{"id":55235,"date":"2026-01-23T06:11:37","date_gmt":"2026-01-22T22:11:37","guid":{"rendered":"https:\/\/flcube.com\/?p=55235"},"modified":"2026-01-23T06:11:38","modified_gmt":"2026-01-22T22:11:38","slug":"abbvie-secures-second-china-approval-for-risankizumab-in-ulcerative-colitis","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=55235","title":{"rendered":"AbbVie Secures Second China Approval for Risankizumab in Ulcerative Colitis"},"content":{"rendered":"\n<p><strong>AbbVie Inc.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/ABBV:NYSE\">NYSE:\u202fABBV<\/a>) announced that China\u2019s <strong>National Medical Products Administration (NMPA)<\/strong> has approved <strong>Risankizumab (SKYRIZI)<\/strong> for adult patients with <strong>moderately to severely active ulcerative colitis (UC)<\/strong> who have had an inadequate response, lost response, or were intolerant to conventional or biologic therapies. This marks the <strong>second major indication<\/strong> for risankizumab in China, following its approval for Crohn\u2019s disease last year.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-regulatory-milestone\">Regulatory Milestone<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Item<\/th><th>Detail<\/th><\/tr><\/thead><tbody><tr><td><strong>Company<\/strong><\/td><td>AbbVie Inc. (NYSE:\u202fABBV)<\/td><\/tr><tr><td><strong>Drug<\/strong><\/td><td>Risankizumab (SKYRIZI)<\/td><\/tr><tr><td><strong>Mechanism<\/strong><\/td><td>Interleukin\u201123 (IL\u201123) inhibitor<\/td><\/tr><tr><td><strong>Approval<\/strong><\/td><td>NMPA (China) for ulcerative colitis<\/td><\/tr><tr><td><strong>Patient Population<\/strong><\/td><td>Adults with moderately to severely active UC, refractory to conventional\/biologic therapies<\/td><\/tr><tr><td><strong>Significance<\/strong><\/td><td>Second indication in China; <strong>first IL\u201123 inhibitor<\/strong> approved for UC globally<\/td><\/tr><tr><td><strong>Previous Approval<\/strong><\/td><td>Crohn\u2019s disease (China, 2025)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-clinical-profile-amp-guideline-support\">Clinical Profile &amp; Guideline Support<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Mechanism:<\/strong> Selective IL\u201123p19 inhibitor that blocks a key inflammatory pathway in ulcerative colitis<\/li>\n\n\n\n<li><strong>Global Innovation:<\/strong> <strong>World\u2019s first IL\u201123 inhibitor<\/strong> approved for UC treatment<\/li>\n\n\n\n<li><strong>Guideline Endorsement:<\/strong><\/li>\n\n\n\n<li><strong>2024 AGA guidelines:<\/strong> Recommended for induction and maintenance therapy in moderate\u2011to\u2011severe UC<\/li>\n\n\n\n<li><strong>2025 ACG guidelines:<\/strong> Included for induction and maintenance treatment<\/li>\n\n\n\n<li><strong>AGA advanced\u2011therapy\u2011naive:<\/strong> Suggested for UC patients naive to advanced therapies<\/li>\n\n\n\n<li><strong>Clinical Differentiation:<\/strong> Offers an alternative mechanism for patients failing TNF inhibitors or vedolizumab<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-impact-amp-commercial-outlook\">Market Impact &amp; Commercial Outlook<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>China UC Market:<\/strong> Estimated <strong>400,000\u2013500,000 patients<\/strong> with moderate\u2011to\u2011severe ulcerative colitis, with diagnosis rates rising<\/li>\n\n\n\n<li><strong>Competitive Landscape:<\/strong> Competes with TNF inhibitors (adalimumab, infliximab) and vedolizumab; IL\u201123 class represents a novel option<\/li>\n\n\n\n<li><strong>Revenue Forecast:<\/strong> Analysts project <strong>\u00a51.5\u20132.0\u202fbillion<\/strong> (US$210\u2013280\u202fmillion) peak annual sales for risankizumab in China\u2019s UC indication by 2029<\/li>\n\n\n\n<li><strong>Strategic Benefit:<\/strong> Strengthens AbbVie\u2019s inflammatory bowel disease franchise in China, leveraging existing Crohn\u2019s disease infrastructure<\/li>\n\n\n\n<li><strong>Pricing &amp; Access:<\/strong> Likely premium pricing; awaiting 2026 NRDL update discussions for reimbursement potential<\/li>\n\n\n\n<li><strong>Launch Timeline:<\/strong> Commercial availability expected Q2\u202f2026<\/li>\n<\/ul>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief includes forward\u2011looking statements regarding commercial expectations, market penetration, and revenue projections for risankizumab in China. Actual results may differ due to competitive dynamics, pricing negotiations, and market adoption rates.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>AbbVie Inc. (NYSE:\u202fABBV) announced that China\u2019s National Medical Products Administration (NMPA) has approved Risankizumab (SKYRIZI)&#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":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[234,65,853,15],"class_list":["post-55235","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-abbvie","tag-auto-immune","tag-nyse-abbv","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>AbbVie Secures Second China Approval for Risankizumab in Ulcerative Colitis - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"AbbVie Inc. (NYSE:\u202fABBV) announced that China\u2019s National Medical Products Administration (NMPA) has approved Risankizumab (SKYRIZI) for adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to conventional or biologic therapies. This marks the second major indication for risankizumab in China, following its approval for Crohn\u2019s disease last year.\" \/>\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=55235\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"AbbVie Secures Second China Approval for Risankizumab in Ulcerative Colitis\" \/>\n<meta property=\"og:description\" content=\"AbbVie Inc. (NYSE:\u202fABBV) announced that China\u2019s National Medical Products Administration (NMPA) has approved Risankizumab (SKYRIZI) for adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to conventional or biologic therapies. 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