Abrocitinib

Atopic dermatitis, as a chronic inflammatory skin disease, has a global prevalence as high as 2%-10%. Patients with moderate to severe atopic dermatitis have long suffered from skin lesions and pruritus in their daily lives, while traditional hormone and immunosuppressant therapies have the pain points of insufficient response rate and frequent adverse reactions. Abrocitinib is a highly selective Janus kinase 1 (JAK1) inhibitor. By blocking the signaling pathways of various inflammatory cytokines such as IL-4, IL-13 and IL-31 mediated by JAK1, it inhibits the inflammatory cascade from the upstream of the pathogenesis. It has been approved for the treatment of refractory, moderate to severe atopic dermatitis in adults and adolescents aged 12 years and older who have inadequate response to other systemic therapies or are unsuitable for the above therapies, providing a new option of oral targeted therapy for patients.

At present, the global market size of abrocitinib has exceeded 1.7 billion US dollars, with a compound annual growth rate of around 42% in the past three years. The growth is mainly driven by the improved clinical recognition of the atopic dermatitis indication and the surging demand in the East Asian market. China is one of the markets with the largest base of atopic dermatitis patients. After abrocitinib was included in the National Reimbursement Drug List in 2022, its annual terminal sales growth rate has exceeded 180%. At present, the domestic preparation market is still dominated by the original research drug, and more than 15 enterprises have laid out the research and development of generic drugs. With the expiration of core patents, the launch of generic drugs will further promote the improvement of clinical accessibility.

The original research enterprise of abrocitinib is Pfizer, with the trade name Cibinqo®. Its compound patent in China will expire in 2032, and the crystal form patent will expire in 2036. The main currently approved dosage form is tablet, with three specifications including 50mg, 100mg and 200mg. It has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and is also a reference preparation designated by the FDA. Up to now, there is no domestic abrocitinib API registered and approved by CDE in China, and only the original research enterprise has obtained the registration approval for imported API. A number of generic drugs have been submitted for marketing application in China and are under the review stage. (Data as of June 2025, please refer to the official website of CDE for the latest information)

In response to the demands for generic drug research and development and quality control of abrocitinib, CATO provides a full set of impurity reference standards for this API, covering all categories such as process impurities and degradation impurities. Most products are in stock, and orders placed before 16:00 can be shipped on the same day. All products meet the requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully support enterprises' API registration and declaration as well as daily quality inspection work.