CR Double-Crane subsidiary wins approval for expanded peritoneal dialysis solution

CR Double-Crane Pharmaceutical Holdings Company Limited announced that its wholly-owned subsidiary, Shanghai Changzheng Fumin Jinshan Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for supplementary drug applications for its peritoneal dialysis solution (lactate) series. The approval covers new 5000ml specifications for Peritoneal Dialysis Solution (Lactate-G1.5%) and Peritoneal Dialysis Solution (Lactate-G2.5%), with corresponding new approval numbers. This expansion includes changing the packaging material to three-layer co-extruded infusion bags for the 5000ml volume.

The series of drugs is used for acute and chronic renal failure patients requiring continuous ambulatory peritoneal dialysis. The subsidiary began research in July 2023, submitting the application on October 23, 2024, and receiving approval on September 3, 2025. As of the announcement date, the company's cumulative R&D investment for this series of drugs totals RMB 1.2174 million (unaudited).

In 2024, the domestic medical market for peritoneal dialysis solution (lactate) had a total sales value of RMB 2.78 billion (terminal price). CR Double-Crane's peritoneal dialysis solution (lactate) series generated RMB 317 million in sales revenue in 2024. This latest approval is expected to enhance the series' market sales and competitive potential.