Ardelyx (ARDX) said Wednesday that a new drug application for tenapanor for the treatment of hyperphosphatemia has received approval from China's Center for Drug Evaluation of the National Medical Products Administration.
Tenapanor received approval to control serum phosphorus levels in dialysis patients with chronic kidney disease with an inadequate response or who are intolerant to phosphorus binders, Ardelyx said.
The company said that following the approval, it will receive a $5 million milestone payment from its collaboration partner in China, Shanghai Fosun Pharmaceutical Industrial Development. Ardelyx said that under the terms of their license agreement, it is eligible to receive up to $100 million in additional developmental and commercialization milestones and tiered royalty payments on net sales of mid-teens to 20%.
The company said Shanghai Fosun Pharmaceutical has the exclusive rights to market and sell tenapanor in China, Hong Kong and Macau, with tenapanor to be marketed with the Chinese trade name Wan Ti Le.
Shares were 1.4% higher ahead of Wednesday's opening bell.
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