{"id":35996,"date":"2025-06-25T15:45:14","date_gmt":"2025-06-25T07:45:14","guid":{"rendered":"https:\/\/flcube.com\/?p=35996"},"modified":"2025-06-25T15:45:15","modified_gmt":"2025-06-25T07:45:15","slug":"henlius-biotech-doses-first-patient-in-japanese-bridging-trial-of-serplulimab-for-es-sclc","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=35996","title":{"rendered":"Henlius Biotech Doses First Patient in Japanese Bridging Trial of Serplulimab for ES-SCLC"},"content":{"rendered":"\n

China-based Shanghai Henlius Biotech Inc. (HKG: 2696<\/a>) announced the successful completion of first patient dosing in a Japanese bridging trial evaluating its anti-PD-1 inhibitor, HanSiZhuang (serplulimab, HLX10), in combination with chemotherapy as first-line treatment for extensive-stage small cell lung cancer (ES-SCLC).<\/p>\n\n\n\n

Trial Details<\/strong>
The trial is a single-arm, open Phase II study designed to support the marketing filing for serplulimab in Japan. It received tacit approval from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). Patients in the study receive serplulimab in combination with carboplatin and etoposide every three weeks. The primary endpoint is response rate at week 24, with secondary endpoints including overall survival, progression-free survival, objective response rate, duration of response, safety, pharmacokinetics, and immunogenicity.<\/p>\n\n\n\n

Global Approvals and Trials<\/strong>
Serplulimab is already approved in China for the treatment of squamous non-small cell lung cancer (sq-NSCLC), ES-SCLC, esophageal squamous cell carcinoma (ESCC), and non-squamous NSCLC (nsq-NSCLC). It also holds approvals in the EU, UK, Singapore, and India. Additionally, serplulimab is undergoing global trials across multiple cancers, including lung, esophageal, head and neck, colorectal, and gastric cancers.-Fineline Info & Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

China-based Shanghai Henlius Biotech Inc. (HKG: 2696) announced the successful completion of first patient dosing…<\/p>\n","protected":false},"author":1,"featured_media":35997,"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":[16,62,270,862],"class_list":["post-35996","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-cancer","tag-clinical-trial-approval-initiation","tag-henlius-biotech","tag-hkg-2696"],"yoast_head":"\nHenlius Biotech Doses First Patient in Japanese Bridging Trial of Serplulimab for ES-SCLC - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China-based Shanghai Henlius Biotech Inc. (HKG: 2696) announced the successful completion of first patient dosing in a Japanese bridging trial evaluating its anti-PD-1 inhibitor, HanSiZhuang (serplulimab, HLX10), in combination with chemotherapy as first-line treatment for extensive-stage small cell lung cancer (ES-SCLC).\" \/>\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=35996\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Henlius Biotech Doses First Patient in Japanese Bridging Trial of Serplulimab for ES-SCLC\" \/>\n<meta property=\"og:description\" content=\"China-based Shanghai Henlius Biotech Inc. (HKG: 2696) announced the successful completion of first patient dosing in a Japanese bridging trial evaluating its anti-PD-1 inhibitor, HanSiZhuang (serplulimab, HLX10), in combination with chemotherapy as first-line treatment for extensive-stage small cell lung cancer (ES-SCLC).\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=35996\" \/>\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=\"2025-06-25T07:45:14+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-06-25T07:45:15+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/06\/2508.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=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=35996#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=35996\"},\"author\":{\"name\":\"Fineline Cube\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\"},\"headline\":\"Henlius Biotech Doses First Patient in Japanese Bridging Trial of Serplulimab for ES-SCLC\",\"datePublished\":\"2025-06-25T07:45:14+00:00\",\"dateModified\":\"2025-06-25T07:45:15+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=35996\"},\"wordCount\":192,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=35996#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2025\\\/06\\\/2508.webp\",\"keywords\":[\"Cancer\",\"Clinical trial approval \\\/ initiation\",\"Henlius Biotech\",\"HKG: 2696\"],\"articleSection\":[\"Company\",\"Drug\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=35996#respond\"]}],\"copyrightYear\":\"2025\",\"copyrightHolder\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"}},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=35996\",\"url\":\"https:\\\/\\\/flcube.com\\\/?p=35996\",\"name\":\"Henlius Biotech Doses First Patient in Japanese Bridging Trial of Serplulimab for ES-SCLC - Insight, China's Pharmaceutical Industry\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=35996#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=35996#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2025\\\/06\\\/2508.webp\",\"datePublished\":\"2025-06-25T07:45:14+00:00\",\"dateModified\":\"2025-06-25T07:45:15+00:00\",\"description\":\"China-based Shanghai Henlius Biotech Inc. (HKG: 2696) announced the successful completion of first patient dosing in a Japanese bridging trial evaluating its anti-PD-1 inhibitor, HanSiZhuang (serplulimab, HLX10), in combination with chemotherapy as first-line treatment for extensive-stage small cell lung cancer (ES-SCLC).\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=35996#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=35996\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=35996#primaryimage\",\"url\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2025\\\/06\\\/2508.webp\",\"contentUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2025\\\/06\\\/2508.webp\",\"width\":1080,\"height\":608,\"caption\":\"Henlius Biotech Doses First Patient in Japanese Bridging Trial of Serplulimab for ES-SCLC\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=35996#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/flcube.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Henlius Biotech Doses First Patient in Japanese Bridging Trial of Serplulimab for ES-SCLC\"}]},{\"@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":"Henlius Biotech Doses First Patient in Japanese Bridging Trial of Serplulimab for ES-SCLC - Insight, China's Pharmaceutical Industry","description":"China-based Shanghai Henlius Biotech Inc. (HKG: 2696) announced the successful completion of first patient dosing in a Japanese bridging trial evaluating its anti-PD-1 inhibitor, HanSiZhuang (serplulimab, HLX10), in combination with chemotherapy as first-line treatment for extensive-stage small cell lung cancer (ES-SCLC).","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=35996","og_locale":"en_US","og_type":"article","og_title":"Henlius Biotech Doses First Patient in Japanese Bridging Trial of Serplulimab for ES-SCLC","og_description":"China-based Shanghai Henlius Biotech Inc. (HKG: 2696) announced the successful completion of first patient dosing in a Japanese bridging trial evaluating its anti-PD-1 inhibitor, HanSiZhuang (serplulimab, HLX10), in combination with chemotherapy as first-line treatment for extensive-stage small cell lung cancer (ES-SCLC).","og_url":"https:\/\/flcube.com\/?p=35996","og_site_name":"Insight, China's Pharmaceutical Industry","article_publisher":"https:\/\/www.facebook.com\/profile.php?id=61566606313834","article_published_time":"2025-06-25T07:45:14+00:00","article_modified_time":"2025-06-25T07:45:15+00:00","og_image":[{"width":1080,"height":608,"url":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/06\/2508.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":"1 minute"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/flcube.com\/?p=35996#article","isPartOf":{"@id":"https:\/\/flcube.com\/?p=35996"},"author":{"name":"Fineline Cube","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a"},"headline":"Henlius Biotech Doses First Patient in Japanese Bridging Trial of Serplulimab for ES-SCLC","datePublished":"2025-06-25T07:45:14+00:00","dateModified":"2025-06-25T07:45:15+00:00","mainEntityOfPage":{"@id":"https:\/\/flcube.com\/?p=35996"},"wordCount":192,"commentCount":0,"publisher":{"@id":"https:\/\/flcube.com\/#organization"},"image":{"@id":"https:\/\/flcube.com\/?p=35996#primaryimage"},"thumbnailUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/06\/2508.webp","keywords":["Cancer","Clinical trial approval \/ initiation","Henlius Biotech","HKG: 2696"],"articleSection":["Company","Drug"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/flcube.com\/?p=35996#respond"]}],"copyrightYear":"2025","copyrightHolder":{"@id":"https:\/\/flcube.com\/#organization"}},{"@type":"WebPage","@id":"https:\/\/flcube.com\/?p=35996","url":"https:\/\/flcube.com\/?p=35996","name":"Henlius Biotech Doses First Patient in Japanese Bridging Trial of Serplulimab for ES-SCLC - Insight, China's Pharmaceutical Industry","isPartOf":{"@id":"https:\/\/flcube.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/flcube.com\/?p=35996#primaryimage"},"image":{"@id":"https:\/\/flcube.com\/?p=35996#primaryimage"},"thumbnailUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/06\/2508.webp","datePublished":"2025-06-25T07:45:14+00:00","dateModified":"2025-06-25T07:45:15+00:00","description":"China-based Shanghai Henlius Biotech Inc. (HKG: 2696) announced the successful completion of first patient dosing in a Japanese bridging trial evaluating its anti-PD-1 inhibitor, HanSiZhuang (serplulimab, HLX10), in combination with chemotherapy as first-line treatment for extensive-stage small cell lung cancer (ES-SCLC).","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=35996#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=35996"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/?p=35996#primaryimage","url":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/06\/2508.webp","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/06\/2508.webp","width":1080,"height":608,"caption":"Henlius Biotech Doses First Patient in Japanese Bridging Trial of Serplulimab for ES-SCLC"},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=35996#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Henlius Biotech Doses First Patient in Japanese Bridging Trial of Serplulimab for ES-SCLC"}]},{"@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\/06\/2508.webp","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/35996","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=35996"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/35996\/revisions"}],"predecessor-version":[{"id":35998,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/35996\/revisions\/35998"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/media\/35997"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=35996"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=35996"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=35996"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}