co., Ltd (Yither Bio) have been recognized as Jiangsu Province's specialized and innovative small and medium-sized enterprises and national high-tech enterprises, respectively. - The kickoff meeting for clinical research on the immunogenicity and safety of quadrivalent influenza virus subunit vaccine for children with nephrotic syndrome was successfully held 12-25
- Influenza virus subunit vaccine (adjuvant) IND application approved 10-30
- The application for the marketing of trivalent influenza virus subunit vaccine has been accepted! 10-08
- Breaking through bottleneck technology, significant progress has been made in the research and development of new adjuvants 08-26
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