The US FDA Granted Orphan Drug Designation to Yisheng Biopharma’s Biological Product for Hepatocellular Carcinoma

BEIJING, Oct. 24, 2016 /PRNewswire/ 

Yisheng Biopharma Co., Ltd. (“Yisheng Biopharma”), 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 product candidate, YS-ON-001, for the treatment of hepatocellular carcinoma. YS-ON-001 is a promising biological product with immunomodulating effects, such as induction of anti-tumor cytokines, activation of NK cells, regulation of macrophage polarization, and suppression of regulatory T cells.

“The orphan drug designation of YS-ON-001 in liver cancer is an important regulatory milestone as we further our clinical development in advanced solid tumor programs, where are limited treatment options,” said Yi Zhang, Chairman and Chief Executive Officer.” YS-ON-001 is an emerging immune-oncology product with its unique immunological mechanism. It demonstrated excellent anti-tumor efficacy against breast, lung, liver and other cancers as compared to the first-line chemotherapies or targeted therapies in animal studies.  The animal studies did not reveal any significant safety concerns.  As the drug entering the clinical development in multiple countries, we look forward to working closely with the US FDA and regulatory authorities in other countries to bring this therapy potentially beneficial to patients with a significant unmet need.”

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 treatment of liver cancer.

About YS-ON-001

YS-ON-001 is a clinical stage biological product based on our proprietary immunomodulating cell technology developed in-house at Yisheng Biopharma. It is a multi-component complex with broad immunomodulating properties, such as promoting Th1-biased immunity, inducing the activation and proliferation of dendritic cell (DC), B and natural killer cells (NK cells), promoting macrophage M1 polarization and downregulating regulatory T cells. YS-ON-001demonstrates excellent efficacy in animal studies against multiple solid tumors, such as breast, lung, liver and other cancers. Toxicology studies in animals also demonstrated good safety of the product.

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, the USA and Singapore.