{"id":35782,"date":"2025-06-23T15:38:57","date_gmt":"2025-06-23T07:38:57","guid":{"rendered":"https:\/\/flcube.com\/?p=35782"},"modified":"2025-06-23T15:38:58","modified_gmt":"2025-06-23T07:38:58","slug":"zai-labs-partner-argenx-secures-eu-approval-for-vygart-in-cidp-treatment","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=35782","title":{"rendered":"Zai Lab’s Partner argenx Secures EU Approval for Vygart in CIDP Treatment"},"content":{"rendered":"\n

China-based Zai Lab Limited\u2019s (NASDAQ: ZLAB<\/a>, HKG: 9688<\/a>) Dutch partner argenx SE (NASDAQ: ARGX<\/a>) announced that the European Commission (EC) has approved Vygart (efgartigimod alfa) 1000mg subcutaneous (SC) injection as a monotherapy for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP) who have previously received corticosteroids or immunoglobulin therapy.<\/p>\n\n\n\n

Mechanism of Action<\/strong>
Efgartigimod SC is a human IgG1 antibody fragment designed to reduce pathogenic immunoglobulin G (IgG) antibodies. It works by binding to the neonatal Fc receptor (FcRn) and blocking IgG recycling. As the world’s first approved FcRn blocker, it is marketed under various names including Vygart Hytrulo in the U.S. and China for generalized myasthenia gravis (gMG) and CIDP, Vygart in Japan for gMG and CIDP, and Vygart in other regions for gMG and CIDP.<\/p>\n\n\n\n

Drug Formulation and Technology<\/strong>
The subcutaneous formulation combines efgartigimod alfa with recombinant human hyaluronidase PH20 (rHuPH20). It leverages Halozyme’s ENHANZE drug delivery technology to enable subcutaneous administration of biologics.<\/p>\n\n\n\n

Partnership and Licensing<\/strong>
Zai Lab entered into an exclusive licensing agreement with argenx in 2021 to develop and commercialize efgartigimod in Greater China, including Mainland China, Hong Kong, Macau, and Taiwan.-Fineline Info & Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

China-based Zai Lab Limited\u2019s (NASDAQ: ZLAB, HKG: 9688) Dutch partner argenx SE (NASDAQ: ARGX) announced…<\/p>\n","protected":false},"author":1,"featured_media":35785,"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":[2037,869,1131,868,15,24,413],"class_list":["post-35782","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-argenx-se","tag-hkg-9688","tag-nasdaq-argx","tag-nasdaq-zlab","tag-product-approvals","tag-rare-orphan-disease-drugs","tag-zai-lab"],"yoast_head":"\nZai Lab's Partner argenx Secures EU Approval for Vygart in CIDP Treatment - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China-based Zai Lab Limited\u2019s (NASDAQ: ZLAB, HKG: 9688) Dutch partner argenx SE (NASDAQ: ARGX) announced that the European Commission (EC) has approved Vygart (efgartigimod alfa) 1000mg subcutaneous (SC) injection as a monotherapy for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP) who have previously received corticosteroids or immunoglobulin therapy.\" \/>\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=35782\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Zai Lab's Partner argenx Secures EU Approval for Vygart in CIDP Treatment\" \/>\n<meta property=\"og:description\" content=\"China-based Zai Lab Limited\u2019s (NASDAQ: ZLAB, HKG: 9688) Dutch partner argenx SE (NASDAQ: ARGX) announced that the European Commission (EC) has approved Vygart (efgartigimod alfa) 1000mg subcutaneous (SC) injection as a monotherapy for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP) who have previously received corticosteroids or immunoglobulin therapy.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=35782\" \/>\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=\"2025-06-23T07:38:57+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-06-23T07:38:58+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/06\/2303.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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