Ningbo Tianyi Medical Appliance (301097.SZ) subsidiary obtains drug registration certificates for multiple new products.

Ningbo Tianyi Medical Appliance (301097.SZ) announced that its subsidiary, Ningbo Tianyi Pharmaceutical Technology Co., Ltd. ("Tianyi Pharmaceutical"), recently received multiple Drug Registration Certificates issued by the National Medical Products Administration. The low-calcium peritoneal dialysis solution and peritoneal dialysis solution approved this time were both filed under a "one drug, multiple specifications" approach and were approved consecutively. The related products are liquids for peritoneal dialysis treatment in patients with end-stage renal disease, removing metabolic waste from the body and correcting electrolyte and acid-base imbalances through peritoneal dialysis. Their core component, glucose, serves as an osmotic agent and is available in three glucose concentration specifications1.5%, 2.5%, and 4.25%to meet the ultrafiltration needs of different patients; electrolytes such as sodium chloride, calcium chloride, magnesium chloride, and sodium lactate, as well as a buffering base, help maintain the balance of electrolytes and acid-base levels in patients. The related products use lactate as the buffer system, among which the low-calcium formulation can reduce risks such as hypercalcemia, better aligning with the clinical needs of long-term dialysis patients, and requires no additional preparation, allowing direct use in peritoneal dialysis treatment, which helps simplify clinical operations and improve treatment safety.