SHANDONG XINHUA (00719) obtained the registration certificate for concentrated solution of sodium, potassium, magnesium, and calcium for injection.

SHANDONG XINHUA (00719) announces that recently, SHANDONG XINHUA Limited (hereinafter referred to as "Shandong Xinhua Pharmaceutical" or "the Company") has received the Drug Registration Certificate for the concentrated solution for injection of sodium, potassium, magnesium, and calcium (hereinafter referred to as "the Product") issued by the National Medical Products Administration. In June 2024, Beijing Minkang Baicao Pharmaceutical Technology Co., Ltd. (hereinafter referred to as "Minkang Baicao") submitted the application for the registration of the market authorization for the concentrated solution for injection of sodium, potassium, magnesium, and calcium to the Center for Drug Evaluation of the National Medical Products Administration (CDE) and it was accepted. In July 2024, Shandong Xinhua Pharmaceutical signed a contract with Minkang Baicao for the production technology and owner transfer of the Product. The contract stipulates that Minkang Baicao will transfer all MAH rights including the manufacturing permit and commercialization rights of the concentrated solution for injection of sodium, potassium, magnesium, and calcium, acquired by them, to Shandong Xinhua Pharmaceutical. Shandong Xinhua Pharmaceutical will pay the transfer fees to Minkang Baicao in stages according to the contract. According to the Shenzhen Stock Exchange Listing Rules and the Company's Articles of Association, this transaction does not require approval from the company's board of directors or shareholders' meeting. This transaction is not considered a related party transaction and does not constitute a major asset restructuring as stipulated in the Regulations on the Management of Major Asset Restructuring of Listed Companies. The Product is used for electrolyte supplementation when infusing solutions containing concentrated glucose or amino acids through central venous administration, to maintain electrolyte balance in adult patients. The Product has not been imported from overseas, and domestic manufacturers have recently obtained approval but have not yet started mass production and sales. The concentrated solution for injection of sodium, potassium, magnesium, and calcium from Shandong Xinhua Pharmaceutical obtained the Drug Registration Certificate in April 2026, which will enrich the company's formulation product series and enhance its competitiveness.