King-Friend's nadroparin calcium injection passes generic drug evaluation

Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. announced that its nadroparin calcium injection (0.3ml: 3075AXaIU and 0.6ml: 6150AXaIU) has received approval from the National Medical Products Administration (NMPA). This approval signifies that the drug passed the consistency evaluation of generic drug quality and efficacy for two existing product specifications, with approval numbers H20194077 and H20191005.

The nadroparin calcium injection is indicated for preventing venous thromboembolic disease in surgical patients at moderate to high risk, treating established deep vein thrombosis, and preventing blood clotting in extracorporeal circulation during hemodialysis. The reference products for King-Friend’s drug are FRAXIPARINE, held by Aspen Pharma Trading Limited, approved in 1994. King-Friend invested approximately RMB 23,559,400 in research and development for this consistency evaluation project.

This successful evaluation is expected to enhance the product's market competitiveness and expand sales. It qualifies the drug for participation in national centralized procurement and will receive greater support in medical insurance payments and institutional procurement. However, the company noted that product sales remain subject to national policies and market conditions.