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IND Application for Influenza Virus Subunit Vaccine (Adjuvanted) Approved
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- Time of issue:2024-10-30
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(Summary description)Recently, Ab&B Bio-Tech Co., Ltd. (Ab&B Bio) and its subsidiary Yither Biotech (Shanghai) Co., Ltd. (Yither Bio) jointly submitted an Investigational New Drug (IND) application for a Class I new drug—the "Influenza Virus Subunit Vaccine (Adjuvanted)"—which has been approved by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA). This approval marks the completion of the company’s full pipeline coverage for subunit influenza vaccines, including both trivalent and quadrivalent formulations, offering tailored options for diverse age groups and populations with specific needs.
IND Application for Influenza Virus Subunit Vaccine (Adjuvanted) Approved
(Summary description)Recently, Ab&B Bio-Tech Co., Ltd. (Ab&B Bio) and its subsidiary Yither Biotech (Shanghai) Co., Ltd. (Yither Bio) jointly submitted an Investigational New Drug (IND) application for a Class I new drug—the "Influenza Virus Subunit Vaccine (Adjuvanted)"—which has been approved by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA). This approval marks the completion of the company’s full pipeline coverage for subunit influenza vaccines, including both trivalent and quadrivalent formulations, offering tailored options for diverse age groups and populations with specific needs.
- Categories:Company news
- Author:
- Origin:
- Time of issue:2024-10-30 14:49
- Views:
Recently, Ab&B Bio-Tech Co., Ltd. (Ab&B Bio) and its subsidiary Yither Biotech (Shanghai) Co., Ltd. (Yither Bio) jointly submitted an Investigational New Drug (IND) application for a Class I new drug—the "Influenza Virus Subunit Vaccine (Adjuvanted)"—which has been approved by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA). This approval marks the completion of the company’s full pipeline coverage for subunit influenza vaccines, including both trivalent and quadrivalent formulations, offering tailored options for diverse age groups and populations with specific needs.
Source: Official Website of the Center for Drug Evaluation (CDE), National Medical Products Administration (NMPA)
Currently, the influenza virus remains one of the most significant respiratory pathogens threatening global public health. Seasonal outbreaks or sporadic cross-species transmission and pandemics significantly impact human health and socioeconomic development. Compared to other age groups, the elderly face higher infection rates and greater risks of severe illness or death from influenza, with risks escalating with age. Both the World Health Organization (WHO) and the Chinese Center for Disease Control and Prevention (China CDC) recommend the elderly as a priority group for influenza vaccination.
The newly approved trivalent influenza virus subunit vaccine (adjuvanted), developed by Ab&B Bio, aligns with WHO recommendations and leverages the company’s proven platform technology and novel adjuvant formulations. It is specifically designed for individuals aged 65 and older. Preclinical studies demonstrate that this adjuvanted vaccine significantly elevates antibody levels and neutralizing antibody titers, offering superior immune response enhancement—making it the optimal choice for elderly populations vulnerable to influenza.
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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