30 May 2023 - - China-based biotechnology company BeiGene, Ltd's (NASDAQ: BGNE) (HKEX: 06160) (SSE: 688235) Brukinsa (zanubrutinib), a Bruton's tyrosine kinase inhibitor, has been approved by Health Canada for the treatment of adult patients with chronic lymphocytic leukemia, the company said.

Typically diagnosed among individuals in their early 70s, CLL is a slow-growing, incurable blood cancer and is the most common leukemia in adults.

The Health Canada approval of Brukinsa for CLL is based on positive efficacy results and a favorable safety profile from two global Phase 3, randomized, open-label, multicenter clinical trials: SEQUOIA (NCT03336333), comparing zanubrutinib against bendamustine plus rituximab in patients with previously untreated CLL, and ALPINE (NCT03734016), comparing zanubrutinib against ibrutinib in patients with relapsed or refractory CLL.

Considered the largest head-to-head study of BTK inhibitors in R/R CLL, the final ALPINE trial data were presented in a late-breaking session at the 64th American Society of Hematology annual meeting in December 2022 and simultaneously reported in The New England Journal of Medicine.

SEQUOIA trial results were published in The Lancet Oncology in August 2022.

CLL is a type of blood cancer. Over 2,200 people in Canada are diagnosed with CLL each year. CLL is more common in men and occurs mainly in people over 60, with the average age of diagnosis in the early 70s.

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.

Brukinsa was specifically designed to deliver targeted 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.

Brukinsa is supported by a broad clinical program which includes more than 4,900 subjects in 35 trials across 29 markets.

To date, Brukinsa is approved in more than 65 markets around the world, including the United States, China, the European Union, Great Britain, Canada, Australia, South Korea, and Switzerland.

BeiGene is a global biotechnology company that is discovering and developing innovative oncology treatments.

The company has a global team of more than 9,400 colleagues spanning five continents, with administrative offices in Basel; Beijing; and Cambridge, US.