{"id":56188,"date":"2026-02-03T22:14:02","date_gmt":"2026-02-03T14:14:02","guid":{"rendered":"https:\/\/flcube.com\/?p=56188"},"modified":"2026-04-21T20:47:03","modified_gmt":"2026-04-21T12:47:03","slug":"hengrui-resubmits-camrelizumab-apatinib-bla-for-hcc-to-fda","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=56188","title":{"rendered":"Hengrui Resubmits Camrelizumab-Apatinib BLA for HCC to FDA"},"content":{"rendered":"\n<p><strong>Jiangsu Hengrui Pharmaceuticals Co., Ltd.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/600276:SHA\">SHA:\u202f600276<\/a>, <a href=\"https:\/\/www.google.com\/finance\/quote\/1276:HKG\">HKG:\u202f1276<\/a>) announced that the <strong>U.S. Food and Drug Administration (FDA)<\/strong> has accepted for review its resubmitted <strong>Biologics License Application (BLA)<\/strong> for the combination therapy of <strong>camrelizumab<\/strong> and <strong>apatinib<\/strong> as first\u2011line treatment for patients with <strong>unresectable or metastatic hepatocellular carcinoma (HCC)<\/strong>. The FDA is expected to act on the filing by <strong>July\u202f23,\u202f2026<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-drug-profile-amp-regulatory-history\">Drug Profile &amp; Regulatory History<\/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>Company<\/strong><\/td><td>Jiangsu Hengrui Pharmaceuticals (SHA:\u202f600276, HKG:\u202f1276)<\/td><\/tr><tr><td><strong>Combination<\/strong><\/td><td>Camrelizumab (anti\u2011PD\u20111 mAb) + Apatinib (VEGFR TKI)<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>Unresectable\/metastatic HCC (first\u2011line)<\/td><\/tr><tr><td><strong>Regulatory Status<\/strong><\/td><td>FDA accepted resubmitted BLA (January\u202f2026)<\/td><\/tr><tr><td><strong>Previous Status<\/strong><\/td><td>Complete Response Letter (CRL) issued March\u202f2025 (manufacturing site issues)<\/td><\/tr><tr><td><strong>Clinical Basis<\/strong><\/td><td>Phase\u202fIII SHR\u20111210\u2011III\u2011310 study<\/td><\/tr><tr><td><strong>PDUFA Date<\/strong><\/td><td>July\u202f23,\u202f2026<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-clinical-data-amp-study-results\">Clinical Data &amp; Study Results<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Trial Design:<\/strong> Phase\u202fIII SHR\u20111210\u2011III\u2011310 study in previously untreated advanced HCC patients<\/li>\n\n\n\n<li><strong>Comparator:<\/strong> Standard therapy sorafenib<\/li>\n\n\n\n<li><strong>Primary Endpoints:<\/strong> Significantly extended both <strong>progression\u2011free survival (PFS)<\/strong> and <strong>overall survival (OS)<\/strong> vs. sorafenib<\/li>\n\n\n\n<li><strong>CRL Resolution:<\/strong> Resubmission addresses FDA\u2019s manufacturing site inspection concerns; no clinical deficiencies cited<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-impact-amp-commercial-outlook\">Market Impact &amp; Commercial Outlook<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Global HCC Market:<\/strong> Valued at <strong>$3\u202fbillion<\/strong> : in 2025, with first\u2011line systemic therapy representing <strong>~60%<\/strong> : of treatable patients<\/li>\n\n\n\n<li><strong>Competitive Landscape:<\/strong> Competition from <strong>Tecentriq + Avastin (Roche)<\/strong>, <strong>Opdivo + Yervoy (BMS)<\/strong>; camrelizumab\u2011apatinib offers all\u2011oral combination advantage<\/li>\n\n\n\n<li><strong>Revenue Potential:<\/strong> Analysts project <strong>$500\u2013800\u202fmillion<\/strong> : peak annual global sales if approved, based on China market dominance and potential ex\u2011China expansion<\/li>\n\n\n\n<li><strong>Strategic Value:<\/strong> US approval would validate Hengrui\u2019s innovation platform and enable global partnerships; China sales already exceed <strong>\u00a52\u202fbillion<\/strong> : annually<\/li>\n\n\n\n<li><strong>Next Steps:<\/strong> FDA review underway; potential approval <strong>Q3\u202f2026<\/strong>; ex\u2011China commercialization partnerships under evaluation<\/li>\n<\/ul>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding regulatory approval timelines, commercial expectations, and revenue projections for the camrelizumab\u2011apatinib combination. Actual results may differ due to FDA review outcomes, competitive dynamics, and market adoption rates.<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\/2026\/02\/600276_20260203_PA76.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 600276_20260203_PA76.\"><\/object><a id=\"wp-block-file--media-38ee5b2a-68de-4d62-8047-25aaa97feafb\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/02\/600276_20260203_PA76.pdf\">600276_20260203_PA76<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/02\/600276_20260203_PA76.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-38ee5b2a-68de-4d62-8047-25aaa97feafb\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA:\u202f600276, HKG:\u202f1276) announced that the U.S. Food and Drug Administration&#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":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,22],"tags":[2586,4228,38,18,852],"class_list":["post-56188","post","type-post","status-publish","format-standard","hentry","category-company","category-medical-device","tag-hengrui-pharmaceuticals","tag-hkg-1276","tag-market-approval-filings","tag-pd-1-l1","tag-sha-600276"],"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>Hengrui Resubmits Camrelizumab-Apatinib BLA for HCC to FDA - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA:\u202f600276, HKG:\u202f1276) announced that the U.S. Food and Drug Administration (FDA) has accepted for review its resubmitted Biologics License Application (BLA) for the combination therapy of camrelizumab and apatinib as first\u2011line treatment for patients with unresectable or metastatic hepatocellular carcinoma (HCC). The FDA is expected to act on the filing by July\u202f23,\u202f2026.\" \/>\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=56188\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Hengrui Resubmits Camrelizumab-Apatinib BLA for HCC to FDA\" \/>\n<meta property=\"og:description\" content=\"Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA:\u202f600276, HKG:\u202f1276) announced that the U.S. Food and Drug Administration (FDA) has accepted for review its resubmitted Biologics License Application (BLA) for the combination therapy of camrelizumab and apatinib as first\u2011line treatment for patients with unresectable or metastatic hepatocellular carcinoma (HCC). 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(SHA:\u202f600276, HKG:\u202f1276) announced that the U.S. Food and Drug Administration (FDA) has accepted for review its resubmitted Biologics License Application (BLA) for the combination therapy of camrelizumab and apatinib as first\u2011line treatment for patients with unresectable or metastatic hepatocellular carcinoma (HCC). 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