On May 6, 2023, BeiGene announced that the National Medical Products Administration (NMPA) of China had approved four related registration applications for 百悦泽 (zanubrutinib), its Bruton's tyrosine kinase inhibitor (BTKi). These include two marketing authorization applications for additional indications, specifically for the treatment of adult patients with newly diagnosed chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), and adult patients with newly diagnosed Waldenström's macroglobulinemia (WM), as well as two supplemental applications converting conditional approvals to full approvals.
Approved Indications of Zanubrutinib
Previously, zanubrutinib received conditional approval from the NMPA in June 2020 for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy, and adult patients with CLL/SLL who have received at least one prior therapy. In June 2021, it obtained conditional NMPA approval for the treatment of adult patients with WM who have received at least one prior therapy. At the end of April 2023, the NMPA converted the conditional approvals of zanubrutinib for adult patients with previously treated CLL/SLL and WM to full approvals.
Basis for the Latest Approvals of Zanubrutinib
The approval of zanubrutinib for the treatment of CLL/SLL is based on data from the SEQUOIA (NCT03336333) study conducted in treatment-naïve patients with CLL/SLL. The approval for WM is supported by results from the ASPEN (NCT03053440) study, which is the first and only global head-to-head Phase 3 clinical trial of a BTK inhibitor conducted in the field of WM to date.
About Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
CLL is a slowly progressive, life-threatening and incurable adult cancer. It is a mature B-cell malignancy characterized by abnormal leukemic B lymphocytes (a type of white blood cell) originating from the bone marrow and accumulating in the peripheral blood, bone marrow and lymphoid tissue. CLL is one of the most common types of leukemia, accounting for approximately one-quarter of new leukemia cases. CLL and SLL represent different manifestations of the same disease. The incidence rate of CLL/SLL in China is approximately 0.18 per 100,000 population, accounting for 1% to 3% of non-Hodgkin lymphoma (NHL) cases.
About Waldenström's Macroglobulinemia (WM)
WM is a rare, indolent lymphoma affecting fewer than 2% of patients with non-Hodgkin lymphoma (NHL). The disease predominantly affects elderly individuals, primarily involving the bone marrow, and may also affect the lymph nodes and spleen. In China, an estimated 88,200 new lymphoma cases are diagnosed annually, of which approximately 91% are classified as NHL, with around 1,000 new cases of WM diagnosed each year.
About 百悦泽 (Zanubrutinib)
Zanubrutinib is a small-molecule Bruton's tyrosine kinase (BTK) inhibitor independently discovered and developed by scientists at BeiGene. It is currently being evaluated in an extensive global clinical development program as a monotherapy and in combination with other therapies for the treatment of a variety of B-cell malignancies. As new BTK proteins are continuously synthesized in the human body, zanubrutinib is engineered to achieve complete and sustained inhibition of BTK through optimized bioavailability, half-life and selectivity. With a differentiated pharmacokinetic profile compared to other approved BTK inhibitors, zanubrutinib has been demonstrated to inhibit the proliferation of malignant B cells in multiple disease-relevant tissues.
