FG-5016, recombinant human collagen type III (rhCIII), is intended to replace animal-derived collagen in a variety of pharmaceutical and medical device applications.

Human Safety Data
FibroGen has successfully completed a human safety study designed to demonstrate the suitability, tolerability and safety of FG-5016 when administered intradermally in multiple injections.

Product Details
FG-5016 is a highly purified and fully characterized biomaterial, which is produced using proprietary recombinant methodology in a yeast expression system free of animal components.

In addition to its use as a biomaterial for various pharmaceutical and medical device applications, FG-5016 serves as the basis of FG-5030 and FG-5017, FibroGen's cosmetic dermal fillers, which are comprised of a crosslinked formulation of FG-5016.

Biocompatibility
FG-5016 has been subjected to and has passed a series of biocompatibility tests designed to address the FDA/ISO Guidelines for such materials. Included were tests of cytotoxicity, skin irritation, hemolysis, partial thromboplastin time, maximization, systemic toxicity, response after implantation, bacterial reverse mutation (Ames), chromosome aberration analysis and the micronucleus cytogenic assay.

Purity
FG-5016 is subjected to a battery of analytical tests that demonstrate its suitability for use in pharmaceutical and medical device applications. These tests characterize product purity, homogeneity, endotoxin levels, bioburden, and the levels of various potential contaminants including those associated with the yeast expression system.