SHANDONG XINHUA Pharmaceutical Co., Ltd. (00719) has announced that it recently received the Drug Registration Certificate for Concentrated Sodium Potassium Magnesium Calcium Injection from the National Medical Products Administration. In June 2024, Beijing Minkang Baicao Pharmaceutical Technology Co., Ltd. submitted an application for market approval of the injection to the Center for Drug Evaluation (CDE), which was accepted. The following month, SHANDONG XINHUA entered into an agreement with Minkang Baicao for the transfer of production technology and marketing authorization holder (MAH) rights for the product. Under the contract, Minkang Baicao will transfer all MAH rights—including but not limited to production, sales, and marketing—to SHANDONG XINHUA in exchange for phased payments. According to relevant regulations, this transaction does not require approval from the company’s board of directors or shareholders and does not constitute a connected transaction or a major asset reorganization. The injection is indicated for electrolyte supplementation in adult patients receiving concentrated glucose or amino acid solutions via central venous infusion to maintain electrolyte balance. The product has not been imported into the market, and domestic manufacturers have only recently obtained approval, with large-scale commercial sales yet to commence. SHANDONG XINHUA’s acquisition of the drug registration certificate in April 2026 is expected to enrich the company’s product portfolio and enhance its competitiveness.
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