{"id":41562,"date":"2025-09-16T17:06:29","date_gmt":"2025-09-16T09:06:29","guid":{"rendered":"https:\/\/flcube.com\/?p=41562"},"modified":"2025-09-16T17:06:29","modified_gmt":"2025-09-16T09:06:29","slug":"guangzhou-baiyunshan-pharmaceutical-launches-phase-i-ii-trial-for-ret%e2%80%91targeted-bys10","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=41562","title":{"rendered":"Guangzhou Baiyunshan Pharmaceutical Launches Phase\u202fI\/II Trial for RET\u2011Targeted BYS10"},"content":{"rendered":"\n<p><strong>Guangzhou Baiyunshan Pharmaceutical Co., Ltd. (<a href=\"https:\/\/www.google.com\/finance\/quote\/600332:SHA\">SHA: 600332<\/a>)<\/strong> announced that the <strong>Center for Drug Evaluation (CDE)<\/strong> of China\u2019s National Medical Products Administration (NMPA) has provided feedback allowing the company to commence an open\u2011label, multicenter Phase\u202fI\/II clinical trial of its selective RET small\u2011molecule inhibitor, <strong>BYS10 tablets<\/strong>. The trial will assess the safety, tolerability, pharmacokinetics, and efficacy of BYS10 in patients with advanced solid tumors harboring RET gene fusions or mutations.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"h-drug-profile\">Drug Profile<\/h4>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Feature<\/th><th>Detail<\/th><\/tr><\/thead><tbody><tr><td><strong>Mechanism<\/strong><\/td><td>Highly selective RET kinase inhibitor<\/td><\/tr><tr><td><strong>Dosage Forms<\/strong><\/td><td>25\u202fmg &amp; 100\u202fmg tablets<\/td><\/tr><tr><td><strong>Indications<\/strong><\/td><td>Advanced solid tumors \u2013 non\u2011small cell lung cancer (NSCLC), medullary thyroid carcinoma (MTC), and other RET\u2011mutated malignancies<\/td><\/tr><tr><td><strong>Phase\u202fI Results<\/strong><\/td><td>Demonstrated potent, durable anti\u2011tumor activity with favorable tolerability in RET\u2011mutant NSCLC, TC, and MTC patients<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"h-trial-design-amp-regulatory-path\">Trial Design &amp; Regulatory Path<\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Open\u2011label, multicenter<\/strong> Phase\u202fI\/II study to evaluate safety, PK, and efficacy.<\/li>\n\n\n\n<li><strong>CDE Approval<\/strong>: Feedback received on September\u202f15,\u202f2025; trial can now begin.<\/li>\n\n\n\n<li><strong>Future Pathway<\/strong>: Successful Phase\u202fII single\u2011arm trial could support marketing approval under NMPA\u2019s accelerated review process.<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"h-market-implications\">Market Implications<\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Targeted Oncology Gap<\/strong> \u2013 RET\u2011driven cancers represent ~1\u20132\u202f% of NSCLC and ~5\u202f% of thyroid cancers; current therapeutic options are limited.<\/li>\n\n\n\n<li><strong>Competitive Landscape<\/strong> \u2013 BYS10 may compete with existing RET inhibitors (e.g., pralsetinib, selpercatinib) but offers a potentially more convenient oral tablet formulation.<\/li>\n\n\n\n<li><strong>Strategic Positioning<\/strong> \u2013 Successful outcomes could position Baiyunshan as a key player in the rapidly expanding precision\u2011oncology market in China.<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"h-company-outlook\">Company Outlook<\/h4>\n\n\n\n<p>Guangzhou Baiyunshan Pharmaceutical\u2019s progression to Phase\u202fI\/II underscores its commitment to developing next\u2011generation targeted therapies. The company\u2019s ability to navigate the NMPA\u2019s rigorous evaluation process and secure timely trial initiation strengthens its pipeline depth and investor appeal.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n\n\n\n<div data-wp-interactive=\"core\/file\" class=\"wp-block-file\"><object data-wp-bind--hidden=\"!state.hasPdfPreview\" hidden class=\"wp-block-file__embed\" data=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/09\/600332_20250916_F5ES.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 600332_20250916_F5ES.\"><\/object><a id=\"wp-block-file--media-274fc863-c62a-4517-9ace-dad58d5a4bc6\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/09\/600332_20250916_F5ES.pdf\">600332_20250916_F5ES<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/09\/600332_20250916_F5ES.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-274fc863-c62a-4517-9ace-dad58d5a4bc6\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Guangzhou Baiyunshan Pharmaceutical Co., Ltd. (SHA: 600332) announced that the Center for Drug Evaluation (CDE)&#8230;<\/p>\n","protected":false},"author":1,"featured_media":41564,"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":[11],"tags":[3901,16,62,3900],"class_list":["post-41562","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-drug","tag-baiyunshan-pharmaceutical","tag-cancer","tag-clinical-trial-approval-initiation","tag-sha-600332"],"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>Guangzhou Baiyunshan Pharmaceutical Launches Phase\u202fI\/II Trial for RET\u2011Targeted BYS10 - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Guangzhou Baiyunshan Pharmaceutical Co., Ltd. (SHA: 600332) announced that the Center for Drug Evaluation (CDE) of China\u2019s National Medical Products Administration (NMPA) has provided feedback allowing the company to commence an open\u2011label, multicenter Phase\u202fI\/II clinical trial of its selective RET small\u2011molecule inhibitor, BYS10 tablets. 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(SHA: 600332) announced that the Center for Drug Evaluation (CDE) of China\u2019s National Medical Products Administration (NMPA) has provided feedback allowing the company to commence an open\u2011label, multicenter Phase\u202fI\/II clinical trial of its selective RET small\u2011molecule inhibitor, BYS10 tablets. 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