{"id":863482,"date":"2025-06-25T06:03:03","date_gmt":"2025-06-25T10:03:03","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/beone-medicines-receives-positive-chmp-opinion-for-tablet-formulation-of-brukinsa\/"},"modified":"2025-06-25T06:03:03","modified_gmt":"2025-06-25T10:03:03","slug":"beone-medicines-receives-positive-chmp-opinion-for-tablet-formulation-of-brukinsa","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/beone-medicines-receives-positive-chmp-opinion-for-tablet-formulation-of-brukinsa\/","title":{"rendered":"BeOne Medicines Receives Positive CHMP Opinion for Tablet Formulation of BRUKINSA\u00ae"},"content":{"rendered":"

<\/p>\n

BeOne Medicines Receives Positive CHMP Opinion for Tablet Formulation of BRUKINSA\u00ae<\/sup><\/b><\/p>\n

BASEL, Switzerland–(BUSINESS WIRE<\/a>)–BeOne Medicines Ltd.<\/a> (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\u00ae<\/sup> (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.<\/p>\n

\n\u201cThe CHMP\u2019s positive opinion of our new tablet formulation of BRUKINSA is an important step toward bringing this thoughtful, patient-centered innovation to people facing certain B-cell cancers across Europe,\u201d said Giancarlo Benelli, Senior Vice President and Head of Europe, BeOne. \u201cWe look forward to a potential approval later this year and remain committed to delivering our impactful medicines to more patients in the region.\u201d<\/p>\n

\nThe BRUKINSA tablets have been shown to be bioequivalent to the BRUKINSA capsules based on the results of two single-dose, open-label, randomized Phase 1 crossover studies in healthy subjects. The recommended dose of BRUKINSA remains \u2013 320 mg daily. The BRUKINSA tablets are 160 mg each, allowing patients to halve their daily pill intake and take two tablets daily. The new tablet formulation maintains BRUKINSA\u2019s dosing flexibility by providing patients and prescribers with the option of once- or twice-daily dosing and is designed to simplify management of dose reductions as per label recommendation. Additionally, the BRUKINSA tablets are smaller than the capsules and have a film coat, which makes them easier to swallow.<\/p>\n

\nBeOne Medicines will begin to convert BRUKINSA from capsules to tabletsin regions outside China in 2025 as part of our commitment to sustainable business practices, including reducing our impact on the environment. This adjustment will decrease the bottle size by ~70% while also enabling the shipment of this medication with reduced temperature controls, which we expect to reduce energy needs, greenhouse gas emissions, and global transport costs.<\/p>\n

\nToday\u2019s announcement follows the U.S. Food and Drug Administration (FDA) approval of the new tablet formulation of BRUKINSA for all five approved indications earlier this month. In the U.S., BRUKINSA is the leader in new patient starts for chronic lymphocytic leukemia (CLL) across all lines of therapy, and for the first time, has become the overall BTK inhibitor market share leader.1<\/sup><\/p>\n

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

\nThis information is intended for a global audience. Product indications vary by region.<\/p>\n

About BeOne Medicines
\n
<\/b>BeOne 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
\n
<\/b>This 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 future potential approval of the tablet formulation of BRUKINSA by the European Commission and the timing of such approval; 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\n\n\n
\n

\n____________________<\/p>\n<\/td>\n<\/tr>\n

\n

1<\/sup> As of May 7, 2025, based on reported sales from Q1 2025 earnings. BeiGene Announces First Quarter 2025 Financial Results and Business Updates \u2013 NASDAQ (US) Website<\/a>.<\/p>\n<\/td>\n<\/tr>\n<\/table>\n

\n\u00a0<\/p>\n

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View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20250623706166\/en\/<\/a><\/span><\/p>\n

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

Media Contact
\n<\/b>
Kim Bencker
\n
+1 610-256-8932
\n
media@beonemed.com<\/a><\/p>\n

KEYWORDS:<\/b> Switzerland Europe<\/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":"

BeOne Medicines Receives Positive CHMP Opinion for Tablet Formulation of BRUKINSA\u00ae BASEL, Switzerland–(BUSINESS WIRE)–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\u00ae (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. \u201cThe CHMP\u2019s positive opinion of our new tablet formulation of BRUKINSA is an important step toward bringing this thoughtful, patient-centered innovation to … <\/p>\n

Continue reading “BeOne Medicines Receives Positive CHMP Opinion for Tablet Formulation of BRUKINSA\u00ae”<\/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-863482","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nBeOne Medicines Receives Positive CHMP Opinion for Tablet Formulation of BRUKINSA\u00ae - 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\/beone-medicines-receives-positive-chmp-opinion-for-tablet-formulation-of-brukinsa\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"BeOne Medicines Receives Positive CHMP Opinion for Tablet Formulation of BRUKINSA\u00ae - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"BeOne Medicines Receives Positive CHMP Opinion for Tablet Formulation of BRUKINSA\u00ae BASEL, Switzerland–(BUSINESS WIRE)–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\u00ae (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. \u201cThe CHMP\u2019s positive opinion of our new tablet formulation of BRUKINSA is an important step toward bringing this thoughtful, patient-centered innovation to … Continue reading "BeOne Medicines Receives Positive CHMP Opinion for Tablet Formulation of BRUKINSA\u00ae"\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/beone-medicines-receives-positive-chmp-opinion-for-tablet-formulation-of-brukinsa\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2025-06-25T10:03:03+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&sty=20250623706166r1&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\\\/beone-medicines-receives-positive-chmp-opinion-for-tablet-formulation-of-brukinsa\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/beone-medicines-receives-positive-chmp-opinion-for-tablet-formulation-of-brukinsa\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"BeOne Medicines Receives Positive CHMP Opinion for Tablet Formulation of BRUKINSA\u00ae\",\"datePublished\":\"2025-06-25T10:03:03+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/beone-medicines-receives-positive-chmp-opinion-for-tablet-formulation-of-brukinsa\\\/\"},\"wordCount\":909,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/beone-medicines-receives-positive-chmp-opinion-for-tablet-formulation-of-brukinsa\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/cts.businesswire.com\\\/ct\\\/CT?id=bwnews&sty=20250623706166r1&sid=flmnd&distro=nx&lang=en\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/beone-medicines-receives-positive-chmp-opinion-for-tablet-formulation-of-brukinsa\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/beone-medicines-receives-positive-chmp-opinion-for-tablet-formulation-of-brukinsa\\\/\",\"name\":\"BeOne Medicines Receives Positive CHMP Opinion for Tablet Formulation of BRUKINSA\u00ae - 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