{"id":30383,"date":"2025-03-25T16:30:13","date_gmt":"2025-03-25T08:30:13","guid":{"rendered":"https:\/\/flcube.com\/?p=30383"},"modified":"2025-03-25T16:30:40","modified_gmt":"2025-03-25T08:30:40","slug":"sino-biopharmaceuticals-culmerciclib-shows-positive-results-in-phase-iii-breast-cancer-trial","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=30383","title":{"rendered":"Sino Biopharmaceutical’s Culmerciclib Shows Positive Results in Phase III Breast Cancer Trial"},"content":{"rendered":"\n

China-based Sino Biopharmaceutical Ltd (HKG: 1177<\/a>) has revealed positive results from the Phase III TQB3616-III-02 study for its Category 1 drug culmerciclib (TQB3616) combined with fulvestrant. The trial focused on na\u00efve patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, locally advanced or metastatic breast cancer.<\/p>\n\n\n\n

Trial Results<\/strong>
The interim analysis from this pivotal Phase III study demonstrated that the combination of culmerciclib and fulvestrant significantly reduced the risk of disease progression or death in first-line advanced breast cancer patients. The primary endpoint was met with both statistical difference and clinical significance, indicating the potential of this treatment regimen to improve outcomes for patients with this specific type of breast cancer.<\/p>\n\n\n\n

Drug Mechanism and Safety<\/strong>
Culmerciclib is a novel cyclin-dependent kinase 2, 4, and 6 (CDK2\/4\/6) inhibitor with enhanced inhibitory effects on CDK2 compared to existing CDK4\/6 inhibitors. The regimen was found to be generally safe and tolerable, positioning it as a promising option for patients who have previously been treated with hormonal therapy. <\/p>\n\n\n\n

Regulatory and Commercial Outlook<\/strong>
Sino Biopharmaceutical is awaiting regulatory decisions in China for the use of culmerciclib in combination with fulvestrant. The positive results from this trial support the potential approval and commercialization of this treatment option, which could address an unmet need in the management of HR+\/HER2- locally advanced or metastatic breast cancer.-Fineline Info & Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

China-based Sino Biopharmaceutical Ltd (HKG: 1177) has revealed positive results from the Phase III TQB3616-III-02…<\/p>\n","protected":false},"author":1,"featured_media":30384,"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":[17,908,313],"class_list":["post-30383","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-clinical-trial-results","tag-hkg-1177","tag-sino-biopharmaceutical"],"yoast_head":"\nSino Biopharmaceutical's Culmerciclib Shows Positive Results in Phase III Breast Cancer Trial - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China-based Sino Biopharmaceutical Ltd (HKG: 1177) has revealed positive results from the Phase III TQB3616-III-02 study for its Category 1 drug culmerciclib (TQB3616) combined with fulvestrant. The trial focused on na\u00efve patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, locally advanced or metastatic breast cancer.\" \/>\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=30383\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Sino Biopharmaceutical's Culmerciclib Shows Positive Results in Phase III Breast Cancer Trial\" \/>\n<meta property=\"og:description\" content=\"China-based Sino Biopharmaceutical Ltd (HKG: 1177) has revealed positive results from the Phase III TQB3616-III-02 study for its Category 1 drug culmerciclib (TQB3616) combined with fulvestrant. The trial focused on na\u00efve patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, locally advanced or metastatic breast cancer.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=30383\" \/>\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=\"2025-03-25T08:30:13+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-03-25T08:30:40+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/03\/2516-png.webp\" \/>\n\t<meta property=\"og:image:width\" content=\"1080\" \/>\n\t<meta property=\"og:image:height\" content=\"608\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Fineline Cube\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter: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 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=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=30383#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=30383\"},\"author\":{\"name\":\"Fineline Cube\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\"},\"headline\":\"Sino Biopharmaceutical’s Culmerciclib Shows Positive Results in Phase III Breast Cancer Trial\",\"datePublished\":\"2025-03-25T08:30:13+00:00\",\"dateModified\":\"2025-03-25T08:30:40+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=30383\"},\"wordCount\":238,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=30383#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2025\\\/03\\\/2516-png.webp\",\"keywords\":[\"Clinical trial results\",\"HKG: 1177\",\"Sino Biopharmaceutical\"],\"articleSection\":[\"Company\",\"Drug\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=30383#respond\"]}],\"copyrightYear\":\"2025\",\"copyrightHolder\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"}},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=30383\",\"url\":\"https:\\\/\\\/flcube.com\\\/?p=30383\",\"name\":\"Sino Biopharmaceutical's Culmerciclib Shows Positive Results in Phase III Breast Cancer Trial - Insight, China's Pharmaceutical Industry\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=30383#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=30383#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2025\\\/03\\\/2516-png.webp\",\"datePublished\":\"2025-03-25T08:30:13+00:00\",\"dateModified\":\"2025-03-25T08:30:40+00:00\",\"description\":\"China-based Sino Biopharmaceutical Ltd (HKG: 1177) has revealed positive results from the Phase III TQB3616-III-02 study for its Category 1 drug culmerciclib (TQB3616) combined with fulvestrant. The trial focused on na\u00efve patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, locally advanced or metastatic breast cancer.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=30383#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=30383\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=30383#primaryimage\",\"url\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2025\\\/03\\\/2516-png.webp\",\"contentUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2025\\\/03\\\/2516-png.webp\",\"width\":1080,\"height\":608,\"caption\":\"Sino Biopharmaceutical's Culmerciclib Shows Positive Results in Phase III Breast Cancer Trial\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=30383#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/flcube.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Sino Biopharmaceutical’s Culmerciclib Shows Positive Results in Phase III Breast Cancer Trial\"}]},{\"@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":"Sino Biopharmaceutical's Culmerciclib Shows Positive Results in Phase III Breast Cancer Trial - Insight, China's Pharmaceutical Industry","description":"China-based Sino Biopharmaceutical Ltd (HKG: 1177) has revealed positive results from the Phase III TQB3616-III-02 study for its Category 1 drug culmerciclib (TQB3616) combined with fulvestrant. The trial focused on na\u00efve patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, locally advanced or metastatic breast cancer.","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=30383","og_locale":"en_US","og_type":"article","og_title":"Sino Biopharmaceutical's Culmerciclib Shows Positive Results in Phase III Breast Cancer Trial","og_description":"China-based Sino Biopharmaceutical Ltd (HKG: 1177) has revealed positive results from the Phase III TQB3616-III-02 study for its Category 1 drug culmerciclib (TQB3616) combined with fulvestrant. The trial focused on na\u00efve patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, locally advanced or metastatic breast cancer.","og_url":"https:\/\/flcube.com\/?p=30383","og_site_name":"Insight, China's Pharmaceutical Industry","article_publisher":"https:\/\/www.facebook.com\/profile.php?id=61566606313834","article_published_time":"2025-03-25T08:30:13+00:00","article_modified_time":"2025-03-25T08:30:40+00:00","og_image":[{"width":1080,"height":608,"url":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/03\/2516-png.webp","type":"image\/png"}],"author":"Fineline Cube","twitter_card":"summary_large_image","twitter_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","twitter_misc":{"Written by":"Fineline Cube","Est. reading time":"2 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/flcube.com\/?p=30383#article","isPartOf":{"@id":"https:\/\/flcube.com\/?p=30383"},"author":{"name":"Fineline Cube","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a"},"headline":"Sino Biopharmaceutical’s Culmerciclib Shows Positive Results in Phase III Breast Cancer Trial","datePublished":"2025-03-25T08:30:13+00:00","dateModified":"2025-03-25T08:30:40+00:00","mainEntityOfPage":{"@id":"https:\/\/flcube.com\/?p=30383"},"wordCount":238,"commentCount":0,"publisher":{"@id":"https:\/\/flcube.com\/#organization"},"image":{"@id":"https:\/\/flcube.com\/?p=30383#primaryimage"},"thumbnailUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/03\/2516-png.webp","keywords":["Clinical trial results","HKG: 1177","Sino Biopharmaceutical"],"articleSection":["Company","Drug"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/flcube.com\/?p=30383#respond"]}],"copyrightYear":"2025","copyrightHolder":{"@id":"https:\/\/flcube.com\/#organization"}},{"@type":"WebPage","@id":"https:\/\/flcube.com\/?p=30383","url":"https:\/\/flcube.com\/?p=30383","name":"Sino Biopharmaceutical's Culmerciclib Shows Positive Results in Phase III Breast Cancer Trial - Insight, China's Pharmaceutical Industry","isPartOf":{"@id":"https:\/\/flcube.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/flcube.com\/?p=30383#primaryimage"},"image":{"@id":"https:\/\/flcube.com\/?p=30383#primaryimage"},"thumbnailUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/03\/2516-png.webp","datePublished":"2025-03-25T08:30:13+00:00","dateModified":"2025-03-25T08:30:40+00:00","description":"China-based Sino Biopharmaceutical Ltd (HKG: 1177) has revealed positive results from the Phase III TQB3616-III-02 study for its Category 1 drug culmerciclib (TQB3616) combined with fulvestrant. The trial focused on na\u00efve patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, locally advanced or metastatic breast cancer.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=30383#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=30383"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/?p=30383#primaryimage","url":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/03\/2516-png.webp","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/03\/2516-png.webp","width":1080,"height":608,"caption":"Sino Biopharmaceutical's Culmerciclib Shows Positive Results in Phase III Breast Cancer Trial"},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=30383#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Sino Biopharmaceutical’s Culmerciclib Shows Positive Results in Phase III Breast Cancer Trial"}]},{"@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":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/03\/2516-png.webp","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/30383","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=30383"}],"version-history":[{"count":2,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/30383\/revisions"}],"predecessor-version":[{"id":30386,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/30383\/revisions\/30386"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/media\/30384"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=30383"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=30383"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=30383"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}