Qidu Pharma Sutoujia® Low-Calcium Peritoneal Dialysis Solution Series Approved for Marketing

On April 21, Sutoujia^® Low-Calcium Peritoneal Dialysis Solution (Bicarbonate-G1.5%/G2.5%/G4.25%) series, independently developed by Qidu Pharmaceutical for the treatment of chronic renal failure, obtained the Class 3 chemical drug registration approval issued by the National Medical Products Administration (NMPA), which is deemed equivalent to passing the generic consistency evaluation. Available in a specification of 2000 mL (725 mL for small-compartment solution and 1275 mL for large-compartment solution), the product adopts a three-layer co-extruded dual-compartment bag packaging system specially designed for peritoneal dialysis solutions. Sutoujia^® is the company’s first approved product in the peritoneal dialysis sector. Among the lineup, Low-Calcium Peritoneal Dialysis Solution (Bicarbonate-G4.25%) is the first generic product approved in China, while the G2.5% and G1.5% variants rank the second and third domestically respectively.

Peritoneal Dialysis (PD) is a renal replacement therapy that utilizes the patient’s own peritoneum as a semipermeable membrane. By regularly infusing dialysis fluid into the abdominal cavity, the therapy removes accumulated metabolic wastes and excess body water based on diffusion, convection and ultrafiltration driven by solute and osmotic gradients between plasma in peritoneal capillaries and dialysate, and maintains the body’s water, electrolyte and acid-base balance. Advances in peritoneal dialysis rely heavily on continuous innovation in dialysis solution formulations. Over nearly five decades since PD was widely applied clinically, peritoneal dialysis solutions have undergone repeated upgrades in composition, production process and other aspects. At present, neutral peritoneal dialysis solutions with low levels of glucose degradation products (GDPs) represent a key research focus and mainstream development trend in the global PD industry. The bicarbonate-based low-calcium peritoneal dialysis solution was launched in Japan in February 2014 for clinical PD treatment of patients with chronic renal failure, mainly indicated for patients with insufficiently improved hypermagnesemia or those prone to hypercalcemia induced by calcium preparations and active vitamin D formulations. China’s domestic market size of peritoneal dialysis solutions reached RMB 6.077 billion in 2025, and market demand is projected to surge continuously alongside the growing population of patients with end-stage renal disease (ESRD).

Qidu Pharmaceutical initiated the R&D of the Sutoujia^® project in 2022. The R&D team formulated targeted control strategies for wholeness of detachable sealing strips and tackled the technical bottleneck of liquid leakage prone to occur in large-volume dual-compartment bags, completing supplementary data submission ahead of schedule. Packaged in dual compartments, the small-compartment solution consists of sodium chloride, magnesium chloride, calcium chloride, sodium lactate and anhydrous dextrose with hydrochloric acid as the pH regulator; the large-compartment solution contains sodium bicarbonate and sodium chloride, with sodium hydroxide for pH adjustment. Compared with conventional peritoneal dialysis products, Sutoujia^® shows prominent advantages as follows:

First, rapid correction of acidosis. Using bicarbonate as the buffer component, the formulation directly participates in in-vivo acid-base regulation to rapidly relieve metabolic acidosis, a common complication among chronic renal failure patients.

Second, enhanced safety via dual-compartment packaging. Acidic dextrose components and alkaline bicarbonate ingredients are isolated in two compartment bags and mixed right before administration, drastically curbing the generation of glucose degradation products (GDPs), thereby alleviating damage to peritoneal mesothelial cells and preventing peritoneal fibrosis.

Third, markedly reduced infusion pain. The mixed solution features a physiological pH ranging from 6.8 to 7.8, closely matching the human internal environment to ease infusion discomfort and improve patients’ treatment compliance and quality of life.

Fourth, scientifically optimized formulation design. Reduced calcium content lowers the risks of complications including hypercalcemia, metastatic calcification, vascular calcification and cardiac lesions, improving overall treatment safety.

Fifth, easy-to-operate administration. Solutions in the compartment bags can be blended simply by breaking the detachable sealing strip, and matched disposable peritoneal drainage bags enable simply trained patients to conduct home-based dialysis independently.

The successful approval of the Sutoujia® product series marks Qidu Pharma’s technical breakthrough in the peritoneal dialysis field and further expands the company’s nephrology product portfolio. The enterprise will accelerate the market launch of a full spectrum of peritoneal dialysis solutions covering bicarbonate, lactate, icodextrin and amino acid formulations to build a comprehensive product matrix spanning mainstream formulas and novel media, delivering more optimized peritoneal dialysis regimens for patients with end-stage renal disease.