{"id":31626,"date":"2025-04-11T17:16:32","date_gmt":"2025-04-11T09:16:32","guid":{"rendered":"https:\/\/flcube.com\/?p=31626"},"modified":"2025-04-11T17:16:33","modified_gmt":"2025-04-11T09:16:33","slug":"zai-labs-partner-argenx-secures-fda-approval-for-vygart-hytrulo-prefilled-syringe-in-gmg-and-cidp","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=31626","title":{"rendered":"Zai Lab&#8217;s Partner argenx Secures FDA Approval for Vygart Hytrulo Prefilled Syringe in gMG and CIDP"},"content":{"rendered":"\n<p>China-based Zai Lab Limited (<a href=\"https:\/\/www.google.com\/finance\/quote\/JD:NASDAQ\">NASDAQ: ZLAB<\/a>, <a href=\"https:\/\/www.google.com\/finance\/quote\/9688:HKG\">HKG: 9688<\/a>) and its Dutch partner argenx SE (<a href=\"https:\/\/www.google.com\/finance\/quote\/ARGX:NASDAQ\">NASDAQ: ARGX<\/a>) have achieved a significant milestone with the U.S. Food and Drug Administration (FDA) approval of a prefilled syringe option for Vygart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc). This new administration method offers added flexibility for adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive and those with chronic inflammatory demyelinating polyneuropathy (CIDP).<\/p>\n\n\n\n<p><strong>Vygart Hytrulo: Innovation in Treatment<\/strong><br>Vygart Hytrulo is the first and currently the only CIDP therapy available in China. The drug combines efgartigimod alfa, a human IgG1 antibody fragment marketed as Vygart, with recombinant human hyaluronidase PH20 (rHuPH20), leveraging Halozyme\u2019s Enhanze drug delivery technology to facilitate subcutaneous (SC) injection. This advancement provides patients with greater convenience and flexibility in managing their conditions.<\/p>\n\n\n\n<p><strong>Zai Lab&#8217;s Role and Market Expansion<\/strong><br>Zai Lab secured the rights to Vygart Hytrulo through a licensing agreement with argenx in 2021. Following this, the drug received marketing approval in China for the treatment of generalized myasthenia gravis (gMG) in July of last year. The recent FDA approval of the prefilled syringe option further strengthens Zai Lab\u2019s position in the global market, offering patients a self-administration alternative and expanding the therapeutic landscape for these debilitating conditions.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>China-based Zai Lab Limited (NASDAQ: ZLAB, HKG: 9688) and its Dutch partner argenx SE (NASDAQ:&#8230;<\/p>\n","protected":false},"author":1,"featured_media":31627,"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":[2037,869,1131,868,413],"class_list":["post-31626","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-zai-lab"],"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>Zai Lab&#039;s Partner argenx Secures FDA Approval for Vygart Hytrulo Prefilled Syringe in gMG and CIDP - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China-based Zai Lab Limited (NASDAQ: ZLAB, HKG: 9688) and its Dutch partner argenx SE (NASDAQ: ARGX) have achieved a significant milestone with the U.S. Food and Drug Administration (FDA) approval of a prefilled syringe option for Vygart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc). This new administration method offers added flexibility for adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive and those with chronic inflammatory demyelinating polyneuropathy (CIDP).\" \/>\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=31626\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Zai Lab&#039;s Partner argenx Secures FDA Approval for Vygart Hytrulo Prefilled Syringe in gMG and CIDP\" \/>\n<meta property=\"og:description\" content=\"China-based Zai Lab Limited (NASDAQ: ZLAB, HKG: 9688) and its Dutch partner argenx SE (NASDAQ: ARGX) have achieved a significant milestone with the U.S. Food and Drug Administration (FDA) approval of a prefilled syringe option for Vygart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc). This new administration method offers added flexibility for adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive and those with chronic inflammatory demyelinating polyneuropathy (CIDP).\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=31626\" \/>\n<meta property=\"og:site_name\" content=\"Insight, China&#039;s Pharmaceutical Industry\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/profile.php?id=61566606313834\" \/>\n<meta property=\"article:published_time\" content=\"2025-04-11T09:16:32+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-04-11T09:16:33+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/04\/1112-png.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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Stay informed, stay ahead with FLCUBE.COM\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Fineline Cube\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=31626#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=31626\"},\"author\":{\"name\":\"Fineline Cube\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\"},\"headline\":\"Zai Lab&#8217;s Partner argenx Secures FDA Approval for Vygart Hytrulo Prefilled Syringe in gMG and CIDP\",\"datePublished\":\"2025-04-11T09:16:32+00:00\",\"dateModified\":\"2025-04-11T09:16:33+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=31626\"},\"wordCount\":233,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=31626#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2025\\\/04\\\/1112-png.webp\",\"keywords\":[\"argenx SE\",\"HKG: 9688\",\"NASDAQ: ARGX\",\"NASDAQ: ZLAB\",\"Zai Lab\"],\"articleSection\":[\"Company\",\"Drug\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=31626#respond\"]}],\"copyrightYear\":\"2025\",\"copyrightHolder\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"}},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=31626\",\"url\":\"https:\\\/\\\/flcube.com\\\/?p=31626\",\"name\":\"Zai Lab's Partner argenx Secures FDA Approval for Vygart Hytrulo Prefilled Syringe in gMG and CIDP - Insight, China&#039;s Pharmaceutical Industry\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=31626#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=31626#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2025\\\/04\\\/1112-png.webp\",\"datePublished\":\"2025-04-11T09:16:32+00:00\",\"dateModified\":\"2025-04-11T09:16:33+00:00\",\"description\":\"China-based Zai Lab Limited (NASDAQ: ZLAB, HKG: 9688) and its Dutch partner argenx SE (NASDAQ: ARGX) have achieved a significant milestone with the U.S. Food and Drug Administration (FDA) approval of a prefilled syringe option for Vygart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc). 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