{"id":21502,"date":"2025-01-14T16:43:02","date_gmt":"2025-01-14T08:43:02","guid":{"rendered":"https:\/\/flcube.com\/?p=21502"},"modified":"2025-01-14T16:43:04","modified_gmt":"2025-01-14T08:43:04","slug":"mercks-keytruda-gains-nmpa-approval-for-hnscc-indication-in-china","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=21502","title":{"rendered":"Merck’s Keytruda Gains NMPA Approval for HNSCC Indication in China"},"content":{"rendered":"\n

US-based Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK<\/a>) has announced that it has received an indication extension approval from the National Medical Products Administration (NMPA) for its blockbuster drug Keytruda (pembrolizumab). The approval is for the use of Keytruda as a monotherapy for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) in patients with tumor expression of PD-L1 (composite positive score [CPS] \u2265 1), as determined through fully validated testing.<\/p>\n\n\n\n

Recent Approval Context<\/strong>
This follows the drug’s approval last month in China for use in combination with chemotherapy for International Federation of Obstetrics and Gynecology (FIGO) 2014 stage III-IVA cervical cancer, further expanding its therapeutic applications in the country.<\/p>\n\n\n\n

Keytruda’s Market Presence in China<\/strong>
First approved in China in 2018, Keytruda has since garnered over 10 indication approvals in the country. These indications span a range of cancers, including melanoma, non-small cell lung cancer, esophageal squamous cell carcinoma, HNSCC, colorectal cancer, hepatocellular carcinoma, triple negative breast cancer, MSI-H\/dMMR solid tumors, gastric cancer, and bile duct cancer. The continued expansion of Keytruda’s indications reflects its significant role in the oncology treatment landscape in China.-Fineline Info & Tech<\/a><\/p>\n\n\n\n

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

US-based Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK) has announced that it has received…<\/p>\n","protected":false},"author":1,"featured_media":21503,"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":[120,2675,176,903,18],"class_list":["post-21502","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-merck","tag-merck-sharp-dohme","tag-msd","tag-nyse-mrk","tag-pd-1-l1"],"yoast_head":"\nMerck's Keytruda Gains NMPA Approval for HNSCC Indication in China - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"US-based Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK) has announced that it has received an indication extension approval from the National Medical Products Administration (NMPA) for its blockbuster drug Keytruda (pembrolizumab). The approval is for the use of Keytruda as a monotherapy for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) in patients with tumor expression of PD-L1 (composite positive score [CPS] \u2265 1), as determined through fully validated testing.\" \/>\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=21502\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Merck's Keytruda Gains NMPA Approval for HNSCC Indication in China\" \/>\n<meta property=\"og:description\" content=\"US-based Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK) has announced that it has received an indication extension approval from the National Medical Products Administration (NMPA) for its blockbuster drug Keytruda (pembrolizumab). The approval is for the use of Keytruda as a monotherapy for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) in patients with tumor expression of PD-L1 (composite positive score [CPS] \u2265 1), as determined through fully validated testing.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=21502\" \/>\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=\"2025-01-14T08:43:02+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-01-14T08:43:04+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/01\/1410.png\" \/>\n\t<meta property=\"og:image:width\" content=\"1080\" \/>\n\t<meta property=\"og:image:height\" content=\"600\" \/>\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=21502#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=21502\"},\"author\":{\"name\":\"Fineline Cube\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\"},\"headline\":\"Merck’s Keytruda Gains NMPA Approval for HNSCC Indication in China\",\"datePublished\":\"2025-01-14T08:43:02+00:00\",\"dateModified\":\"2025-01-14T08:43:04+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=21502\"},\"wordCount\":205,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=21502#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2025\\\/01\\\/1410.png\",\"keywords\":[\"Merck\",\"Merck Sharp & Dohme\",\"MSD\",\"NYSE: MRK\",\"PD-1\\\/L1\"],\"articleSection\":[\"Company\",\"Drug\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=21502#respond\"]}],\"copyrightYear\":\"2025\",\"copyrightHolder\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"}},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=21502\",\"url\":\"https:\\\/\\\/flcube.com\\\/?p=21502\",\"name\":\"Merck's Keytruda Gains NMPA Approval for HNSCC Indication in China - Insight, China's Pharmaceutical Industry\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=21502#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=21502#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2025\\\/01\\\/1410.png\",\"datePublished\":\"2025-01-14T08:43:02+00:00\",\"dateModified\":\"2025-01-14T08:43:04+00:00\",\"description\":\"US-based Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK) has announced that it has received an indication extension approval from the National Medical Products Administration (NMPA) for its blockbuster drug Keytruda (pembrolizumab). The approval is for the use of Keytruda as a monotherapy for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) in patients with tumor expression of PD-L1 (composite positive score [CPS] \u2265 1), as determined through fully validated testing.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=21502#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=21502\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=21502#primaryimage\",\"url\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2025\\\/01\\\/1410.png\",\"contentUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2025\\\/01\\\/1410.png\",\"width\":1080,\"height\":600,\"caption\":\"Merck's Keytruda Gains NMPA Approval for HNSCC Indication in China\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=21502#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/flcube.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Merck’s Keytruda Gains NMPA Approval for HNSCC Indication in China\"}]},{\"@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":"Merck's Keytruda Gains NMPA Approval for HNSCC Indication in China - Insight, China's Pharmaceutical Industry","description":"US-based Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK) has announced that it has received an indication extension approval from the National Medical Products Administration (NMPA) for its blockbuster drug Keytruda (pembrolizumab). The approval is for the use of Keytruda as a monotherapy for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) in patients with tumor expression of PD-L1 (composite positive score [CPS] \u2265 1), as determined through fully validated testing.","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=21502","og_locale":"en_US","og_type":"article","og_title":"Merck's Keytruda Gains NMPA Approval for HNSCC Indication in China","og_description":"US-based Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK) has announced that it has received an indication extension approval from the National Medical Products Administration (NMPA) for its blockbuster drug Keytruda (pembrolizumab). The approval is for the use of Keytruda as a monotherapy for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) in patients with tumor expression of PD-L1 (composite positive score [CPS] \u2265 1), as determined through fully validated testing.","og_url":"https:\/\/flcube.com\/?p=21502","og_site_name":"Insight, China's Pharmaceutical Industry","article_publisher":"https:\/\/www.facebook.com\/profile.php?id=61566606313834","article_published_time":"2025-01-14T08:43:02+00:00","article_modified_time":"2025-01-14T08:43:04+00:00","og_image":[{"width":1080,"height":600,"url":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/01\/1410.png","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=21502#article","isPartOf":{"@id":"https:\/\/flcube.com\/?p=21502"},"author":{"name":"Fineline Cube","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a"},"headline":"Merck’s Keytruda Gains NMPA Approval for HNSCC Indication in China","datePublished":"2025-01-14T08:43:02+00:00","dateModified":"2025-01-14T08:43:04+00:00","mainEntityOfPage":{"@id":"https:\/\/flcube.com\/?p=21502"},"wordCount":205,"commentCount":0,"publisher":{"@id":"https:\/\/flcube.com\/#organization"},"image":{"@id":"https:\/\/flcube.com\/?p=21502#primaryimage"},"thumbnailUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/01\/1410.png","keywords":["Merck","Merck Sharp & Dohme","MSD","NYSE: MRK","PD-1\/L1"],"articleSection":["Company","Drug"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/flcube.com\/?p=21502#respond"]}],"copyrightYear":"2025","copyrightHolder":{"@id":"https:\/\/flcube.com\/#organization"}},{"@type":"WebPage","@id":"https:\/\/flcube.com\/?p=21502","url":"https:\/\/flcube.com\/?p=21502","name":"Merck's Keytruda Gains NMPA Approval for HNSCC Indication in China - Insight, China's Pharmaceutical Industry","isPartOf":{"@id":"https:\/\/flcube.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/flcube.com\/?p=21502#primaryimage"},"image":{"@id":"https:\/\/flcube.com\/?p=21502#primaryimage"},"thumbnailUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/01\/1410.png","datePublished":"2025-01-14T08:43:02+00:00","dateModified":"2025-01-14T08:43:04+00:00","description":"US-based Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK) has announced that it has received an indication extension approval from the National Medical Products Administration (NMPA) for its blockbuster drug Keytruda (pembrolizumab). The approval is for the use of Keytruda as a monotherapy for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) in patients with tumor expression of PD-L1 (composite positive score [CPS] \u2265 1), as determined through fully validated testing.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=21502#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=21502"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/?p=21502#primaryimage","url":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/01\/1410.png","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/01\/1410.png","width":1080,"height":600,"caption":"Merck's Keytruda Gains NMPA Approval for HNSCC Indication in China"},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=21502#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Merck’s Keytruda Gains NMPA Approval for HNSCC Indication in China"}]},{"@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\/01\/1410.png","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/21502","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=21502"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/21502\/revisions"}],"predecessor-version":[{"id":21504,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/21502\/revisions\/21504"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/media\/21503"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=21502"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=21502"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=21502"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}