{"id":33696,"date":"2025-05-19T18:02:55","date_gmt":"2025-05-19T10:02:55","guid":{"rendered":"https:\/\/flcube.com\/?p=33696"},"modified":"2025-05-19T18:02:56","modified_gmt":"2025-05-19T10:02:56","slug":"shanghai-henlius-biotech-doses-first-patient-in-phase-i-iii-study-of-hlx13-for-hepatocellular-carcinoma","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=33696","title":{"rendered":"Shanghai Henlius Biotech Doses First Patient in Phase I\/III Study of HLX13 for Hepatocellular Carcinoma"},"content":{"rendered":"\n<p>Shanghai Henlius Biotech Inc. (<a href=\"https:\/\/www.google.com\/finance\/quote\/2696:HKG\">HKG: 2696<\/a>) announced the completion of first patient dosing in a Phase I\/III clinical study for HLX13, a biosimilar of Bristol-Myers Squibb\u2019s (BMS, <a href=\"https:\/\/www.google.com\/finance\/quote\/BMY:NYSE\">NYSE: BMY<\/a>) Yervoy (ipilimumab). The trial is focused on first-line unresectable advanced hepatocellular carcinoma (HCC) in China.<\/p>\n\n\n\n<p><strong>Clinical Study Design<\/strong><br>The multi-center, randomized, double-blinded, parallel-controlled Phase I\/III study aims to evaluate the pharmacokinetics (PK), efficacy, safety, and immunogenicity similarity of HLX13 compared with Yervoy in na\u00efve unresectable HCC patients.<\/p>\n\n\n\n<p><strong>HLX13 Development and Applications<\/strong><br>HLX13 is a cytotoxic T-lymphocyte antigen 4 (CTLA-4) monoclonal antibody (mAb) being developed for the treatment of liver cancer, melanoma, advanced renal cell carcinoma, and metastatic colorectal cancer with highly unstable microsatellite or mismatch repair defect. In April of this year, Henlius Bio entered into a licensing deal with Sandoz (SIX: SDZ), granting the Swiss pharmaceutical company development, manufacturing, and commercialization rights to HLX13 in Australia, Canada, Europe, Japan, and the US.<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\/05\/2025051600712_c.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 2025051600712_c.\"><\/object><a id=\"wp-block-file--media-7709e8b9-fac8-411c-9b04-e6185ea719c7\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/05\/2025051600712_c.pdf\">2025051600712_c<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/05\/2025051600712_c.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-7709e8b9-fac8-411c-9b04-e6185ea719c7\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Shanghai Henlius Biotech Inc. (HKG: 2696) announced the completion of first patient dosing in a&#8230;<\/p>\n","protected":false},"author":1,"featured_media":33698,"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":[7,11],"tags":[43,429,428,62,270,862,849],"class_list":["post-33696","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-biosimilars","tag-bms","tag-bristol-myers-squibb","tag-clinical-trial-approval-initiation","tag-henlius-biotech","tag-hkg-2696","tag-nyse-bmy"],"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>Shanghai Henlius Biotech Doses First Patient in Phase I\/III Study of HLX13 for Hepatocellular Carcinoma - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Shanghai Henlius Biotech Inc. (HKG: 2696) announced the completion of first patient dosing in a Phase I\/III clinical study for HLX13, a biosimilar of Bristol-Myers Squibb\u2019s (BMS, NYSE: BMY) Yervoy (ipilimumab). The trial is focused on first-line unresectable advanced hepatocellular carcinoma (HCC) in China.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/flcube.com\/?p=33696\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Shanghai Henlius Biotech Doses First Patient in Phase I\/III Study of HLX13 for Hepatocellular Carcinoma\" \/>\n<meta property=\"og:description\" content=\"Shanghai Henlius Biotech Inc. (HKG: 2696) announced the completion of first patient dosing in a Phase I\/III clinical study for HLX13, a biosimilar of Bristol-Myers Squibb\u2019s (BMS, NYSE: BMY) Yervoy (ipilimumab). 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