Ardelyx announces acceptance of NDA for tenapanor in China

Ardelyx announced that a New Drug Application, NDA, for tenapanor has been accepted for review by China’s Center for Drug Evaluation of the National Medical Products Administration, NMPA, for the control of serum phosphorus in adult patients with chronic kidney disease on hemodialysis. This acceptance triggers a $2 million milestone payment to Ardelyx under the terms of the license agreement between Ardelyx and its collaboration partner in China, Shanghai Fosun Pharmaceutical Industrial Development. A potential approval of the NDA submission in China is expected by the end of 2024. Under the terms of its agreement with Fosun Pharma, Ardelyx received an upfront payment of $12 million and is eligible to receive additional developmental and commercialization milestones of up to $110 million and tiered royalty payments on net sales ranging from the mid-teens to 20 percent. Fosun Pharma has the exclusive rights to market and sell tenapanor in China, Hong Kong and Macau.