On June 22, 2021, BeiGene announced that the National Medical Products Administration (NMPA) of China had granted conditional approval to 百悦泽 (zanubrutinib) for the treatment of adult patients with Waldenström's macroglobulinemia (WM) who have received at least one prior therapy. The New Drug Application (NDA) for this new indication was placed under priority review by the Center for Drug Evaluation (CDE) of NMPA in October 2020.
NMPA Grants Conditional Approval to 百悦泽
The conditional approval of 百悦泽 by NMPA for the treatment of WM patients with at least one prior line of therapy is based on the safety and efficacy results from a single-arm pivotal Phase 2 clinical trial (NCT03332173). With a median follow-up duration of 14.9 months, the trial’s primary endpoint—Major Response Rate (MRR)—assessed by an Independent Review Committee (IRC) was 72.1% (95% CI: 56.3, 84.7). MRR is defined as the composite of complete response, very good partial response, and partial response. The safety profile observed in this trial was consistent with previous findings.
The recommended total daily dose of 百悦泽 for the treatment of WM patients in China is 320 mg.
About Waldenström's Macroglobulinemia
Waldenström's macroglobulinemia is a rare indolent lymphoma, accounting for less than 2% of non-Hodgkin lymphoma (NHL) cases. The disease predominantly affects elderly patients and is primarily localized to the bone marrow, though it may also involve lymph nodes and the spleen. In China, there are approximately 88,200 new lymphoma cases annually, of which around 91% are classified as NHL, translating to roughly 1,000 new WM cases in China each year.
About 百悦泽 (Zanubrutinib)
百悦泽 (zanubrutinib) is a small-molecule inhibitor of Bruton’s tyrosine kinase (BTK) independently discovered and developed by scientists at BeiGene. It is currently being evaluated in a broad global clinical development program as a monotherapy and in combination with other therapeutic regimens for the treatment of a variety of B-cell malignancies.
As new BTK protein is continuously synthesized in the human body, 百悦泽 is engineered to deliver complete, sustained BTK inhibition through optimized pharmacokinetic properties including bioavailability, half-life, and selectivity. Distinguished by a differentiated pharmacokinetic profile relative to other approved BTK inhibitors, 百悦泽 can suppress the proliferation of malignant B cells in multiple disease-relevant tissue sites.
百悦泽 has received approvals for the following indications in the regions listed below:
November 2019: Approved in the United States for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy;
June 2020: Approved in China for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy;
June 2020: Approved in China for the treatment of adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who have received at least one prior therapy;
June 2021: Approved in China for the treatment of adult patients with Waldenström's macroglobulinemia (WM) who have received at least one prior therapy;
February 2021: Approved in the United Arab Emirates for the treatment of patients with relapsed or refractory MCL;
March 2021: Approved in Canada for the treatment of adult patients with Waldenström's macroglobulinemia (WM).
