{"id":72492,"date":"2026-08-14T11:54:32","date_gmt":"2026-08-14T03:54:32","guid":{"rendered":"https:\/\/flcube.com\/?p=72492"},"modified":"2026-08-14T11:54:34","modified_gmt":"2026-08-14T03:54:34","slug":"tj-biopharma-and-biogen-win-nmpa-approval-for-felzartamab-jingfei-in-multiple-myeloma-first-commercial-milestone-under-greater-china-licensing-deal","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=72492","title":{"rendered":"TJ Biopharma and Biogen Win NMPA Approval for Felzartamab (JINGFEI) in Multiple Myeloma \u2013 First Commercial Milestone Under Greater China Licensing Deal"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>TJ Biopharma<\/strong> and <strong>Biogen Inc.<\/strong> (NASDAQ: <strong>BIIB<\/strong>) announced today that <strong>felzartamab for injection<\/strong> (brand name: <strong>JINGFEI<\/strong>) has received approval from China&#8217;s <strong>National Medical Products Administration (NMPA)<\/strong>. The <strong>anti\u2011CD38 monoclonal antibody<\/strong> is approved <strong>in combination with lenalidomide and dexamethasone<\/strong> for the treatment of adult patients with <strong>multiple myeloma<\/strong> who have received <strong>at least one prior line of therapy<\/strong>.<\/p>\n\n\n\n<h2 id=\"h-regulatory-milestone\" class=\"wp-block-heading\">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>Agency<\/strong><\/td><td>NMPA (China)<\/td><\/tr><tr><td><strong>Product<\/strong><\/td><td>Felzartamab for injection (brand name: <strong>JINGFEI<\/strong>)<\/td><\/tr><tr><td><strong>Drug Class<\/strong><\/td><td>Anti\u2011CD38 monoclonal antibody<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>Multiple myeloma in adult patients with \u22651 prior line of therapy<\/td><\/tr><tr><td><strong>Regimen<\/strong><\/td><td>In combination with <strong>lenalidomide<\/strong> and <strong>dexamethasone<\/strong><\/td><\/tr><tr><td><strong>Approval Date<\/strong><\/td><td>13 Aug 2026<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 id=\"h-drug-profile-amp-licensing-structure\" class=\"wp-block-heading\">Drug Profile &amp; Licensing Structure<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Molecule:<\/strong> <strong>Felzartamab<\/strong>, an <strong>anti\u2011CD38 monoclonal antibody<\/strong> with broad therapeutic potential across a range of <strong>immune\u2011mediated diseases<\/strong> and <strong>hematologic malignancies<\/strong><\/li>\n\n\n\n<li><strong>Licensing Agreement:<\/strong> In <strong>April 2026<\/strong>, TJ Biopharma entered into an agreement granting <strong>Biogen exclusive rights to felzartamab in Greater China<\/strong><\/li>\n\n\n\n<li><strong>Commercialization:<\/strong> <strong>Biogen<\/strong> will be responsible for commercializing felzartamab under the agreement following this approval<\/li>\n\n\n\n<li><strong>Manufacturing Supply:<\/strong> <strong>TJ Biopharma<\/strong> will handle commercial supply from its <strong>GMP manufacturing facility in Hangzhou<\/strong><\/li>\n<\/ul>\n\n\n\n<h2 id=\"h-commercial-division-of-responsibilities\" class=\"wp-block-heading\">Commercial Division of Responsibilities<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Responsibility<\/th><th>Party<\/th><\/tr><\/thead><tbody><tr><td><strong>Commercialization (Greater China)<\/strong><\/td><td>Biogen Inc.<\/td><\/tr><tr><td><strong>Commercial Manufacturing Supply<\/strong><\/td><td>TJ Biopharma (Hangzhou GMP facility)<\/td><\/tr><tr><td><strong>Exclusive Rights Territory<\/strong><\/td><td>Greater China (licensed to Biogen)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 id=\"h-market-impact-amp-outlook\" class=\"wp-block-heading\">Market Impact &amp; Outlook<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Established Treatment Backbone:<\/strong> The approved triplet regimen (<strong>felzartamab + lenalidomide + dexamethasone<\/strong>) targets the large, recurring population of relapsed\/refractory <strong>multiple myeloma<\/strong> patients in China, one of the most common hematologic malignancies.<\/li>\n\n\n\n<li><strong>Anti\u2011CD38 Class Competition:<\/strong> Felzartamab enters a competitive anti\u2011CD38 market in China, where differentiation will hinge on clinical performance, pricing, and Biogen&#8217;s commercial execution.<\/li>\n\n\n\n<li><strong>Platform Validation:<\/strong> The approval validates <strong>TJ Biopharma&#8217;s<\/strong> antibody development and GMP manufacturing capabilities, with the Hangzhou facility positioned to supply commercial demand.<\/li>\n\n\n\n<li><strong>Pipeline Optionality:<\/strong> Felzartamab&#8217;s stated potential across <strong>immune\u2011mediated diseases and hematologic malignancies<\/strong> suggests future indication expansion opportunities beyond multiple myeloma under the Biogen partnership.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding the commercialization of felzartamab by Biogen, manufacturing supply by TJ Biopharma, and potential future indications. Actual results may differ due to risks including market adoption, competitive dynamics, regulatory requirements, and manufacturing performance.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>TJ Biopharma and Biogen Inc. (NASDAQ: BIIB) announced today that felzartamab for injection (brand name:&#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":[351,993,527],"class_list":["post-72492","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-biogen","tag-nasdaq-biib","tag-tj-biopharma"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.5 (Yoast SEO v28.2) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>TJ Biopharma and Biogen Win NMPA Approval for Felzartamab (JINGFEI) in Multiple Myeloma \u2013 First Commercial Milestone Under Greater China Licensing Deal - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"TJ Biopharma and Biogen Inc. (NASDAQ: BIIB) announced today that felzartamab for injection (brand name: JINGFEI) has received approval from China&#039;s National Medical Products Administration (NMPA). The anti\u2011CD38 monoclonal antibody is approved in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior line of therapy.\" \/>\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=72492\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"TJ Biopharma and Biogen Win NMPA Approval for Felzartamab (JINGFEI) in Multiple Myeloma \u2013 First Commercial Milestone Under Greater China Licensing Deal\" \/>\n<meta property=\"og:description\" content=\"TJ Biopharma and Biogen Inc. (NASDAQ: BIIB) announced today that felzartamab for injection (brand name: JINGFEI) has received approval from China&#039;s National Medical Products Administration (NMPA). The anti\u2011CD38 monoclonal antibody is approved in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior line of therapy.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=72492\" \/>\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=\"2026-08-14T03:54:32+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-08-14T03:54:34+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"2560\" \/>\n\t<meta property=\"og:image:height\" content=\"1894\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\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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