Shandong Xinhua Pharmaceutical Company Limited (“Xinhua Pharmaceutical”) has received a Notification of Approval of Supplementary Drug Application from China’s National Medical Products Administration (NMPA), authorising the transfer of Marketing Authorisation Holder (MAH) rights for its Potassium Chloride Granules. The approval—Notification No. 2026B02488—concludes that the application meets all regulatory requirements under the Measures for the Administration of Post-marketing Changes of Drugs (Trial).
The approved product is a prescription-only formulation presented as granules, with each sachet containing 1.5 g of potassium chloride. It is registered under National Medicine Zhunzi H20254945 and is indicated for the treatment and prevention of hypokalaemia, including cases accompanied by metabolic alkalosis when dietary or diuretic adjustments prove insufficient.
The MAH transfer stems from an August 2023 agreement in which Guangzhou Aige Biotechnology Company Limited assigned all formulation production approvals and commercialisation rights for Potassium Chloride Granules to Xinhua Pharmaceutical. The technology transfer fee will be settled in instalments, and the transaction neither constitutes a related-party transaction nor a significant asset restructuring under Shenzhen Stock Exchange rules.
Listed as a Category A treatment in the 2025 National Drug Catalogue for Basic Medical Insurance, Work-Related Injury Insurance and Maternity Insurance, potassium chloride products generated approximately RMB 0.79 billion in sales across China’s public medical institutions in 2025. Securing MAH status positions Xinhua Pharmaceutical to expand its finished-dosage portfolio and strengthen market competitiveness.
Management notes that pharmaceutical sales remain sensitive to changes in industry policy, tendering procedures and market dynamics, and advises investors to consider associated uncertainties when assessing the company’s future performance.
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