Chongqing Zhifei Biological Products Co., Ltd. (300122.SZ) announced that a clinical trial application for its intranasal recombinant respiratory syncytial virus vaccine (chimpanzee adenovirus vector) has been formally accepted by the National Medical Products Administration (NMPA).
The vaccine, developed by the company's wholly-owned subsidiary, Beijing Zhifei Luzhu Biopharmaceutical Co., Ltd., received the drug clinical trial application acceptance notice (Acceptance No. CXSL2600844). If no objections or negative opinions are received from the Center for Drug Evaluation within 60 days from the acceptance date, Zhifei Luzhu may proceed with clinical trials according to the submitted plan.
This intranasal recombinant RSV vaccine is designed to prevent lower respiratory tract infections caused by RSV. By inducing a mucosal immune response in the respiratory tract through intranasal immunization, it aims to build the first line of immune defense. This method simultaneously stimulates humoral and cellular immunity, offering a more convenient vaccination approach and potentially providing a novel, non-invasive preventive option for high-risk populations.
As of the date of this announcement, according to the official website of the NMPA, no respiratory syncytial virus vaccine has been approved for marketing in China. The vaccine candidate from Chongqing Zhifei Biological Products Co.,Ltd. leverages the dual advantages of the chimpanzee adenovirus vector to elicit both cellular and humoral immunity. Combined with the convenience of intranasal administration that mimics the natural infection route, it is expected to improve vaccination compliance while fully stimulating a multi-layered immune response to enhance the vaccine's protective effect.
The product employs a differentiated intranasal vaccine technology pathway to achieve comprehensive coverage for different population needs. This advancement further promotes the validation and implementation of the intranasal mucosal immunity vaccine technology route, potentially opening new avenues for the prevention and control of respiratory infectious diseases.