21 June 2021 - - Biotechnology company BeiGene, Ltd's (NASDAQ: BGNE) (HKEX: 06160) Brukinsa (zanubrutinib) has received conditional approval from the China National Medical Products Administration for the treatment of adult patients with Waldenström's macroglobulinemia who have received at least one prior therapy, the company said.

The supplemental new drug application was previously granted priority review by the Center for Drug Evaluation of the NMPA in October 2020.

The conditional approval granted by the NMPA was based on findings from a single-arm pivotal Phase 2 trial (NCT03332173) in China evaluating the safety and efficacy of BRUKINSA in patients with WM who have received at least one prior therapy.

With a median study follow-up time of 14.9 months, the primary endpoint of major response rate as assessed by independent review committee was 72.1% (95% CI: 56.3, 84.7); MRR is defined as the combined rate of complete responses, very good partial responses, and partial responses.

The adverse reaction profile was generally consistent with previous findings.

The recommended total daily dose of Brukinsa for WM in China is 320mg.

Waldenström's macroglobulinemia is a rare, slow-growing lymphoma that occurs in less than 2% of patients with non-Hodgkin's lymphoma. 1 The disease usually affects older adults and is primarily found in the bone marrow, although it may also impact lymph nodes and the spleen.

In China, there are an estimated 88,200 patients diagnosed with lymphoma each year. Approximately 91% of these cases are classified as NHL, amounting to ~1,000 newly diagnosed WM patients per year in China.

Brukinsa is a small molecule inhibitor of Bruton's tyrosine kinase discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies.

Because new BTK is continuously synthesized, Brukinsa was specifically designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity.

With differentiated pharmacokinetics compared to other approved BTK inhibitors, Brukinsa has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease relevant tissues.

BeiGene has portfolio of more than 40 clinical candidates. BeiGene is a headquarter-less company by design, with a growing global team of approximately 6,000 colleagues across five continents.