{"id":34211,"date":"2025-05-27T12:50:47","date_gmt":"2025-05-27T04:50:47","guid":{"rendered":"https:\/\/flcube.com\/?p=34211"},"modified":"2025-05-27T12:50:48","modified_gmt":"2025-05-27T04:50:48","slug":"fosun-pharmas-hlx22-granted-orphan-drug-designation-by-eu-commission","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=34211","title":{"rendered":"Fosun Pharma&#8217;s HLX22 Granted Orphan Drug Designation by EU Commission"},"content":{"rendered":"\n<p>China-based Shanghai Fosun Pharmaceutical (Group) Co., Ltd (<a href=\"https:\/\/www.google.com\/finance\/quote\/600196:SHA\">SHA: 600196<\/a>, <a href=\"https:\/\/www.google.com\/finance\/quote\/2196:HKG\">HKG: 2196<\/a>) announced that it has received orphan drug designation (ODD) from the European Commission (EC) for HLX22, an HER2-targeted monoclonal antibody (mAb) licensed from AbClon, Inc. This designation is for the treatment of gastric cancer (GC). Earlier this year in March, HLX22 was also granted ODD for the same indication in the US.<\/p>\n\n\n\n<p><strong>Clinical Trial Progress<\/strong><br>HLX22 is currently undergoing multiple Phase II and global multi-center Phase III clinical trials. The Phase I study in China has been completed, marking a significant step in the drug&#8217;s development.<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\/600196_20250527_RTNX.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 600196_20250527_RTNX.\"><\/object><a id=\"wp-block-file--media-154ae69d-2323-4f31-bd40-069cc1c4825c\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/05\/600196_20250527_RTNX.pdf\">600196_20250527_RTNX<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/05\/600196_20250527_RTNX.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-154ae69d-2323-4f31-bd40-069cc1c4825c\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>China-based Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) announced that it has&#8230;<\/p>\n","protected":false},"author":1,"featured_media":34214,"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":[16,159,893,15,24,892],"class_list":["post-34211","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-cancer","tag-fosun-pharmaceutical","tag-hkg-2196","tag-product-approvals","tag-rare-orphan-disease-drugs","tag-sha-600196"],"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>Fosun Pharma&#039;s HLX22 Granted Orphan Drug Designation by EU Commission - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China-based Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) announced that it has received orphan drug designation (ODD) from the European Commission (EC) for HLX22, an HER2-targeted monoclonal antibody (mAb) licensed from AbClon, Inc. This designation is for the treatment of gastric cancer (GC). Earlier this year in March, HLX22 was also granted ODD for the same indication in the US.\" \/>\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=34211\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Fosun Pharma&#039;s HLX22 Granted Orphan Drug Designation by EU Commission\" \/>\n<meta property=\"og:description\" content=\"China-based Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) announced that it has received orphan drug designation (ODD) from the European Commission (EC) for HLX22, an HER2-targeted monoclonal antibody (mAb) licensed from AbClon, Inc. This designation is for the treatment of gastric cancer (GC). 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