Chongqing Zhifei Biological Products announced that its wholly-owned subsidiary, Beijing Zhifei Lvzhu Biopharmaceutical, has received a drug clinical trial approval notice from the National Medical Products Administration for its recombinant rotavirus subunit vaccine produced in E. coli. The approval allows clinical trials to proceed for the prevention of acute gastroenteritis caused by rotavirus infection. The vaccine uses recombinant E. coli technology to produce recombinant VP8 proteins of three genotypes, covering a broad spectrum of globally circulating strains, with features such as more stable and durable immunogenicity. Four oral rotavirus vaccines are already approved for marketing in China, while this vaccine is administered by injection, which is expected to enrich the company's pipeline of vaccines for digestive tract infections. The company stated that this approval will not have a significant impact on near-term performance, and that subsequent clinical trials and market launch remain uncertain.
Chongqing Zhifei Bio ProductsWholly-owned subsidiary received NMPA clinical trial approval for its recombinant rotavirus subunit vaccine, advancing its pipeline.
