Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196), a China-based pharmaceutical company, has announced a market approval filing to the National Medical Products Administration (NMPA) in China for its in-licensed tenapanor. The drug is indicated for the control of hyperphosphatemia in adult patients with chronic kidney disease (CKD) who are undergoing hemodialysis treatment.
Licensing Deal with Ardelyx Inc. and Regional Rights
Fosun Pharma secured a licensing deal with US firm Ardelyx Inc. in December 2017, acquiring exclusive rights to clinically develop and commercialize the innovative chemical tenapanor in the China mainland, Hong Kong, and Macau. This strategic move positions Fosun Pharma to potentially bring a new treatment option to patients in the region.
Regulatory Progress and Clinical Trials
Tenapanor is awaiting a regulatory decision in the US for the hyperphosphatemia indication in CKD patients. The drug has already obtained market approval to treat irritable bowel syndrome with constipation in the US, achieved in September 2019. In March 2023, tenapanor was filed for approval in Hong Kong, following the conclusion of a Phase I clinical study in the China mainland.-Fineline Info & Tech
