Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its tenapanor, an innovative phosphate absorption inhibitor, in China. The drug, commercially known as Wan Ti Le, is now available for controlling serum phosphorus levels in dialysis patients with chronic kidney disease (CKD) who have an inadequate response or are intolerant to phosphorus binders.
Drug Profile
Tenapanor is an intestinal sodium/hydrogen exchanger 3 (NHE3) inhibitor licensed by Fosun Pharma from US-based Ardelyx, Inc. in December 2017. The drug works by inhibiting NHE3, tightening intercellular connections and reducing the permeability of the paracellular pathway, which is the main route for intestinal phosphate absorption. This mechanism allows for reduced phosphate absorption and lower blood phosphorus levels.
Approval History
- September 2019: First approved in the U.S. for the treatment of irritable bowel syndrome with constipation.
- November 2023: Approved in Hong Kong for the same indication.
- October 2023: Received FDA approval to reduce serum phosphorus in adults with CKD on dialysis as an add-on therapy for patients with an inadequate response to phosphate binders or intolerance to any dose of phosphate binder therapy.-Fineline Info & Tech
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