{"id":67306,"date":"2026-06-04T14:59:57","date_gmt":"2026-06-04T06:59:57","guid":{"rendered":"https:\/\/flcube.com\/?p=67306"},"modified":"2026-06-04T14:59:58","modified_gmt":"2026-06-04T06:59:58","slug":"changchun-high-new-tech-secures-nmpa-clinical-trial-approval-for-gensci155-in-dual-indications-bronchopulmonary-dysplasia-and-acute-ischemic-stroke","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=67306","title":{"rendered":"Changchun High &amp; New Tech Secures NMPA Clinical Trial Approval for GenSci155 in Dual Indications: Bronchopulmonary Dysplasia and Acute Ischemic Stroke"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>Changchun High &amp; New Technology Industries (Group) Inc.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/000661:SHE\">SHE: 000661<\/a>) announced it has received <strong>clinical trial approval<\/strong> from China&#8217;s <strong>National Medical Products Administration (NMPA)<\/strong> for its <strong>Category 1 therapeutic biologic<\/strong>, <strong>GenSci155<\/strong>. The novel agent will be evaluated in two distinct therapeutic areas: <strong>prevention of bronchopulmonary dysplasia (BPD) in premature infants<\/strong> and <strong>treatment of acute ischemic stroke (AIS)<\/strong>.<\/p>\n\n\n\n<h2 id=\"h-regulatory-milestone-amp-development-status\" class=\"wp-block-heading\">Regulatory Milestone &amp; Development Status<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Parameter<\/th><th>Detail<\/th><\/tr><\/thead><tbody><tr><td><strong>Company<\/strong><\/td><td>Changchun High &amp; New Technology Industries (Group) Inc. (SHE: 000661)<\/td><\/tr><tr><td><strong>Regulatory Authority<\/strong><\/td><td>National Medical Products Administration (NMPA), China<\/td><\/tr><tr><td><strong>Approval Type<\/strong><\/td><td>Clinical trial authorization<\/td><\/tr><tr><td><strong>Product Classification<\/strong><\/td><td>Category 1 therapeutic biologic (first-in-class)<\/td><\/tr><tr><td><strong>Molecular Identity<\/strong><\/td><td>Long-acting fatty acid-conjugated recombinant human insulin-like growth factor-1 (IGF-1) analog<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">This approval positions GenSci155 as a potential first-in-class therapy addressing significant unmet medical needs in both neonatal intensive care and neurovascular emergency settings.<\/p>\n\n\n\n<h2 id=\"h-dual-therapeutic-applications\" class=\"wp-block-heading\">Dual Therapeutic Applications<\/h2>\n\n\n\n<h3 id=\"h-bronchopulmonary-dysplasia-bpd-prevention-in-premature-infants\" class=\"wp-block-heading\">Bronchopulmonary Dysplasia (BPD) Prevention in Premature Infants<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Mechanism:<\/strong> Corrects rapid postnatal decline of IGF-1 levels in premature infants<\/li>\n\n\n\n<li><strong>Therapeutic Approach:<\/strong> Preventive therapy promoting lung organogenesis<\/li>\n\n\n\n<li><strong>Key Actions:<\/strong><\/li>\n\n\n\n<li>Promotes alveolarization and vascularization of developing lungs<\/li>\n\n\n\n<li>Supports early development of lungs and other organs through upstream mechanism<\/li>\n\n\n\n<li>Improves overall organ maturation and growth<\/li>\n\n\n\n<li><strong>Clinical Impact:<\/strong> Potential to fundamentally reduce risk of multiple preterm complications beyond BPD<\/li>\n<\/ul>\n\n\n\n<h3 id=\"h-acute-ischemic-stroke-ais-treatment\" class=\"wp-block-heading\">Acute Ischemic Stroke (AIS) Treatment<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Mechanism:<\/strong> Activates IGF-1 receptor (IGF-1R)-mediated downstream signaling pathways<\/li>\n\n\n\n<li><strong>Neuroprotective Effects:<\/strong><\/li>\n\n\n\n<li>Reduces ischemia-reperfusion injury<\/li>\n\n\n\n<li>Promotes neuronal and glial cell survival<\/li>\n\n\n\n<li>Improves neurovascular function<\/li>\n\n\n\n<li><strong>Therapeutic Goal:<\/strong> Neuroprotective and reparative effects in acute stroke setting<\/li>\n<\/ul>\n\n\n\n<h2 id=\"h-scientific-rationale-amp-innovation-profile\" class=\"wp-block-heading\">Scientific Rationale &amp; Innovation Profile<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Molecular Engineering:<\/strong> Fatty acid conjugation extends half-life compared to native IGF-1<\/li>\n\n\n\n<li><strong>Dual Indication Strategy:<\/strong> Leverages IGF-1&#8217;s fundamental role in both developmental biology and neuroprotection<\/li>\n\n\n\n<li><strong>First-in-Class Potential:<\/strong> No currently approved therapies specifically targeting IGF-1 deficiency in premature infants or utilizing IGF-1 analogs for acute stroke<\/li>\n\n\n\n<li><strong>Upstream Mechanism:<\/strong> Addresses root cause rather than symptomatic management in BPD prevention<\/li>\n<\/ul>\n\n\n\n<h2 id=\"h-market-opportunity-amp-unmet-needs\" class=\"wp-block-heading\">Market Opportunity &amp; Unmet Needs<\/h2>\n\n\n\n<h3 id=\"h-bpd-market-context\" class=\"wp-block-heading\">BPD Market Context<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Incidence:<\/strong> Affects 20-30% of very low birth weight infants (&lt;1,500g)<\/li>\n\n\n\n<li><strong>Current Standard:<\/strong> Supportive care with no disease-modifying therapies<\/li>\n\n\n\n<li><strong>Economic Burden:<\/strong> Significant long-term healthcare costs due to chronic respiratory complications<\/li>\n<\/ul>\n\n\n\n<h3 id=\"h-ais-market-context\" class=\"wp-block-heading\">AIS Market Context<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Patient Population:<\/strong> Approximately 2.5 million stroke cases annually in China<\/li>\n\n\n\n<li><strong>Treatment Gap:<\/strong> Limited therapeutic window for existing interventions (tPA, thrombectomy)<\/li>\n\n\n\n<li><strong>Neuroprotection Need:<\/strong> No approved agents specifically designed to protect neural tissue during acute phase<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">The dual indication strategy provides Changchun High &amp; New Tech with diversified clinical and commercial pathways while addressing critical gaps in current treatment paradigms.<\/p>\n\n\n\n<h2 id=\"h-strategic-implications\" class=\"wp-block-heading\">Strategic Implications<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Innovation Leadership:<\/strong> Demonstrates China&#8217;s growing capability in complex biologic development<\/li>\n\n\n\n<li><strong>Global Potential:<\/strong> Success in either indication could support international regulatory filings<\/li>\n\n\n\n<li><strong>Platform Validation:<\/strong> IGF-1 analog platform may support additional indications in developmental and neurological disorders<\/li>\n\n\n\n<li><strong>Competitive Advantage:<\/strong> First-mover status in IGF-1-based BPD prevention creates significant intellectual property moat<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward-looking statements regarding clinical development timelines, regulatory pathways, and market opportunities for GenSci155. Actual results may differ materially due to clinical trial outcomes, regulatory decisions, competitive developments, and market 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\/06\/\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\u6279\u51c6\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\u6279\u51c6\u7684\u516c\u544a.\"><\/object><a id=\"wp-block-file--media-81fb2294-ae1f-45b2-8f14-8f56ee25e841\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/06\/\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\u6279\u51c6\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\u6279\u51c6\u7684\u516c\u544a<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/06\/\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\u6279\u51c6\u7684\u516c\u544a.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-81fb2294-ae1f-45b2-8f14-8f56ee25e841\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Changchun High &amp; New Technology Industries (Group) Inc. (SHE: 000661) announced it has received clinical&#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":[2929,62,1171],"class_list":["post-67306","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-changchun-high-new-technology-industries","tag-clinical-trial-approval-initiation","tag-she-000661"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.5 (Yoast SEO v27.7) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Changchun High &amp; New Tech Secures NMPA Clinical Trial Approval for GenSci155 in Dual Indications: Bronchopulmonary Dysplasia and Acute Ischemic Stroke - 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 it has received clinical trial approval from China's National Medical Products Administration (NMPA) for its Category 1 therapeutic biologic, GenSci155. The novel agent will be evaluated in two distinct therapeutic areas: prevention of bronchopulmonary dysplasia (BPD) in premature infants and treatment of acute ischemic stroke (AIS).","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=67306#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=67306"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=67306#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Changchun High &amp; New Tech Secures NMPA Clinical Trial Approval for GenSci155 in Dual Indications: Bronchopulmonary Dysplasia and Acute Ischemic Stroke"}]},{"@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\/67306","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=67306"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/67306\/revisions"}],"predecessor-version":[{"id":67310,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/67306\/revisions\/67310"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=67306"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=67306"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=67306"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}