{"id":64605,"date":"2026-05-07T13:32:27","date_gmt":"2026-05-07T05:32:27","guid":{"rendered":"https:\/\/flcube.com\/?p=64605"},"modified":"2026-05-07T13:32:28","modified_gmt":"2026-05-07T05:32:28","slug":"changchun-high-techs-subsidiary-genescience-advances-gensci155-long-acting-igf-1-analog-for-preterm-infants-and-stroke-patients","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=64605","title":{"rendered":"Changchun High-Tech&#8217;s Subsidiary GeneScience Advances GenSci155 \u2013 Long-Acting IGF-1 Analog for Preterm Infants and Stroke Patients"},"content":{"rendered":"\n<p><strong>Changchun High &amp; New Technology Industries (Group) Inc.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/000661:SHE\">SHE: 000661<\/a>) announced that the <strong>National Medical Products Administration (NMPA)<\/strong> has accepted for review the <strong>clinical filing<\/strong> of <strong>GenSci155<\/strong>, a <strong>Category 1 biologic product<\/strong> developed by its subsidiary <strong>Changchun GeneScience Pharmaceutical Inc.<\/strong> The <strong>long-acting, sustained-release recombinant human insulin-like growth factor-1 (IGF-1) analog<\/strong> is being developed for two distinct indications: <strong>prevention of bronchopulmonary dysplasia (BPD) in preterm infants<\/strong> and <strong>treatment of acute ischemic stroke (AIS)<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-regulatory-milestone\">Regulatory Milestone<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Item<\/th><th>Detail<\/th><\/tr><\/thead><tbody><tr><td><strong>Agency<\/strong><\/td><td>NMPA (China)<\/td><\/tr><tr><td><strong>Status<\/strong><\/td><td>Clinical filing accepted for review<\/td><\/tr><tr><td><strong>Product<\/strong><\/td><td>GenSci155 (Category 1 biologic) \u2013 long-acting IGF-1 analog<\/td><\/tr><tr><td><strong>Indications<\/strong><\/td><td>Prevention of BPD in preterm infants; Treatment of acute ischemic stroke (AIS)<\/td><\/tr><tr><td><strong>Developer<\/strong><\/td><td>Changchun GeneScience Pharmaceutical Inc. (subsidiary of Changchun High-Tech)<\/td><\/tr><tr><td><strong>Announcement Date<\/strong><\/td><td>7 May 2026<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-drug-profile-amp-dual-indication-strategy\">Drug Profile &amp; Dual-Indication Strategy<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-bronchopulmonary-dysplasia-bpd-prevention\">Bronchopulmonary Dysplasia (BPD) Prevention<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Patient Population:<\/strong> Preterm infants at risk of developing chronic lung disease<\/li>\n\n\n\n<li><strong>Administration:<\/strong> Flexible <strong>intravenous or subcutaneous injection<\/strong> options<\/li>\n\n\n\n<li><strong>Advantage:<\/strong> <strong>More stable IGF-1 exposure profile<\/strong> demonstrated in preclinical studies<\/li>\n\n\n\n<li><strong>Clinical Benefit:<\/strong> Supports different growth and development stages, potentially <strong>improving long-term treatment adherence<\/strong><\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-acute-ischemic-stroke-ais-treatment\">Acute Ischemic Stroke (AIS) Treatment<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Patient Population:<\/strong> Adults experiencing acute phase of ischemic stroke<\/li>\n\n\n\n<li><strong>Administration:<\/strong> <strong>Rapid intravenous bolus<\/strong> delivery for immediate intervention<\/li>\n\n\n\n<li><strong>Therapeutic Window:<\/strong> Enables <strong>early neuroprotective intervention<\/strong> during critical acute phase<\/li>\n\n\n\n<li><strong>Clinical Benefit:<\/strong> Provides <strong>sustained neuroprotection<\/strong> before and after reperfusion therapy, <strong>maximizing clinical benefits<\/strong> within therapeutic time window and <strong>improving long-term functional outcomes<\/strong><\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-innovation-amp-market-opportunity\">Innovation &amp; Market Opportunity<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Therapeutic Area<\/th><th>Market Need<\/th><th>GenSci155 Differentiation<\/th><\/tr><\/thead><tbody><tr><td><strong>Neonatal Care<\/strong><\/td><td>Limited options for BPD prevention; current treatments often inadequate<\/td><td>First long-acting IGF-1 analog with flexible administration routes tailored for preterm infant physiology<\/td><\/tr><tr><td><strong>Stroke Therapy<\/strong><\/td><td>Narrow therapeutic window; need for neuroprotective agents that complement reperfusion<\/td><td>Sustained neuroprotection that bridges pre- and post-reperfusion phases, potentially extending effective treatment window<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>The dual-indication approach leverages the fundamental role of IGF-1 in both <strong>lung development<\/strong> and <strong>neuroprotection<\/strong>, representing a strategic application of a single molecular entity across distinct patient populations with high unmet medical needs.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-strategic-implications\">Strategic Implications<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>China Neonatal Health:<\/strong> With approximately <strong>1 million preterm births annually<\/strong> in China, effective BPD prevention represents a significant public health opportunity.<\/li>\n\n\n\n<li><strong>Stroke Burden:<\/strong> China faces one of the world&#8217;s highest stroke burdens, with <strong>over 2.4 million new stroke cases annually<\/strong>, creating substantial demand for innovative neuroprotective therapies.<\/li>\n\n\n\n<li><strong>Biologics Leadership:<\/strong> As a <strong>Category 1 biologic<\/strong>, GenSci155 positions Changchun High-Tech at the forefront of China&#8217;s domestic biopharmaceutical innovation ecosystem.<\/li>\n\n\n\n<li><strong>Global Potential:<\/strong> The novel long-acting IGF-1 analog platform could have applications beyond the initial indications, providing a foundation for future pipeline expansion.<\/li>\n<\/ul>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward-looking statements regarding regulatory progress, clinical development, and market opportunities for GenSci155. Actual results may differ due to risks including clinical trial outcomes, regulatory decisions, and competitive dynamics.<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\/2026\/05\/\u957f\u6625\u9ad8\u65b0\uff1a\u5173\u4e8e\u5b50\u516c\u53f8GenSci155\u6ce8\u5c04\u6db2\u5883\u5185\u751f\u4ea7\u836f\u54c1\u6ce8\u518c\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7\u83b7\u5f97\u53d7\u7406\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\u53f8GenSci155\u6ce8\u5c04\u6db2\u5883\u5185\u751f\u4ea7\u836f\u54c1\u6ce8\u518c\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7\u83b7\u5f97\u53d7\u7406\u7684\u516c\u544a.\"><\/object><a id=\"wp-block-file--media-fd10547f-3c44-4ec7-80f7-cae99bea8442\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/05\/\u957f\u6625\u9ad8\u65b0\uff1a\u5173\u4e8e\u5b50\u516c\u53f8GenSci155\u6ce8\u5c04\u6db2\u5883\u5185\u751f\u4ea7\u836f\u54c1\u6ce8\u518c\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7\u83b7\u5f97\u53d7\u7406\u7684\u516c\u544a.pdf\">\u957f\u6625\u9ad8\u65b0\uff1a\u5173\u4e8e\u5b50\u516c\u53f8GenSci155\u6ce8\u5c04\u6db2\u5883\u5185\u751f\u4ea7\u836f\u54c1\u6ce8\u518c\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7\u83b7\u5f97\u53d7\u7406\u7684\u516c\u544a<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/05\/\u957f\u6625\u9ad8\u65b0\uff1a\u5173\u4e8e\u5b50\u516c\u53f8GenSci155\u6ce8\u5c04\u6db2\u5883\u5185\u751f\u4ea7\u836f\u54c1\u6ce8\u518c\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7\u83b7\u5f97\u53d7\u7406\u7684\u516c\u544a.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-fd10547f-3c44-4ec7-80f7-cae99bea8442\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Changchun High &amp; New Technology Industries (Group) Inc. (SHE: 000661) announced that the National Medical&#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":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[2929,90,358,1171],"class_list":["post-64605","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-changchun-high-new-technology-industries","tag-clinical-trial-filings","tag-genescience-pharmaceutical","tag-she-000661"],"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>Changchun High-Tech&#039;s Subsidiary GeneScience Advances GenSci155 \u2013 Long-Acting IGF-1 Analog for Preterm Infants and Stroke Patients - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Changchun High &amp; New Technology Industries (Group) Inc. 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(SHE: 000661) announced that the National Medical Products Administration (NMPA) has accepted for review the clinical filing of GenSci155, a Category 1 biologic product developed by its subsidiary Changchun GeneScience Pharmaceutical Inc. 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(SHE: 000661) announced that the National Medical Products Administration (NMPA) has accepted for review the clinical filing of GenSci155, a Category 1 biologic product developed by its subsidiary Changchun GeneScience Pharmaceutical Inc. The long-acting, sustained-release recombinant human insulin-like growth factor-1 (IGF-1) analog is being developed for two distinct indications: prevention of bronchopulmonary dysplasia (BPD) in preterm infants and treatment of acute ischemic stroke (AIS).","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=64605#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=64605"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=64605#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Changchun High-Tech&#8217;s Subsidiary GeneScience Advances GenSci155 \u2013 Long-Acting IGF-1 Analog for Preterm Infants and Stroke Patients"}]},{"@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\/64605","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=64605"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/64605\/revisions"}],"predecessor-version":[{"id":64608,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/64605\/revisions\/64608"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=64605"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=64605"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=64605"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}