Articles from BeOne Medicines Ltd.

In a significant showcase for investors, BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, will announce major advancements to its industry-leading oncology pipeline during today’s investor R&D Day. The event comes at a pivotal moment for the Company, which has more than 40 clinical and commercial stage assets in development, a signal of both scale and ambition.

BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued a positive opinion recommending approval of a new film-coated tablet formulation of BRUKINSA® (zanubrutinib) for all approved indications. The CHMP positive opinion will now be reviewed by the European Commission, which will grant the marketing authorization for the tablet formulation in the European Union and in the European Economic Area countries Norway and Iceland.

BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, will present new clinical data from three cornerstone hematology assets at the European Hematology Association (EHA) Congress. Four oral presentations highlight the promising clinical activity of BeOne’s next-generation BCL2 inhibitor sonrotoclax, BTK protein degrader BGB-16673, and the backbone of our hematology franchise, BTK inhibitor BRUKINSA (zanubrutinib), which has the broadest label globally of any approved BTK inhibitor. These data reinforce the company’s strategic vision to redefine the standard of care for B-cell malignancies.

BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved a new tablet formulation of BRUKINSA® (zanubrutinib) for all five approved indications. BRUKINSA remains the leader in new chronic lymphocytic leukemia (CLL) patient starts across all lines of therapy in the U.S., and for the first time, has become the overall BTK inhibitor market share leader.1

BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that it will host an Investor R&D Day in New York City and via webcast on June 26, 2025 at 8:30 am ET. John V. Oyler, Co-Founder, Chairman, and CEO of BeOne, along with the Company's leadership team and distinguished key opinion leaders, will provide an update on BeOne’s extensive global innovation pipeline and platforms, including new assets, targets and clinical data, and will share insights on the Company's vision, differentiated capabilities, and value creation drivers.

BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, announced new clinical data from its emerging breast cancer pipeline at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. Poster presentations feature preliminary results of the dose escalation studies of two investigational molecules: BG-C9074, a novel B7-H4-targeting antibody-drug conjugate (ADC) in patients with advanced solid tumors, including breast cancer, and BG-68501, a cyclin-dependent kinase-2 inhibitor (CDK2i), in HR+/HER2- breast cancer patients with prior CDK4/6i exposure.

BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today will present new data from the Arm C and D cohorts of the pivotal, global Phase 3 SEQUOIA trial of BRUKINSA® (zanubrutinib). The findings underscore the strong and consistent efficacy of BRUKINSA across CLL patient types, including high-risk mutation status. These data will be presented in two rapid oral presentations at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL.

BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company formerly known as BeiGene, Ltd., today announced its new name and redomiciliation to Switzerland are officially in effect, marking a significant milestone in the Company’s evolution.