Tenapanor Approved in China for Hyperphosphatemia

Core Viewpoint - Ardelyx, Inc. has received approval for tenapanor in China to manage serum phosphorus levels in dialysis patients with chronic kidney disease, marking a significant step in addressing unmet medical needs in this patient population [1][4]. Company Summary - Ardelyx is a biopharmaceutical company focused on developing innovative, first-in-class medicines for significant unmet medical needs [1][6]. - The company has two commercial products approved in the United States, IBSRELA® and XPHOZAH®, both containing tenapanor [6]. - Ardelyx has established agreements for the development and commercialization of tenapanor outside the U.S., including a partnership with Fosun Pharma in China [6]. Industry Summary - As of the end of 2023, over one million patients in China were on maintenance hemodialysis, with an annual growth rate of approximately 12% [3]. - Among these patients, 76% suffer from hyperphosphatemia, with only 39% achieving target phosphate levels according to local standards [3]. - If the target range for serum phosphate is set according to Chinese guidelines, the achievement rate drops to 26.7% [3].