{"id":70809,"date":"2026-07-28T18:43:28","date_gmt":"2026-07-28T10:43:28","guid":{"rendered":"https:\/\/flcube.com\/?p=70809"},"modified":"2026-07-28T18:43:29","modified_gmt":"2026-07-28T10:43:29","slug":"hengruis-tissue-factor-targeting-adc-shr-4375-receives-fda-orphan-drug-designation-for-pancreatic-cancer","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=70809","title":{"rendered":"Hengrui&#8217;s Tissue Factor-Targeting ADC SHR-4375 Receives FDA Orphan Drug Designation for Pancreatic Cancer"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>Jiangsu Hengrui Pharmaceuticals Co., Ltd.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/beta\/quote\/600276:SHA\">SHA: 600276<\/a>; <a href=\"https:\/\/www.google.com\/finance\/beta\/quote\/1276:HKG\">HKG: 1276<\/a>) announced that its <strong>innovative antibody-drug conjugate (ADC)<\/strong>, <strong>SHR-4375 injection<\/strong>, has been granted <strong>Orphan Drug Designation (ODD)<\/strong> by the <strong>U.S. Food and Drug Administration (FDA)<\/strong> for the treatment of <strong>pancreatic cancer<\/strong>. The tissue factor (TF)-targeting ADC is independently developed by Hengrui and currently in <strong>Phase 2 clinical trials in China<\/strong>, representing a significant advancement in addressing one of oncology&#8217;s most challenging malignancies.<\/p>\n\n\n\n<h2 id=\"h-development-overview\" class=\"wp-block-heading\">Development Overview<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Item<\/th><th>Detail<\/th><\/tr><\/thead><tbody><tr><td><strong>Sponsor<\/strong><\/td><td>Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276)<\/td><\/tr><tr><td><strong>Drug Candidate<\/strong><\/td><td>SHR-4375 injection<\/td><\/tr><tr><td><strong>Drug Class<\/strong><\/td><td>Tissue factor (TF)-targeting antibody-drug conjugate (ADC)<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>Pancreatic cancer<\/td><\/tr><tr><td><strong>Regulatory Milestone<\/strong><\/td><td>FDA Orphan Drug Designation (ODD)<\/td><\/tr><tr><td><strong>Milestone Date<\/strong><\/td><td>28 Jul 2026<\/td><\/tr><tr><td><strong>Clinical Stage (China)<\/strong><\/td><td>Phase 2<\/td><\/tr><tr><td><strong>Development Status<\/strong><\/td><td>Independently developed by Hengrui Pharma<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 id=\"h-drug-profile-amp-mechanism-of-action\" class=\"wp-block-heading\">Drug Profile &amp; Mechanism of Action<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Target:<\/strong> Tissue Factor (TF) expressed on tumor cell surface<\/li>\n\n\n\n<li><strong>Antibody Moiety:<\/strong> Specifically binds to TF on pancreatic cancer cells<\/li>\n\n\n\n<li><strong>Internalization:<\/strong> Endocytosis-mediated uptake into target tumor cells<\/li>\n\n\n\n<li><strong>Payload Release:<\/strong> Intracellular cleavage releases cytotoxic payload<\/li>\n\n\n\n<li><strong>Primary Effect:<\/strong> Direct induction of tumor cell apoptosis<\/li>\n\n\n\n<li><strong>Bystander Effect:<\/strong> Released toxin diffuses to extracellular space, killing adjacent TF-negative tumor cells<\/li>\n\n\n\n<li><strong>Therapeutic Innovation:<\/strong> Dual killing mechanism addresses tumor heterogeneity common in pancreatic cancer<\/li>\n<\/ul>\n\n\n\n<h2 id=\"h-clinical-context-pancreatic-cancer\" class=\"wp-block-heading\">Clinical Context \u2013 Pancreatic Cancer<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Parameter<\/th><th>Clinical Significance<\/th><\/tr><\/thead><tbody><tr><td><strong>5-Year Survival Rate<\/strong><\/td><td>&lt;10% (one of the lowest among solid tumors)<\/td><\/tr><tr><td><strong>Treatment Challenges<\/strong><\/td><td>Dense stromal barrier, immunosuppressive microenvironment, late diagnosis<\/td><\/tr><tr><td><strong>Current Standard<\/strong><\/td><td>Limited options with modest survival benefits<\/td><\/tr><tr><td><strong>Unmet Need<\/strong><\/td><td>High priority for novel targeted therapies with improved efficacy<\/td><\/tr><tr><td><strong>Orphan Drug Rationale<\/strong><\/td><td>Affects fewer than 200,000 patients annually in the US<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">The ODD recognizes both the severity of pancreatic cancer and the potential of SHR-4375 to address critical unmet needs in this patient population.<\/p>\n\n\n\n<h2 id=\"h-market-impact-amp-strategic-implications\" class=\"wp-block-heading\">Market Impact &amp; Strategic Implications<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Orphan Drug Benefits:<\/strong> ODD provides <strong>7 years of market exclusivity<\/strong> in the US upon approval, plus tax credits, fee waivers, and protocol assistance<\/li>\n\n\n\n<li><strong>Pancreatic Cancer Market:<\/strong> Despite low prevalence, high unmet need supports premium pricing; global pancreatic cancer therapeutics market projected to reach <strong>$3.5 billion by 2030<\/strong><\/li>\n\n\n\n<li><strong>ADC Competitive Position:<\/strong> Positions Hengrui among elite developers of next-generation ADCs with bystander effects, joining companies like <strong>Daiichi Sankyo<\/strong> and <strong>ImmunoGen<\/strong><\/li>\n\n\n\n<li><strong>Global Development Strategy:<\/strong> FDA ODD validates international potential and may accelerate regulatory pathways in other major markets<\/li>\n\n\n\n<li><strong>China-US Bridge:<\/strong> Demonstrates successful navigation of both Chinese and US regulatory frameworks, enhancing Hengrui&#8217;s global credibility<\/li>\n\n\n\n<li><strong>Platform Validation:<\/strong> Success of SHR-4375 could validate Hengrui&#8217;s ADC platform for additional TF-expressing solid tumors<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward-looking statements regarding clinical development, regulatory pathways, and commercial potential for SHR-4375. Actual results may differ due to risks including clinical trial outcomes, regulatory decisions, competitive dynamics, and market acceptance.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced that its innovative antibody-drug conjugate&#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_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_feature_clip_id":0,"_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},"jetpack_post_was_ever_published":false},"categories":[7,11],"tags":[35,2586,4228,24,852],"class_list":["post-70809","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-adc-xdc","tag-hengrui-pharmaceuticals","tag-hkg-1276","tag-rare-orphan-disease-drugs","tag-sha-600276"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.5 (Yoast SEO v28.1) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Hengrui&#039;s Tissue Factor-Targeting ADC SHR-4375 Receives FDA Orphan Drug Designation for Pancreatic Cancer - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced that its innovative antibody-drug conjugate (ADC), SHR-4375 injection, has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer. The tissue factor (TF)-targeting ADC is independently developed by Hengrui and currently in Phase 2 clinical trials in China, representing a significant advancement in addressing one of oncology&#039;s most challenging malignancies.\" \/>\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=70809\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Hengrui&#039;s Tissue Factor-Targeting ADC SHR-4375 Receives FDA Orphan Drug Designation for Pancreatic Cancer\" \/>\n<meta property=\"og:description\" content=\"Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced that its innovative antibody-drug conjugate (ADC), SHR-4375 injection, has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer. 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