{"id":53124,"date":"2026-01-06T22:36:04","date_gmt":"2026-01-06T14:36:04","guid":{"rendered":"https:\/\/flcube.com\/?p=53124"},"modified":"2026-01-06T22:36:05","modified_gmt":"2026-01-06T14:36:05","slug":"yifan-pharmaceuticals-f-652-wins-nmpa-ind-for-gvhd-therapy","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=53124","title":{"rendered":"Yifan Pharmaceutical&#8217;s F-652 Wins NMPA IND for GVHD Therapy"},"content":{"rendered":"\n<p><strong>Yifan Pharmaceutical Co., Ltd<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/002019:SHE\">SHE: 002019<\/a>) announced that its <strong>Recombinant Human Interleukin\u201122\u2011Fc Fusion Protein for Injection (F\u2011652)<\/strong> has received approval from <strong>China\u2019s National Medical Products Administration (NMPA)<\/strong> to initiate a <strong>Phase\u202f2 clinical trial<\/strong> for the treatment of <strong>graft\u2011versus\u2011host disease (GVHD)<\/strong>. The drug, developed on Yifan\u2019s proprietary <strong>Di\u2011Kine bimolecular platform<\/strong>, represents a <strong>first\u2011in\u2011class IL\u201122\u2011Fc fusion protein<\/strong> with potential applications across multiple inflammatory diseases.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-product-amp-regulatory-milestone\">Product &amp; Regulatory 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>F\u2011652 (Recombinant Human Interleukin\u201122\u2011Fc Fusion Protein)<\/td><\/tr><tr><td><strong>Company<\/strong><\/td><td>Yifan Pharmaceutical Co., Ltd (002019.SZ)<\/td><\/tr><tr><td><strong>Regulatory Status<\/strong><\/td><td>NMPA IND approval for Phase\u202f2<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>Graft\u2011versus\u2011host disease (GVHD)<\/td><\/tr><tr><td><strong>Technology<\/strong><\/td><td>Di\u2011Kine bimolecular platform<\/td><\/tr><tr><td><strong>Mechanism<\/strong><\/td><td>Mimics natural IL\u201122 with extended half\u2011life via Fc fusion<\/td><\/tr><tr><td><strong>Previous Studies<\/strong><\/td><td>aGVHD, alcoholic hepatitis (AH), acute\u2011on\u2011chronic liver failure (ACLF)<\/td><\/tr><tr><td><strong>Significance<\/strong><\/td><td>First IL\u201122\u2011Fc fusion protein in clinical development for GVHD<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-technology-profile-il-22-fc-fusion\">Technology Profile: IL\u201122\u2011Fc Fusion<\/h2>\n\n\n\n<p><strong>Mechanism of Action<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>IL\u201122 Mimicry<\/strong>: Binds to IL\u201122 receptors on target tissues, promoting <strong>epithelial regeneration<\/strong> and <strong>anti\u2011inflammatory effects<\/strong><\/li>\n\n\n\n<li><strong>Fc Fusion Advantage<\/strong>: Extends <strong>half\u2011life<\/strong> and <strong>clinical efficacy<\/strong> by <strong>10\u201120x<\/strong> vs. native IL\u201122<\/li>\n\n\n\n<li><strong>CHO Cell Production<\/strong>: Expressed in CHO cells via genetic engineering, ensuring <strong>high purity<\/strong> and <strong>scalable manufacturing<\/strong><\/li>\n<\/ul>\n\n\n\n<p><strong>Clinical Differentiation<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Steroid\u2011Sparing Potential<\/strong>: Addresses <strong>inflammatory cascade<\/strong> without systemic immunosuppression<\/li>\n\n\n\n<li><strong>Broad Applicability<\/strong>: Mechanism relevant to <strong>GVHD, AH, ACLF<\/strong>, and potentially <strong>inflammatory bowel disease<\/strong><\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-opportunity-gvhd-in-china\">Market Opportunity: GVHD 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>Allogeneic Transplants<\/strong>: <strong>8,000\u201110,000<\/strong> performed annually in China<\/li>\n\n\n\n<li><strong>GVHD Incidence<\/strong>: <strong>30\u201150%<\/strong> of recipients develop acute GVHD; <strong>15\u201130%<\/strong> develop chronic GVHD<\/li>\n\n\n\n<li><strong>Treatment Gap<\/strong>: <strong>\u00a52\u20113\u202fbillion<\/strong> China GVHD market (2025), growing at <strong>15% CAGR<\/strong><\/li>\n\n\n\n<li><strong>Unmet Need<\/strong>: Limited options beyond <strong>corticosteroids<\/strong> (first\u2011line) and <strong>ruxolitinib<\/strong> (second\u2011line)<\/li>\n<\/ul>\n\n\n\n<p><strong>F\u2011652 Peak Sales Potential<\/strong>: <strong>\u00a5800\u202fmillion\u20111.2\u202fbillion<\/strong> (US$110\u2011170\u202fmillion) by 2030, assuming <strong>10\u201112%<\/strong> market penetration in steroid\u2011refractory patients.<\/p>\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>Therapy<\/th><th>Company<\/th><th>Mechanism<\/th><th>Stage (China)<\/th><th>Annual Cost (\u00a5)<\/th><\/tr><\/thead><tbody><tr><td><strong>Methylprednisolone<\/strong><\/td><td>Various<\/td><td>Corticosteroid<\/td><td>Standard of care<\/td><td>\u00a55,000\u20118,000<\/td><\/tr><tr><td><strong>Ruxolitinib<\/strong><\/td><td>Incyte\/Novartis<\/td><td>JAK1\/2 inhibitor<\/td><td>Approved<\/td><td>\u00a5180,000\u2011200,000<\/td><\/tr><tr><td><strong>Mesenchymal Stem Cells<\/strong><\/td><td>Various<\/td><td>Cell therapy<\/td><td>Clinical trials<\/td><td>\u00a5300,000\u2011500,000<\/td><\/tr><tr><td><strong>F\u2011652<\/strong><\/td><td><strong>Yifan Pharmaceutical<\/strong><\/td><td>IL\u201122\u2011Fc fusion<\/td><td><strong>Phase\u202fII<\/strong><\/td><td><strong>\u00a550,000\u201180,000<\/strong> (projected)<\/td><\/tr><tr><td><strong>Ibrutinib<\/strong><\/td><td>J&amp;J<\/td><td>BTK inhibitor<\/td><td>Off\u2011label use<\/td><td>\u00a5150,000\u2011180,000<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><strong>Differentiation<\/strong>: F\u2011652\u2019s <strong>novel IL\u201122 mechanism<\/strong> offers <strong>tissue\u2011protective<\/strong> rather than immunosuppressive effects, potentially <strong>reducing infection risk<\/strong> in transplant patients.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-clinical-development-pathway\">Clinical Development Pathway<\/h2>\n\n\n\n<p><strong>Previous Studies<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>aGVHD<\/strong>: Phase\u202f1b showed <strong>promising safety<\/strong> and <strong>clinical activity<\/strong> signals<\/li>\n\n\n\n<li><strong>Alcoholic Hepatitis<\/strong>: Demonstrated <strong>survival benefit<\/strong> trends in small cohort<\/li>\n\n\n\n<li><strong>ACLF<\/strong>: Observed <strong>liver regeneration markers<\/strong> improvement<\/li>\n<\/ul>\n\n\n\n<p><strong>Phase\u202f2 Design (GVHD)<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Population<\/strong>: Steroid\u2011refractory acute GVHD patients (n=60\u201180)<\/li>\n\n\n\n<li><strong>Primary Endpoint<\/strong>: <strong>Complete response rate<\/strong> at Day\u202f28<\/li>\n\n\n\n<li><strong>Secondary Endpoints<\/strong>: Overall response rate, steroid\u2011sparing, survival at 6 months<\/li>\n\n\n\n<li><strong>Timeline<\/strong>: Initiation Q1\u202f2026; topline data Q4\u202f2026<\/li>\n<\/ul>\n\n\n\n<p><strong>Expansion Potential<\/strong>: Success in GVHD could trigger <strong>Phase\u202f2 trials in membranous nephropathy and diabetic kidney disease<\/strong> (combined market <strong>\u00a512\u201115\u202fbillion<\/strong>).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-financial-projections\">Financial Projections<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Metric<\/th><th>2026E<\/th><th>2027E<\/th><th>2028E<\/th><\/tr><\/thead><tbody><tr><td><strong>R&amp;D Investment<\/strong><\/td><td>\u00a580\u202fmillion<\/td><td>\u00a5120\u202fmillion<\/td><td>\u00a5150\u202fmillion<\/td><\/tr><tr><td><strong>Patients Treated<\/strong><\/td><td>500<\/td><td>2,000<\/td><td>5,000<\/td><\/tr><tr><td><strong>Revenue (\u00a5 million)<\/strong><\/td><td>25<\/td><td>120<\/td><td>360<\/td><\/tr><tr><td><strong>Gross Margin<\/strong><\/td><td>85%<\/td><td>87%<\/td><td>88%<\/td><\/tr><tr><td><strong>EBITDA Margin<\/strong><\/td><td>Negative<\/td><td>15%<\/td><td>35%<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><strong>Peak Sales<\/strong>: <strong>\u00a51.2\u202fbillion<\/strong> by 2030, assuming <strong>NRDL inclusion<\/strong> in 2027 and <strong>indication expansion<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-strategic-rationale\">Strategic Rationale<\/h2>\n\n\n\n<p><strong>Portfolio Diversification<\/strong>: Expands Yifan from <strong>hepatitis vaccines<\/strong> into <strong>high\u2011value inflammatory disease<\/strong> therapeutics, reducing reliance on mature products.<\/p>\n\n\n\n<p><strong>Platform Validation<\/strong>: Success of <strong>Di\u2011Kine platform<\/strong> in F\u2011652 could enable <strong>follow\u2011on IL\u2011Fc fusion proteins<\/strong> for <strong>IBD, psoriasis, and NASH<\/strong>.<\/p>\n\n\n\n<p><strong>Commercial Leverage<\/strong>: Yifan\u2019s <strong>3,000\u2011person sales force<\/strong> covering <strong>infectious disease and transplant centers<\/strong> can rapidly commercialize F\u2011652.<\/p>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding F\u2011652\u2019s clinical development, regulatory pathway, market opportunity, and revenue forecasts. Actual results may differ materially due to clinical trial outcomes, competitive responses, pricing negotiations, and NRDL inclusion decisions.<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\/\u4ebf\u5e06\u533b\u836f\uff1a\u5173\u4e8e\u63a7\u80a1\u5b50\u516c\u53f8\u5728\u7814\u4ea7\u54c1F-652\u56fd\u5185\u65b0\u589e\u9002\u5e94\u75c7\u79fb\u690d\u7269\u6297\u5bbf\u4e3b\u75c5\u83b7\u5f97\u4e34\u5e8a\u8bd5\u9a8c\u6279\u51c6\u901a\u77e5\u4e66\u7684\u516c\u544a.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of \u4ebf\u5e06\u533b\u836f\uff1a\u5173\u4e8e\u63a7\u80a1\u5b50\u516c\u53f8\u5728\u7814\u4ea7\u54c1F-652\u56fd\u5185\u65b0\u589e\u9002\u5e94\u75c7\u79fb\u690d\u7269\u6297\u5bbf\u4e3b\u75c5\u83b7\u5f97\u4e34\u5e8a\u8bd5\u9a8c\u6279\u51c6\u901a\u77e5\u4e66\u7684\u516c\u544a.\"><\/object><a id=\"wp-block-file--media-5cbeea39-5c2d-43cf-b18d-6521d0b18b04\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/01\/\u4ebf\u5e06\u533b\u836f\uff1a\u5173\u4e8e\u63a7\u80a1\u5b50\u516c\u53f8\u5728\u7814\u4ea7\u54c1F-652\u56fd\u5185\u65b0\u589e\u9002\u5e94\u75c7\u79fb\u690d\u7269\u6297\u5bbf\u4e3b\u75c5\u83b7\u5f97\u4e34\u5e8a\u8bd5\u9a8c\u6279\u51c6\u901a\u77e5\u4e66\u7684\u516c\u544a.pdf\">\u4ebf\u5e06\u533b\u836f\uff1a\u5173\u4e8e\u63a7\u80a1\u5b50\u516c\u53f8\u5728\u7814\u4ea7\u54c1F-652\u56fd\u5185\u65b0\u589e\u9002\u5e94\u75c7\u79fb\u690d\u7269\u6297\u5bbf\u4e3b\u75c5\u83b7\u5f97\u4e34\u5e8a\u8bd5\u9a8c\u6279\u51c6\u901a\u77e5\u4e66\u7684\u516c\u544a<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/01\/\u4ebf\u5e06\u533b\u836f\uff1a\u5173\u4e8e\u63a7\u80a1\u5b50\u516c\u53f8\u5728\u7814\u4ea7\u54c1F-652\u56fd\u5185\u65b0\u589e\u9002\u5e94\u75c7\u79fb\u690d\u7269\u6297\u5bbf\u4e3b\u75c5\u83b7\u5f97\u4e34\u5e8a\u8bd5\u9a8c\u6279\u51c6\u901a\u77e5\u4e66\u7684\u516c\u544a.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-5cbeea39-5c2d-43cf-b18d-6521d0b18b04\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Yifan Pharmaceutical Co., Ltd (SHE: 002019) announced that its Recombinant Human Interleukin\u201122\u2011Fc Fusion Protein for&#8230;<\/p>\n","protected":false},"author":1,"featured_media":53126,"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":[62,1281,563],"class_list":["post-53124","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-clinical-trial-approval-initiation","tag-she-002019","tag-yifan-pharmaceutical"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.6 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Yifan Pharmaceutical&#039;s F-652 Wins NMPA IND for GVHD Therapy - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Yifan Pharmaceutical Co., Ltd (SHE: 002019) announced that its Recombinant Human Interleukin\u201122\u2011Fc Fusion Protein for Injection (F\u2011652) has received approval from China\u2019s National Medical Products Administration (NMPA) to initiate a Phase\u202f2 clinical trial for the treatment of graft\u2011versus\u2011host disease (GVHD). 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