Evocalcet

After chronic kidney disease progresses to the end stage, secondary hyperparathyroidism is an extremely common clinical complication. Long-term abnormal elevation of parathyroid hormone levels can induce multiple high-risk risks such as bone metabolism disorder and vascular calcification, and it is a core intervention target for improving the quality of life of patients. As the first calcimimetic approved worldwide, etelcalcetide allosterically regulates the calcium-sensing receptor on the surface of parathyroid cells to improve the sensitivity of the receptor to extracellular calcium ions, inhibits parathyroid hormone secretion without increasing blood calcium concentration, and simultaneously improves calcium and phosphorus metabolism disorder. At present, it has been recommended by multiple authoritative guidelines for the treatment of secondary hyperparathyroidism in dialysis patients, and can also be used for the control of hypercalcemia in patients with parathyroid carcinoma.

The global etelcalcetide market size exceeded 1.2 billion US dollars in 2022. In recent years, with the continuous growth of the chronic kidney disease dialysis population, the market has maintained a stable annual growth rate of around 6%. In terms of the domestic market, due to the high price of the original drug, the penetration rate has always been lower than 5% in the past. With generic drugs entering the centralized procurement in 2021, the price has dropped by more than 90%, and clinical accessibility has been greatly improved. The sales volume of etelcalcetide in domestic sample hospitals in 2023 increased by more than 370% year-on-year. At present, the market is dominated by domestic generic preparations, the competitive landscape is relatively scattered, and the top 3 enterprises account for about 60% of the market share.

The original research enterprise of etelcalcetide is Amgen, and the original brand name is Sensipar (Gaiping). Its US compound patent expired in 2018, and the core Chinese patent expired in 2019. The main dosage form approved for the original drug is tablet, with specifications including 30mg, 60mg and 90mg. It has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and is also a reference preparation recognized by the FDA. In terms of domestic API registration, more than 10 enterprises have obtained A-status registration numbers for etelcalcetide APIs after approval by the CDE, and multiple domestic manufacturers have had generic preparations approved for marketing and included in centralized procurement. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of etelcalcetide impurity reference standards. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and the impurity structures have been fully characterized, which can meet the full-process R&D needs such as API registration and declaration, quality research, and stability investigation.