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FG-4592 oral anemia therapy receives CTA approval from SFDA

November 15, 2015

The scope and scale of insurance reform continues to increase. In particular, the Chinese government has made treatment of CKD a national health care priority. Focused government efforts have resulted in the rapid expansion of dialysis services, including creation of additional hemodialysis facilities in urban areas and increased use of peritoneal dialysis in the countryside, and improved access to ESA therapy.

ESA Market in China and Potential for FG-4592

The current ESA market in China is relatively small but growing with increased patient access to dialysis. Although the anemic patient population is four times that of the US, only one sixth the number of US anemia patients is currently treated. In addition to previous limitations on health insurance and access to dialysis services, high cost of ESA, complexity of administration as well as need for refrigerated transport and storage have contributed to low ESA sales. As a result, the ESA market in China was only $100 million vs. $5 billion in the US in 2009.

In addition, except in certain major hospitals, anemic CKD patients generally go untreated, resulting in low average hemoglobin levels. The only publicly available data on hemoglobin levels in China is from the Shanghai Dialysis Registry where maintenance levels for anemia-corrected patients are on average 10.3 g/dL. Since Shanghai is among the Chinese cities with the highest level of medical treatment in the country, the hemoglobin correction level reached across China is believed to be lower than that in Shanghai, less than 10 g/dL, compared with an average of 11.8 g/dL among dialysis patients in the US.

Given the vast geography, the size of population and the aggregate healthcare cost of dialysis treatment in the country, the need for oral anemia therapy is far greater in China than in Western countries. FG-4592 could potentially revolutionize anemia treatment in China by offering less expensive, more easily administered oral therapy, particularly for the 70% of people residing in rural areas far from tertiary hospitals and predialysis patients who are still employed and are challenged to come to medical centers frequently to receive ESA injections. The greater treatment accesibility offered by FG-4592 will potentially enable more patients to be treated to the higher hemoglobin targets that are recommended by medical associations worldwide, allowing for better patient outcomes.

Source : FibroGen, Inc.