{"id":33249,"date":"2025-05-13T12:37:05","date_gmt":"2025-05-13T04:37:05","guid":{"rendered":"https:\/\/flcube.com\/?p=33249"},"modified":"2025-05-13T12:37:05","modified_gmt":"2025-05-13T04:37:05","slug":"remegens-disitamab-vedotin-phase-iii-study-meets-pfs-and-os-endpoints","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=33249","title":{"rendered":"RemeGen&#8217;s Disitamab Vedotin Phase III Study Meets PFS and OS Endpoints"},"content":{"rendered":"\n<p>China-based RemeGen Ltd (<a href=\"https:\/\/www.google.com\/finance\/quote\/9995:HKG\">HKG: 9995<\/a>) announced that its Phase III clinical study for the antibody drug conjugate (ADC) disitamab vedotin (RC48) in combination with the PD-1 inhibitor toripalimab has achieved its two primary endpoints of progression-free survival (PFS) and overall survival (OS). The study compared the combination therapy to standard chemotherapy as a first-line treatment for HER2-expressing locally advanced or metastatic urothelial carcinoma (la\/mUC).<\/p>\n\n\n\n<p><strong>Clinical Study Results<\/strong><br>Major subgroup analyses demonstrated that the combination of disitamab vedotin and toripalimab significantly improved PFS and OS compared to standard chemotherapy, regardless of cisplatin eligibility or HER2 expression levels. The regimen also exhibited a manageable safety profile with tolerable adverse reactions.<\/p>\n\n\n\n<p><strong>Regulatory Plans<\/strong><br>RemeGen plans to file a Biologic License Application (BLA) for this indication with the Center of Drug Evaluation of the National Medical Products Administration (NMPA) in China.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n\n\n\n<div data-wp-interactive=\"core\/file\" class=\"wp-block-file\"><object data-wp-bind--hidden=\"!state.hasPdfPreview\" hidden class=\"wp-block-file__embed\" data=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/05\/688331_20250513_YCBA.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 688331_20250513_YCBA.\"><\/object><a id=\"wp-block-file--media-a09a8a7d-2c7b-431e-ad2c-ee7d203bd80a\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/05\/688331_20250513_YCBA.pdf\">688331_20250513_YCBA<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/05\/688331_20250513_YCBA.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-a09a8a7d-2c7b-431e-ad2c-ee7d203bd80a\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>China-based RemeGen Ltd (HKG: 9995) announced that its Phase III clinical study for the antibody&#8230;<\/p>\n","protected":false},"author":1,"featured_media":33252,"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":[35,16,17,29,1155,18,375],"class_list":["post-33249","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-adc-xdc","tag-cancer","tag-clinical-trial-results","tag-combination-therapy","tag-hkg-9995","tag-pd-1-l1","tag-remegen"],"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>RemeGen&#039;s Disitamab Vedotin Phase III Study Meets PFS and OS Endpoints - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China-based RemeGen Ltd (HKG: 9995) announced that its Phase III clinical study for the antibody drug conjugate (ADC) disitamab vedotin (RC48) in combination with the PD-1 inhibitor toripalimab has achieved its two primary endpoints of progression-free survival (PFS) and overall survival (OS). The study compared the combination therapy to standard chemotherapy as a first-line treatment for HER2-expressing locally advanced or metastatic urothelial carcinoma (la\/mUC).\" \/>\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=33249\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"RemeGen&#039;s Disitamab Vedotin Phase III Study Meets PFS and OS Endpoints\" \/>\n<meta property=\"og:description\" content=\"China-based RemeGen Ltd (HKG: 9995) announced that its Phase III clinical study for the antibody drug conjugate (ADC) disitamab vedotin (RC48) in combination with the PD-1 inhibitor toripalimab has achieved its two primary endpoints of progression-free survival (PFS) and overall survival (OS). The study compared the combination therapy to standard chemotherapy as a first-line treatment for HER2-expressing locally advanced or metastatic urothelial carcinoma (la\/mUC).\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=33249\" \/>\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=\"2025-05-13T04:37:05+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/05\/1304.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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