Chicago, IL, September 21, 2026 — Sus Clinicals, Inc.® has received U.S. Food & Drug Administration authorization to commercialize cancer cell lines derived from the Company’s proprietary Oncopig®. Following a thorough review, the FDA determined that the commercialization of these cell lines for use in research animals does not require further regulatory oversight.
Sus Clinicals accelerates qualification of life-saving cancer therapeutics through its proprietary Oncopig. This platform allows for the induction of human-like tumors across a variety of target organs in as little as two weeks. This predictive platform addresses one of the key barriers in therapeutic development – the lack of sufficiently predictive large animal models at the preclinical stage. The Oncopig can generate data to help researchers successfully advance development of drugs, diagnostics and devices prior to human trials.
The FDA’s Center for Veterinary Medicine (CVM) provides regulatory oversight of genetically-engineered animals, and materials derived from such animals, used in biomedical research. CVM has said that it may exercise “enforcement discretion” on a case-by-case basis if, after a risk-based review, it determines that the product is low risk to humans, animals and the environment.
The Company received enforcement discretion for the Oncopig in 2022. This follow-up FDA review allows for commercialization of Oncopig-derived cell lines. Cell lines are available across a range of cancer, including hepatocellular carcinoma, pancreatic ductal adenocarcinoma, and glioblastoma.
“Oncopig-derived cell lines can help our clients advance preclinical research in advance of large animal work,” said Dr. Kyle Schachtschneider, Vice President of Research & Development and Services for Sus Clinicals. “Researchers can, for example, conduct key in vitro with Oncopig cells, or easily generate tumors in mice, allowing them to screen compounds and perform various assessments that can pave the way for subsequent testing in the Oncopig.” Sus Clinicals has scientific facilities in Chicago, Illinois, and is headquartered in Cincinnati, Ohio.