Shandong Xinhua Pharma Secures FDA Approval for New Drug

Shandong Xinhua Pharmaceutical Company Limited Class H (HK:0719) has released an update.

Shandong Xinhua Pharmaceutical Company Limited has announced that its abbreviated new drug application (ANDA) for sevelamer carbonate tablets has received approval from the U.S. Food and Drug Administration (FDA). This development positions the company to enter the market with a prescription drug designed to control hyperphosphatemia in adults with chronic kidney disease undergoing dialysis. The tablets, originally developed by Sanofi Genzyme, are already used in over 40 countries, enhancing their market potential.

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