SHANDONG XINHUA Receives Approval Notice for Potassium Chloride Granules Supplemental Application

SHANDONG XINHUA (00719) announced that Shandong Xinhua Pharmaceutical Co., Ltd. recently received a Drug Supplement Application Approval Notice for Potassium Chloride Granules from the National Medical Products Administration. The notice approves the supplemental application for the transfer of the marketing authorization holder of the product. In August 2023, Xinhua Pharmaceutical signed a contract with Guangzhou Aige Biotechnology Co., Ltd. for the transfer of production technology and marketing authorization holder rights for the product. The contract stipulates that Guangzhou Aige will transfer all MAH rights for Potassium Chloride Granules, including but not limited to production, sales, and marketing, to Xinhua Pharmaceutical in a one-time transaction. Xinhua Pharmaceutical will pay the relevant transfer fees to Guangzhou Aige in stages according to the contract. According to relevant regulations, this transaction does not require review by the company's board of directors or shareholders' meeting. The transaction does not constitute a connected transaction nor a major asset reorganization as defined by relevant measures. In March 2026, Xinhua Pharmaceutical submitted the supplemental application for the change of marketing authorization holder to the NMPA, which was accepted. The approval notice was received in April 2026, with the review conclusion stating that the application complies with post-marketing change management requirements, approving the change of marketing authorization holder. The product is used to treat and prevent hypokalemia with or without metabolic alkalosis, when dietary management with potassium-rich foods or reduced diuretic dosage is insufficient. It is listed as a Class A drug in the National Reimbursement Drug List. According to relevant statistics, sales of potassium chloride in Chinese public medical institutions reached approximately RMB 790 million in 2025. With the NMPA's approval in April 2026, Xinhua Pharmaceutical becoming the marketing authorization holder for Potassium Chloride Granules will help enrich the company's product portfolio and enhance its competitiveness.