Maxacalcitol

Chronic kidney disease-related secondary hyperparathyroidism is a common complication in patients with end-stage renal disease. Long-term progression can lead to bone pain, fractures and even vascular calcification, which severely reduces the quality of life of patients. As a third-generation active vitamin D3 analog, maxacalcitol can selectively act on the vitamin D receptor of the parathyroid gland and inhibit the excessive synthesis and secretion of parathyroid hormone. Meanwhile, its effects on blood calcium and blood phosphorus are significantly lower than those of traditional vitamin D preparations. It is currently the preferred drug for clinical treatment of secondary hyperparathyroidism in dialysis patients, especially suitable for high-risk groups with poor control of calcium and phosphorus levels.

At present, the global market size of maxacalcitol has exceeded 300 million US dollars. In recent years, with the steady growth of the dialysis patient base, the compound annual growth rate has remained at around 7%. The domestic market is still in a stage of rapid expansion. In 2023, the terminal sales in public medical institutions exceeded 200 million yuan, with a growth rate of more than 18%. The current market is still dominated by the original research product, and the number of domestic generic drug declaration enterprises is small, so the competition pattern is relatively loose. With the improvement of clinical cognition of related indications, there is still a large room for improvement of market penetration in the future.

The original research enterprise of maxacalcitol is Chugai Pharmaceutical Co., Ltd. of Japan, and the original research brand name is "Oxarol". The core compound patent of maxacalcitol expired in 2008 in major markets such as Japan and the United States, and the compound patent in China also expired in 2008. The main dosage forms approved for the original research product are injections, with specifications including 2.5μg/1mL and 5μg/1mL. The original research injection has been included in the Reference Listed Drug Catalogue of chemical drugs published by the NMPA. Up to now, the maxacalcitol active pharmaceutical ingredients of multiple domestic enterprises have passed the evaluation of the CDE and obtained A-status registration numbers, and the maxacalcitol injections of another 3 domestic pharmaceutical enterprises have been approved for marketing. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for maxacalcitol API. Most of the products are available from stock. For in-stock products, orders placed before 16:00 can be shipped on the same day. All reference standards meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, which can fully meet the reference standard needs in the whole process of API R&D, quality research and production.