We are committed to providing accelerated access to transformative medical treatment for patients in China. Through our Beijing subsidiary, FibroGen China, and in parallel with our global program, we pursued development of roxadustat for anemia associated with chronic kidney disease (CKD) as a domestic Class 1 drug. We have received marketing authorization from the National Medical Products Administration (NMPA) for roxadustat for the treatment of patients with anemia caused by chronic kidney disease (CKD) in patients who are on dialysis and those not on dialysis. In taking this approach to introducing world-class innovations in China, we hope to be a leader, ushering in a new paradigm to address urgent unmet medical needs.
Anemia is currently undertreated in China’s rapidly growing number of dialysis-stage patients, and is generally not treated in non-dialysis patients. As the China pharmaceutical market continues to grow at an accelerated pace, we believe that the demand for anemia therapy will continue to rise. Furthermore, with an expanding CKD population, the central government has set a mandate to make dialysis care in China more available. While the infrastructure to support this mandate is in the early stages of development, the expansion of government reimbursement and build-out of dialysis facilities will drive demand. Roxadustat is a particularly promising candidate to meet the needs of this growing patient population and the government’s initiative to provide access to the nation.
In China, options for treating corneal blindness are severely limited due to an extreme shortage of donor corneas, and alternative sources of treatment for corneal blindness are needed. Despite the fact that there are approximately four to five million patients in China with corneal blindness, and an incidence of at least 100,000 new cases of corneal blindness each year, the vast majority of cases go untreated. In 2007, for example, only about 3,000 corneal grafts were performed in China.
We believe FG-5200 may represent a therapeutic option that is more widely available and with reduced risk of the immunogenicity associated with use of donor tissues.