Yisheng Biopharma Co., Ltd. (“Yisheng Biopharma”), a biopharmaceutical company focusing on research, development, manufacturing, sales and marketing of immunological biologics and vaccines, announced that it has received Investigational New Drug (IND) clearance from the National Medical Products Administration (NMPA) of China to initiate a clinical trial of YS-ON-001, a first-in-class immuno-oncology product for the treatment of advanced solid tumors.
“The IND clearance for YS-ON-001 by the China NMPA marks the third product entering clinical development based on our PIKA technology platform. This milestone once again demonstrates Yisheng’s capability and commitment to the advancement of immunological technology for biopharmaceutical market. PIKA immuno-modulating technology has been officially recognized three times since 2013 as a “National New Medical Innovation” by the Chinese government. We plan to move forward with the clinical development of YS-ON-001 in China to bring it to the market as efficiently as possible. Yisheng Biopharma will continue to expand our portfolio in new immunological therapeutics and vaccines to benefit patients in need of new options,” commented by David Shao, Ph.D., President and Chief Executive Officer of Yisheng Biopharma.
YS-ON-001 consists of a complex of protein and PIKA immunomodulating agent and is designed to reduce immunosuppressive effects within the tumor microenvironment and enhance antitumor immune responses. YS-ON-001 is capable of increasing CD4+ and CD8+ T-cell responses, increasing the proportion of natural killer and natural killer T cells and promoting higher expression level of PD-L1 receptors in tumor tissues. YS-ON-001 also showed the reduction in the number of T regulatory cells and myeloid-derived suppressor cells. YS-ON-001 can be delivered via intramuscular, subcutaneous or intratumoral injection and has demonstrated a highly effective tumor growth inhibition in preclinical studies with models of breast, lung, liver, colorectal, prostate and other cancers.
YS-ON-001 has received Orphan Drug Designation from the U.S FDA for development of the treatment for both hepatocellular cancer and pancreatic cancer, and is approved for use in Cambodia as YivykaTM.
About Yisheng Biopharma Co., Ltd.
Yisheng Biopharma is a global, fully integrated biopharmaceutical company engaged in discovering, developing and commercializing innovative biotherapeutics for cancer and infectious disease using its novel PIKA® immunomodulating technology. PIKA technology augments both innate and adaptive immune responses through the TLR3, RIG-I and MDA5 pathways. Products in clinical development include YS-ON-001 for the treatment of advanced solid tumors, YS-HBV-001 hepatitis B vaccine, and the PIKA rabies vaccine for accelerated protection against rabies infection. The Company has two marketed products in China and South Asia market. Yisheng Biopharma is headquartered in Beijingwith approximately 640 employees in China, Singapore, Cambodia and the U.S.