Lotilaner

In recent years, the clinical treatment demand for alopecia has been continuously rising, and the emergence of new JAK inhibitors has brought a new non-hormonal treatment option for patients with moderate to severe alopecia areata. Ritlecitinib is a topical dual JAK1/TYK2 inhibitor, which blocks the signal transduction of pro-inflammatory cytokines by inhibiting the Janus kinase signaling pathway, reduces the inflammatory response around hair follicles, and restores the normal growth cycle of hair follicles. It is mainly used for the treatment of alopecia areata in people aged 12 years and above, combining the low systemic exposure risk of local administration with definite hair regrowth efficacy, filling the gap in topical treatment for adolescents with alopecia areata.

At present, the global market size of alopecia areata treatment has exceeded USD 2.3 billion, with a compound annual growth rate of more than 12%, among which the market share of topical JAK inhibitors is rapidly increasing at an annual growth rate of 18%. In the domestic market, ritlecitinib, as the first topical JAK inhibitor specially developed for alopecia areata, has not had any generic drug approved for marketing yet, and the original research product is in the market exclusivity period. With the increase in the consultation rate of domestic alopecia areata patients and the coverage of adolescent indications, the market demand for its API is expected to enter a rapid growth stage in the next 3 years.

The original research enterprise of ritlecitinib is Concert Pharmaceuticals, a US company, and the original trade name is Litfulo. Its core compound patent in the United States will expire in 2038, and the compound patent in China will expire in 2039. The dosage form approved by the original research is topical ointment, with a specification of 10 mg (1%) ritlecitinib per gram. This dosage form has been included in the US FDA Reference Listed Drug Catalog, but has not yet been included in the *Catalogue of Chemical Products* of China. As of the retrieval date, there is no publicly announced registration number of ritlecitinib API in China, and the domestic marketing application of the original research preparation is under review, and there is no approved domestic or imported preparation variety. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for ritlecitinib API, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. Relevant reference standards comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, which can fully meet the impurity analysis needs in the process of drug research and development, quality research and production, and help enterprises efficiently promote the development projects of related generic drugs.