Acalabrutinib

In response to the clinical treatment needs of B-cell malignancies such as relapsed/refractory mantle cell lymphoma, the emergence of highly selective BTK inhibitors has greatly reduced the risk of off-target adverse reactions associated with traditional treatments. Acalabrutinib is a second-generation irreversible Bruton's Tyrosine Kinase (BTK) inhibitor, which covalently binds to the C481 site of BTK, blocks the transduction of B-cell receptor signaling pathways, and inhibits the proliferation, migration and survival of malignant B cells. Currently, the approved indications of this drug cover mantle cell lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma in patients who have received at least one prior line of therapy, and it can also be used for the treatment of Waldenström's macroglobulinemia, providing a better treatment option for patients who cannot tolerate the adverse reactions of first-generation BTK inhibitors.

The global acalabrutinib market size had exceeded USD 2.2 billion in 2023, with a compound annual growth rate of over 35% in the past three years. The growth momentum mainly comes from the continuous increase in the penetration rate of first-line medication for chronic lymphocytic leukemia. At present, the global market is still dominated by the original research product. With the expiration of core patents one after another, the layout of generic drugs is gradually heating up, and pharmaceutical companies in China, India and other countries have started to file applications for the marketing of generic drugs. In terms of the domestic market, only the original research product has been approved for marketing so far, and no domestic generic drug has been approved. The generic drug substitution space is expected to exceed RMB 3 billion in the next 3 to 5 years.

The original research enterprise of acalabrutinib is AstraZeneca, with the trade name Calquence. Its core compound patent will expire in 2027 in the United States, and the core patent in China will expire in 2026. At present, the main dosage form of the original research product approved is capsules, with a specification of 100 mg. This product has been included in the *Catalogue of Chemical Reference Preparations (59th Batch)* of China, and also listed in the FDA Reference Preparations Catalogue. In terms of domestic API registration, only the API of the original research enterprise has obtained the A-status registration number, and no domestic API has passed the CDE registration. More than 10 domestic pharmaceutical companies have submitted clinical or marketing applications for acalabrutinib preparations. (Data as of September 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for acalabrutinib API. All impurities have undergone strict structural confirmation and standardization, which can meet the needs of API registration and declaration, quality research and release testing under multiple regulatory systems such as Chinese Pharmacopoeia and FDA. Most products are in stock, and orders placed before 16:00 can be shipped on the same day, fully supporting the schedule requirements of pharmaceutical companies' R&D and production.