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Shijiazhuang Sihua Pharmaceutical Group’s Low-Calcium Peritoneal Dialysis Solution (Lactate-Based, 4.25%) Has Passed the Consistency Evaluation

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Honors Announcement

发布时间：2025-05-28

【概要描述】 On May 28, the low-calcium peritoneal dialysis solution (lactate-based—G4.25%, 2,000 ml) submitted by Shijiazhuang Sihua Pharmaceutical Group was approved by the National Medical Products Administration following the evaluation of generic drug quality and therapeutic equivalence, marking another significant achievement in the company’s efforts to enhance the technical quality of its dialysis products. To date, the Group has cumulatively obtained approval for 171 specifications across 127 product varieties.

Shijiazhuang Sihua Pharmaceutical Group’s Low-Calcium Peritoneal Dialysis Solution (Lactate-Based, 4.25%) Has Passed the Consistency Evaluation

On May 28, the low-calcium peritoneal dialysis solution (lactate-based—G4.25%, 2,000 ml) submitted by Shijiazhuang Sihua Pharmaceutical Group was approved by the National Medical Products Administration following the evaluation of generic drug quality and therapeutic equivalence, marking another significant achievement in the company’s efforts to enhance the technical quality of its dialysis products. To date, the Group has had a total of 171 product specifications across 127 varieties approved under this evaluation.

According to reports, low-calcium peritoneal dialysis solution (lactate-based, 4.25%) is primarily indicated for patients with acute and chronic renal failure who require continuous ambulatory peritoneal dialysis because non-dialytic therapies have proven ineffective. The low-calcium peritoneal dialysis solution (lactate-based, 4.25%) that has now passed the evaluation is one of the core formulations in the peritoneal dialysis solution portfolio, capable of meeting clinical treatment needs across a range of osmolarities.

Driven by the rising prevalence of diabetes and kidney disease, as well as advances in medical technology, China’s peritoneal dialysis market has expanded steadily in recent years, exhibiting strong growth momentum. Data indicate that the size of China’s peritoneal dialysis solution market has surpassed RMB 5 billion and continues to grow.

Focusing on clinical needs, the Group has continuously developed a comprehensive portfolio of peritoneal dialysis solutions, proactively expanded its market presence, and achieved numerous breakthroughs in innovative R&D. To date, all six products in the Group’s peritoneal dialysis solution (lactate-based) and low-calcium peritoneal dialysis solution (lactate-based) series have successfully passed the consistency evaluation. Notably, the lactate-based peritoneal dialysis solutions (G 1.5% and 2.5%) were the first to receive approval following the evaluation, while the low-calcium lactate-based solutions (G 1.5% and 2.5%) became the second to do so. These achievements have further strengthened the Company’s product portfolio advantage in the field of renal therapy.

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