{"id":877753,"date":"2025-08-21T06:03:08","date_gmt":"2025-08-21T10:03:08","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/european-commission-approves-tablet-formulation-of-beone-medicines-brukinsa-for-all-approved-indications\/"},"modified":"2025-08-21T06:03:08","modified_gmt":"2025-08-21T10:03:08","slug":"european-commission-approves-tablet-formulation-of-beone-medicines-brukinsa-for-all-approved-indications","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/european-commission-approves-tablet-formulation-of-beone-medicines-brukinsa-for-all-approved-indications\/","title":{"rendered":"European Commission Approves Tablet Formulation of BeOne Medicines\u2019 BRUKINSA\u00ae for All Approved Indications"},"content":{"rendered":"

<\/p>\n

European Commission Approves Tablet Formulation of BeOne Medicines\u2019 BRUKINSA\u00ae<\/sup> for All Approved Indications<\/b><\/p>\n

Tablets will advance treatment simplicity and convenience to meet patient needs across Europe<\/i><\/p>\n

SAN CARLOS, Calif.–(BUSINESS WIRE<\/a>)–BeOne Medicines Ltd.<\/a> (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the European Commission has approved a new film-coated tablet formulation of BRUKINSA\u00ae<\/sup> (zanubrutinib) for all approved indications.<\/p>\n

\n“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,\u201d said Giancarlo Benelli, Senior Vice President and Head of Europe, BeOne. \u201cWith 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.”<\/p>\n

\nThe 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.<\/p>\n

Important Safety Information<\/b><\/p>\n

\nThe current European Summary of Product Characteristics (SmPC) of BRUKINSA is available from the website of the European Medicines Agency<\/a>.<\/p>\n

\nThe information provided in this press release is intended for a global audience.<\/p>\n

About BRUKINSA\u00ae<\/sup> (zanubrutinib)<\/b><\/p>\n

\nBRUKINSA is an orally available, small molecule inhibitor of Bruton\u2019s tyrosine kinase (BTK) designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared with other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease-relevant tissues.<\/p>\n

\nBRUKINSA has the broadest label globally of any BTK inhibitor and is the only BTK inhibitor to provide the flexibility of once or twice daily dosing. Additionally, BRUKINSA is the only BTK inhibitor to demonstrate PFS superiority to a first-generation BTK inhibitor in a Phase 3 study.<\/p>\n

\nThe global BRUKINSA clinical development program includes approximately 7,100 patients enrolled in 30 countries and regions across more than 35 trials. BRUKINSA is approved for at least one indication in more than 75 markets, and more than 200,000 patients have been treated globally.<\/p>\n

About BeOne Medicines<\/b><\/p>\n

\nBeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.<\/p>\n

\nTo learn more about BeOne, please visit www.beonemedicines.com<\/a> and follow us on LinkedIn<\/a>, X<\/a>, Facebook<\/a> and Instagram<\/a>.<\/p>\n

Forward-Looking Statement<\/b><\/p>\n

\nThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the potential benefits of the tablet formulation of BRUKINSA; the replacement of BRUKINSA capsules with tablets; and BeOne\u2019s plans, commitments, aspirations, and goals under the heading \u201cAbout BeOne.\u201d Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeOne\u2019s ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing, and progress of clinical trials and marketing approval; BeOne\u2019s ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeOne\u2019s ability to obtain and maintain protection of intellectual property for its medicines and technology; BeOne\u2019s reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeOne\u2019s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products and its ability to obtain additional funding for operations and to complete the development of its drug candidates and maintain profitability; and those risks more fully discussed in the section entitled \u201cRisk Factors\u201d in BeOne\u2019s most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeOne\u2019s subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeOne undertakes no duty to update such information unless required by law.<\/p>\n

\nTo access BeOne media resources, please visit ourNewsroom<\/b><\/a>.<\/p>\n

\"\"<\/p>\n

View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20250821182068\/en\/<\/a><\/span><\/p>\n

Investor Contact
\n<\/b>
Liza Heapes
\n
+1 857-302-5663
\n
ir@beonemed.com<\/a><\/p>\n

Media Contact
\n<\/b>
Kyle Blankenship
\n
+1 667-351-5176
\n
media@beonemed.com<\/a><\/p>\n

KEYWORDS:<\/b> Europe United States North America California<\/p>\n

INDUSTRY KEYWORDS:<\/b> Biotechnology Health Pharmaceutical Clinical Trials Oncology<\/p>\n

MEDIA:<\/b><\/p>\n\n\n\n\n
Logo<\/b><\/font><\/td>\n<\/tr>\n
\"Logo\"<\/td>\n<\/tr>\n
<\/font><\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

European Commission Approves Tablet Formulation of BeOne Medicines\u2019 BRUKINSA\u00ae for All Approved Indications Tablets will advance treatment simplicity and convenience to meet patient needs across Europe SAN CARLOS, Calif.–(BUSINESS WIRE)–BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the European Commission has approved a new film-coated tablet formulation of BRUKINSA\u00ae (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,\u201d said Giancarlo Benelli, Senior Vice President and Head of Europe, BeOne. \u201cWith more than 200,000 patients treated globally and the broadest label of any BTK inhibitor … <\/p>\n

Continue reading “European Commission Approves Tablet Formulation of BeOne Medicines\u2019 BRUKINSA\u00ae for All Approved Indications”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-877753","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nEuropean Commission Approves Tablet Formulation of BeOne Medicines\u2019 BRUKINSA\u00ae for All Approved Indications - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/european-commission-approves-tablet-formulation-of-beone-medicines-brukinsa-for-all-approved-indications\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"European Commission Approves Tablet Formulation of BeOne Medicines\u2019 BRUKINSA\u00ae for All Approved Indications - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"European Commission Approves Tablet Formulation of BeOne Medicines\u2019 BRUKINSA\u00ae for All Approved Indications Tablets will advance treatment simplicity and convenience to meet patient needs across Europe SAN CARLOS, Calif.–(BUSINESS WIRE)–BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the European Commission has approved a new film-coated tablet formulation of BRUKINSA\u00ae (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,\u201d said Giancarlo Benelli, Senior Vice President and Head of Europe, BeOne. \u201cWith more than 200,000 patients treated globally and the broadest label of any BTK inhibitor … Continue reading "European Commission Approves Tablet Formulation of BeOne Medicines\u2019 BRUKINSA\u00ae for All Approved Indications"\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/european-commission-approves-tablet-formulation-of-beone-medicines-brukinsa-for-all-approved-indications\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2025-08-21T10:03:08+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&sty=20250821182068r1&sid=flmnd&distro=nx&lang=en\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/european-commission-approves-tablet-formulation-of-beone-medicines-brukinsa-for-all-approved-indications\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/european-commission-approves-tablet-formulation-of-beone-medicines-brukinsa-for-all-approved-indications\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"European Commission Approves Tablet Formulation of BeOne Medicines\u2019 BRUKINSA\u00ae for All Approved Indications\",\"datePublished\":\"2025-08-21T10:03:08+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/european-commission-approves-tablet-formulation-of-beone-medicines-brukinsa-for-all-approved-indications\\\/\"},\"wordCount\":815,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/european-commission-approves-tablet-formulation-of-beone-medicines-brukinsa-for-all-approved-indications\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/cts.businesswire.com\\\/ct\\\/CT?id=bwnews&sty=20250821182068r1&sid=flmnd&distro=nx&lang=en\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/european-commission-approves-tablet-formulation-of-beone-medicines-brukinsa-for-all-approved-indications\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/european-commission-approves-tablet-formulation-of-beone-medicines-brukinsa-for-all-approved-indications\\\/\",\"name\":\"European Commission Approves Tablet Formulation of BeOne Medicines\u2019 BRUKINSA\u00ae for All Approved Indications - 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