{"id":2357,"date":"2024-09-26T15:39:10","date_gmt":"2024-09-26T07:39:10","guid":{"rendered":"https:\/\/flcube.com\/?p=2357"},"modified":"2024-10-25T00:01:35","modified_gmt":"2024-10-24T16:01:35","slug":"innovent-biologics-submits-market-approval-filing-for-picankibart-in-plaque-psoriasis-to-chinas-cde","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=2357","title":{"rendered":"Innovent Biologics Submits Market Approval Filing for Picankibart in Plaque Psoriasis to China’s CDE"},"content":{"rendered":"\n

Innovent Biologics Inc., (HKG: 1801<\/a>), a leading biopharmaceutical company based in China, has reportedly submitted a market approval filing to the Center for Drug Evaluation (CDE) for its investigational drug picankibart (IBI112), intended for the treatment of moderate to severe plaque psoriasis.<\/p>\n\n\n\n

Picankibart, a recombinant anti-interleukin 23p19 subunit (IL-23p19) antibody injection, works by specifically binding to the IL-23p19 subunit, thereby inhibiting IL-23 from binding to cell surface receptors. This targeted action may offer a more effective treatment option for patients suffering from psoriasis or other autoimmune diseases.<\/p>\n\n\n\n

The Phase III CLEAR-1 study achieved all primary and key secondary endpoints in May 2024, with 500 subjects enrolled. Participants were randomized in a 1:2:2 ratio to receive placebo or picankibart 200 mg every 4 weeks at weeks 0, 4, and 8, followed by 200 mg or 100 mg every 12 weeks. The results demonstrated that at week 16, a significantly higher proportion of subjects treated with picankibart achieved PASI 90 and sPGA 0 or 1 compared with placebo (80.3% vs. 2.0% for PASI 90 and 93.5% vs. 13.1% for sPGA 0\/1, both p<0.0001). Notably, CLEAR-1 is the first global Phase 3 registration study in the IL-23p19 class to report over 80% of subjects achieved PASI 90 after 16 weeks of treatment. The efficacy was sustained, with PASI 90 response rate and sPGA 0\/1 response rate at 84.9% and 85.9%, respectively, at 52 weeks.- Flcube.com<\/a><\/p>\n\n\n\n

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Innovent Biologics Inc., (HKG: 1801), a leading biopharmaceutical company based in China, has reportedly submitted…<\/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":[65,910,198,38],"class_list":["post-2357","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-auto-immune","tag-hkg-1801","tag-innovent-biologics","tag-market-approval-filings"],"yoast_head":"\nInnovent Biologics Submits Market Approval Filing for Picankibart in Plaque Psoriasis to China's CDE - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Innovent Biologics Inc., (HKG: 1801), a leading biopharmaceutical company based in China, has reportedly submitted a market approval filing to the Center for Drug Evaluation (CDE) for its investigational drug picankibart (IBI112), intended for the treatment of moderate to severe plaque psoriasis.\" \/>\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=2357\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Innovent Biologics Submits Market Approval Filing for Picankibart in Plaque Psoriasis to China's CDE\" \/>\n<meta property=\"og:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. 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