FG-5030 and FG-5017 are FibroGen's cosmetic dermal fillers comprised of recombinant human collagen type III formulated for optimal safety and efficacy (persistence) as an injectible gel for use in dermal augmentation.

Development Status
FibroGen has completed a human safety clinical trial of recombinant human collagen type III used in the dermal filler. Efficacy testing of our dermal fillers is planned to start in 2007.

Product Details
FG-5030 and FG-5017 dermal fillers are comprised of a crosslinked formulation of recombinant human collagen type III. FibroGen scientists have discovered that formulations based on type III collagen persist longer than those based on type I in in vitro models. Thus, the product represents a filler with all the attributes of classical collagen injectibles (e.g., ease of administration) with the added benefits of a fully synthetic human collagen with longer persistence.

Biocompatibility
FibroGen recombinant human collagen type III 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
FibroGen recombinant human collagen type III is subjected to a battery of analytical tests that demonstrate its suitability as a dermal filler. These tests characterize product purity, homogeneity, endotoxin levels, bioburden, and the levels of various potential contaminants including those associated with the yeast expression system.