Cinacalcet

Patients with chronic kidney disease on maintenance dialysis often suffer from secondary hyperparathyroidism (SHPT). Long-term disorders of calcium and phosphorus metabolism can induce serious complications such as vascular calcification and fracture. The advent of cinacalcet has brought more precise treatment options for these patients. As the world's first calcimimetic agent, it can allosterically activate the calcium-sensing receptor on the surface of parathyroid cells, inhibit the excessive secretion of parathyroid hormone, and reduce the levels of blood calcium and blood phosphorus at the same time. In addition to dialysis-related SHPT, it can also be used to treat hypercalcemia in patients with parathyroid carcinoma, and is currently a first-line drug recommended by guidelines in relevant fields.

The number of patients with end-stage renal disease in China exceeds 3 million, and the annual growth rate of the dialysis population remains above 10%, driving the continuous expansion of the cinacalcet market size. In 2023, the terminal sales of cinacalcet in domestic public medical institutions exceeded 1.8 billion yuan. After the expiry of the original research compound patent in 2021, domestic generic drug enterprises have entered the market one after another. At present, the generic drugs of nearly 20 enterprises have been approved for marketing. This variety has been included in the national centralized drug procurement, and the maximum price reduction of the selected products is more than 90% compared with the original research drug, which greatly improves the accessibility of medication for patients, and the market structure has gradually shifted from original research dominance to a pattern of joint competition between original research drugs and generic drugs.

The original research enterprise of cinacalcet is Kyowa Hakko Kirin Co., Ltd., and the original research trade name is "Regpara". Its Chinese compound patent expired in March 2021. The main dosage form approved for the original research is tablet, with two specifications of 25mg and 75mg. It has been included in the China Listed Drug Catalog as a reference preparation, and is also included in the FDA Reference Preparation Catalog. Up to now, there are more than 30 registration records of cinacalcet API on the CDE API registration platform, among which nearly 20 are in "A" status, and a number of domestic enterprises have obtained the marketing approval of cinacalcet tablets. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of cinacalcet impurity reference standards, covering all categories such as synthetic process impurities and degradation impurities. Most of the products are available from stock. Orders for in-stock products placed before 16:00 can be shipped on the same day. All reference standards comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can fully meet the use requirements of different scenarios such as API R&D, quality research and registration declaration.