Shots:
- China’s NMPA has approved NDA of tenapanor for hyperphosphatemia in CKD pts on dialysis who inadequately responded or are intolerant to phosphorus binders
- Approval was based on data from 2 Fosun Pharma studies (PK study & pivotal trial in CKD pts on dialysis), plus clinical studies from Ardelyx
- Approval triggered $5M milestone payment to Ardelyx under its licensing deal with Fosun Pharma, that granted Fosun exclusive rights to market tenapanor (chinese trade name: Wan Ti Le) in China, Hong Kong, & Macau, in exchange for ~$100M in development & commercialization milestones, plus net sales-based tiered royalties from mid-teens to 20%
Ref: Globenewswire | Image: Ardelyx
Related News:- Telix Pharmaceuticals Reports the US FDA’s BLA Acceptance with Priority Review of Zircaix (89Zr-DFO-girentuximab) for Kidney Cancer Imaging
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