{"id":52230,"date":"2025-12-30T13:46:43","date_gmt":"2025-12-30T05:46:43","guid":{"rendered":"https:\/\/flcube.com\/?p=52230"},"modified":"2025-12-30T13:46:44","modified_gmt":"2025-12-30T05:46:44","slug":"tj-biopharma-and-jumpcan-secure-be-trial-approval-for-localized-eftansomatropin-in-china","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=52230","title":{"rendered":"TJ Biopharma and Jumpcan Secure BE Trial Approval for Localized Eftansomatropin in China"},"content":{"rendered":"\n<p><strong>TJ Biopharma (Hangzhou) Co., Ltd.<\/strong> and <strong>Jumpcan Holdings Group<\/strong> announced that the <strong>Center for Drug Evaluation (CDE)<\/strong> of China\u2019s <strong>National Medical Products Administration (NMPA)<\/strong> has approved a <strong>bioequivalence (BE) clinical trial<\/strong> for locally manufactured <strong>Eftansomatropin alpha injection<\/strong>, advancing the companies\u2019 comprehensive localization strategy for the <strong>first and only long\u2011acting fusion protein growth hormone<\/strong> in China.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-regulatory-amp-development-milestone\">Regulatory &amp; Development 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>Product<\/strong><\/td><td>Eftansomatropin alpha injection (long\u2011acting growth hormone)<\/td><\/tr><tr><td><strong>Technology<\/strong><\/td><td>Patented hyFc fusion protein (human GH + human immunoglobulin)<\/td><\/tr><tr><td><strong>CDE BE Trial Approval<\/strong><\/td><td>Acceptance No.: <strong>CXSL2500596<\/strong> (Dec\u202f2025)<\/td><\/tr><tr><td><strong>Import Drug Application (IDL) Withdrawal<\/strong><\/td><td>JXSS2400105 ( voluntarily withdrawn to prioritize local NDA)<\/td><\/tr><tr><td><strong>Collaboration Origin<\/strong><\/td><td>Strategic partnership signed <strong>Nov\u202f2021<\/strong><\/td><\/tr><tr><td><strong>Localization Status<\/strong><\/td><td>Technology transfer and process optimization <strong>completed<\/strong>; production capacity <strong>fully ready<\/strong><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-technology-profile-hyfc-fusion-platform\">Technology Profile: hyFc Fusion Platform<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Mechanism<\/strong>: Covalently fuses recombinant human growth hormone to a modified human immunoglobulin Fc fragment, creating a <strong>stable, long\u2011acting<\/strong> biologic<\/li>\n\n\n\n<li><strong>Key Advantages<\/strong>:<\/li>\n\n\n\n<li><strong>Extended Half\u2011Life<\/strong>: Enables <strong>once\u2011weekly<\/strong> dosing vs. daily injections<\/li>\n\n\n\n<li><strong>Preserved Bioactivity<\/strong>: Maintains full GH receptor binding and signaling<\/li>\n\n\n\n<li><strong>Manufacturing Scalability<\/strong>: Fusion protein design allows cost\u2011effective production in CHO cells<\/li>\n\n\n\n<li><strong>Patient Convenience<\/strong>: Reduces injection frequency, improving adherence and quality of life<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-strategic-localization-rationale\">Strategic Localization Rationale<\/h2>\n\n\n\n<p><strong>Import\u2192Local Pivot<\/strong>: Withdrawing the IDL and pursuing a <strong>localized New Drug Application<\/strong> accelerates <strong>regulatory approval timeline by 12\u201118 months<\/strong> and positions the product for:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>NRDL Negotiation<\/strong>: Local manufacturing qualifies for <strong>2026\u20112027 National Reimbursement Drug List<\/strong> inclusion<\/li>\n\n\n\n<li><strong>Cost Competitiveness<\/strong>: Domestic production reduces unit cost by <strong>40\u201150%<\/strong> vs. imported equivalent<\/li>\n\n\n\n<li><strong>Supply Chain Security<\/strong>: Eliminates import dependencies and cold\u2011chain logistics risks<\/li>\n\n\n\n<li><strong>Market Access<\/strong>: Enables <strong>hospital listing<\/strong> in Tier\u202f2\u20113 cities where import biologics face procurement barriers<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-clinical-path-amp-market-opportunity\">Clinical Path &amp; Market Opportunity<\/h2>\n\n\n\n<p><strong>BE Trial Design<\/strong>: Single\u2011center, randomized, double\u2011blind study comparing pharmacokinetic\/pharmacodynamic equivalence between imported and locally produced Eftansomatropin alpha in <strong>120 pediatric GHD patients<\/strong>; primary endpoint: <strong>AUC\u2080\u2011\u209c and C_max ratio 90% CI within 80\u2011125%<\/strong>.<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Milestone<\/th><th>Target Date<\/th><th>Significance<\/th><\/tr><\/thead><tbody><tr><td><strong>BE trial completion<\/strong><\/td><td>Q3\u202f2026<\/td><td>Data supports local NDA submission<\/td><\/tr><tr><td><strong>NDA filing<\/strong><\/td><td>Q4\u202f2026<\/td><td>Accelerated review pathway (Category\u202f1)<\/td><\/tr><tr><td><strong>NMPA approval<\/strong><\/td><td>Q3\u202f2027<\/td><td>First locally made long\u2011acting GH<\/td><\/tr><tr><td><strong>Commercial launch<\/strong><\/td><td>Q4\u202f2027<\/td><td>Capture peak sales season<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><strong>Market Size<\/strong>: China\u2019s <strong>growth hormone market<\/strong> reached <strong>\u00a59.2\u202fbillion<\/strong> in 2025, with <strong>long\u2011acting GH<\/strong> segment growing at <strong>30% CAGR<\/strong> but comprising only <strong>8%<\/strong> of total prescriptions, indicating massive conversion potential from daily injections.<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Parameter<\/th><th>2027E<\/th><th>2030E<\/th><\/tr><\/thead><tbody><tr><td><strong>Pediatric GHD patients<\/strong><\/td><td>310,000<\/td><td>340,000<\/td><\/tr><tr><td><strong>Long\u2011acting GH penetration<\/strong><\/td><td>12%<\/td><td>25%<\/td><\/tr><tr><td><strong>Eftansomatropin peak share<\/strong><\/td><td>35%<\/td><td>45%<\/td><\/tr><tr><td><strong>Projected annual sales<\/strong><\/td><td>\u00a5850\u202fmillion<\/td><td>\u00a52.1\u202fbillion (US$120\u2011295\u202fmillion)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-competitive-landscape\">Competitive Landscape<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Product<\/th><th>Company<\/th><th>Half\u2011Life<\/th><th>Stage<\/th><th>Annual Cost (\u00a5)<\/th><\/tr><\/thead><tbody><tr><td><strong>Eftansomatropin alpha<\/strong><\/td><td><strong>TJ Biopharma \/ Jumpcan<\/strong><\/td><td>7\u201110 days<\/td><td>BE trial<\/td><td>\u00a535,000\u201140,000 (projected)<\/td><\/tr><tr><td><strong>Jintropin<\/strong> (daily)<\/td><td>GeneScience<\/td><td>0.5 days<\/td><td>Marketed<\/td><td>\u00a545,000\u201160,000<\/td><\/tr><tr><td><strong>Somapacitan<\/strong><\/td><td>Novo Nordisk<\/td><td>7 days<\/td><td>Phase\u202f3 (China)<\/td><td>\u00a555,000\u201170,000<\/td><\/tr><tr><td><strong>Lonapegsomatropin<\/strong> (Skytrofa)<\/td><td>Ascendis Pharma<\/td><td>7 days<\/td><td>Approved (US\/EU)<\/td><td>\u00a570,000+ (import)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><strong>Differentiation<\/strong>: Eftansomatropin\u2019s <strong>hyFc fusion<\/strong> offers <strong>potentially longer half\u2011life<\/strong> and <strong>lower immunogenicity<\/strong> vs. PEGylated competitors, while <strong>local manufacturing<\/strong> ensures <strong>pricing advantage<\/strong> and <strong>NRDL access<\/strong>.<\/p>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><\/p>\n\n\n\n<p>This brief contains forward\u2011looking statements regarding Eftansomatropin alpha\u2019s regulatory timeline, market penetration, and revenue projections. Actual results may differ due to BE trial outcomes, competitive responses, and NRDL negotiation dynamics.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>TJ Biopharma (Hangzhou) Co., Ltd. and Jumpcan Holdings Group announced that the Center for Drug&#8230;<\/p>\n","protected":false},"author":1,"featured_media":52232,"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":[2418,527],"class_list":["post-52230","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-jumpcan-pharmaceutical","tag-tj-biopharma"],"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>TJ Biopharma and Jumpcan Secure BE Trial Approval for Localized Eftansomatropin in China - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"TJ Biopharma (Hangzhou) Co., Ltd. and Jumpcan Holdings Group announced that the Center for Drug Evaluation (CDE) of China\u2019s National Medical Products Administration (NMPA) has approved a bioequivalence (BE) clinical trial for locally manufactured Eftansomatropin alpha injection, advancing the companies\u2019 comprehensive localization strategy for the first and only long\u2011acting fusion protein growth hormone in China.\" \/>\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=52230\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"TJ Biopharma and Jumpcan Secure BE Trial Approval for Localized Eftansomatropin in China\" \/>\n<meta property=\"og:description\" content=\"TJ Biopharma (Hangzhou) Co., Ltd. and Jumpcan Holdings Group announced that the Center for Drug Evaluation (CDE) of China\u2019s National Medical Products Administration (NMPA) has approved a bioequivalence (BE) clinical trial for locally manufactured Eftansomatropin alpha injection, advancing the companies\u2019 comprehensive localization strategy for the first and only long\u2011acting fusion protein growth hormone in China.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=52230\" \/>\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=\"2025-12-30T05:46:43+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-12-30T05:46:44+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/12\/3001.webp\" \/>\n\t<meta property=\"og:image:width\" content=\"1080\" \/>\n\t<meta property=\"og:image:height\" content=\"608\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Fineline Cube\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. 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