Yisheng receives approval for rabies vaccine clinical study
Yisheng Biopharma Co., Ltd., a biopharmaceutical company focusing on research, development, manufacturing, sales and marketing of immune modulator biotherapeutics and vaccines, has announced that the China Food and Drug Administration (CFDA) has provided clearance to proceed with a clinical trial of its PIKA rabies vaccine. The PIKA rabies vaccine has the potential to become a “best-in-class” rabies vaccine and was independently developed by Yisheng Biopharma using proprietary toll-like receptor-3 (TLR-3) immunomodulating technology. This product candidate was granted orphan drug designation by the U.S. FDA in 2016 and has been funded as a “National Key Medicine Innovation” by the government of China. This programme was also cited by the Strategic Advisory Group of Experts (SAGE) Working Group on rabies vaccines and immunoglobulins, affiliated with the World Health Organization (WHO), in 2017. The PIKA rabies vaccine has completed Phase I and Phase II clinical studies in Singapore and the Company is preparing for a Phase III pivotal trial at sites in Southeast Asia countries.