{"id":79204,"date":"2026-09-07T12:41:23","date_gmt":"2026-09-07T04:41:23","guid":{"rendered":"https:\/\/flcube.com\/?p=79204"},"modified":"2026-09-07T12:41:24","modified_gmt":"2026-09-07T04:41:24","slug":"nmpa-accepts-medilink-therapeutics-nda-for-tam-peli-self-developed-b7-h3-targeting-adc-for-relapsed-small-cell-lung-cancer","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=79204","title":{"rendered":"NMPA Accepts MediLink Therapeutics&#8217; NDA for Tam\u2011Peli, Self\u2011Developed B7\u2011H3\u2011Targeting ADC for Relapsed Small Cell Lung Cancer"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>MediLink Therapeutics<\/strong> announced that the New Drug Application (NDA) for <strong>Tam\u2011Peli<\/strong> (tamatanmab pelidotin for injection; R&amp;D code: <strong>YL201<\/strong>), its self\u2011developed <strong>B7\u2011H3<\/strong>\u2011targeting antibody\u2011drug conjugate (ADC), has been accepted by China&#8217;s <strong>National Medical Products Administration (NMPA)<\/strong> for the treatment of relapsed <strong>small cell lung cancer (SCLC)<\/strong>, under acceptance number CXSS2600135. The filing marks a pivotal regulatory step for the <strong>B7\u2011H3<\/strong> ADC and follows the company&#8217;s landmark global licensing deal with <strong>Roche<\/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>Field<\/th><th>Detail<\/th><\/tr><\/thead><tbody><tr><td>Agency<\/td><td><strong>National Medical Products Administration (NMPA)<\/strong>, China<\/td><\/tr><tr><td>Filing Type<\/td><td>New Drug Application (NDA) \u2014 accepted<\/td><\/tr><tr><td>Acceptance Number<\/td><td>CXSS2600135<\/td><\/tr><tr><td>Product<\/td><td><strong>Tam\u2011Peli<\/strong> (tamatanmab pelidotin for injection; <strong>YL201<\/strong>)<\/td><\/tr><tr><td>Drug Class<\/td><td><strong>B7\u2011H3<\/strong>\u2011targeting antibody\u2011drug conjugate (ADC)<\/td><\/tr><tr><td>Proposed Indication<\/td><td>Relapsed <strong>small cell lung cancer (SCLC)<\/strong><\/td><\/tr><tr><td>Company<\/td><td><strong>MediLink Therapeutics<\/strong><\/td><\/tr><tr><td>Date<\/td><td>02 Sep 2026<\/td><\/tr><tr><td>Next Steps<\/td><td><strong>NMPA<\/strong> review toward potential approval in China<\/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:<\/strong> <strong>Tam\u2011Peli<\/strong> (tamatanmab pelidotin for injection, <strong>YL201<\/strong>), self\u2011developed by <strong>MediLink Therapeutics<\/strong>.<\/li>\n\n\n\n<li><strong>Target:<\/strong> <strong>B7\u2011H3<\/strong>, an immunomodulatory checkpoint antigen broadly overexpressed across multiple solid tumors.<\/li>\n\n\n\n<li><strong>Platform:<\/strong> Built on the company&#8217;s proprietary tumor microenvironment\u2011cleavable camptothecin toxin\u2011linker platform (<strong>TMALIN<\/strong>).<\/li>\n\n\n\n<li><strong>Mechanism:<\/strong> The tumor microenvironment\u2011cleavable linker is designed to release the camptothecin payload selectively within tumors, aiming to balance potency with systemic safety.<\/li>\n\n\n\n<li><strong>Pipeline Expansion:<\/strong> Development is being jointly advanced across multiple solid tumor indications beyond <strong>SCLC<\/strong>.<\/li>\n<\/ul>\n\n\n\n<h2 id=\"h-global-licensing-agreement-roche-partnership\" class=\"wp-block-heading\">Global Licensing Agreement \u2013 Roche Partnership<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Term<\/th><th>Detail<\/th><\/tr><\/thead><tbody><tr><td>Agreement Date<\/td><td>January 2026<\/td><\/tr><tr><td>Partner<\/td><td><strong>Roche<\/strong><\/td><\/tr><tr><td>Structure<\/td><td>Exclusive license agreement<\/td><\/tr><tr><td>Rights Granted<\/td><td>Exclusive rights to develop, manufacture, and commercialize <strong>Tam\u2011Peli<\/strong> globally<\/td><\/tr><tr><td>Excluded Territories<\/td><td>Mainland China, Hong Kong, and Macao<\/td><\/tr><tr><td>Upfront &amp; Near\u2011Term Milestones<\/td><td>USD 570 million received by <strong>MediLink Therapeutics<\/strong><\/td><\/tr><tr><td>Additional Economics<\/td><td>Development, regulatory, and commercial milestone payments, plus tiered royalties on net sales outside the designated territories<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">Under the January 2026 exclusive license agreement, <strong>Roche<\/strong> obtained the global rights to <strong>Tam\u2011Peli<\/strong> excluding Mainland China, Hong Kong, and Macao. Leveraging their respective strengths, the two parties will join forces to accelerate the <strong>B7\u2011H3<\/strong> ADC&#8217;s global R&amp;D and regulatory filing process, jointly advancing development and commercialization across multiple solid tumor indications. <strong>MediLink Therapeutics<\/strong> received an upfront and near\u2011term milestone payment of USD 570 million and remains eligible for additional milestone payments and tiered royalties on net sales outside the designated territories.<\/p>\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>Regulatory Momentum:<\/strong> NDA acceptance by the <strong>NMPA<\/strong> moves <strong>Tam\u2011Peli<\/strong> closer to potential approval for relapsed <strong>SCLC<\/strong> \u2014 a setting with high unmet need and limited effective options.<\/li>\n\n\n\n<li><strong>Global Validation:<\/strong> The exclusive worldwide partnership with <strong>Roche<\/strong>, including USD 570 million in upfront and near\u2011term payments, underscores external confidence in the <strong>TMALIN<\/strong> platform and the <strong>B7\u2011H3<\/strong> ADC class.<\/li>\n\n\n\n<li><strong>Dual\u2011Track Commercialization:<\/strong> <strong>MediLink Therapeutics<\/strong> retains Greater China rights while <strong>Roche<\/strong> leads the rest of the world, enabling parallel regional and global launches.<\/li>\n\n\n\n<li><strong>Indication Expansion:<\/strong> Joint development across multiple solid tumor indications positions <strong>Tam\u2011Peli<\/strong> as a potential multi\u2011label asset within <strong>B7\u2011H3<\/strong>\u2011expressing cancers.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Forward\u2011Looking Statements<\/strong> \u2014 This brief contains forward\u2011looking statements regarding <strong>MediLink Therapeutics<\/strong>&#8216; <strong>Tam\u2011Peli<\/strong> (<strong>YL201<\/strong>), including the <strong>NMPA<\/strong> review of the NDA for relapsed <strong>small cell lung cancer<\/strong>, the global collaboration with <strong>Roche<\/strong>, and potential milestone payments, royalties, and expansion across solid tumor indications. Such statements are based on current expectations and are subject to risks and uncertainties, including regulatory review, clinical development, and commercialization risks. Actual results may differ materially. Nothing herein constitutes investment advice or an offer to buy or sell any securities.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>MediLink Therapeutics announced that the New Drug Application (NDA) for Tam\u2011Peli (tamatanmab pelidotin for injection;&#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":[35,16,38,372],"class_list":["post-79204","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-adc-xdc","tag-cancer","tag-market-approval-filings","tag-medilink-therapeutics"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.5 (Yoast SEO v28.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>NMPA Accepts MediLink Therapeutics&#039; NDA for Tam\u2011Peli, Self\u2011Developed B7\u2011H3\u2011Targeting ADC for Relapsed Small Cell Lung Cancer - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"MediLink Therapeutics announced that the New Drug Application (NDA) for Tam\u2011Peli (tamatanmab pelidotin for injection; R&amp;D code: YL201), its self\u2011developed B7\u2011H3\u2011targeting antibody\u2011drug conjugate (ADC), has been accepted by China&#039;s National Medical Products Administration (NMPA) for the treatment of relapsed small cell lung cancer (SCLC), under acceptance number CXSS2600135. The filing marks a pivotal regulatory step for the B7\u2011H3 ADC and follows the company&#039;s landmark global licensing deal with Roche.\" \/>\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=79204\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"NMPA Accepts MediLink Therapeutics&#039; NDA for Tam\u2011Peli, Self\u2011Developed B7\u2011H3\u2011Targeting ADC for Relapsed Small Cell Lung Cancer\" \/>\n<meta property=\"og:description\" content=\"MediLink Therapeutics announced that the New Drug Application (NDA) for Tam\u2011Peli (tamatanmab pelidotin for injection; R&amp;D code: YL201), its self\u2011developed B7\u2011H3\u2011targeting antibody\u2011drug conjugate (ADC), has been accepted by China&#039;s National Medical Products Administration (NMPA) for the treatment of relapsed small cell lung cancer (SCLC), under acceptance number CXSS2600135. 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