{"id":69407,"date":"2026-07-06T11:27:16","date_gmt":"2026-07-06T03:27:16","guid":{"rendered":"https:\/\/flcube.com\/?p=69407"},"modified":"2026-07-06T11:27:17","modified_gmt":"2026-07-06T03:27:17","slug":"changchun-high-new-tech-secures-nmpa-clinical-approval-for-gensci164-pth1r-agonist-in-hypoparathyroidism-treatment","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=69407","title":{"rendered":"Changchun High &amp; New Tech Secures NMPA Clinical Approval for GenSci164 PTH1R Agonist in Hypoparathyroidism Treatment"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>Changchun High &amp; New Tech<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/000661:SHE\">SHE: 000661<\/a>) announced it has received clinical trial approval from China&#8217;s <strong>National Medical Products Administration (NMPA)<\/strong> for <strong>GenSci164<\/strong>, an investigational <strong>PTH1R agonist<\/strong> developed for the treatment of <strong>hypoparathyroidism (HP)<\/strong>. The drug candidate leverages GenSci&#8217;s proprietary <strong>Duratide long-acting, sustained-release peptide technology<\/strong> to address a significant unmet medical need in calcium and phosphorus metabolism disorders.<\/p>\n\n\n\n<h2 id=\"h-clinical-development-overview\" class=\"wp-block-heading\">Clinical Development Overview<\/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>Company<\/strong><\/td><td>Changchun High &amp; New Tech (SHE: 000661)<\/td><\/tr><tr><td><strong>Drug Candidate<\/strong><\/td><td>GenSci164<\/td><\/tr><tr><td><strong>Classification<\/strong><\/td><td>Therapeutic Biological-1 product<\/td><\/tr><tr><td><strong>Target Indication<\/strong><\/td><td>Hypoparathyroidism (HP)<\/td><\/tr><tr><td><strong>Regulatory Milestone<\/strong><\/td><td>NMPA clinical trial approval<\/td><\/tr><tr><td><strong>Approval Date<\/strong><\/td><td>04 Jul 2026<\/td><\/tr><tr><td><strong>Development Stage<\/strong><\/td><td>Pre-clinical to Phase I transition<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 id=\"h-drug-profile-amp-mechanism-of-action\" class=\"wp-block-heading\">Drug Profile &amp; Mechanism of Action<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Molecule Type:<\/strong> PTH1R agonist (parathyroid hormone receptor 1 agonist)<\/li>\n\n\n\n<li><strong>Technology Platform:<\/strong> <strong>Duratide<\/strong> \u2013 proprietary long-acting, sustained-release peptide technology<\/li>\n\n\n\n<li><strong>Structural Innovation:<\/strong> Novel and unique structural design combined with extended-release mechanism<\/li>\n\n\n\n<li><strong>Pharmacokinetic Advantage:<\/strong> Significantly extended half-life of active peptide in vivo compared to conventional PTH analogs<\/li>\n\n\n\n<li><strong>Therapeutic Mechanism:<\/strong> Regulates calcium and phosphorus metabolism by:<\/li>\n\n\n\n<li>Increasing blood calcium levels<\/li>\n\n\n\n<li>Lowering blood phosphorus levels<\/li>\n\n\n\n<li>Restoring both parameters to normal physiological range<\/li>\n<\/ul>\n\n\n\n<h2 id=\"h-market-opportunity-amp-unmet-need\" class=\"wp-block-heading\">Market Opportunity &amp; Unmet Need<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Hypoparathyroidism Landscape:<\/strong> Rare endocrine disorder affecting approximately 37-70 per 100,000 individuals globally, characterized by insufficient parathyroid hormone production<\/li>\n\n\n\n<li><strong>Current Treatment Limitations:<\/strong> Standard therapy relies on high-dose calcium and active vitamin D supplements, which fail to fully normalize calcium-phosphorus homeostasis and carry risks of long-term complications including renal impairment and ectopic calcification<\/li>\n\n\n\n<li><strong>Competitive Differentiation:<\/strong> GenSci164 represents a <strong>physiologic replacement approach<\/strong> that mimics natural PTH function, potentially offering superior metabolic control compared to symptomatic management<\/li>\n\n\n\n<li><strong>Commercial Potential:<\/strong> First-in-class PTH1R agonist with extended half-life could command premium pricing in orphan drug markets across China, Asia-Pacific, and potentially global territories<\/li>\n<\/ul>\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>Platform Validation:<\/strong> Successful development of GenSci164 would validate GenSci&#8217;s <strong>Duratide technology platform<\/strong> for other peptide-based therapeutics requiring sustained release profiles<\/li>\n\n\n\n<li><strong>Orphan Drug Designation:<\/strong> Likely eligible for orphan drug incentives in multiple jurisdictions, providing market exclusivity and development support<\/li>\n\n\n\n<li><strong>Pipeline Expansion:<\/strong> Demonstrates Changchun High &amp; New Tech&#8217;s commitment to expanding beyond traditional biologics into specialized endocrine disorders<\/li>\n\n\n\n<li><strong>Partnership Potential:<\/strong> Strong clinical data could attract international partnership interest for ex-China development and commercialization rights<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">The NMPA clinical approval marks a critical milestone in advancing GenSci164 toward addressing the fundamental pathophysiology of hypoparathyroidism rather than merely managing its symptoms, potentially establishing a new standard of care for HP patients.<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\/07\/\u957f\u6625\u9ad8\u65b0\uff1a\u5173\u4e8e\u5b50\u516c\u53f8GenSci164\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\u53f8GenSci164\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-d93e42e4-d8bc-4432-863c-6ce9ef665e90\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/07\/\u957f\u6625\u9ad8\u65b0\uff1a\u5173\u4e8e\u5b50\u516c\u53f8GenSci164\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\u53f8GenSci164\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\/07\/\u957f\u6625\u9ad8\u65b0\uff1a\u5173\u4e8e\u5b50\u516c\u53f8GenSci164\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-d93e42e4-d8bc-4432-863c-6ce9ef665e90\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Changchun High &amp; New Tech (SHE: 000661) announced it has received clinical trial approval from&#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_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_feature_clip_id":0,"_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},"jetpack_post_was_ever_published":false},"categories":[7,11],"tags":[2929,62,1171],"class_list":["post-69407","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 v27.9) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Changchun High &amp; 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