Halometasone

Glucocorticoid drugs are one of the core categories for anti-inflammatory treatment in dermatology. As a potent halogen-containing topical glucocorticoid, halometasone binds to intracellular glucocorticoid receptors to inhibit the transcription and release of inflammatory factors and reduce capillary permeability, exerting excellent anti-inflammatory, anti-allergic, anti-proliferative and antipruritic effects. It is clinically mainly used for non-infectious inflammatory dermatoses that are responsive to glucocorticoid therapy, including seborrheic dermatitis, contact dermatitis, atopic dermatitis, localized neurodermatitis, nummular dermatitis and psoriasis vulgaris. Its applicable population covers adults and children over 2 years old, and it is a first-line topical treatment option for moderate to severe chronic inflammatory dermatoses.

The global market size of halometasone is approximately USD 180 million, with a compound annual growth rate of around 3.2% in the past three years. The growth drivers mainly come from the rising prevalence of chronic dermatoses and the improvement of the standardization of topical hormone use at the primary care level. The domestic market size is approximately RMB 230 million, among which the original research product accounts for nearly 62% of the market share. Domestic generic drugs have gradually increased their penetration rate in recent years through consistency evaluation. At present, 3 enterprises have obtained marketing approval for halometasone cream. The supply pattern of API is relatively concentrated, with fewer than 5 domestic manufacturers holding registration qualifications.

The original research enterprise of halometasone is Organon, a subsidiary of Pfizer, and the original brand name is "Sicorten". Its core compound patent has expired in major global markets before 2010, and the compound patent in China also expired in 2010. The formulations of the original research product approved in China include halometasone cream (0.05%, 10g:5mg per tube) and halometasone triclosan cream (0.05% halometasone + 1% triclosan, 10g per tube). Both preparations have been included in the China Listed Drug Catalogue as reference preparations. On the API level, there are currently 7 halometasone-related registration numbers on the domestic CDE API registration platform, 4 of which have been approved for use in marketed preparations. The domestic preparation approval enterprises cover the original research enterprise and 3 domestic generic drug enterprises. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of halometasone impurity reference standards. Most products are available from stock. Stock orders paid before 16:00 can be shipped on the same day. All products meet the requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA. Complete technical materials including impurity structure confirmation and purity calibration are available, which can fully meet the needs of the whole process of API R&D, quality research and compliance declaration.