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.
免責聲明：投資有風險，本文並非投資建議，以上內容不應被視為任何金融產品的購買或出售要約、建議或邀請，作者或其他用戶的任何相關討論、評論或帖子也不應被視為此類內容。本文僅供一般參考，不考慮您的個人投資目標、財務狀況或需求。TTM對信息的準確性和完整性不承擔任何責任或保證，投資者應自行研究並在投資前尋求專業建議。