Research & Development
Yisheng Biopharma wins China FDA approval to commence PIKA rabies vaccine clinical study in Asia
9 October 2018 -

Biopharmaceutical company Yisheng Biopharma Co Ltd reported on Monday the receipt of China Food and Drug Administration (CFDA) clearance to proceed with a Phase III clinical trial of its PIKA rabies vaccine in Southeast Asia countries.

Rabies is reportedly a vaccine-preventable viral zoonotic disease responsible for an estimated 59,000 human deaths in over 100 countries every year. The majority of cases occur in Africa and Asia.

In conjunction, the company's PIKA rabies vaccine has completed Phase I and Phase II clinical studies in Singapore.

The company added that the rabies vaccine has the potential to become a "best-in-class" rabies vaccine and was independently developed using its proprietary toll-like receptor-3 (TLR-3) immunomodulating technology. This product candidate was granted orphan drug designation by the US FDA 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.

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