{"id":40535,"date":"2025-09-02T11:10:39","date_gmt":"2025-09-02T03:10:39","guid":{"rendered":"https:\/\/flcube.com\/?p=40535"},"modified":"2025-09-02T11:10:40","modified_gmt":"2025-09-02T03:10:40","slug":"hansoh-pharma-secures-second-fda%e2%80%91approved-indication-for-inebilizumab-in-igg4%e2%80%91related-disease","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=40535","title":{"rendered":"Hansoh Pharma Secures Second FDA\u2011Approved Indication for Inebilizumab in IgG4\u2011Related Disease"},"content":{"rendered":"\n<p>China-based Hansoh Pharmaceutical Group Co., Ltd (<a href=\"https:\/\/www.google.com\/finance\/quote\/3692:HKG\">HKG: 3692<\/a>) announced that its <strong>inebilizumab<\/strong> injection has received a second indication approval from the National Medical Products Administration (NMPA) for the treatment of adult patients with <strong>immunoglobulin\u202fG4\u2011related disease (IgG4\u2011RD)<\/strong>. The approval followed a priority\u2011review designation on 8\u202fFebruary\u202f2025, underscoring the drug\u2019s expanding therapeutic reach.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-what-is-inebilizumab\">What is Inebilizumab?<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Mechanism<\/strong> \u2013 A depleting monoclonal antibody that targets CD19\u2011expressing B\u2011cells, reducing pathogenic autoantibody production.<\/li>\n\n\n\n<li><strong>Development History<\/strong> \u2013 Hansoh Pharma secured exclusive rights to develop and commercialize the drug in mainland China, Hong\u202fKong, and Macau via a 2019 licensing agreement with Viela Bio (now part of Amgen).<\/li>\n\n\n\n<li><strong>Global Regulatory Milestones<\/strong> \u2013 Approved by the U.S. FDA (2020), Japan\u2019s MHLW (2021), and the EMA (2022).<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-key-regulatory-timeline\">Key Regulatory Timeline<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Date<\/th><th>Event<\/th><th>Region<\/th><\/tr><\/thead><tbody><tr><td><strong>24\u202fMay\u202f2019<\/strong><\/td><td>Licensing agreement with Viela Bio<\/td><td>Mainland China, HK, Macau<\/td><\/tr><tr><td><strong>Feb\u202f2025<\/strong><\/td><td>Priority review granted for IgG4\u2011RD indication<\/td><td>China<\/td><\/tr><tr><td><strong>Mar\u202f2022<\/strong><\/td><td>First Chinese NMPA approval for AQP4\u2011positive NMOSD<\/td><td>China<\/td><\/tr><tr><td><strong>Jan\u202f2023<\/strong><\/td><td>Added to National Reimbursement Drug List (NRDL)<\/td><td>China<\/td><\/tr><tr><td><strong>Nov\u202f2024<\/strong><\/td><td>NRDL renewal<\/td><td>China<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-implications-for-patients-and-the-market\">Implications for Patients and the Market<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Broader Therapeutic Options<\/strong> \u2013 Patients with IgG4\u2011RD, a rare autoimmune condition, now have access to a targeted biologic that directly depletes disease\u2011causing B\u2011cells.<\/li>\n\n\n\n<li><strong>Reimbursement Advantage<\/strong> \u2013 Inclusion on the NRDL enhances affordability and accessibility across China\u2019s public healthcare system.<\/li>\n\n\n\n<li><strong>Strategic Positioning<\/strong> \u2013 Hansoh Pharma strengthens its portfolio in the rapidly growing biologics market, leveraging its Amgen partnership for global distribution.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) announced that its inebilizumab injection has received&#8230;<\/p>\n","protected":false},"author":1,"featured_media":40537,"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":[363,1182,15],"class_list":["post-40535","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-hansoh-pharmaceutical","tag-hkg-3692","tag-product-approvals"],"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>Hansoh Pharma Secures Second FDA\u2011Approved Indication for Inebilizumab in IgG4\u2011Related Disease - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Hansoh Pharma (HKG: 3692) has received approval for its second indication of inebilizumab injection to treat adult immunoglobulin\u202fG4\u2011related disease (IgG4\u2011RD). 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