{"id":14638,"date":"2023-08-28T16:10:00","date_gmt":"2023-08-28T08:10:00","guid":{"rendered":"https:\/\/flcube.com\/?p=14638"},"modified":"2024-11-24T16:12:30","modified_gmt":"2024-11-24T08:12:30","slug":"junshi-biosciences-senaparib-nda-accepted-by-nmpa-for-ovarian-cancer-maintenance-treatment","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=14638","title":{"rendered":"Junshi Biosciences&#8217; Senaparib NDA Accepted by NMPA for Ovarian Cancer Maintenance Treatment"},"content":{"rendered":"\n<p>China\u2019s Junshi Biosciences (<a href=\"https:\/\/www.google.com\/finance\/quote\/1877:HKG\">HKG: 1877<\/a>; <a href=\"https:\/\/www.google.com\/finance\/quote\/688180:SHA\">SHA: 688180<\/a>) has announced that the New Drug Application (NDA) for senaparib (JS109\/IMP4297), a PARP inhibitor co-developed with compatriot firm Impact Therapeutics Inc., has been accepted for review by the National Medical Products Administration (NMPA). The intended indication is for use as a maintenance treatment in patients with stage III-IV epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have achieved complete or partial remission after first-line platinum chemotherapy.<\/p>\n\n\n\n<p><strong>FLAMES Study Supports NDA Filing<\/strong><br>The filing is supported by the FLAMES study, a randomized, double-blind, placebo-controlled, multi-center Phase III study. The study assessed the efficacy and safety of senaparib as a maintenance treatment for FIGO stage III-IV ovarian cancer patients with complete remission or partial remission following first-line platinum chemotherapy. Interim analysis results from the FLAMES study demonstrated that senaparib could significantly prolong the progression-free survival (PFS) of patients with advanced ovarian cancer, with benefits observed regardless of the breast cancer susceptibility gene (BRCA) status.<\/p>\n\n\n\n<p><strong>Orphan Drug Designation and Broadening Patient Population<\/strong><br>Senaparib was awarded orphan drug designation status for use in small cell lung cancer combined with temozolomide in the US in August 2022. In the ovarian cancer field, the population sensitive to PARP inhibitors has expanded from BRCA mutant populations to HRD positive populations. Studies have shown that HRD negative populations are also expected to benefit from PARP inhibitor treatment, further expanding the potential patient base for senaparib.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>China\u2019s Junshi Biosciences (HKG: 1877; SHA: 688180) has announced that the New Drug Application (NDA)&#8230;<\/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":[899,296,38,767,900],"class_list":["post-14638","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-hkg-1877","tag-junshi-biosciences","tag-market-approval-filings","tag-parp","tag-sha-688180"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.6 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Junshi Biosciences&#039; Senaparib NDA Accepted by NMPA for Ovarian Cancer Maintenance Treatment - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China\u2019s Junshi Biosciences (HKG: 1877; SHA: 688180) has announced that the New Drug Application (NDA) for senaparib (JS109\/IMP4297), a PARP inhibitor co-developed with compatriot firm Impact Therapeutics Inc., has been accepted for review by the National Medical Products Administration (NMPA). The intended indication is for use as a maintenance treatment in patients with stage III-IV epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have achieved complete or partial remission after first-line platinum chemotherapy.\" \/>\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=14638\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Junshi Biosciences&#039; Senaparib NDA Accepted by NMPA for Ovarian Cancer Maintenance Treatment\" \/>\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=14638\" \/>\n<meta property=\"og:site_name\" content=\"Insight, China&#039;s Pharmaceutical Industry\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/profile.php?id=61566606313834\" \/>\n<meta property=\"article:published_time\" content=\"2023-08-28T08:10:00+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-11-24T08:12:30+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=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=14638#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=14638\"},\"author\":{\"name\":\"Fineline Cube\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\"},\"headline\":\"Junshi Biosciences&#8217; Senaparib NDA Accepted by NMPA for Ovarian Cancer Maintenance Treatment\",\"datePublished\":\"2023-08-28T08:10:00+00:00\",\"dateModified\":\"2024-11-24T08:12:30+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=14638\"},\"wordCount\":252,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"keywords\":[\"HKG: 1877\",\"Junshi Biosciences\",\"Market approval filings\",\"PARP\",\"SHA: 688180\"],\"articleSection\":[\"Company\",\"Drug\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=14638#respond\"]}],\"copyrightYear\":\"2023\",\"copyrightHolder\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"}},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=14638\",\"url\":\"https:\\\/\\\/flcube.com\\\/?p=14638\",\"name\":\"Junshi Biosciences' Senaparib NDA Accepted by NMPA for Ovarian Cancer Maintenance Treatment - Insight, China&#039;s Pharmaceutical Industry\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\"},\"datePublished\":\"2023-08-28T08:10:00+00:00\",\"dateModified\":\"2024-11-24T08:12:30+00:00\",\"description\":\"China\u2019s Junshi Biosciences (HKG: 1877; SHA: 688180) has announced that the New Drug Application (NDA) for senaparib (JS109\\\/IMP4297), a PARP inhibitor co-developed with compatriot firm Impact Therapeutics Inc., has been accepted for review by the National Medical Products Administration (NMPA). The intended indication is for use as a maintenance treatment in patients with stage III-IV epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have achieved complete or partial remission after first-line platinum chemotherapy.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=14638#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=14638\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=14638#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/flcube.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Junshi Biosciences&#8217; Senaparib NDA Accepted by NMPA for Ovarian Cancer Maintenance Treatment\"}]},{\"@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":"Junshi Biosciences' Senaparib NDA Accepted by NMPA for Ovarian Cancer Maintenance Treatment - Insight, China&#039;s Pharmaceutical Industry","description":"China\u2019s Junshi Biosciences (HKG: 1877; SHA: 688180) has announced that the New Drug Application (NDA) for senaparib (JS109\/IMP4297), a PARP inhibitor co-developed with compatriot firm Impact Therapeutics Inc., has been accepted for review by the National Medical Products Administration (NMPA). The intended indication is for use as a maintenance treatment in patients with stage III-IV epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have achieved complete or partial remission after first-line platinum chemotherapy.","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=14638","og_locale":"en_US","og_type":"article","og_title":"Junshi Biosciences' Senaparib NDA Accepted by NMPA for Ovarian Cancer Maintenance Treatment","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=14638","og_site_name":"Insight, China&#039;s Pharmaceutical Industry","article_publisher":"https:\/\/www.facebook.com\/profile.php?id=61566606313834","article_published_time":"2023-08-28T08:10:00+00:00","article_modified_time":"2024-11-24T08:12:30+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":"2 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/flcube.com\/?p=14638#article","isPartOf":{"@id":"https:\/\/flcube.com\/?p=14638"},"author":{"name":"Fineline Cube","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a"},"headline":"Junshi Biosciences&#8217; Senaparib NDA Accepted by NMPA for Ovarian Cancer Maintenance Treatment","datePublished":"2023-08-28T08:10:00+00:00","dateModified":"2024-11-24T08:12:30+00:00","mainEntityOfPage":{"@id":"https:\/\/flcube.com\/?p=14638"},"wordCount":252,"commentCount":0,"publisher":{"@id":"https:\/\/flcube.com\/#organization"},"keywords":["HKG: 1877","Junshi Biosciences","Market approval filings","PARP","SHA: 688180"],"articleSection":["Company","Drug"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/flcube.com\/?p=14638#respond"]}],"copyrightYear":"2023","copyrightHolder":{"@id":"https:\/\/flcube.com\/#organization"}},{"@type":"WebPage","@id":"https:\/\/flcube.com\/?p=14638","url":"https:\/\/flcube.com\/?p=14638","name":"Junshi Biosciences' Senaparib NDA Accepted by NMPA for Ovarian Cancer Maintenance Treatment - Insight, China&#039;s Pharmaceutical Industry","isPartOf":{"@id":"https:\/\/flcube.com\/#website"},"datePublished":"2023-08-28T08:10:00+00:00","dateModified":"2024-11-24T08:12:30+00:00","description":"China\u2019s Junshi Biosciences (HKG: 1877; SHA: 688180) has announced that the New Drug Application (NDA) for senaparib (JS109\/IMP4297), a PARP inhibitor co-developed with compatriot firm Impact Therapeutics Inc., has been accepted for review by the National Medical Products Administration (NMPA). The intended indication is for use as a maintenance treatment in patients with stage III-IV epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have achieved complete or partial remission after first-line platinum chemotherapy.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=14638#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=14638"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=14638#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Junshi Biosciences&#8217; Senaparib NDA Accepted by NMPA for Ovarian Cancer Maintenance Treatment"}]},{"@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\/14638","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=14638"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/14638\/revisions"}],"predecessor-version":[{"id":14639,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/14638\/revisions\/14639"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=14638"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=14638"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=14638"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}