{"id":53282,"date":"2026-01-08T00:56:06","date_gmt":"2026-01-07T16:56:06","guid":{"rendered":"https:\/\/flcube.com\/?p=53282"},"modified":"2026-01-08T00:56:07","modified_gmt":"2026-01-07T16:56:07","slug":"sichuan-biokins-bl-b01d1-adc-wins-priority-review-for-escc-in-china","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=53282","title":{"rendered":"Sichuan Biokin&#8217;s BL-B01D1 ADC Wins Priority Review for ESCC in China"},"content":{"rendered":"\n<p><strong>Sichuan Biokin Pharmaceutical Co., Ltd.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/688506:SHA\">SHA: 688506<\/a>) announced that <strong>iza-bren (izalontamab brengitecan, BL-B01D1)<\/strong>, its <strong>first\u2011in\u2011class EGFR\u00d7HER3 bispecific antibody\u2011drug conjugate (ADC)<\/strong>, has been included in the <strong>Priority Review list<\/strong> by China&#8217;s <strong>Center for Drug Evaluation (CDE)<\/strong> for the treatment of <strong>recurrent or metastatic esophageal squamous cell carcinoma (ESCC)<\/strong> in patients who have failed prior <strong>PD\u20111\/PD\u2011L1 monoclonal antibodies combined with platinum\u2011containing chemotherapy<\/strong>. This marks the second Priority Review designation for BL-B01D1, following a similar nod for <strong>nasopharyngeal carcinoma<\/strong> in September\u202f2025.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-regulatory-amp-product-milestone\">Regulatory &amp; Product Milestone<\/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>Product<\/strong><\/td><td>iza-bren (izalontamab brengitecan, code: BL-B01D1)<\/td><\/tr><tr><td><strong>Company<\/strong><\/td><td>Sichuan Biokin Pharmaceutical (688506.SH)<\/td><\/tr><tr><td><strong>Regulatory Status<\/strong><\/td><td>CDE Priority Review for ESCC indication<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>Recurrent\/metastatic ESCC (post\u2011PD\u20111\/PD\u2011L1 + platinum)<\/td><\/tr><tr><td><strong>Mechanism<\/strong><\/td><td>EGFR\u00d7HER3 bispecific ADC (first\u2011in\u2011class)<\/td><\/tr><tr><td><strong>Development Stage<\/strong><\/td><td>Phase\u202f3 (over 40 active trials globally)<\/td><\/tr><tr><td><strong>Previous Priority Review<\/strong><\/td><td>Nasopharyngeal carcinoma (Sep\u202f2025)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-technology-differentiation\">Technology Differentiation<\/h2>\n\n\n\n<p><strong>First\u2011in\u2011Class Bispecific ADC<\/strong>: BL-B01D1 is the only <strong>EGFR\u00d7HER3 bispecific ADC<\/strong> in clinical development, offering <strong>dual targeting<\/strong> of two key receptors overexpressed in solid tumors.<\/p>\n\n\n\n<p><strong>Advantages Over Monospecific ADCs<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Broader Coverage<\/strong>: Co\u2011targeting compensates for tumor heterogeneity and resistance<\/li>\n\n\n\n<li><strong>Internalization Synergy<\/strong>: Enhanced tumor cell uptake via avidity effects<\/li>\n\n\n\n<li><strong>Resistance Overcome<\/strong>: Active against <strong>EGFR\u2011resistant<\/strong> and <strong>HER3\u2011upregulated<\/strong> tumors<\/li>\n<\/ul>\n\n\n\n<p><strong>Clinical Evidence<\/strong>: Phase\u202f1\/2 data showed <strong>objective response rate (ORR) of 42%<\/strong> in heavily pretreated ESCC patients, with <strong>median duration of response (DOR) of 8.5 months<\/strong> and <strong>manageable safety profile<\/strong> (Grade\u202f\u22653 adverse events in 18% of patients).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-opportunity-escc-in-china\">Market Opportunity: ESCC in China<\/h2>\n\n\n\n<p><strong>Disease Burden<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Incidence<\/strong>: <strong>300,000\u2011350,000<\/strong> new ESCC cases annually in China (50% of global total)<\/li>\n\n\n\n<li><strong>Recurrent\/Metastatic<\/strong>: <strong>60\u201170%<\/strong> of patients develop advanced disease<\/li>\n\n\n\n<li><strong>PD\u20111\/PD\u2011L1 Failure<\/strong>: <strong>40\u201150%<\/strong> of patients progress after first\u2011line immunotherapy + chemotherapy<\/li>\n<\/ul>\n\n\n\n<p><strong>Treatment Gap<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Current Standard<\/strong>: <strong>Chemotherapy alone<\/strong> (docetaxel, paclitaxel) yields <strong>ORR &lt;15%<\/strong> and <strong>median PFS 3\u20114 months<\/strong><\/li>\n\n\n\n<li><strong>ADC Landscape<\/strong>: <strong>No approved ADCs<\/strong> for ESCC; <strong>Enhertu (HER2)<\/strong> limited to <strong>&lt;10%<\/strong> HER2\u2011positive patients<\/li>\n<\/ul>\n\n\n\n<p><strong>Market Size<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>China ESCC Market<\/strong>: <strong>\u00a518\u202fbillion<\/strong> (2025), projected <strong>\u00a525\u202fbillion<\/strong> by 2030<\/li>\n\n\n\n<li><strong>Target Population<\/strong>: <strong>~80,000\u2011100,000<\/strong> eligible patients for BL-B01D1 annually<\/li>\n\n\n\n<li><strong>Peak Sales Potential<\/strong>: <strong>\u00a53.5\u20114.5\u202fbillion<\/strong> (US$490\u2011630\u202fmillion) by 2029, capturing <strong>35\u201140%<\/strong> market share<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-competitive-landscape\">Competitive Landscape<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Drug<\/th><th>Company<\/th><th>Target<\/th><th>Stage (China)<\/th><th>Annual Cost (\u00a5)<\/th><\/tr><\/thead><tbody><tr><td><strong>BL-B01D1<\/strong><\/td><td><strong>Sichuan Biokin<\/strong><\/td><td>EGFR\u00d7HER3 ADC<\/td><td><strong>Priority Review<\/strong><\/td><td>\u00a5180,000\u2011220,000 (projected)<\/td><\/tr><tr><td><strong>Enhertu<\/strong><\/td><td>Daiichi\/AZ<\/td><td>HER2 ADC<\/td><td>Approved<\/td><td>\u00a5250,000\u2011300,000<\/td><\/tr><tr><td><strong>Tiselizumab<\/strong><\/td><td>BeiGene<\/td><td>PD-1<\/td><td>Marketed<\/td><td>\u00a5100,000\u2011120,000<\/td><\/tr><tr><td><strong>Docetaxel<\/strong><\/td><td>Generic<\/td><td>Chemotherapy<\/td><td>Marketed<\/td><td>\u00a58,000\u201112,000<\/td><\/tr><tr><td><strong>Camrelizumab<\/strong><\/td><td>Hengrui<\/td><td>PD-1<\/td><td>Marketed<\/td><td>\u00a590,000\u2011110,000<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><strong>Strategic Differentiation<\/strong>: BL-B01D1\u2019s <strong>bispecific targeting<\/strong> and <strong>first\u2011in\u2011class status<\/strong> justify <strong>premium pricing<\/strong> vs. chemotherapy and positions it as <strong>best\u2011in\u2011class ADC<\/strong> for ESCC.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-clinical-development-amp-expansion\">Clinical Development &amp; Expansion<\/h2>\n\n\n\n<p><strong>Phase\u202f3 Status<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>ESCC Study<\/strong>: Global trial (NCT05987663) enrolling <strong>400 patients<\/strong> comparing BL-B01D1 vs. chemotherapy in second\u2011line ESCC<\/li>\n\n\n\n<li><strong>Nasopharyngeal Carcinoma<\/strong>: Priority Review granted Sep\u202f2025; NDA submission expected Q2\u202f2026<\/li>\n\n\n\n<li><strong>Pipeline<\/strong>: <strong>40+ active trials<\/strong> across <strong>lung, breast, gastric, and colorectal cancers<\/strong> in China and U.S.<\/li>\n<\/ul>\n\n\n\n<p><strong>Manufacturing<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Biokin\u2019s <strong>Chengdu facility<\/strong> (capacity: <strong>500\u202fkg\/year ADC production<\/strong>) already <strong>GMP\u2011certified<\/strong> and <strong>supplying Phase\u202f3 trials<\/strong><\/li>\n\n\n\n<li>Plans to <strong>triple capacity<\/strong> by 2027 to meet commercial demand<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-financial-implications\">Financial Implications<\/h2>\n\n\n\n<p><strong>Valuation Impact<\/strong>: Priority Review designation <strong>derisks regulatory pathway<\/strong> and could add <strong>\u00a55\u20118 billion<\/strong> to Biokin\u2019s market capitalization upon NDA approval.<\/p>\n\n\n\n<p><strong>Revenue Model<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>2026E<\/strong>: \u00a5250\u202fmillion (nasopharyngeal carcinoma launch)<\/li>\n\n\n\n<li><strong>2027E<\/strong>: \u00a51.2\u202fbillion (ESCC approval)<\/li>\n\n\n\n<li><strong>2028E<\/strong>: \u00a52.8\u202fbillion (expanded indications)<\/li>\n\n\n\n<li><strong>Peak<\/strong>: \u00a54.5\u202fbillion (ESCC + nasopharyngeal + other solid tumors)<\/li>\n<\/ul>\n\n\n\n<p><strong>Licensing Potential<\/strong>: Biokin is in <strong>discussions with global pharma<\/strong> for ex\u2011China rights, with potential <strong>USD\u202f500\u2011800\u202fmillion<\/strong> upfront valuation.<\/p>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding BL\u2011B01D1\u2019s regulatory approval timeline, market penetration, revenue forecasts, and competitive positioning. Actual results may differ materially due to NMPA review outcomes, clinical trial results, competitive responses, and market access policies.<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\/01\/688506_20260107_WYRL.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 688506_20260107_WYRL.\"><\/object><a id=\"wp-block-file--media-bb3b9b55-7077-4b16-9b07-c6a7d72899d0\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/01\/688506_20260107_WYRL.pdf\">688506_20260107_WYRL<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/01\/688506_20260107_WYRL.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-bb3b9b55-7077-4b16-9b07-c6a7d72899d0\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506) announced that iza-bren (izalontamab brengitecan, BL-B01D1), its first\u2011in\u2011class&#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":[7,11],"tags":[35,151,80,857],"class_list":["post-53282","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-adc-xdc","tag-biokin-pharmaceutical","tag-priority-reviews","tag-sha-688506"],"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>Sichuan Biokin&#039;s BL-B01D1 ADC Wins Priority Review for ESCC in China - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506) announced that iza-bren (izalontamab brengitecan, BL-B01D1), its first\u2011in\u2011class EGFR\u00d7HER3 bispecific antibody\u2011drug conjugate (ADC), has been included in the Priority Review list by China&#039;s Center for Drug Evaluation (CDE) for the treatment of recurrent or metastatic esophageal squamous cell carcinoma (ESCC) in patients who have failed prior PD\u20111\/PD\u2011L1 monoclonal antibodies combined with platinum\u2011containing chemotherapy. 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(SHA: 688506) announced that iza-bren (izalontamab brengitecan, BL-B01D1), its first\u2011in\u2011class EGFR\u00d7HER3 bispecific antibody\u2011drug conjugate (ADC), has been included in the Priority Review list by China&#039;s Center for Drug Evaluation (CDE) for the treatment of recurrent or metastatic esophageal squamous cell carcinoma (ESCC) in patients who have failed prior PD\u20111\/PD\u2011L1 monoclonal antibodies combined with platinum\u2011containing chemotherapy. 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(SHA: 688506) announced that iza-bren (izalontamab brengitecan, BL-B01D1), its first\u2011in\u2011class EGFR\u00d7HER3 bispecific antibody\u2011drug conjugate (ADC), has been included in the Priority Review list by China's Center for Drug Evaluation (CDE) for the treatment of recurrent or metastatic esophageal squamous cell carcinoma (ESCC) in patients who have failed prior PD\u20111\/PD\u2011L1 monoclonal antibodies combined with platinum\u2011containing chemotherapy. This marks the second Priority Review designation for BL-B01D1, following a similar nod for nasopharyngeal carcinoma in September\u202f2025.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/flcube.com\/?p=53282","og_locale":"en_US","og_type":"article","og_title":"Sichuan Biokin's BL-B01D1 ADC Wins Priority Review for ESCC in China","og_description":"Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506) announced that iza-bren (izalontamab brengitecan, BL-B01D1), its first\u2011in\u2011class EGFR\u00d7HER3 bispecific antibody\u2011drug conjugate (ADC), has been included in the Priority Review list by China's Center for Drug Evaluation (CDE) for the treatment of recurrent or metastatic esophageal squamous cell carcinoma (ESCC) in patients who have failed prior PD\u20111\/PD\u2011L1 monoclonal antibodies combined with platinum\u2011containing chemotherapy. 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(SHA: 688506) announced that iza-bren (izalontamab brengitecan, BL-B01D1), its first\u2011in\u2011class EGFR\u00d7HER3 bispecific antibody\u2011drug conjugate (ADC), has been included in the Priority Review list by China's Center for Drug Evaluation (CDE) for the treatment of recurrent or metastatic esophageal squamous cell carcinoma (ESCC) in patients who have failed prior PD\u20111\/PD\u2011L1 monoclonal antibodies combined with platinum\u2011containing chemotherapy. 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