Peficitinib

The pathogenesis of autoimmune diseases and tumors is often accompanied by abnormal activation of the JAK kinase pathway. As a new generation of highly selective JAK1 inhibitor, abrocitinib precisely targets the kinase domain of JAK1 to block the signal transduction of downstream inflammatory factors such as IL-4, IL-13 and IFN-γ, and demonstrates a lower risk of off-target side effects in the treatment of autoimmune diseases such as atopic dermatitis and rheumatoid arthritis. Compared with the first-generation non-selective JAK inhibitors, it has significant clinical advantages in reducing the incidence of adverse reactions such as anemia and infection, and is currently mainly used for the systemic treatment of adult patients with moderate to severe atopic dermatitis.

The global patient base of atopic dermatitis exceeds 200 million, with moderate to severe patients accounting for approximately 30%, and the market demand for highly selective JAK inhibitors continues to expand. In 2023, the global market size of JAK1 inhibitors has exceeded USD 9 billion, among which the segment track for atopic dermatitis indication has a compound annual growth rate of 42%. As a highly selective JAK1 candidate drug with leading clinical progress, abrocitinib is currently in the phase III clinical trial stage globally. More than 10 domestic pharmaceutical companies have laid out the generic drug R&D pipelines of this variety, and it is expected to become a popular generic variety in the field of autoimmune diseases after the patent expires.

The original research enterprise of abrocitinib is Pfizer Inc. of the United States, and the original brand name is Cibinqo. The expiration dates of its core compound patents in Europe and the United States are 2036 and 2037 respectively, and the expiration date of the compound patent in China is 2036. The main dosage form of the original research drug that has been approved is tablet, with specifications including 50mg, 100mg and 200mg, and it has been included in the FDA Orange Book Reference Listed Drug Catalog. At present, China has not approved the import and marketing of this original research preparation. There is no API registration information of this variety in the database of the Center for Drug Evaluation (CDE) of the National Medical Products Administration, and no relevant generic preparation has been approved for marketing in China. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for abrocitinib. 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 regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the reference substance use needs of pharmaceutical companies in various stages of R&D, quality research and registration declaration of this variety.