Calcipotriol

As a common chronic inflammatory skin disease, psoriasis has a global prevalence of approximately 2% to 3%, and patients often suffer from long-term recurrent skin lesions. Topical therapy is the first-line option for patients with mild to moderate psoriasis. Calcipotriol is a vitamin D3 analog. By binding to vitamin D receptors on the surface of keratinocytes, it inhibits the excessive proliferation of keratinocytes, induces their normal differentiation, and regulates the release of local inflammatory factors to reduce the inflammatory response at skin lesions. In addition to being used alone for the topical treatment of psoriasis vulgaris, it can also be used in combination with glucocorticoids to improve efficacy and reduce the risk of adverse reactions caused by long-term use of hormones, and its applicable population covers adult psoriasis patients and pediatric psoriasis patients aged 6 and above.

From the perspective of the global market, the market size of calcipotriol-related preparations was approximately USD 1.2 billion in 2023, with a compound annual growth rate of 4.2% in the past three years. The growth is mainly driven by the improvement of psoriasis diagnosis and treatment rate in emerging markets and the promotion of compound preparations. For the domestic market, the sales of calcipotriol preparations at the terminal of public medical institutions exceeded RMB 1.8 billion in 2023, with generic drugs accounting for more than 60%. At present, calcipotriol preparations from more than 20 enterprises have been approved for marketing. After the implementation of centralized procurement, the prices of related products have dropped by more than 70%, and the clinical accessibility has been greatly improved, which has also driven the growth of demand for upstream API.

The original manufacturer of calcipotriol is LEO Pharma, with the original brand name Daivonex. Its core compound patent expired in 2001 in Europe, 2003 in the United States, and 1999 in China. The main dosage forms approved for the original product include ointment (0.005%, 15g/tube, 30g/tube), liniment (0.005%, 30ml/bottle) and compound preparations. Among them, the original ointment and liniment have been included in the China Listed Medicines Catalogue as reference preparations, and also included in the FDA Reference Preparations List. According to the domestic API registration platform, more than 10 enterprises have obtained A status registration numbers for calcipotriol API at present. The domestic approved calcipotriol preparations cover multiple dosage forms such as ointment, liniment, gel and compound preparations, which can fully meet the needs of different clinical scenarios. (Data as of October 2024, please refer to the official website of CDE for the latest information)

In response to the needs of impurity research and quality control in the production process of calcipotriol API and preparations, CATO can provide a full set of impurity reference standards for this API. The products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA. Most impurities have sufficient stock in reserve, and in-stock products ordered before 16:00 can be shipped on the same day, which can efficiently support enterprises to complete the whole process of impurity research, registration and declaration, and daily quality inspection.