27 June 2019 | News
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.
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.