Xinhua Pharmaceutical obtains Chinese approval for Sevelamer Carbonate suspension

Bulletin Express06-01

Shandong Xinhua Pharmaceutical has received National Medical Products Administration approval for its Sevelamer Carbonate for Suspension, securing Drug Registration Certificates H20264551 and H20264552 for 0.80 g and 2.40 g oral formulations.

The class-3 chemical prescription drug is indicated for controlling hyperphosphatemia in adult chronic kidney disease patients, both on dialysis and with serum phosphorus levels of at least 1.78 mmol/L prior to dialysis. The product is listed as Category B in the 2025 National Drug Reimbursement Catalogue, facilitating broad market access.

Sevelamer-related preparations generated approximately RMB750.00 million (USD-equivalent not disclosed) in sales across China’s public medical institutions in 2025, underscoring the addressable market for Xinhua Pharmaceutical’s entry.

Management expects the new approval to expand the company’s pharmaceutical portfolio and strengthen overall competitiveness. The board notes that future sales performance remains sensitive to policy changes, tendering dynamics and broader market conditions, and advises investors to monitor related risks.

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