{"id":20710,"date":"2023-03-20T22:12:00","date_gmt":"2023-03-20T14:12:00","guid":{"rendered":"https:\/\/flcube.com\/?p=20710"},"modified":"2025-01-06T22:14:35","modified_gmt":"2025-01-06T14:14:35","slug":"shouyao-holdings-receives-cde-approval-for-phase-ii-study-of-third-generation-alk-inhibitor","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=20710","title":{"rendered":"Shouyao Holdings Receives CDE Approval for Phase II Study of Third-Generation ALK Inhibitor"},"content":{"rendered":"\n

Beijing-based Shouyao Holdings (Beijing) Co., Ltd (SHA: 688197<\/a>) has announced that it has received clinical trial approval from the Center for Drug Evaluation (CDE) to conduct a single-arm pivotal Phase II clinical study. The study will focus on patients with ALK gene fusion-positive advanced non-small cell lung cancer (NSCLC) who have experienced disease progression or toxicity intolerance following treatment with second-generation anaplastic lymphoma kinase (ALK) inhibitors.<\/p>\n\n\n\n

Development and Mechanism of the Drug<\/strong>
The Category 1 drug candidate is a third-generation ALK inhibitor designed to treat ALK-positive NSCLC that is resistant to first and second-generation ALK inhibitors. It demonstrates a strong inhibitory effect on wild-type ALK kinases and key drug-resistant mutants of the first\/second-generation ALK inhibitors. This action blocks their signal transduction pathways, ultimately achieving effective inhibition of the growth of mutant tumors.<\/p>\n\n\n\n

Previous Clinical Results and Future Outlook<\/strong>
In previous clinical studies, the drug has shown significant antitumor activity in patients with ALK inhibitor resistance, including resistance to first-generation and second-generation drugs. It was well tolerated, with a low incidence of drug-related adverse reactions, most of which were mild to moderate (grade 1-2). If the results of the Phase II study are as anticipated, a conditional market approval filing is expected, according to the announcement.-Fineline Info & Tech<\/a><\/p>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

Beijing-based Shouyao Holdings (Beijing) Co., Ltd (SHA: 688197) has announced that it has received clinical…<\/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":[16,62,1173,344,33],"class_list":["post-20710","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-cancer","tag-clinical-trial-approval-initiation","tag-sha-688197","tag-shouyao-holdings","tag-tkis-egfr-vegf-btk-etc"],"yoast_head":"\nShouyao Holdings Receives CDE Approval for Phase II Study of Third-Generation ALK Inhibitor - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Beijing-based Shouyao Holdings (Beijing) Co., Ltd (SHA: 688197) has announced that it has received clinical trial approval from the Center for Drug Evaluation (CDE) to conduct a single-arm pivotal Phase II clinical study. 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