{"id":25747,"date":"2022-09-15T21:16:00","date_gmt":"2022-09-15T13:16:00","guid":{"rendered":"https:\/\/flcube.com\/?p=25747"},"modified":"2025-02-06T21:19:37","modified_gmt":"2025-02-06T13:19:37","slug":"suzhou-zelgen-completes-phase-ii-study-of-jakinib-for-ankylosing-spondylitis","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=25747","title":{"rendered":"Suzhou Zelgen Completes Phase II Study of Jakinib for Ankylosing Spondylitis"},"content":{"rendered":"\n<p>Suzhou Zelgen Biopharmaceuticals Co., Ltd (<a href=\"https:\/\/www.google.com\/finance\/quote\/688266:SHA\">SHA: 688266<\/a>) announced the successful completion of a multi-center, randomized double-blinded, placebo parallel controlled Phase II clinical study for its jakinib, a Janus kinase (JAK) inhibitor, in patients with active ankylosing spondylitis (AS). The study demonstrated robust results, meeting the pre-set statistical standards and showing significant improvements in key efficacy indicators.<\/p>\n\n\n\n<p><strong>Clinical Trial Results<\/strong><br>At 16 weeks of treatment, the percentage of patients achieving an ankylosing spondylitis 20% response (ASAS20) was 62.9% for the jakinib 100 mg Bid group, 59.4% for the 75 mg Bid group, and 33.3% for the placebo control group. These results met the pre-set statistical standard. Important secondary efficacy indicators also showed significant improvements, with the ASAS40 ratio being 55.2% for the jakinib 100 mg Bid group, 48.1% for the 75 mg Bid group, and 20.0% for the placebo group.<\/p>\n\n\n\n<p><strong>Future Development Plans<\/strong><br>Zelgen plans to conduct key registration clinical trials after communicating with the Center for Drug Evaluation (CDE) in a pre-phase III communication. This next step is crucial in advancing jakinib as a potential new treatment option for patients with ankylosing spondylitis.<\/p>\n\n\n\n<p><strong>Understanding Ankylosing Spondylitis<\/strong><br>Ankylosing spondylitis (AS) is a chronic inflammatory disease that primarily affects the sacroiliac joints, vertebral condyles, paraspinal soft tissues, and peripheral joints. It can also be accompanied by extra-articular manifestations. In severe cases, spinal deformity and ankylosis may occur. The prevalence of ankylosing spondylitis varies by country, with a preliminary survey indicating a prevalence of about 0.3% in China.<\/p>\n\n\n\n<p><strong>Mechanism of Action<\/strong><br>Jakinib works by blocking the signal transducer and activator of transcription (STAT) and JAK signaling pathways, thereby improving immune-related inflammatory effects. This mechanism of action makes jakinib a promising candidate for treating the chronic inflammation associated with ankylosing spondylitis.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) announced the successful completion of a multi-center, randomized&#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":[65,17,905,246],"class_list":["post-25747","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-auto-immune","tag-clinical-trial-results","tag-sha-688266","tag-zelgen-biopharmaceuticals"],"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>Suzhou Zelgen Completes Phase II Study of Jakinib for Ankylosing Spondylitis - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) announced the successful completion of a multi-center, randomized double-blinded, placebo parallel controlled Phase II clinical study for its jakinib, a Janus kinase (JAK) inhibitor, in patients with active ankylosing spondylitis (AS). 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