{"id":35967,"date":"2025-06-25T12:33:32","date_gmt":"2025-06-25T04:33:32","guid":{"rendered":"https:\/\/flcube.com\/?p=35967"},"modified":"2025-06-25T12:33:33","modified_gmt":"2025-06-25T04:33:33","slug":"medilink-therapeutics-yl201-wins-fda-breakthrough-therapy-designation-for-sclc","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=35967","title":{"rendered":"Medilink Therapeutics&#8217; YL201 Wins FDA Breakthrough Therapy Designation for SCLC"},"content":{"rendered":"\n<p>Suzhou-based Medilink Therapeutics announced that it has received Breakthrough Therapy Designation (BTD) from the US Food and Drug Administration (FDA) for its YL201, an antibody drug conjugate (ADC) targeting B7H3, for the treatment of small-cell lung cancer (SCLC).<\/p>\n\n\n\n<p><strong>Drug Profile<\/strong><br>YL201 is developed via Medilink\u2019s TMALIN technology platform and is designed to deliver cytotoxic agents specifically to cancer cells expressing B7H3, a protein frequently overexpressed in various solid tumors.<\/p>\n\n\n\n<p><strong>Clinical Development<\/strong><br>The drug is currently undergoing multiple clinical trials globally and has entered Phase III studies in China for SCLC and nasopharyngeal carcinoma. Both indications have been awarded BTD in China, underscoring the significant unmet medical need and the potential of YL201 to address these conditions effectively.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Suzhou-based Medilink Therapeutics announced that it has received Breakthrough Therapy Designation (BTD) from the US&#8230;<\/p>\n","protected":false},"author":1,"featured_media":35970,"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":[35,34,16,372],"class_list":["post-35967","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-adc-xdc","tag-breakthrough-therapy","tag-cancer","tag-medilink-therapeutics"],"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>Medilink Therapeutics&#039; YL201 Wins FDA Breakthrough Therapy Designation for SCLC - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Suzhou-based Medilink Therapeutics announced that it has received Breakthrough Therapy Designation (BTD) from the US Food and Drug Administration (FDA) for its YL201, an antibody drug conjugate (ADC) targeting B7H3, for the treatment of small-cell lung cancer (SCLC).\" \/>\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=35967\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Medilink Therapeutics&#039; YL201 Wins FDA Breakthrough Therapy Designation for SCLC\" \/>\n<meta property=\"og:description\" content=\"Suzhou-based Medilink Therapeutics announced that it has received Breakthrough Therapy Designation (BTD) from the US Food and Drug Administration (FDA) for its YL201, an antibody drug conjugate (ADC) targeting B7H3, for the treatment of small-cell lung cancer (SCLC).\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=35967\" \/>\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=\"2025-06-25T04:33:32+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-06-25T04:33:33+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/06\/2501.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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