The new anti-cancer drug OB318 against hepatocellular carcinoma developed by Oneness Biotech Co., Ltd. was approved for phase I clinical trials by US FDA on Dec. 25, 2014.
After three years of development, Oneness Biotech completed the production development and studies of nonclinical pharmacology, pharmacokinetics and toxicology for IND application. The FDA approved the application for human clinical trials for OB318, which will be used as an anti-cancer drug against hepatocellular carcinoma. In addition to the effective control of the raw material source and product quality, Oneness Biotech has also filed global patent applications in, for example, the United States, Japan, EU, Malaysia, China, and the Republic of China, and will continue the development of an anti-cancer drug in conformity with international standards.