Zhifei Biotech (300122.SZ): Nasal spray recombinant respiratory syncytial virus vaccine (chimpanzee adenovirus vector) clinical trial application accepted

Zhitong Finance App News, Zhifei Biotech (300122.SZ) issued an announcement. The company recently learned that the nasal spray recombinant respiratory syncytial virus vaccine (chimpanzee adenovirus vector) (hereinafter referred to as “nasal spray recombinant RSV vaccine”) developed by its wholly-owned subsidiary Beijing Zhifei Luzhu Biopharmaceutical Co., Ltd. (hereinafter referred to as “Zhifei Luzhu”) has obtained a notice of acceptance of the drug clinical trial application from the State Drug Administration (acceptance number: CXSL2600844). If no negative or questioning opinions have been received from the Drug Review Center within 60 days from the date of acceptance, Zhifei Green Bamboo may conduct clinical trials according to the submitted plan.

The nasal spray recombinant RSV vaccine developed by Zhifei Green Bamboo is intended to prevent lower respiratory tract infections caused by RSV. It induces respiratory mucosal immune response through nasal spray immunity and establishes the first respiratory immune barrier. It can simultaneously stimulate humoral immunity and cellular immunity. The vaccination method is more convenient, and is expected to provide a novel non-invasive prevention option for people at high risk of RSV.

As of the disclosure date of this announcement, after checking the official website of the State Drug Administration, no respiratory syncytial virus vaccine has been approved for marketing and use in China. Zhifei Luzhu's nasal spray recombinant RSV vaccine uses the dual advantages of chimpanzee adenovirus vectors to stimulate cellular immunity and humoral immunity, and the convenience of nasal spray administration simulating natural infection routes. On the premise of improving vaccination compliance, it is expected to fully stimulate multi-level immune responses and enhance vaccine protection effects. The product uses a differentiated nasal spray technology path to achieve full coverage of the needs of different groups of people, promotes further implementation and verification of the nasal spray mucosal immunization vaccine technology route, and opens up new ideas for the prevention and control of respiratory infectious diseases.