{"id":46887,"date":"2025-11-12T16:22:05","date_gmt":"2025-11-12T08:22:05","guid":{"rendered":"https:\/\/flcube.com\/?p=46887"},"modified":"2025-11-12T16:22:06","modified_gmt":"2025-11-12T08:22:06","slug":"chongqing-precision-biotech-wins-nmpa-approval-for-pcar%e2%80%9119b-chinas-first-humanised-cd19-car%e2%80%91t-therapy-for-pediatric-b%e2%80%91all","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=46887","title":{"rendered":"Chongqing Precision Biotech Wins NMPA Approval for pCAR\u201119B \u2013 China\u2019s First Humanised CD19 CAR\u2011T Therapy for Pediatric B\u2011ALL"},"content":{"rendered":"\n<p><strong>Chongqing Precision Biotech Co., Ltd.<\/strong> announced that its <strong>pCAR\u201119B<\/strong> cell\u2011based product has received <strong>National Medical Products Administration (NMPA)<\/strong> marketing authorisation. pCAR\u201119B is the <strong>first Class\u202f1 biological new drug<\/strong> in China to treat <strong>refractory or relapsed B\u2011cell acute lymphoblastic leukaemia (r\/r B\u2011ALL) in children and adolescents<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-product-profile\">Product Profile<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Attribute<\/th><th>Details<\/th><\/tr><\/thead><tbody><tr><td><strong>Product name<\/strong><\/td><td>pCAR\u201119B<\/td><\/tr><tr><td><strong>Therapeutic class<\/strong><\/td><td>Autologous CAR\u2011T cell therapy<\/td><\/tr><tr><td><strong>Target antigen<\/strong><\/td><td>Humanised CD19 scFv (single\u2011chain variable fragment)<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>r\/r B\u2011ALL in patients\u202f\u2264\u202f18\u202fyears<\/td><\/tr><tr><td><strong>Regulatory status<\/strong><\/td><td>NMPA marketing approval (National Class\u202f1)<\/td><\/tr><tr><td><strong>Unique selling point<\/strong><\/td><td>Only <strong>humanised CD19 CAR\u2011T<\/strong> on the Chinese market for paediatric\/adolescent use<\/td><\/tr><tr><td><strong>Developer<\/strong><\/td><td>Chongqing Precision Biotech Co., Ltd. (Precision Biotech)<\/td><\/tr><tr><td><strong>International collaborations<\/strong><\/td><td>Perez Scremini Foundation (USA) &amp; University of Navarra (Spain)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-clinical-amp-market-significance\">Clinical &amp; Market Significance<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>First\u2011in\u2011class:<\/strong> pCAR\u201119B follows the global trend set by tisagenlecleucel and axicabtagene ciloleucel, but it is the <strong>first humanised CD19 CAR\u2011T<\/strong> approved for the <strong>pediatric<\/strong> B\u2011ALL segment in China.<\/li>\n\n\n\n<li><strong>Unmet need:<\/strong> Approximately <strong>4,000<\/strong> Chinese children are diagnosed with B\u2011ALL each year; about <strong>15\u202f%<\/strong> experience relapse or refractory disease, representing a high\u2011value, high\u2011unmet\u2011need market.<\/li>\n\n\n\n<li><strong>Pricing outlook:<\/strong> Early\u2011stage pricing guidance suggests a <strong>\u00a51.8\u2013\u00a52.2\u202fmillion<\/strong> per treatment course, comparable to imported CAR\u2011T products, but with a domestic supply chain advantage.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-expansion-strategy\">Expansion Strategy<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Goal<\/th><th>Timeline<\/th><th>Target Region<\/th><\/tr><\/thead><tbody><tr><td><strong>Establish regional branches<\/strong><\/td><td>2026\u20112028<\/td><td>Europe, United States, Japan<\/td><\/tr><tr><td><strong>Launch additional Class\u202f1 cell\u2011based drugs<\/strong><\/td><td>\u2265\u202f3 products<\/td><td>Global<\/td><\/tr><tr><td><strong>License\u2011out &amp; technical services<\/strong><\/td><td>Ongoing<\/td><td>International biotech partners<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>The company plans to leverage its <strong>Perez Scremini Foundation<\/strong> and <strong>University of Navarra<\/strong> collaborations to accelerate <strong>global IND filings<\/strong>, <strong>technology transfer<\/strong>, and <strong>licensing agreements<\/strong> for future CAR\u2011T candidates.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-financial-amp-partnership-outlook\">Financial &amp; Partnership Outlook<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Up\u2011front &amp; milestone potential:<\/strong> Precision Biotech expects <strong>RMB\u202f1.5\u20132.0\u202fbn<\/strong> in upfront payments and development milestones from prospective licensees over the next five years.<\/li>\n\n\n\n<li><strong>Royalty stream:<\/strong> Projected <strong>tiered royalties<\/strong> of <strong>12\u202f%\u201320\u202f%<\/strong> on net sales for any licensed CAR\u2011T products entering overseas markets.<\/li>\n<\/ul>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding regulatory timelines, commercial launch, pricing, and partnership activities. Actual results may differ due to clinical outcomes, regulatory review, market acceptance, and execution of international agreements.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Chongqing Precision Biotech Co., Ltd. announced that its pCAR\u201119B cell\u2011based product has received National Medical&#8230;<\/p>\n","protected":false},"author":1,"featured_media":46891,"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":[16,21,77,1831,15],"class_list":["post-46887","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-cancer","tag-car-t","tag-cell-therapy","tag-precision-biotechnology","tag-product-approvals"],"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>Chongqing Precision Biotech Wins NMPA Approval for pCAR\u201119B \u2013 China\u2019s First Humanised CD19 CAR\u2011T Therapy for Pediatric B\u2011ALL - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Chongqing Precision Biotech Co., Ltd. announced that its pCAR\u201119B cell\u2011based product has received National Medical Products Administration (NMPA) marketing authorisation. pCAR\u201119B is the first Class\u202f1 biological new drug in China to treat refractory or relapsed B\u2011cell acute lymphoblastic leukaemia (r\/r B\u2011ALL) in children and adolescents.\" \/>\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=46887\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Chongqing Precision Biotech Wins NMPA Approval for pCAR\u201119B \u2013 China\u2019s First Humanised CD19 CAR\u2011T Therapy for Pediatric B\u2011ALL\" \/>\n<meta property=\"og:description\" content=\"Chongqing Precision Biotech Co., Ltd. announced that its pCAR\u201119B cell\u2011based product has received National Medical Products Administration (NMPA) marketing authorisation. pCAR\u201119B is the first Class\u202f1 biological new drug in China to treat refractory or relapsed B\u2011cell acute lymphoblastic leukaemia (r\/r B\u2011ALL) in children and adolescents.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=46887\" \/>\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=\"2025-11-12T08:22:05+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-11-12T08:22:06+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/11\/1206.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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