{"id":38740,"date":"2025-08-07T10:49:23","date_gmt":"2025-08-07T02:49:23","guid":{"rendered":"https:\/\/flcube.com\/?p=38740"},"modified":"2025-08-12T14:28:49","modified_gmt":"2025-08-12T06:28:49","slug":"hengruis-trastuzumab-rezetecan-granted-fda-orphan-drug-designation-for-gastric-cancer-treatment","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=38740","title":{"rendered":"Hengrui&#8217;s Trastuzumab Rezetecan Granted FDA Orphan Drug Designation for Gastric Cancer Treatment"},"content":{"rendered":"\n<p>China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (<a href=\"https:\/\/www.google.com\/finance\/quote\/1276:HKG\">HKG: 1276<\/a>, <a href=\"https:\/\/www.google.com\/finance\/quote\/600276:SHA\">SHA: 600276<\/a>) announced that it has received orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) for its trastuzumab rezetecan. The designation covers the treatment of gastric cancer or gastroesophageal junction adenocarcinoma (GC\/GEJC) in combination with adebrelimab and chemotherapy.<\/p>\n\n\n\n<p><strong>Drug Profile<\/strong><br>Trastuzumab rezetecan is an in-house developed HER2-targeted antibody drug conjugate (ADC) therapy. In May 2025, it was authorized by China&#8217;s National Medical Products Administration (NMPA) to treat adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring activating HER2 (ERBB2) mutations. These patients have previously received at least one systemic therapy.<\/p>\n\n\n\n<p><strong>Market Landscape<\/strong><br>Globally, similar products already on the market include Roche&#8217;s Kadcyla (trastuzumab emtansine), Enhertu (trastuzumab deruxtecan) co-developed by AstraZeneca and Daiichi Sankyo, and RemeGen&#8217;s disitamab vedotin.<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\/08\/600276_20250807_3ZAU.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 600276_20250807_3ZAU.\"><\/object><a id=\"wp-block-file--media-28d2b5f2-3f07-4cda-8690-30462aecb54d\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/08\/600276_20250807_3ZAU.pdf\">600276_20250807_3ZAU<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/08\/600276_20250807_3ZAU.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-28d2b5f2-3f07-4cda-8690-30462aecb54d\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (HKG: 1276, SHA: 600276) announced that it has received&#8230;<\/p>\n","protected":false},"author":1,"featured_media":38742,"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":[35,130,194,2586,4228,24,375,163,852],"class_list":["post-38740","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-adc-xdc","tag-astrazeneca","tag-daiichi-sankyo","tag-hengrui-pharmaceuticals","tag-hkg-1276","tag-rare-orphan-disease-drugs","tag-remegen","tag-roche","tag-sha-600276"],"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>Hengrui&#039;s Trastuzumab Rezetecan Granted FDA Orphan Drug Designation for Gastric Cancer Treatment - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (HKG: 1267, SHA: 600276) announced that it has received orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) for its trastuzumab rezetecan. The designation covers the treatment of gastric cancer or gastroesophageal junction adenocarcinoma (GC\/GEJC) in combination with adebrelimab and chemotherapy.\" \/>\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=38740\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Hengrui&#039;s Trastuzumab Rezetecan Granted FDA Orphan Drug Designation for Gastric Cancer Treatment\" \/>\n<meta property=\"og:description\" content=\"China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (HKG: 1267, SHA: 600276) announced that it has received orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) for its trastuzumab rezetecan. 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