{"id":15832,"date":"2023-07-26T00:26:00","date_gmt":"2023-07-25T16:26:00","guid":{"rendered":"https:\/\/flcube.com\/?p=15832"},"modified":"2024-11-30T00:37:37","modified_gmt":"2024-11-29T16:37:37","slug":"hanchorbios-hcb101-receives-wfda-approval-for-multi-region-clinical-study","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=15832","title":{"rendered":"HanchorBio&#8217;s HCB101 Receives WFDA Approval for Multi-Region Clinical Study"},"content":{"rendered":"\n<p>Taiwan-based HanchorBio has announced that it has received approval from the Taiwan Food and Drug Administration (WFDA) to conduct a multi-region, multi-center clinical study for its innovative fusion protein, HCB101.<\/p>\n\n\n\n<p><strong>HCB101: A Promising Fusion Protein for Cancer Treatment<\/strong><br>HCB101 is an engineered SIRP linked to IgG4-Fc \u03b1 fusion proteins that can block the escape mechanism of tumor cells and trigger the phagocytic activity of macrophages towards tumor cells. Preclinical data indicate that HCB101 is expected to be more efficacious and safer than CD47 monoclonal antibodies or SIRP \u03b1 fusion proteins, making it a potentially significant advancement in cancer treatment.<\/p>\n\n\n\n<p><strong>Design and Expectations of the HCB101-101 Study<\/strong><br>The HCB101-101 study is a multi-region, multi-center, non-blind, dosage exploration first-in-human (FIH) study designed to assess the safety, tolerability, pharmacokinetics, and preliminary clinical anti-tumor efficacy in advanced solid tumors or recurrent refractory non-Hodgkin lymphoma. The study is expected to commence during the third quarter of 2023 in the US, following its approval in April this year.<\/p>\n\n\n\n<p><strong>Global Development of SIRP\u03b1 Fusion Proteins<\/strong><br>Meanwhile, in China, other SIRP\u03b1 fusion proteins are under development, including CSPC Pharmaceutical\u2019s JMT601 (under fast-track review in the US), ImmuneOnco\u2019s IMM01, and Sumgen Biotech\u2019s SG404. These developments highlight the global interest and progress in this therapeutic area.<a href=\"https:\/\/flcube.com\">-Fineline Info &amp; Tech<\/a><\/p>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Taiwan-based HanchorBio has announced that it has received approval from the Taiwan Food and Drug&#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":[16,62,171,2308,229,2490],"class_list":["post-15832","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-cancer","tag-clinical-trial-approval-initiation","tag-cspc-pharmaceutical","tag-hanchorbio","tag-immuneonco-biopharmaceuticals","tag-sumgen-biotech"],"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>HanchorBio&#039;s HCB101 Receives WFDA Approval for Multi-Region Clinical Study - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Taiwan-based HanchorBio has announced that it has received approval from the Taiwan Food and Drug Administration (WFDA) to conduct a multi-region, multi-center clinical study for its innovative fusion protein, HCB101.\" \/>\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=15832\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"HanchorBio&#039;s HCB101 Receives WFDA Approval for Multi-Region Clinical Study\" \/>\n<meta property=\"og:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. 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