{"id":32265,"date":"2025-04-23T14:28:45","date_gmt":"2025-04-23T06:28:45","guid":{"rendered":"https:\/\/flcube.com\/?p=32265"},"modified":"2025-04-23T14:28:46","modified_gmt":"2025-04-23T06:28:46","slug":"imbioray-gains-nmpa-approval-for-phase-iitrial-of-ibr854-in-advanced-rcc","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=32265","title":{"rendered":"iMBIORAY Gains NMPA Approval for Phase IITrial of IBR854 in Advanced RCC"},"content":{"rendered":"\n<p>Hangzhou-based cancer immunotherapy specialist iMBIORAY has received approval from China&#8217;s National Medical Products Administration (NMPA) to conduct a Phase II clinical study of its IBR854 in combination with pazopanib for advanced renal cell carcinoma (RCC). This marks a significant step forward in the development of this innovative therapy.<\/p>\n\n\n\n<p><strong>IBR854: First Non-Viral, Non-Genetically Modified CAR-NK Cell Therapy<\/strong><br>IBR854, an in-house developed conjugated antibody redirecting ready-to-use allogeneic NK cells (CAR-raNK) product, is composed of a 5T4 antibody and NK cells. It represents the first non-viral vector, non-genetically modified CAR-NK cell immunotherapy for solid tumors in China. The 5T4 antigen, a highly glycosylated protein found on the cell surface, is widely distributed in various malignant tumors.<\/p>\n\n\n\n<p><strong>Clinical Progress and Safety Profile<\/strong><br>The Phase I clinical study results demonstrated that IBR854 has good safety and tolerability. Building on these findings, the Phase II study will further evaluate the efficacy and safety of IBR854 in combination with pazopanib for the treatment of advanced RCC.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Hangzhou-based cancer immunotherapy specialist iMBIORAY has received approval from China&#8217;s National Medical Products Administration (NMPA)&#8230;<\/p>\n","protected":false},"author":1,"featured_media":32266,"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":[77,62,3259,33],"class_list":["post-32265","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-drug","tag-cell-therapy","tag-clinical-trial-approval-initiation","tag-imbioray","tag-tkis-egfr-vegf-btk-etc"],"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>iMBIORAY Gains NMPA Approval for Phase IITrial of IBR854 in Advanced RCC - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Hangzhou-based cancer immunotherapy specialist iMBIORAY has received approval from China&#039;s National Medical Products Administration (NMPA) to conduct a Phase II clinical study of its IBR854 in combination with pazopanib for advanced renal cell carcinoma (RCC). 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