{"id":48982,"date":"2025-11-25T19:45:13","date_gmt":"2025-11-25T11:45:13","guid":{"rendered":"https:\/\/flcube.com\/?p=48982"},"modified":"2025-11-25T19:45:14","modified_gmt":"2025-11-25T11:45:14","slug":"qihan-biotechs-qt-019b-universal-car-t-wins-implied-nmpa-approval","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=48982","title":{"rendered":"Qihan-Biotech&#8217;s QT-019B Universal CAR-T Wins Implied NMPA Approval"},"content":{"rendered":"\n<p><strong>Hangzhou Qihan Biotech Co., Ltd. <\/strong> announced that its New Drug Clinical Trial (IND) application for <strong>QT-019B<\/strong>, its first self\u2011developed <strong>universal dual\u2011target (CD19\/BCMA) CAR\u2011T cell product<\/strong> with global rights, has been granted <strong>implied approval<\/strong> by China\u2019s <strong>National Medical Products Administration (NMPA)<\/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>Product<\/strong><\/td><td>QT\u2011019B Cell Injection (universal CAR\u2011T)<\/td><\/tr><tr><td><strong>Company<\/strong><\/td><td>Hangzhou Qihan Biotech Engineering Life<\/td><\/tr><tr><td><strong>Agency<\/strong><\/td><td>NMPA (China)<\/td><\/tr><tr><td><strong>Approval Type<\/strong><\/td><td>IND implied approval<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>Hematologic malignancies (CD19\/BCMA\u2011positive)<\/td><\/tr><tr><td><strong>Technology<\/strong><\/td><td>Allogeneic dual\u2011target CAR\u2011T (CD19 + BCMA)<\/td><\/tr><tr><td><strong>Global Rights<\/strong><\/td><td>Retained by Qihan Biotech<\/td><\/tr><tr><td><strong>Next Step<\/strong><\/td><td>Initiate Phase\u202fI\/II trial Q1\u202f2026<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-technology-profile\">Technology Profile<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Product Type:<\/strong> <strong>&#8220;Off\u2011the\u2011shelf&#8221; allogeneic CAR\u2011T<\/strong> , manufactured from healthy donor leukapheresis<\/li>\n\n\n\n<li><strong>Dual Targeting:<\/strong> Engineered to <strong>stably express two CARs<\/strong> targeting <strong>CD19 and BCMA<\/strong> simultaneously, enabling clearance of dual\u2011positive tumor cells<\/li>\n\n\n\n<li><strong>GvHD Mitigation:<\/strong> <strong>T\u2011cell receptor (TCR) knockout<\/strong> eliminates graft\u2011versus\u2011host disease risk<\/li>\n\n\n\n<li><strong>Immune Evasion:<\/strong> <strong>Multi\u2011gene editing<\/strong> achieves <strong>low immunogenicity<\/strong> to reduce host NK\/T\u2011cell mediated rejection<\/li>\n\n\n\n<li><strong>Strategic Position:<\/strong> First <strong>universal dual\u2011target CAR\u2011T<\/strong> with implied NMPA approval in China<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-context-amp-outlook\">Market Context &amp; Outlook<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Metric<\/th><th>Value<\/th><\/tr><\/thead><tbody><tr><td><strong>China CAR\u2011T Market (2024)<\/strong><\/td><td>\u00a54.5\u202fbillion (US$620\u202fmillion)<\/td><\/tr><tr><td><strong>Allogeneic CAR\u2011T Share<\/strong><\/td><td>&lt;5% (dominated by autologous)<\/td><\/tr><tr><td><strong>CD19\/BCMA Dual\u2011Positive Patients<\/strong><\/td><td>~15\u201120% of relapsed\/refractory multiple myeloma and lymphoma<\/td><\/tr><tr><td><strong>Peak Sales Forecast (QT\u2011019B)<\/strong><\/td><td><strong>\u00a52.5\u20114.0\u202fbillion<\/strong> (US$340\u2011540\u202fmillion) by 2032<\/td><\/tr><tr><td><strong>Competitive Advantage<\/strong><\/td><td><strong>Off\u2011the\u2011shelf<\/strong> availability vs. 2\u20114 week autologous manufacturing<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Manufacturing:<\/strong> Allogeneic platform enables <strong>scale\u2011up to 1,000+ doses\/batch<\/strong>, reducing cost to <strong>30\u201140% of autologous CAR\u2011T<\/strong><\/li>\n\n\n\n<li><strong>Clinical Strategy:<\/strong> Initial focus on <strong>relapsed\/refractory multiple myeloma<\/strong>; potential expansion to <strong>B\u2011cell lymphomas<\/strong><\/li>\n\n\n\n<li><strong>Global Path:<\/strong> NMPA IND approval strengthens position for <strong>U.S. IND filing<\/strong> via FDA&#8217;s allogeneic CAR\u2011T guidance<\/li>\n<\/ul>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding QT\u2011019B\u2019s clinical development, manufacturing scale\u2011up, and commercial potential. Actual results may differ materially due to risks including clinical trial outcomes, immune rejection challenges, and competitive dynamics in the cell therapy market.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Hangzhou Qihan Biotech Co., Ltd. announced that its New Drug Clinical Trial (IND) application for&#8230;<\/p>\n","protected":false},"author":1,"featured_media":48984,"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":[65,21,77,62,4284],"class_list":["post-48982","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-auto-immune","tag-car-t","tag-cell-therapy","tag-clinical-trial-approval-initiation","tag-qihan-biotech"],"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>Qihan-Biotech&#039;s QT-019B Universal CAR-T Wins Implied NMPA Approval - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Hangzhou Qihan Biotech Co., Ltd. announced that its New Drug Clinical Trial (IND) application for QT-019B, its first self\u2011developed universal dual\u2011target (CD19\/BCMA) CAR\u2011T cell product with global rights, has been granted implied approval by China\u2019s National Medical Products Administration (NMPA).\" \/>\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=48982\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Qihan-Biotech&#039;s QT-019B Universal CAR-T Wins Implied NMPA Approval\" \/>\n<meta property=\"og:description\" content=\"Hangzhou Qihan Biotech Co., Ltd. announced that its New Drug Clinical Trial (IND) application for QT-019B, its first self\u2011developed universal dual\u2011target (CD19\/BCMA) CAR\u2011T cell product with global rights, has been granted implied approval by China\u2019s National Medical Products Administration (NMPA).\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=48982\" \/>\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=\"2025-11-25T11:45:13+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-11-25T11:45:14+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/11\/2501-1.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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