Yisheng Biopharma Announces Clearance from China FDA to Proceed with PIKA Rabies Vaccine Clinical Study
Published: Oct 08, 2018
BEIJING, Oct. 8, 2018 /PRNewswire/ -- YiSheng BioPharma Co., Ltd. ("Yisheng Biopharma"), a biopharmaceutical company focusing on research, development, manufacturing, sales and marketing of immune modulator biotherapeutics and vaccines, today 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 program 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.
Rabies is 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. More than 40 percent of cases occur in children less than 15 years of age.
"The clearance to proceed from the CFDA represents a major milestone for our PIKA rabies vaccine program, as China represents the largest worldwide market opportunity for rabies vaccines," commented Hui Shao, Ph.D., President and CEO of Yisheng Biopharma. "Our PIKA rabies vaccine demonstrated an accelerated onset immune response that allows a three-visit, one-week regimen as compared to the currently available vaccine with a five-visit, one-month or three-visit, three-week regimen. With no overt toxicities observed in animal studies and no vaccine-related serious or severe adverse events observed in clinical trials, we expect that the PIKA Rabies Vaccine has the potential to become a next generation rabies vaccine and capture significant market share in China, Southeast Asia, Africa and Latin America."
"We have already been in the preparation phase for clinical studies in China and we expect to kick off enrollment of human subjects in early 2019," said Yi Zhang, Chairman and PIKA rabies vaccine project leader. "We look forward to working closely with the CFDA and regulatory authorities in other countries to bring this promising product to market as soon as possible."
About Yisheng Biopharma Co., Ltd.
Yisheng Biopharma is a global biopharmaceutical company discovering, developing and commercializing innovative immunological biologics. With over 600 employees worldwide and operations in China, the United States, Singapore and certain Southeast Asian countries. For more information, please visit www.yishengbio.com.
SOURCE Yisheng Biopharma Co., Ltd.