Chongqing Zhifei Biological Products (300122.SZ): The recombinant rotavirus subunit vaccine (Escherichia coli) has obtained approval for clinical trials.

Chongqing Zhifei Biological Products (300122.SZ) announced recently that its wholly-owned subsidiary, Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd. (hereinafter referred to as "Zhifei Lvzhu"), has received the notification of clinical trial approval from the National Medical Products Administration for its recombinant rotavirus subunit vaccine (derived from E. coli) (notification number: 2026LP02707). The approval permits the initiation of clinical trials aimed at preventing acute gastroenteritis caused by rotavirus infection. As of the date of this announcement, a search of the National Medical Products Administration's official website indicates that four oral rotavirus vaccines have been approved for use in China. The company's recombinant rotavirus subunit vaccine (derived from E. coli) is produced using fermentation and purification processes involving recombinant E. coli, resulting in three genotypes of recombinant VP8 protein, which is prepared as a vaccine adsorbed with an adjuvant. This vaccine covers a broad spectrum of globally circulating strains and has a high safety profile. The vaccine is administered via injection, bypassing the intestinal microenvironment barrier, and is characterized by more stable and lasting immunogenicity, as well as a longer window for vaccination.