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中慧元通流感病毒亚单位疫苗(佐剂)IND申请获批

Influenza virus subunit vaccine (adjuvant) IND application approved

中慧元通 等信源发布 2024-10-30 14:54

可切换为仅中文


Recently, Ab&B Bio-Tech Co.,Ltd(Ab&B Bio)and its subsidiary Yither biotech (Shanghai) Co., Ltd (Yither Bio) jointly applied for a Class I new drug 'Influenza Virus Subunit Vaccine (Adjuvant)' IND application, which has been approved by the Drug Evaluation Center (CDE) of the China National Medical Products Administration.

最近,Ab&B Bio-Tech Co.,Ltd(Ab&B Bio)及其子公司Yither biotech(Shanghai)Co.,Ltd(Yither Bio)联合申请了一类新药“流感病毒亚单位疫苗(佐剂)”IND申请,该申请已获得中国国家医药产品管理局药物评估中心(CDE)的批准。

The approval of this vaccine marks the completion of the full coverage of the company's subunit influenza vaccine product pipeline for trivalent and quadrivalent influenza virus subunit vaccines, providing the most accurate selection for different age groups and different demand groups..

该疫苗的批准标志着该公司针对三价和四价流感病毒亚单位疫苗的亚单位流感疫苗产品线的全面覆盖,为不同年龄组和不同需求群体提供了最准确的选择。。

Source: Government Service Website of the Drug Evaluation Center of the National Medical Products Administration

资料来源:国家药品监督管理局药品评价中心政府服务网站

At present, influenza virus remains one of the important respiratory pathogens threatening human public health. Seasonal influenza outbreaks or occasional cross species transmission and pandemics of influenza virus have significant impacts on human health and socio-economic development. Compared to other age groups, the elderly have a higher infection rate and a greater risk of severe illness and death after contracting the flu, which increases with age.

目前,流感病毒仍然是威胁人类公共健康的重要呼吸道病原体之一。季节性流感爆发或偶尔的跨物种传播和流感病毒大流行对人类健康和社会经济发展产生重大影响。与其他年龄组相比,老年人感染流感后的感染率更高,患严重疾病和死亡的风险更大,并且随着年龄的增长而增加。

WHO and the Chinese Center for Disease Control and Prevention recommend elderly people as one of the priority groups for influenza vaccination..

世卫组织和中国疾病预防控制中心建议老年人作为流感疫苗接种的优先人群之一。。

The trivalent influenza virus subunit vaccine (adjuvant) approved this time is an adjuvant containing influenza vaccine developed by the company in response to the WHO's recommendation for influenza vaccination, using the company's mature platform technology and new adjuvants, suitable for the elderly population aged 65 and above.

此次批准的三价流感病毒亚单位疫苗(佐剂)是该公司根据世卫组织流感疫苗接种建议开发的含佐剂的流感疫苗,使用该公司成熟的平台技术和新的佐剂,适用于65岁及以上的老年人群。

Preclinical studies have shown that adjuvanted influenza virus subunit vaccines can significantly increase the body's antibody levels and neutralizing antibody titers, and have significant advantages in enhancing immune response capabilities, providing the optimal choice for the elderly population to cope with influenza..

临床前研究表明,佐剂流感病毒亚单位疫苗可以显着提高身体的抗体水平和中和抗体滴度,并且在增强免疫应答能力方面具有显着优势,为老年人群应对流感提供了最佳选择。。