{"id":3805,"date":"2024-05-15T21:11:07","date_gmt":"2024-05-15T13:11:07","guid":{"rendered":"https:\/\/flcube.com\/?p=3805"},"modified":"2024-10-22T18:38:59","modified_gmt":"2024-10-22T10:38:59","slug":"zai-lab-advances-vygart-hytrulo-for-cidp-with-sbla-filing-in-china","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=3805","title":{"rendered":"Zai Lab Advances Vygart Hytrulo for CIDP with sBLA Filing in China"},"content":{"rendered":"\n<p>Zai Lab Ltd (<a href=\"https:\/\/www.google.com\/finance\/quote\/ZLAB:NASDAQ\">NASDAQ: ZLAB<\/a>; <a href=\"https:\/\/www.google.com\/finance\/quote\/9688:HKG\">HKG: 9688<\/a>), a biopharmaceutical company based in China, has announced the filing of a supplemental Biologics License Application (sBLA) in China for Vygart Hytrulo (efgartigimod alfa subcutaneous injection; SC). The sBLA seeks to expand Vygart&#8217;s indication to include the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP), and the application has been granted both breakthrough therapy designation (BTD) and priority review status.<\/p>\n\n\n\n<p>Vygart Hytrulo is a subcutaneous combination of efgartigimod alfa, a human IgG1 antibody fragment sold under the brand name Vygart, and recombinant human hyaluronidase PH20 (rHuPH20). It utilizes Halozyme&#8217;s Enhanze drug delivery technology to facilitate the subcutaneous injection of biologics. Originally licensed from the US firm Argenx for development in Greater China in a deal inked in 2021, Zai received initial approval for the drug to treat generalized myasthenia gravis (MG) in September 2023.<\/p>\n\n\n\n<p>CIDP is a rare neurological disease that affects an estimated 50,000 individuals, with only a fraction responding adequately to the standard treatment of corticosteroids.- <a href=\"https:\/\/flcube.com\">Flcube.com<\/a><\/p>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688), a biopharmaceutical company based in China, has announced&#8230;<\/p>\n","protected":false},"author":1,"featured_media":0,"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":[869,868,413],"class_list":["post-3805","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-hkg-9688","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 Advances Vygart Hytrulo for CIDP with sBLA Filing in China - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688), a biopharmaceutical company based in China, has announced the filing of a supplemental Biologics License Application (sBLA) in China for Vygart Hytrulo (efgartigimod alfa subcutaneous injection; SC). The sBLA seeks to expand Vygart&#039;s indication to include the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP), and the application has been granted both breakthrough therapy designation (BTD) and priority review status.\" \/>\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=3805\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Zai Lab Advances Vygart Hytrulo for CIDP with sBLA Filing in China\" \/>\n<meta property=\"og:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. FLCUBE delivers reliable data, news, and intelligence to broaden your horizons and sharpen your decision-making. 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