Yisheng Biopharma Co., Ltd. (“Yisheng Biopharma”), a biopharmaceutical company focusing on research, development, manufacturing, sales and marketing of immunological biologics and vaccines, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) for its lead immuno-oncology candidate, YS-ON-001, for the treatment of pancreatic cancer. To date the US FDA has granted YS-ON-001 two ODDs for the treatment of pancreatic cancer and hepatocellular carcinoma. YS-ON-001 is a clinical-stage immuno-oncology biologic product with unique immunomodulating mechanism and broad spectrum of anti-tumor activity.
Dr. Hui Shao, the President and CEO of Yisheng Biopharma, commented, “The orphan drug designation of YS-ON-001 in pancreatic cancer is an important regulatory milestone as it will accelerate our clinical development in this particular oncology indication where pancreatic cancer is one of the deadliest cancers and is estimated to be the fourth leading cause of cancer-related death in the United States in 2018, according to the American Cancer Society.”
“YS-ON-001 is an emerging immuno-oncology product with multiple modes of action in changing tumor microenvironment, such as induction of anti-tumor cytokines, activation of NK cells, regulation of macrophage polarization and suppression of regulatory T cells. We believe it has great potential to become a mono-therapeutic agent or be combined with standard of care chemotherapies, targeted therapies and checkpoint inhibitors or with other emerging immunotherapies that produce additive or synergistic treatment effects,” commented by Mr. Zhang Yi, the Project Leader and Chairman of Yisheng Biopharma.
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.
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-001 demonstrates excellent efficacy in animal studies against multiple solid tumors, such as breast, lung, liver, pancreatic 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 700 employees in China, the USA and Singapore.
SOURCE Yisheng Biopharma Co., Ltd.