Etelcalcetide

Patients with chronic kidney disease undergoing long-term dialysis often suffer from secondary hyperparathyroidism (SHPT). Excessively high parathyroid hormone levels can induce serious complications such as abnormal bone metabolism and cardiovascular calcification, and traditional treatment regimens can hardly accurately balance efficacy and medication safety. Etelcalcetide is a calcimimetic drug, which allosterically activates the calcium-sensing receptor on the parathyroid gland, simultaneously inhibits parathyroid hormone secretion, and reduces blood calcium and blood phosphorus levels. It is currently the first long-acting injection preparation that can simultaneously improve the three core indicators of SHPT. It is mainly used for the treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease receiving hemodialysis. Compared with short-acting preparations, it greatly reduces the frequency of administration and improves patients' treatment compliance.

The global market size related to etelcalcetide had exceeded USD 1.2 billion in 2023, with a compound annual growth rate maintained at around 18%. The growth momentum mainly comes from the expansion of the dialysis patient group and the increased clinical recognition of long-acting preparations. The Chinese market is still in its initial stage. After the preparation was first approved for import in 2021, with the advancement of local generic drug R&D, the domestic market size is expected to exceed RMB 1.5 billion in 2027. In the current competitive landscape, the original research product still occupies the major global market share. More than 10 domestic pharmaceutical companies have laid out generic drug R&D, and the supply gap of API is relatively obvious.

The original research enterprise of etelcalcetide is Kai Pharma, which was later acquired by Amgen, and the original research trade name is Parsabiv. Its core compound patent in the United States expired in 2026, and the expiration date of the compound patent in China is 2027. The dosage form approved for the original research product is injection, with three specifications including 2.5mg, 5mg and 10mg, which have been included in the FDA Reference Listed Drug Catalog and the *Catalogue of Reference Preparations for Chemical Drugs (9th Batch)* of China. Up to now, there is no generic etelcalcetide preparation approved for marketing in China, and no enterprise has submitted an A-status registration number on the API registration platform, with only 3 enterprises in the phase I publicity stage. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of etelcalcetide impurity reference standards, most of which are in stock. In-stock products ordered before 16:00 will be shipped on the same day, which can meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and provide stable reference standard support for pharmaceutical enterprises in API R&D, quality research and generic drug consistency evaluation.