氘可来昔替尼

As a chronic immune-mediated disease affecting more than 125 million people worldwide, psoriasis faces clinical pain points such as insufficient response rate and frequent adverse reactions with existing systemic therapeutic drugs. Deucravacitinib is the first approved allosteric inhibitor of tyrosine kinase 2 (TYK2). It selectively binds to the JH2 regulatory domain of TYK2, inhibits the signaling pathways of pro-inflammatory cytokines such as IL-23, IL-12 and type I interferon mediated by TYK2, and avoids inhibiting the JAK1/2/3 family kinases at the same time, which greatly reduces off-target related adverse reactions. At present, this drug is mainly used for systemic treatment or combined phototherapy for adult patients with moderate to severe plaque psoriasis. It has shown better skin lesion clearance effect than commonly used PDE4 inhibitors in clinical trials, and has better long-term safety, providing a new treatment option for patients intolerant to traditional biological agents.

As a heavyweight innovative drug in the global psoriasis field, the global sales of deucravacitinib had exceeded 1.8 billion US dollars in 2023, and its market size is expected to exceed 4 billion US dollars in 2027, with a compound annual growth rate of nearly 22%. In terms of the Chinese market, the drug was approved for import in 2022 and quickly entered clinical application. Its in-hospital sales scale exceeded 300 million yuan in 2023. At present, only the original research product exclusively occupies the market, and more than 10 domestic pharmaceutical companies have laid out generic drug research and development. With the subsequent expiration of patents and the launch of generic drugs, clinical accessibility will be further improved, and the domestic market growth rate is expected to remain above 45% in the next three years.

The original research enterprise of deucravacitinib is Bristol-Myers Squibb, and the original research trade name is "Sotyktu" (the Chinese translation of the trade name is "颂狄多"). Its core compound patent expires in 2037 in the United States, and the Chinese compound patent expires in 2036. At present, the main dosage form approved by the original research is tablet, with a specification of 6mg. The original research product has been included in the *Catalogue of Reference Preparations of Chemical Drugs* issued by the NMPA, and is also a reference preparation recognized by the FDA. As of the retrieval time, no generic deucravacitinib preparation has been approved for marketing in China, and no enterprise has submitted a marketing registration application for the API on the CDE API registration platform. (Data as of June 2025, please refer to the official CDE website for the latest information)

For the research and development and quality control requirements of deucravacitinib, CATO can provide a full set of impurity reference standards for this API. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the relevant requirements of drug research and development, quality research and generic drug consistency evaluation.