{"id":44862,"date":"2025-10-28T16:28:35","date_gmt":"2025-10-28T08:28:35","guid":{"rendered":"https:\/\/flcube.com\/?p=44862"},"modified":"2025-10-28T16:28:35","modified_gmt":"2025-10-28T08:28:35","slug":"alphamab-oncology-secures-fda-fast%e2%80%91track-designation-for-her2-bispecific-adc-jskn003-in-platinum%e2%80%91resistant-ovarian-cancer","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=44862","title":{"rendered":"Alphamab Oncology Secures FDA Fast\u2011Track Designation for HER2 Bispecific ADC JSKN003 in Platinum\u2011Resistant Ovarian Cancer"},"content":{"rendered":"\n<p>China\u2011based Alphamab Oncology (<a href=\"https:\/\/www.google.com\/finance\/quote\/9966:HKG\">HKG: 9966<\/a>) announced today that the U.S. Food and Drug Administration (FDA) has granted <strong>Fast\u2011Track Designation (FTD)<\/strong> to its independently developed HER2 bispecific antibody\u2011drug conjugate (ADC) <strong>JSKN003<\/strong>. The designation targets patients with <strong>advanced or metastatic platinum\u2011resistant recurrent epithelial ovarian, primary peritoneal, or fallopian\u2011tube cancer (PROC)<\/strong>, irrespective of HER2 expression level.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-product-highlights\"><strong>Product Highlights<\/strong><\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Homogeneous, DAR\u20114 ADC<\/strong> \u2013 JSKN003 is engineered via site\u2011specific conjugation to Fc glycans of an\u00adbenitamab, achieving a drug\u2011to\u2011antibody ratio of 4.<\/li>\n\n\n\n<li><strong>Dual\u2011epitope Binding<\/strong> \u2013 The bispecific format simultaneously engages two HER2 epitopes, enhancing cellular endocytosis and intracellular release of a topoisomerase\u2011I inhibitor.<\/li>\n\n\n\n<li><strong>Superior Pharmacology<\/strong> \u2013 Compared with existing ADCs, JSKN003 shows improved serum stability, lower hematologic toxicity, stronger tumor inhibition, and a pronounced bystander killing effect, widening its therapeutic window.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-strategic-partnership-in-china\"><strong>Strategic Partnership in China<\/strong><\/h2>\n\n\n\n<p>In September\u202f2024, Alphamab entered a licensing agreement with <strong>JMT\u2011Bio<\/strong>, a wholly\u2011owned subsidiary of CSPC Pharmaceutical Group. JMT\u2011Bio now holds the exclusive license to develop, commercialise, and sublicense JSKN003 for all oncology indications in <strong>Mainland China<\/strong> (excluding Hong Kong, Macau, and Taiwan) and serves as the sole <strong>Marketing Authorization Holder (MAH)<\/strong> for the region. Alphamab retains exclusive manufacturing rights.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-forward-looking-statements\">Forward\u2011Looking Statements<\/h3>\n\n\n\n<p>This release contains forward\u2011looking statements that involve risks and uncertainties. Actual results may differ materially.<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\/10\/2025102701437_c.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 2025102701437_c.\"><\/object><a id=\"wp-block-file--media-0b06ba6f-bc7f-4c48-b794-d26678ba333a\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/10\/2025102701437_c.pdf\">2025102701437_c<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/10\/2025102701437_c.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-0b06ba6f-bc7f-4c48-b794-d26678ba333a\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>China\u2011based Alphamab Oncology (HKG: 9966) announced today that the U.S. Food and Drug Administration (FDA)&#8230;<\/p>\n","protected":false},"author":1,"featured_media":44865,"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":[35,187,16,854],"class_list":["post-44862","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-adc-xdc","tag-alphamab-oncology","tag-cancer","tag-hkg-9966"],"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>Alphamab Oncology Secures FDA Fast\u2011Track Designation for HER2 Bispecific ADC JSKN003 in Platinum\u2011Resistant Ovarian Cancer - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China\u2011based Alphamab Oncology (HKG: 9966) announced today that the U.S. Food and Drug Administration (FDA) has granted Fast\u2011Track Designation (FTD) to its independently developed HER2 bispecific antibody\u2011drug conjugate (ADC) JSKN003. The designation targets patients with advanced or metastatic platinum\u2011resistant recurrent epithelial ovarian, primary peritoneal, or fallopian\u2011tube cancer (PROC), irrespective of HER2 expression level.\" \/>\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=44862\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Alphamab Oncology Secures FDA Fast\u2011Track Designation for HER2 Bispecific ADC JSKN003 in Platinum\u2011Resistant Ovarian Cancer\" \/>\n<meta property=\"og:description\" content=\"China\u2011based Alphamab Oncology (HKG: 9966) announced today that the U.S. Food and Drug Administration (FDA) has granted Fast\u2011Track Designation (FTD) to its independently developed HER2 bispecific antibody\u2011drug conjugate (ADC) JSKN003. 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