Beigene (688235.SH) has released its annual report for 2025, revealing a significant financial turnaround. During the reporting period, the company achieved operating revenue of 38.225 billion yuan, representing a year-on-year increase of 40.46%. Net profit attributable to shareholders of the listed company reached 1.461 billion yuan. After adjusting for non-recurring gains and losses, the net profit attributable to shareholders was 1.42 billion yuan. Basic earnings per share stood at 1.03 yuan.
The group's net cash flow from operating activities for the period was 13.713 billion yuan. Annual research and development expenditure totaled 15.508 billion yuan.
The report highlighted Brukinsa® (zanubrutinib), a next-generation, oral Bruton's tyrosine kinase (BTK) inhibitor. Its design aims to achieve complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With a differentiated pharmacokinetic profile compared to other approved BTK inhibitors, Brukinsa® has demonstrated efficacy in inhibiting malignant B-cell proliferation across multiple disease-related tissues.
Brukinsa® is the BTK inhibitor with the broadest global approval for indications and is the only one offering flexible dosing—either once or twice daily. In June 2025, the U.S. Food and Drug Administration (FDA) approved a film-coated tablet formulation, providing greater convenience and flexibility for patients.
The drug is approved for five indications: chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), Waldenström's macroglobulinemia (WM), relapsed/refractory mantle cell lymphoma (R/R MCL), relapsed/refractory marginal zone lymphoma (R/R MZL), and relapsed/refractory follicular lymphoma (R/R FL). It has gained approval in over 75 markets and is reimbursed in approximately 60.
In the United States, Brukinsa® received accelerated FDA approval in November 2019 for treating adult patients with MCL who had received at least one prior therapy. Subsequent approvals were based on head-to-head trial results against ibrutinib for WM patients, followed by accelerated approval for R/R MZL patients previously treated with at least one anti-CD20 regimen. In January 2023, based on two Phase 3 trial outcomes, it was approved for treating adult patients with either previously untreated or relapsed CLL or SLL.
Brukinsa® is the only BTK inhibitor to demonstrate superior progression-free survival (PFS) compared to ibrutinib across all patient groups, including high-risk patients with 17p deletion/TP53 mutation. In March 2024, the FDA granted accelerated approval for Brukinsa® in combination with obinutuzumab for treating R/R FL patients. Finally, in June 2025, the FDA approved the film-coated tablet formulation of Brukinsa® for all its approved indications.
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