FibroGen Inc. said China's National Medical Products Administration approved roxadustat to treat anemia associated with chronic kidney disease in patients on dialysis.
The application from the San Francisco-based company's unit, FibroGen (China) Medical Technology Development Co. Ltd., was supported by positive late-stage trial data.
FibroGen is collaborating with AstraZeneca PLC to develop and market roxadustat in China. The U.K.-based pharmaceutical giant will manage the drug's commercialization, while FibroGen will handle manufacturing, further development, as well as medical and regulatory affairs.
Roxadustat's launch in China is expected in the second half of 2019.
Anemia, which is a deficiency in healthy red blood cells or hemoglobin, commonly develops in association with chronic kidney disease. There are an estimated 120 million people in China with chronic kidney disease, about 500,000 of whom are on dialysis and may be suffering from anemia, FibroGen said, citing a Lancet survey.
The company said China is the first country to clear roxadustat for marketing. FibroGen, along with Tokyo's Astellas Pharma Inc., had filed for Japanese approval of the drug in October.