Recently, Zhifei Biological’s wholly-owned subsidiary, Beijing Zhifei Green Bamboo, has completed preparations for Phase III clinical trials in Bangladesh for its independently developed bivalent Shigella conjugate vaccine (hereinafter referred to as the “bivalent Shigella conjugate vaccine”), in accordance with the clinical trial approval document issued by the Bangladesh Directorate General of Drug Administration. Subject enrollment is about to commence.
The bivalent Shigella conjugate vaccine is used to prevent acute intestinal infectious diseases caused by Shigella flexneri and Shigella sonnei, namely bacillary dysentery. This vaccine is the world’s first to prevent infection by both S. flexneri and S. sonnei. Its Phase III clinical trials in China were launched in December 2021. To date, no similar vaccine has been approved for marketing globally.
Shigellosis, an intestinal infectious disease caused by Shigella bacteria, is characterized by abdominal pain, diarrhea, tenesmus, and dysentery. All age groups are susceptible, but it is most common in infants and the elderly. Classified as a Class B infectious disease in China, it poses a significant threat to public health. According to the World Health Organization, shigellosis affects an estimated 164.7 million people globally each year. The four main serogroups of Shigella responsible for shigellosis are: Shigella dysenteriae, Shigella flexneri, Shigella boydii, and Shigella sonnei. Globally, infections caused by S. flexneri and S. sonnei account for over 90% of all cases.