Ardelyx announced on February 26, 2025, the approval of a New Drug Application by China’s Center for Drug Evaluation of the National Medical Products Administration for tenapanor. The approval is for controlling serum phosphorus levels in dialysis patients with chronic kidney disease (CKD) who have an inadequate response or are intolerant to phosphorus binders.
This regulatory milestone triggers a $5 million milestone payment to Ardelyx from its collaboration partner, Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. (Fosun Pharma). Ardelyx is also eligible to receive additional developmental and commercialization milestones of up to $100 million, along with tiered royalty payments on net sales ranging from the mid-teens to 20 percent.
The Chinese market represents a significant opportunity, with over one million patients on maintenance hemodialysis at the end of 2023, and an annual growth rate of approximately 12%. Data indicates that 76% of these patients suffer from hyperphosphatemia, with only 39% achieving target phosphate levels under current standards.
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