Ibrutinib

As the world's first approved Bruton's tyrosine kinase (BTK) inhibitor, ibrutinib irreversibly binds to the active site of BTK and blocks the conduction of B cell receptor signaling pathways, thereby inhibiting the proliferation, adhesion and migration of malignant B cells. Compared with traditional immunochemotherapy, its oral administration route and lower toxic and side effects have greatly improved patients' treatment compliance. It has now been approved for the treatment of a variety of B-cell malignant hematological tumors such as chronic lymphocytic leukemia/small lymphocytic lymphoma, mantle cell lymphoma, and Waldenström's macroglobulinemia, providing the possibility of long-term survival for elderly patients who cannot tolerate chemotherapy and patients with relapsed and refractory diseases.

The peak global market of ibrutinib once exceeded US$9 billion. With the successive launch of generic drugs, the market size has declined in recent years, but it still maintains steady growth in emerging markets. In terms of the domestic market, the terminal sales in public medical institutions exceeded RMB 2 billion in 2022. Up to now, generic drugs from nearly 10 enterprises have been approved for marketing, all of which have been included in the national centralized procurement. The winning bid price has dropped by more than 90% compared with that of the original drug, which has significantly reduced the medication burden of patients, and also driven the continuous release of demand for upstream API.

The original ibrutinib was jointly developed by Johnson & Johnson and Pharmacyclics, with the original brand name Imbruvica®. Its core compound patent expires in 2026 in the United States, and the compound patent in China expired in 2024. The dosage form approved for the original drug is capsule, with the specification of 140 mg, which has been included in the *Catalogue of Reference Preparations for Chemical Drugs* of China and the FDA Reference Preparation Catalogue. Up to now, more than 30 domestic enterprises have completed the registration of ibrutinib API in CDE, and those with the status of A can supply preparation enterprises. In addition, more than 20 enterprises have obtained approval for the marketing of ibrutinib preparations. (Data as of June 2025, please refer to the official CDE website for the latest information.)

CATO provides a full set of impurity reference standards for ibrutinib API. Most products are in stock. Orders for in-stock products placed before 16:00 will be shipped on the same day. They meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully meet the needs of API manufacturers and preparation R&D institutions for quality research and compliance declaration.