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European Commission Approves Tablet Formulation of BeOne Medicines¡¯ BRUKINSA¢ç for All Approved Indication

Tablets will advance treatment simplicity and convenience to meet patient needs across Europe
Date: 2025-09-07

SAN CARLOS, CALIF. -- BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, announced that the European Commission has approved a new film-coated tablet formulation of BRUKINSA® (zanubrutinib) for all approved indications.

“Developed to meet the real-world needs of patients, the new BRUKINSA tablet formulation aims to simplify treatment, reduce pill burden, and enhance ease of administration, reflecting our continuous focus on patient-centered innovation,” said Giancarlo Benelli, Senior Vice President and Head of Europe, BeOne. “With more than 200,000 patients treated globally and the broadest label of any BTK inhibitor in Europe, BRUKINSA’s differentiated clinical profile continues to make an impact for people facing certain B-cell cancers.”

The recommended dose of BRUKINSA continues to be 320 mg daily. The BRUKINSA tablets are 160 mg each, allowing patients to halve their daily pill intake from four pills to two. Additionally, they are smaller than the capsules and have film coatings, which make them easier to swallow.

Important Safety Information

The current European Summary of Product Characteristics (SmPC) of BRUKINSA is available from the website of the European Medicines Agency.

The information provided in this press release is intended for a global audience.



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