Yisheng Biopharma Co., Ltd., a biopharmaceutical company focusing on research, development, manufacturing, sales and marketing of immuno-therapeutic products and vaccines, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for its lead vaccine candidate, PIKA rabies vaccine, which is an innovative rabies vaccine independently developed by Yisheng Biopharma, using its proprietary toll-like receptor-3 (TLR-3) activation technology. This project was named a "National Key Medicine Innovation" in 2013, and is currently under Phase II clinical development.
"The orphan drug designation of our vaccine candidate for rabies prophylaxis is an important regulatory milestone as we have been working in this area for over seven years, an area where little advancement or improvement has been achieved for some time," said Yi Zhang, Chairman and Chief Executive Officer. "This product has great potential to provide superior clinical benefit to patients as compared to current rabies vaccines. As this product is already in Phase II clinical study, we look forward to working closely with the US FDA and regulatory authorities in other countries to bring this promising product to market."
Orphan drug designation is granted by the FDA Office of Orphan Products Development (OOPD) to novel drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S. The OOPD provides incentives for sponsors to develop products for rare diseases, which may include tax credits towards the cost of clinical trials and prescription drug user fee waivers. The orphan drug designation would also entitle Yisheng Biopharma to a seven-year period of marketing exclusivity in the United States pending FDA approval for the marketing clearance.