{"id":18997,"date":"2023-05-08T10:15:00","date_gmt":"2023-05-08T02:15:00","guid":{"rendered":"https:\/\/flcube.com\/?p=18997"},"modified":"2024-12-20T10:19:55","modified_gmt":"2024-12-20T02:19:55","slug":"beigenes-brukinsa-receives-nmpa-approval-for-expanded-use-in-leukemia-and-lymphoma","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=18997","title":{"rendered":"BeiGene’s Brukinsa Receives NMPA Approval for Expanded Use in Leukemia and Lymphoma"},"content":{"rendered":"\n

China-based BeiGene (NASDAQ: BGNE<\/a>, HKG: 6160<\/a>, SHA: 688235<\/a>) has announced that it has received approval from China’s National Medical Products Administration (NMPA) for four applications related to Brukinsa (zanubrutinib), the company’s Bruton\u2019s tyrosine kinase inhibitor (BTKi). The approvals include two supplemental New Drug Applications (sNDAs) for the treatment of treatment-na\u00efve adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) and Waldenstr\u00f6m’s macroglobulinemia (WM), along with two sNDAs that convert previous conditional approvals to regular approval.<\/p>\n\n\n\n

Brukinsa’s Regulatory Milestones and Treatment Scope<\/strong>
Brukinsa received conditional approvals from the NMPA in June 2020 for the treatment of adults with CLL\/SLL and mantle cell lymphoma (MCL) who have received at least one prior therapy. In June 2021, conditional approval was also granted for the treatment of adult patients with WM who have received at least one prior therapy. The NMPA has now converted these conditional approvals to regular approvals for R\/R CLL\/SLL and R\/R WM, marking a significant regulatory milestone for BeiGene.<\/p>\n\n\n\n

Implications for Patients and the Healthcare Sector<\/strong>
The conversion of conditional approvals to regular approvals for R\/R CLL\/SLL and R\/R WM signifies a positive step forward in providing patients with more treatment options. This development is expected to have a substantial impact on the healthcare sector, offering a broader range of therapeutic choices for patients suffering from these conditions.-Fineline Info & Tech<\/a><\/p>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

China-based BeiGene (NASDAQ: BGNE, HKG: 6160, SHA: 688235) has announced that it has received approval…<\/p>\n","protected":false},"author":1,"featured_media":0,"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":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[2092,16,847,846,15,848,33],"class_list":["post-18997","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-beone-medicines","tag-cancer","tag-hkg-6160","tag-nasdaq-bgne","tag-product-approvals","tag-sha-688235","tag-tkis-egfr-vegf-btk-etc"],"yoast_head":"\nBeiGene's Brukinsa Receives NMPA Approval for Expanded Use in Leukemia and Lymphoma - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China-based BeiGene (NASDAQ: BGNE, HKG: 6160, SHA: 688235) has announced that it has received approval from China's National Medical Products Administration (NMPA) for four applications related to Brukinsa (zanubrutinib), the company's Bruton\u2019s tyrosine kinase inhibitor (BTKi). The approvals include two supplemental New Drug Applications (sNDAs) for the treatment of treatment-na\u00efve adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) and Waldenstr\u00f6m's macroglobulinemia (WM), along with two sNDAs that convert previous conditional approvals to regular approval.BeiGene\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/flcube.com\/?p=18997\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"BeiGene's Brukinsa Receives NMPA Approval for Expanded Use in Leukemia and Lymphoma\" \/>\n<meta property=\"og:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. FLCUBE delivers reliable data, news, and intelligence to broaden your horizons and sharpen your decision-making. Stay informed, stay ahead with FLCUBE.COM\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=18997\" \/>\n<meta property=\"og:site_name\" content=\"Insight, China's Pharmaceutical Industry\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/profile.php?id=61566606313834\" \/>\n<meta property=\"article:published_time\" content=\"2023-05-08T02:15:00+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-12-20T02:19:55+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"2560\" \/>\n\t<meta property=\"og:image:height\" content=\"1894\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Fineline Cube\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Fineline Cube\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=18997#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=18997\"},\"author\":{\"name\":\"Fineline Cube\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\"},\"headline\":\"BeiGene’s Brukinsa Receives NMPA Approval for Expanded Use in Leukemia and Lymphoma\",\"datePublished\":\"2023-05-08T02:15:00+00:00\",\"dateModified\":\"2024-12-20T02:19:55+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=18997\"},\"wordCount\":247,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"keywords\":[\"BeOne Medicines\",\"Cancer\",\"HKG: 6160\",\"NASDAQ: BGNE\",\"Product approvals\",\"SHA: 688235\",\"TKIs (EGFR VEGF BTK etc.)\"],\"articleSection\":[\"Company\",\"Drug\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=18997#respond\"]}],\"copyrightYear\":\"2023\",\"copyrightHolder\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"}},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=18997\",\"url\":\"https:\\\/\\\/flcube.com\\\/?p=18997\",\"name\":\"BeiGene's Brukinsa Receives NMPA Approval for Expanded Use in Leukemia and Lymphoma - Insight, China's Pharmaceutical Industry\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\"},\"datePublished\":\"2023-05-08T02:15:00+00:00\",\"dateModified\":\"2024-12-20T02:19:55+00:00\",\"description\":\"China-based BeiGene (NASDAQ: BGNE, HKG: 6160, SHA: 688235) has announced that it has received approval from China's National Medical Products Administration (NMPA) for four applications related to Brukinsa (zanubrutinib), the company's Bruton\u2019s tyrosine kinase inhibitor (BTKi). The approvals include two supplemental New Drug Applications (sNDAs) for the treatment of treatment-na\u00efve adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) and Waldenstr\u00f6m's macroglobulinemia (WM), along with two sNDAs that convert previous conditional approvals to regular approval.BeiGene\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=18997#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=18997\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=18997#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/flcube.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"BeiGene’s Brukinsa Receives NMPA Approval for Expanded Use in Leukemia and Lymphoma\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\",\"url\":\"https:\\\/\\\/flcube.com\\\/\",\"name\":\"Insight, China's Pharmaceutical Industry\",\"description\":\"Fineline Insights, Pharma Clarity\",\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/flcube.com\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\",\"name\":\"Fineline Infomation and Technology\",\"alternateName\":\"Fineline Info & Tech\",\"url\":\"https:\\\/\\\/flcube.com\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2024\\\/11\\\/Fineline-info-tech-scaled.jpg\",\"contentUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2024\\\/11\\\/Fineline-info-tech-scaled.jpg\",\"width\":2560,\"height\":1894,\"caption\":\"Fineline Infomation and Technology\"},\"image\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/logo\\\/image\\\/\"},\"sameAs\":[\"https:\\\/\\\/www.facebook.com\\\/profile.php?id=61566606313834\"]},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\",\"name\":\"Fineline Cube\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g\",\"url\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g\",\"contentUrl\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g\",\"caption\":\"Fineline Cube\"},\"sameAs\":[\"https:\\\/\\\/flcube.com\"],\"url\":\"https:\\\/\\\/flcube.com\\\/?author=1\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"BeiGene's Brukinsa Receives NMPA Approval for Expanded Use in Leukemia and Lymphoma - Insight, China's Pharmaceutical Industry","description":"China-based BeiGene (NASDAQ: BGNE, HKG: 6160, SHA: 688235) has announced that it has received approval from China's National Medical Products Administration (NMPA) for four applications related to Brukinsa (zanubrutinib), the company's Bruton\u2019s tyrosine kinase inhibitor (BTKi). The approvals include two supplemental New Drug Applications (sNDAs) for the treatment of treatment-na\u00efve adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) and Waldenstr\u00f6m's macroglobulinemia (WM), along with two sNDAs that convert previous conditional approvals to regular approval.BeiGene","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/flcube.com\/?p=18997","og_locale":"en_US","og_type":"article","og_title":"BeiGene's Brukinsa Receives NMPA Approval for Expanded Use in Leukemia and Lymphoma","og_description":"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. FLCUBE delivers reliable data, news, and intelligence to broaden your horizons and sharpen your decision-making. Stay informed, stay ahead with FLCUBE.COM","og_url":"https:\/\/flcube.com\/?p=18997","og_site_name":"Insight, China's Pharmaceutical Industry","article_publisher":"https:\/\/www.facebook.com\/profile.php?id=61566606313834","article_published_time":"2023-05-08T02:15:00+00:00","article_modified_time":"2024-12-20T02:19:55+00:00","og_image":[{"width":2560,"height":1894,"url":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg","type":"image\/jpeg"}],"author":"Fineline Cube","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Fineline Cube","Est. reading time":"1 minute"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/flcube.com\/?p=18997#article","isPartOf":{"@id":"https:\/\/flcube.com\/?p=18997"},"author":{"name":"Fineline Cube","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a"},"headline":"BeiGene’s Brukinsa Receives NMPA Approval for Expanded Use in Leukemia and Lymphoma","datePublished":"2023-05-08T02:15:00+00:00","dateModified":"2024-12-20T02:19:55+00:00","mainEntityOfPage":{"@id":"https:\/\/flcube.com\/?p=18997"},"wordCount":247,"commentCount":0,"publisher":{"@id":"https:\/\/flcube.com\/#organization"},"keywords":["BeOne Medicines","Cancer","HKG: 6160","NASDAQ: BGNE","Product approvals","SHA: 688235","TKIs (EGFR VEGF BTK etc.)"],"articleSection":["Company","Drug"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/flcube.com\/?p=18997#respond"]}],"copyrightYear":"2023","copyrightHolder":{"@id":"https:\/\/flcube.com\/#organization"}},{"@type":"WebPage","@id":"https:\/\/flcube.com\/?p=18997","url":"https:\/\/flcube.com\/?p=18997","name":"BeiGene's Brukinsa Receives NMPA Approval for Expanded Use in Leukemia and Lymphoma - Insight, China's Pharmaceutical Industry","isPartOf":{"@id":"https:\/\/flcube.com\/#website"},"datePublished":"2023-05-08T02:15:00+00:00","dateModified":"2024-12-20T02:19:55+00:00","description":"China-based BeiGene (NASDAQ: BGNE, HKG: 6160, SHA: 688235) has announced that it has received approval from China's National Medical Products Administration (NMPA) for four applications related to Brukinsa (zanubrutinib), the company's Bruton\u2019s tyrosine kinase inhibitor (BTKi). The approvals include two supplemental New Drug Applications (sNDAs) for the treatment of treatment-na\u00efve adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) and Waldenstr\u00f6m's macroglobulinemia (WM), along with two sNDAs that convert previous conditional approvals to regular approval.BeiGene","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=18997#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=18997"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=18997#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"BeiGene’s Brukinsa Receives NMPA Approval for Expanded Use in Leukemia and Lymphoma"}]},{"@type":"WebSite","@id":"https:\/\/flcube.com\/#website","url":"https:\/\/flcube.com\/","name":"Insight, China's Pharmaceutical Industry","description":"Fineline Insights, Pharma Clarity","publisher":{"@id":"https:\/\/flcube.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/flcube.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/flcube.com\/#organization","name":"Fineline Infomation and Technology","alternateName":"Fineline Info & Tech","url":"https:\/\/flcube.com\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/#\/schema\/logo\/image\/","url":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg","width":2560,"height":1894,"caption":"Fineline Infomation and Technology"},"image":{"@id":"https:\/\/flcube.com\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/profile.php?id=61566606313834"]},{"@type":"Person","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a","name":"Fineline Cube","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","caption":"Fineline Cube"},"sameAs":["https:\/\/flcube.com"],"url":"https:\/\/flcube.com\/?author=1"}]}},"jetpack_publicize_connections":[],"jetpack_featured_media_url":"","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/18997","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=18997"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/18997\/revisions"}],"predecessor-version":[{"id":18998,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/18997\/revisions\/18998"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=18997"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=18997"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=18997"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}