FibroGen is implementing a dual commercialization program designed to capitalize on specific performance characteristics of our recombinant collagens and synthetic gelatins. We are developing end-user products where the opportunities are significant (e.g., recombinant human collagen Type III formulated for use as a cosmetic dermal filler), and we are establishing a supply business that addresses the large demand for synthetic alternatives to animal-derived collagen and gelatin in the medical and pharmaceutical industries.

FibroGen's in-house fermentation capacity enables the production of recombinant collagens and synthetic gelatins for clinical and development purposes. We expect to establish a strategic relationship with a manufacturing partner for large-scale manufacturing, and we are currently preparing Master Files (see below) to facilitate the incorporation of FibroGen biomaterials into our customers' existing and future products. In the U.S., a Master File is submitted to the appropriate Food and Drug Administration (FDA) reviewing center (e.g., CDRH, CDER, CBER) to provide detailed information related to the production of the product under review. Data will also be available for European and Japanese regulatory filings. Please contact customerservice@fibrogen.com for more information.

FibroGen currently has two Master File programs in development for the following products:

• FG-5016 is highly pure and fully characterized recombinant human collagen type III. Potential applications include hemostats, drug delivery, stents and vascular graft coatings, tissue engineering, and cell culture. FibroGen has completed a safety study of FG-5016 in normal volunteers in Europe. Data from this study will be included in the Master File for use by FibroGen's customers.

• FG-5009 is a soluble recombinant gelatin optimized for stabilization of vaccines and biologics. FibroGen has successfully completed a human safety study of FG-009. Data from this study will be included in the Master File for use by FibroGen's customers.

Learn more about working with FibroGen and our available products.