{"id":28240,"date":"2025-02-28T10:17:24","date_gmt":"2025-02-28T02:17:24","guid":{"rendered":"https:\/\/flcube.com\/?p=28240"},"modified":"2025-02-28T10:17:26","modified_gmt":"2025-02-28T02:17:26","slug":"huadong-medicines-adc-hdm2005-granted-fda-orphan-drug-designation-for-mcl","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=28240","title":{"rendered":"Huadong Medicine’s ADC HDM2005 Granted FDA Orphan Drug Designation for MCL"},"content":{"rendered":"\n

China-based Huadong Medicine Co., Ltd (SHE: 000963<\/a>) announced that its antibody-drug conjugate (ADC) HDM2005 has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of mantle cell lymphoma (MCL).<\/p>\n\n\n\n

Drug Mechanism and Preclinical Results<\/strong>
Preclinical studies have shown that after HDM2005 enters the body, the antibody portion specifically binds to target cells expressing tumor antigens. Once internalized by tumor cells, cytotoxic substances are released inside the cell to target and kill tumor cells. Existing data indicates that HDM2005 has favorable medicinal properties and a good safety profile.<\/p>\n\n\n\n

Regulatory Approvals<\/strong>
HDM2005 has received clinical trial approval from both the US FDA and China’s National Medical Products Administration (NMPA) in 2024, paving the way for further development of the drug in treating MCL.-Fineline Info & Tech<\/a><\/p>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that its antibody-drug conjugate (ADC) HDM2005 has…<\/p>\n","protected":false},"author":1,"featured_media":28280,"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":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[35,16,114,24,887],"class_list":["post-28240","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-adc-xdc","tag-cancer","tag-huadong-medicine","tag-rare-orphan-disease-drugs","tag-she-000963"],"yoast_head":"\nHuadong Medicine's ADC HDM2005 Granted FDA Orphan Drug Designation for MCL - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that its antibody-drug conjugate (ADC) HDM2005 has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of mantle cell lymphoma (MCL).\" \/>\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=28240\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Huadong Medicine's ADC HDM2005 Granted FDA Orphan Drug Designation for MCL\" \/>\n<meta property=\"og:description\" content=\"China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that its antibody-drug conjugate (ADC) HDM2005 has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of mantle cell lymphoma (MCL).\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=28240\" \/>\n<meta property=\"og:site_name\" content=\"Insight, China's Pharmaceutical Industry\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/profile.php?id=61566606313834\" \/>\n<meta property=\"article:published_time\" content=\"2025-02-28T02:17:24+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-02-28T02:17:26+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/02\/2801-png.avif\" \/>\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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