{"id":36112,"date":"2025-06-26T22:32:12","date_gmt":"2025-06-26T14:32:12","guid":{"rendered":"https:\/\/flcube.com\/?p=36112"},"modified":"2025-06-26T22:33:23","modified_gmt":"2025-06-26T14:33:23","slug":"ema-panel-recommends-brukinsa-tablet-formulation-for-approval","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=36112","title":{"rendered":"EMA Panel Recommends Brukinsa Tablet Formulation for Approval"},"content":{"rendered":"\n

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of Brukinsa (zanubrutinib) in a new film-coated tablet formulation for all currently approved indications, according to\u00a0BeOne Medicines Ltd. (NASDAQ: ONC<\/a>, HKG: 6160<\/a>, SHA: 688235<\/a>). <\/p>\n\n\n\n

Formulation Transition<\/strong>
The transition from capsule to tablet formulation will be implemented globally outside of China in a phased manner starting in 2025. This change is part of BeOne’s commitment to sustainability.<\/p>\n\n\n\n

Sustainability Benefits<\/strong>
The new tablet formulation features a 70% reduction in vial size and reduces energy consumption associated with temperature-controlled shipping. This is expected to lower greenhouse gas emissions and global logistics costs, minimizing environmental impact.<\/p>\n\n\n\n

US FDA Approval<\/strong>
Earlier in June, the U.S. FDA approved the tablet formulation of zanubrutinib for all five approved indications.-Fineline Info & Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)…<\/p>\n","protected":false},"author":1,"featured_media":36113,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[185,2092,16,847,3046,848,33],"class_list":["post-36112","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-beigene","tag-beone-medicines","tag-cancer","tag-hkg-6160","tag-nasdaq-onc","tag-sha-688235","tag-tkis-egfr-vegf-btk-etc"],"yoast_head":"\nEMA Panel Recommends Brukinsa Tablet Formulation for Approval - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of Brukinsa (zanubrutinib) in a new film-coated tablet formulation for all currently approved indications, according to\u00a0BeOne Medicines Ltd. 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