zanubrutinib

In response to the clinical treatment needs of B-cell malignancies such as relapsed/refractory mantle cell lymphoma and chronic lymphocytic leukemia, the advent of Bruton's Tyrosine Kinase (BTK) inhibitors has greatly improved the long-term survival benefit of patients. As a new generation of BTK inhibitor independently developed in China, zanubrutinib can block the BTK-mediated B-cell proliferation signal more accurately and persistently by optimizing the molecular structure, while reducing the non-specific inhibition of other kinases and off-target adverse reactions. At present, it has been approved for multiple indications such as adult mantle cell lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma, and Waldenström's macroglobulinemia. It is the first anti-tumor new drug developed locally in China that has obtained FDA approval, filling the gap of domestic innovative BTK inhibitors in the international market.

The global market size of zanubrutinib had exceeded US$900 million in 2023, with a compound annual growth rate of over 120% in the recent three years, which far outpaces that of the first-generation BTK inhibitors. In terms of the Chinese market, the sales of zanubrutinib at public medical institution terminals exceeded RMB 1.5 billion in 2023. After the seventh batch of national centralized drug procurement in 2024, its price dropped by more than 60%, and the accessibility for patients has been greatly improved. In the current market structure, the original research product occupies the majority of the market share, and 5 domestic enterprises have submitted marketing applications for generic zanubrutinib. With the expiration of core patents one after another, the generic drug track will see rapid expansion.

Zanubrutinib is independently developed by BeiGene, and the trade name of the original research product is "Brukinsa". Its core compound patent in China will expire in 2033, and the core patent in the United States will expire in 2035. The main currently approved dosage form is capsule, with two specifications of 80 mg and 160 mg. The original research preparation has been included in the Chinese *Catalogue of Reference Preparations for Chemical Drugs* and the FDA Reference Preparation Catalogue. In terms of API registration, BeiGene's zanubrutinib API has completed A-status registration with the CDE, and the zanubrutinib API registrations of 3 domestic enterprises are currently in the publicity stage. A total of 8 domestic zanubrutinib preparations have been approved for marketing. (Data as of April 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of zanubrutinib impurity reference standards, all of which meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA. Most products are regularly in stock, and orders placed before 16:00 can be shipped on the same day. It can provide stable reference standard supply support for pharmaceutical enterprises in generic drug R&D, quality research and consistency evaluation, effectively shortening the R&D cycle and reducing compliance risks.