Chongqing Zhifei Biological Products Co.,Ltd. (300122.SZ) has announced that its wholly-owned subsidiary, Beijing Zhifei Luzhu Biopharmaceutical Co., Ltd., has obtained a drug clinical trial approval notice (Notice No. 2026LP02707) from the National Medical Products Administration for the recombinant rotavirus subunit vaccine (E. coli). The approval permits the initiation of clinical trials for the prevention of acute gastroenteritis caused by rotavirus infection.

As of the date of this announcement, a review of the National Medical Products Administration's official website shows that four oral rotavirus vaccines have been approved for marketing in China. The company's recombinant rotavirus subunit vaccine (E. coli) is produced through recombinant E. coli fermentation and purification processes, yielding three genotypes of recombinant VP8 protein, which is then adsorbed with an adjuvant to formulate the vaccine.

This vaccine offers broad coverage of global epidemic strain lineages and exhibits a high safety profile. The vaccine is administered via injection, bypassing the intestinal microenvironment barrier, and is characterized by more stable and durable immunogenicity, as well as a longer vaccination window period.