{"id":44007,"date":"2025-10-21T21:04:03","date_gmt":"2025-10-21T13:04:03","guid":{"rendered":"https:\/\/flcube.com\/?p=44007"},"modified":"2025-10-21T21:04:03","modified_gmt":"2025-10-21T13:04:03","slug":"changchun-high%e2%80%91tech-secures-nmpa-approval-for-gensci139-bispecific-adc-in-advanced-solid-tumors","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=44007","title":{"rendered":"Changchun High\u2011Tech Secures NMPA Approval for GenSci139 Bispecific ADC in Advanced Solid Tumors"},"content":{"rendered":"\n<p><strong>Changchun High\u2011Tech (<a href=\"https:\/\/www.google.com\/finance\/quote\/000661:SHE\">SHE: 000661<\/a>)<\/strong> announced today that its wholly\u2011owned subsidiary, <strong>GenSci (GeneScience Pharmaceutical)<\/strong>, has received <strong>clinical trial approval<\/strong> from the <strong>National Medical Products Administration (NMPA)<\/strong> for <strong>GenSci139<\/strong> as a <strong>monotherapy<\/strong> in the treatment of <strong>advanced solid tumors<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-product-highlights-gensci139\"><strong>Product Highlights \u2013 GenSci139<\/strong><\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Bispecific Antibody\u2011Drug Conjugate (BsADC)<\/strong> \u2013 simultaneously targets <strong>EGFR<\/strong> and <strong>HER2<\/strong>.<\/li>\n\n\n\n<li><strong>Innovative Linker<\/strong> \u2013 internally developed, highly stable, hydrophilic cleavable linker that ensures controlled release of the payload.<\/li>\n\n\n\n<li><strong>Potent Payload<\/strong> \u2013 topoisomerase\u202fI inhibitor covalently attached to the BsADC.<\/li>\n\n\n\n<li><strong>Mechanism of Action<\/strong><\/li>\n\n\n\n<li>Binds EGFR\u202f\/\u202fHER2\u2011expressing tumor cells, blocking <strong>EGFR homodimers<\/strong>, <strong>HER2 homodimers<\/strong>, and <strong>EGFR\u2011HER2 heterodimers<\/strong>.<\/li>\n\n\n\n<li>Induces receptor internalization, delivering the topoisomerase\u202fI inhibitor directly into the cancer cell to trigger apoptosis.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-clinical-development-pathway\"><strong>Clinical Development Pathway<\/strong><\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>NMPA Approval<\/strong> \u2013 marks the green light to initiate a <strong>Phase\u202fI\/II<\/strong> dose\u2011escalation study in patients with EGFR\u2011 and\/or HER2\u2011positive solid tumors.<\/li>\n\n\n\n<li><strong>Strategic Positioning<\/strong> \u2013 GenSci139 is positioned to address unmet needs in patients who have progressed on existing EGFR\/HER2\u2011targeted therapies.<\/li>\n\n\n\n<li><strong>Future Milestones<\/strong> \u2013 Upon successful early\u2011phase data, GenSci will pursue a global regulatory submission, leveraging the robust pre\u2011clinical profile of the bispecific platform.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-company-amp-market-context\"><strong>Company &amp; Market Context<\/strong><\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Changchun High\u2011Tech<\/strong> \u2013 a leading Chinese biopharmaceutical developer with a portfolio spanning oncology, immunology, and rare diseases.<\/li>\n\n\n\n<li><strong>GenSci (GeneScience Pharmaceutical)<\/strong> \u2013 an independent research\u2011driven subsidiary focused on next\u2011generation antibody\u2011drug conjugates.<\/li>\n\n\n\n<li><strong>Competitive Landscape<\/strong> \u2013 GenSci139\u2019s dual\u2011epitope engagement and hydrophilic linker differentiate it from existing EGFR\/HER2 ADCs, offering potential for superior efficacy and safety.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-forward-looking-statements\"><strong>Forward\u2011Looking Statements<\/strong><\/h3>\n\n\n\n<p>This release contains forward\u2011looking statements that involve risks and uncertainties. Actual results may differ materially.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n\n\n\n<div data-wp-interactive=\"core\/file\" class=\"wp-block-file\"><object data-wp-bind--hidden=\"!state.hasPdfPreview\" hidden class=\"wp-block-file__embed\" data=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/10\/\u957f\u6625\u9ad8\u65b0\uff1a\u5173\u4e8e\u5b50\u516c\u53f8\u6ce8\u5c04\u7528GenSci139\u5883\u5185\u751f\u4ea7\u836f\u54c1\u4e34\u5e8a\u8bd5\u9a8c\u83b7\u6279\u7684\u516c\u544a.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of \u957f\u6625\u9ad8\u65b0\uff1a\u5173\u4e8e\u5b50\u516c\u53f8\u6ce8\u5c04\u7528GenSci139\u5883\u5185\u751f\u4ea7\u836f\u54c1\u4e34\u5e8a\u8bd5\u9a8c\u83b7\u6279\u7684\u516c\u544a.\"><\/object><a id=\"wp-block-file--media-e12a20b7-e9c8-491f-8b99-21b7f34d2bdb\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/10\/\u957f\u6625\u9ad8\u65b0\uff1a\u5173\u4e8e\u5b50\u516c\u53f8\u6ce8\u5c04\u7528GenSci139\u5883\u5185\u751f\u4ea7\u836f\u54c1\u4e34\u5e8a\u8bd5\u9a8c\u83b7\u6279\u7684\u516c\u544a.pdf\">\u957f\u6625\u9ad8\u65b0\uff1a\u5173\u4e8e\u5b50\u516c\u53f8\u6ce8\u5c04\u7528GenSci139\u5883\u5185\u751f\u4ea7\u836f\u54c1\u4e34\u5e8a\u8bd5\u9a8c\u83b7\u6279\u7684\u516c\u544a<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/10\/\u957f\u6625\u9ad8\u65b0\uff1a\u5173\u4e8e\u5b50\u516c\u53f8\u6ce8\u5c04\u7528GenSci139\u5883\u5185\u751f\u4ea7\u836f\u54c1\u4e34\u5e8a\u8bd5\u9a8c\u83b7\u6279\u7684\u516c\u544a.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-e12a20b7-e9c8-491f-8b99-21b7f34d2bdb\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Changchun High\u2011Tech (SHE: 000661) announced today that its wholly\u2011owned subsidiary, GenSci (GeneScience Pharmaceutical), has received&#8230;<\/p>\n","protected":false},"author":1,"featured_media":44008,"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":[35,16,2929,62,358,1171],"class_list":["post-44007","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-adc-xdc","tag-cancer","tag-changchun-high-new-technology-industries","tag-clinical-trial-approval-initiation","tag-genescience-pharmaceutical","tag-she-000661"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.6 (Yoast SEO v27.5) - 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Insight, China&#039;s Pharmaceutical Industry","isPartOf":{"@id":"https:\/\/flcube.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/flcube.com\/?p=44007#primaryimage"},"image":{"@id":"https:\/\/flcube.com\/?p=44007#primaryimage"},"thumbnailUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/10\/2105.webp","datePublished":"2025-10-21T13:04:03+00:00","description":"Changchun High\u2011Tech (SHE: 000661) announced today that its wholly\u2011owned subsidiary, GenSci (GeneScience Pharmaceutical), has received clinical trial approval from the National Medical Products Administration (NMPA) for GenSci139 as a monotherapy in the treatment of advanced solid tumors.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=44007#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=44007"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/?p=44007#primaryimage","url":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/10\/2105.webp","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/10\/2105.webp","width":1080,"height":608,"caption":"Changchun High\u2011Tech Secures NMPA Approval for GenSci139 Bispecific ADC in Advanced Solid Tumors"},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=44007#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Changchun High\u2011Tech Secures NMPA Approval for GenSci139 Bispecific ADC in Advanced Solid Tumors"}]},{"@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\/10\/2105.webp","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/44007","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=44007"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/44007\/revisions"}],"predecessor-version":[{"id":44010,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/44007\/revisions\/44010"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/media\/44008"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=44007"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=44007"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=44007"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}