{"id":20589,"date":"2023-03-24T16:55:00","date_gmt":"2023-03-24T08:55:00","guid":{"rendered":"https:\/\/flcube.com\/?p=20589"},"modified":"2025-01-06T16:58:55","modified_gmt":"2025-01-06T08:58:55","slug":"sunshine-guojian-completes-patient-enrollment-for-ssgj-611-phase-ii-study-in-atopic-dermatitis","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=20589","title":{"rendered":"Sunshine Guojian Completes Patient Enrollment for SSGJ-611 Phase II Study in Atopic Dermatitis"},"content":{"rendered":"\n<p>China-based Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd, a subsidiary of 3SBio Inc. (<a href=\"https:\/\/www.google.com\/finance\/quote\/1530:HKG\">HKG: 1530<\/a>), has announced the completion of patient enrollment in a China-based Phase II clinical study for its SSGJ-611, an IL-4R\u03b1 monoclonal antibody (mAb). The drug is being evaluated as a treatment for moderate to severe atopic dermatitis (AD).<\/p>\n\n\n\n<p><strong>Study Design and Previous Results<\/strong><br>The multicenter, randomized, double-blind, placebo-controlled Phase II study is designed to assess the efficacy and safety of SSGJ-611 subcutaneous injection in three dose groups: first dose 600 mg+300 mg Q2W, first dose 600 mg+300 mg Q4W, and a placebo group. Previous Phase Ia and Ib studies conducted in the United States and China, respectively, have shown strong indications of good safety, tolerability, and clinical efficacy.<\/p>\n\n\n\n<p><strong>Mechanism of Action and Global Context<\/strong><br>SSGJ-611 works by blocking the signal transduction of IL-4 and IL-13 through specific binding to IL-4R\u03b1, thereby regulating immune function and alleviating diseases such as atopic dermatitis. Globally, commercially available IL-4R antibodies include Regeneron\/Sanofi&#8217;s Dupixent (dupilumab), which is approved for moderate to severe AD, asthma, chronic sinusitis with nasal polyps, and eosinophilic esophagitis. SSGJ-611 demonstrates high similarity with dupilumab in terms of mechanism of action and preclinical and clinical trial data. Sunshine Guojian is actively exploring a more effective clinical medication regimen than dupilumab (Q4W).<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>China-based Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd, a subsidiary of 3SBio Inc. (HKG: 1530), has&#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":[116,65,17,1061,398],"class_list":["post-20589","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-3sbio","tag-auto-immune","tag-clinical-trial-results","tag-hkg-1530","tag-sunshine-guojian-pharmaceutical"],"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>Sunshine Guojian Completes Patient Enrollment for SSGJ-611 Phase II Study in Atopic Dermatitis - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China-based Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd, a subsidiary of 3SBio Inc. 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