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Zanubrutinib
API’s Name CAS No. US DMF Patent Expiry Date (US) Current Status Zanubrutinib 1691249-45-2 Q2, 2027 Apr.21, 2034 estimated PV Completion – Q1, 2027 [Product]
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[Indication]
1. Mantle Cell Lymphoma (MCL)：Zanubrutinib is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least one prior therapy.
2. Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)：Zanubrutinib is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
3. Waldenström’s Macroglobulinemia (WM)：Zanubrutinib is indicated for the treatment of adult patients with relapsed or refractory Waldenström’s macroglobulinemia (WM).
4. Follicular Lymphoma (FL)：Zanubrutinib in combination with obinutuzumab is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least two prior systemic therapies.