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.
About Yisheng Biopharma Co., Ltd.
Yisheng Biopharma Co., Ltd. is a biopharmaceutical company headquartered in Beijing, China, focusing on the research, development, manufacturing and sales and marketing of immunological and vaccine products, with approximately 1000 employees in China, USA and Singapore.
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SOURCE Yisheng Biopharma Co., Ltd.