China Medical System Holdings Ltd (CMS, HKG: 0867) has announced a rights assignment agreement with fellow Chinese firm WinHealth Investment (HK) Ltd concerning Velphoro (sucroferric oxyhydroxide). Initially, CMS entered into a licensing agreement with WinHealth in June of the previous year, which granted WinHealth exclusive rights for regulatory filing, import, promotion, distribution, use, and marketing of the drug in Greater China, encompassing mainland China, Hong Kong, Macau, and Taiwan. The license agreement was set for a duration of 15 years from the product’s first commercial sale in the region.
Under the terms of the new assignment deal, WinHealth will now relinquish the aforementioned rights and responsibilities associated with Velphoro back to CMS. The Category 5.1 innovative drug, which received priority review status and was approved in China in February 2023, is the nation’s first iron-based non-calcium phosphate binder. It is indicated for controlling serum phosphorus levels in adult patients with chronic kidney disease (CKD) undergoing hemodialysis or peritoneal dialysis and for controlling serum phosphorus levels in patients with stages 4-5 CKD, defined as a glomerular filtration rate of less than 30 mL/min/1.73m², aged 12 years and above, or in pediatric CKD patients undergoing dialysis. The drug is included in the National Reimbursement Drug List (NRDL).- Flcube.com