Qidu Pharmaceutical’s Ruihuanjia® – Hemofiltration Replacement Fluid of Sodium Citrate Receives NMPA Approval for Marketing

Qidu Pharmaceutical’s independently developed continuous renal replacement therapy (CRRT) product, Ruihuanjia® – Hemofiltration Replacement Fluid of Sodium Citrate, has recently been approved by the National Medical Products Administration (NMPA) with the approval number GYZZ H20265430. The product is available in a 5000 mL strength containing sodium chloride 25.15 g and sodium citrate 26.45 g, packaged in a three-layer co-extruded bag for hemofiltration replacement fluid. As a Category 4 chemical drug application, it is deemed to have passed the generic drug consistency evaluation.

Continuous renal replacement therapy (CRRT) is a core life-support intervention in intensive care for patients with acute kidney injury and multiple organ dysfunction. During treatment, blood contact with extracorporeal circuits can activate coagulation and lead to filter clotting, necessitating anticoagulation to maintain circuit patency. However, anticoagulation simultaneously increases the risk of systemic bleeding. Therefore, establishing a safe anticoagulation strategy that effectively prevents extracorporeal circuit clotting while minimizing systemic bleeding risk is critical to ensuring CRRT efficacy. Hemofiltration Replacement Fluid of Sodium Citrate provides localized anticoagulation in the extracorporeal circuit, significantly reducing systemic bleeding risk, and is particularly suitable for patients who cannot receive systemic heparin anticoagulation. This product is recommended by multiple authoritative guidelines and consensus statements, including the Clinical Practice Guideline For Quality Control Of Hemodiafiltration, Expert Consensus on the Emergency Clinical Application of Blood Purification, and Expert Consensus on Severe Acute Kidney Injury, and is included in Category B of the National Reimbursement Drug List. With the sustained growth of the domestic kidney disease patient population, China’s hemofiltration product market reached RMB 6.077 billion in 2025, representing an 18.31% increase year-over-year, reflecting rapidly rising clinical demand.

Compared with similar products, Ruihuanjia® offers four major advantages:

1. Integrated anticoagulation and fluid supplementation. This product combines “local anticoagulation” with “replacement fluid supplementation” in one formulation. By administering via pre-dilution in the extracorporeal circuit, it achieves effective localized anticoagulation while simultaneously delivering CRRT replacement fluid, thereby simplifying the treatment protocol.

2. Convenient and safe operation. The 5000 mL large-volume design reduces the frequency of bag changes and line connection procedures, shortens emergency preparation time, and lowers the risk of healthcare-associated infections caused by frequent manipulation.

3. Reduced medical risks. Compared with heparin and argatroban, citrate effectively prevents filter and circuit clotting without increasing bleeding risk. Moreover, compared to conventional high-concentration sodium citrate regimens, this product achieves comparable efficacy while reducing total citrate load, thereby minimizing the risk of citrate accumulation.

4. Coverage for both adult and pediatric patients. Its broad clinical applicability provides a new therapeutic option for CRRT in pediatric populations.

The successful approval of Ruihuanjia® fills the gap in Qidu Pharmaceutical’s portfolio of replacement fluids for localized anticoagulation, enriches its blood purification pipeline, and strengthens its product layout in the plasma substitute segment. Looking ahead, the company will accelerate the launch of hemofiltration replacement fluids in multiple concentration strengths, aiming to build a comprehensive product matrix covering mainstream formulations and novel media to meet diverse clinical treatment needs.