Oclacitinib

As the world's first JAK kinase inhibitor approved for the treatment of canine allergic dermatitis, oclacitinib highly selectively blocks the signaling pathways of allergy-related cytokines such as IL-31, IL-4 and IL-13 mediated by JAK1, so as to rapidly relieve pruritus symptoms and reduce skin inflammatory injury. Compared with traditional glucocorticoids and antihistamines, it has the advantages of fast onset of action and low incidence of adverse reactions, and is currently a recognized first-line therapeutic drug in the field of companion animal dermatology. It is mainly used for the control of pruritus symptoms related to atopic dermatitis and allergic dermatitis in dogs aged one year and above, and is widely used in the global pet medical market.

The global market size of oclacitinib for pets had exceeded 1.3 billion US dollars in 2023, with a compound annual growth rate of over 12%. With the continuous increase of the global pet ownership rate and the rising consultation rate of companion animal dermatosis, the market size is expected to exceed 2.2 billion US dollars by 2028. At present, the supply side of the market is dominated by the original research product, and the number of approved generic drugs worldwide is small. China's pet drug market is still dominated by imported original research preparations, while local enterprises are still in the stage of generic drug application, and there is a significant gap in the supply of API.

The original research enterprise of oclacitinib is Pfizer Inc. of the United States, and the original research trade name is Apoquel. The core compound patent in the United States expires in 2030, and the core compound patent in China expires in 2027. The originally approved dosage form is oral tablet, with three specifications of 3.6mg, 5.4mg and 16mg. It has been included in the FDA Reference Listed Drug Catalog for Veterinary Drugs, and also included in China's Imported Pet Drug Registration Catalog. Up to now, no enterprise in China has obtained the CDE registration number of oclacitinib API, only the imported original research preparation has been approved for marketing, and no domestic generic preparation has been approved. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO provides a full set of oclacitinib impurity reference standards, most of which are in stock. Orders for in-stock products placed before 16:00 will be shipped on the same day. The products can meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and provide stable and reliable reference standard support for drug R&D, quality research and generic drug application.