{"id":12254,"date":"2024-11-12T14:18:31","date_gmt":"2024-11-12T06:18:31","guid":{"rendered":"https:\/\/flcube.com\/?p=12254"},"modified":"2024-11-12T14:18:34","modified_gmt":"2024-11-12T06:18:34","slug":"zai-lab-and-argenx-receive-nmpa-approval-for-vygart-hytrulo-in-chronic-inflammatory-demyelinating-polyneuropathy","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=12254","title":{"rendered":"Zai Lab and argenx Receive NMPA Approval for Vygart Hytrulo in Chronic Inflammatory Demyelinating Polyneuropathy"},"content":{"rendered":"\n

China-based biotech Zai Lab Ltd (NASDAQ: ZLAB<\/a>; HKG: 9688<\/a>) and its US partner argenx SE (NASDAQ: ARGX<\/a>) have announced the receipt of supplementary Biologic License Application (sBLA) approval from the National Medical Products Administration (NMPA) for Vygart Hytrulo (efgartigimod alfa subcutaneous injection; SC). This approval allows Vygart Hytrulo to be used for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP), a debilitating immune-mediated peripheral nervous system disorder.<\/p>\n\n\n\n

Vygart Hytrulo: First CIDP Therapy in China<\/strong>
Vygart Hytrulo is the first and currently the only CIDP therapy available in China. It combines efgartigimod alfa, a human IgG1 antibody fragment marketed as Vygart, with recombinant human hyaluronidase PH20 (rHuPH20), utilizing Halozyme\u2019s Enhanze drug delivery technology to facilitate subcutaneous injection delivery of biologics. Zai Lab acquired rights to the drug through a licensing deal with argenx in 2021, which was followed by marketing approval for use in generalized myasthenia gravis (gMG) in July of this year.<\/p>\n\n\n\n

Regulatory Approval Based on ADHERE Study<\/strong>
The NMPA’s regulatory decision is based on positive results from the ADHERE study, a multi-center, randomized, double-blinded, placebo-controlled trial assessing Vygart Hytrulo in CIDP. The study included an open-label phase, where patients who responded to the treatment entered a randomized, placebo-controlled phase. Subgroup analysis of Chinese subjects demonstrated that Vygart Hytrulo reduced the risk of recurrence by 69% compared to placebo. The safety and tolerability of weekly efgartigimod alfa subcutaneous injections in the Chinese patient cohort were consistent with those observed in the global study participants.-Fineline Info & Tech<\/a><\/p>\n\n\n\n

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

China-based biotech Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688) and its US partner argenx SE…<\/p>\n","protected":false},"author":1,"featured_media":12256,"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":[2037,869,1131,868,15,413],"class_list":["post-12254","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-zai-lab"],"yoast_head":"\nZai Lab and argenx Receive NMPA Approval for Vygart Hytrulo in Chronic Inflammatory Demyelinating Polyneuropathy - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China-based biotech Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688) and its US partner argenx SE (NASDAQ: ARGX) have announced the receipt of supplementary Biologic License Application (sBLA) approval from the National Medical Products Administration (NMPA) for Vygart Hytrulo (efgartigimod alfa subcutaneous injection; SC). This approval allows Vygart Hytrulo to be used for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP), a debilitating immune-mediated peripheral nervous system disorder.\" \/>\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=12254\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Zai Lab and argenx Receive NMPA Approval for Vygart Hytrulo in Chronic Inflammatory Demyelinating Polyneuropathy\" \/>\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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