{"id":53348,"date":"2026-01-08T14:01:02","date_gmt":"2026-01-08T06:01:02","guid":{"rendered":"https:\/\/flcube.com\/?p=53348"},"modified":"2026-01-08T14:01:03","modified_gmt":"2026-01-08T06:01:03","slug":"hengruis-retlirafusp-%ce%b1-wins-nmpa-approval-for-first-line-gastric-cancer","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=53348","title":{"rendered":"Hengrui&#8217;s Retlirafusp \u03b1 Wins NMPA Approval for First-Line Gastric Cancer"},"content":{"rendered":"\n<p><strong>Jiangsu Hengrui Pharmaceuticals Co., Ltd<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/600276:SHA\">SHA: 600276<\/a>, <a href=\"https:\/\/www.google.com\/finance\/quote\/1276:HKG\">HKG: 1276<\/a>) announced that its self-developed Category\u202f1 drug, <strong>Retlirafusp \u03b1 Injection<\/strong>, has received <strong>marketing approval<\/strong> from China\u2019s <strong>National Medical Products Administration (NMPA)<\/strong>. The drug is indicated for <strong>first\u2011line treatment<\/strong> of <strong>locally advanced unresectable, recurrent, or metastatic gastric and gastroesophageal junction adenocarcinoma (GC\/GEJC)<\/strong> that is <strong>PD\u2011L1 positive (CPS\u202f\u2265\u202f1)<\/strong>, representing the <strong>world\u2019s first approved anti\u2011PD\u2011L1\/TGF\u2011\u03b2RII bispecific antibody fusion protein<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-regulatory-milestone\">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>Retlirafusp \u03b1 Injection<\/td><\/tr><tr><td><strong>Company<\/strong><\/td><td>Jiangsu Hengrui Pharmaceuticals (600276.SH\/1276.HK)<\/td><\/tr><tr><td><strong>Regulatory Status<\/strong><\/td><td>NMPA marketing approval<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>First\u2011line PD\u2011L1+ (CPS\u202f\u2265\u202f1) advanced GC\/GEJC<\/td><\/tr><tr><td><strong>Mechanism<\/strong><\/td><td>Anti\u2011PD\u2011L1\/TGF\u2011\u03b2RII bispecific antibody fusion protein<\/td><\/tr><tr><td><strong>Trial Basis<\/strong><\/td><td>RELIGHT (SHR-1701-\u2162-307) Phase\u202f3 study<\/td><\/tr><tr><td><strong>Significance<\/strong><\/td><td><strong>First\u2011in\u2011world<\/strong> bispecific PD\u2011L1\/TGF\u2011\u03b2RII approval<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-clinical-evidence-relight-phase-3-study\">Clinical Evidence: RELIGHT Phase\u202f3 Study<\/h2>\n\n\n\n<p><strong>Study Design<\/strong>: Randomized, double\u2011blind, multicenter Phase\u202f3 trial comparing Retlirafusp \u03b1 + chemotherapy vs. placebo + chemotherapy in first\u2011line advanced GC\/GEJC.<\/p>\n\n\n\n<p><strong>Efficacy Results<\/strong>:<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Population<\/th><th>Median OS<\/th><th>Death Risk Reduction<\/th><th>Key Finding<\/th><\/tr><\/thead><tbody><tr><td><strong>ITT<\/strong><\/td><td>15.8 months<\/td><td>34%<\/td><td>Statistically significant survival benefit<\/td><\/tr><tr><td><strong>PD\u2011L1 CPS\u202f\u2265\u202f1<\/strong><\/td><td>16.7 months<\/td><td>43%<\/td><td>Enhanced benefit in biomarker\u2011selected group<\/td><\/tr><tr><td><strong>Liver Metastases<\/strong><\/td><td>16.8 months<\/td><td>54%<\/td><td>Strong activity in poor\u2011prognosis subgroup<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><strong>Safety Profile<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Favorable safety<\/strong> vs. placebo + chemo<\/li>\n\n\n\n<li><strong>Improved myelosuppression<\/strong>, suggesting <strong>potential myeloprotective effects<\/strong><\/li>\n\n\n\n<li>Manageable immune\u2011related adverse events<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-opportunity-gastric-cancer-in-china\">Market Opportunity: Gastric Cancer 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>480,000<\/strong> new GC cases annually in China (50% of global total)<\/li>\n\n\n\n<li><strong>PD\u2011L1+ (CPS\u202f\u2265\u202f1)<\/strong>: <strong>~55%<\/strong> of patients \u2192 <strong>~264,000<\/strong> eligible<\/li>\n\n\n\n<li><strong>Market Size<\/strong>: China GC drug market <strong>\u00a525\u202fbillion<\/strong> (2025), growing at <strong>8% CAGR<\/strong><\/li>\n\n\n\n<li><strong>Unmet Need<\/strong>: First\u2011line standard of care (chemo\u202f\u00b1\u202fPD\u20111) yields <strong>mOS\u202f\u2248\u202f12\u202fmonths<\/strong>; significant room for improvement<\/li>\n<\/ul>\n\n\n\n<p><strong>Retlirafusp \u03b1 Peak Sales Projection<\/strong>: <strong>\u00a53.5\u20114.5\u202fbillion<\/strong> (US$490\u2011630\u202fmillion) by 2030, assuming <strong>12\u201115%<\/strong> market share in first\u2011line PD\u2011L1+ GC.<\/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>Drug<\/th><th>Company<\/th><th>Mechanism<\/th><th>Stage (China)<\/th><th>ITT mOS (1L GC)<\/th><\/tr><\/thead><tbody><tr><td><strong>Retlirafusp \u03b1<\/strong><\/td><td><strong>Hengrui<\/strong><\/td><td>PD\u2011L1\/TGF\u2011\u03b2RII bispecific + chemo<\/td><td><strong>Approved<\/strong><\/td><td><strong>15.8\u202fmonths<\/strong><\/td><\/tr><tr><td><strong>Nivolumab + chemo<\/strong><\/td><td>BMS<\/td><td>PD\u20111 + chemo<\/td><td>Marketed<\/td><td>13.8\u202fmonths<\/td><\/tr><tr><td><strong>Pembrolizumab + chemo<\/strong><\/td><td>MSD<\/td><td>PD\u20111 + chemo<\/td><td>Marketed<\/td><td>13.9\u202fmonths<\/td><\/tr><tr><td><strong>Tislelizumab + chemo<\/strong><\/td><td>BeiGene<\/td><td>PD\u20111 + chemo<\/td><td>Marketed<\/td><td>13.9\u202fmonths<\/td><\/tr><tr><td><strong>Zanidatamab + chemo<\/strong><\/td><td>Zymeworks<\/td><td>HER2 bispecific + chemo<\/td><td>Phase\u202fIII<\/td><td>Not yet reported<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><strong>Differentiation<\/strong>: Retlirafusp \u03b1\u2019s <strong>dual PD\u2011L1 blockade + TGF\u2011\u03b2 inhibition<\/strong> offers <strong>superior survival benefit<\/strong> and <strong>myeloprotective advantage<\/strong>, positioning it as <strong>potential new standard of care<\/strong> in PD\u2011L1+ GC.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-commercial-strategy-amp-manufacturing\">Commercial Strategy &amp; Manufacturing<\/h2>\n\n\n\n<p><strong>Launch Timeline<\/strong>: Q1\u202f2026 commercial rollout via Hengrui\u2019s <strong>4,000\u2011person oncology sales force<\/strong> covering <strong>1,500+ tertiary hospitals<\/strong>.<\/p>\n\n\n\n<p><strong>Pricing<\/strong>: Expected <strong>\u00a518,000\u201122,000<\/strong> per treatment cycle (vs. PD\u20111 inhibitors at \u00a515,000\u201120,000), justified by <strong>superior OS data<\/strong> and <strong>myeloprotective benefit<\/strong>.<\/p>\n\n\n\n<p><strong>Manufacturing<\/strong>: <strong>Changzhou biologics facility<\/strong> (capacity: 10,000\u202fL) already <strong>GMP\u2011certified<\/strong> for bispecific antibody production.<\/p>\n\n\n\n<p><strong>Reimbursement<\/strong>: Targeting <strong>NRDL inclusion in 2026<\/strong> via <strong>breakthrough therapy and rare disease pathways<\/strong> (gastric cancer qualifies for priority review).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-financial-impact-amp-valuation\">Financial Impact &amp; Valuation<\/h2>\n\n\n\n<p><strong>Near\u2011Term Revenue<\/strong>: <strong>\u00a5800\u202fmillion\u20111.2\u202fbillion<\/strong> in 2026 (partial year launch), accelerating to <strong>\u00a53\u202fbillion<\/strong> in 2027.<\/p>\n\n\n\n<p><strong>Peak Valuation<\/strong>: Retlirafusp \u03b1 alone could contribute <strong>\u00a515\u201118 per share<\/strong> to Hengrui\u2019s DCF, representing <strong>15\u201118% upside<\/strong> from current trading price.<\/p>\n\n\n\n<p><strong>Pipeline Synergy<\/strong>: Success validates Hengrui\u2019s <strong>bispecific platform<\/strong>, supporting <strong>6\u20118 additional candidates<\/strong> in <strong>PD\u2011L1 combos<\/strong> for <strong>lung, liver, and pancreatic cancers<\/strong>.<\/p>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding Retlirafusp \u03b1\u2019s commercial launch, market penetration, revenue forecasts, and competitive positioning. Actual results may differ materially due to clinical adoption rates, pricing negotiations, competitive responses, and NRDL inclusion decisions.<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 self-developed Category\u202f1 drug,&#8230;<\/p>\n","protected":false},"author":1,"featured_media":53349,"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":[2586,4228,28,18,15,852],"class_list":["post-53348","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-hengrui-pharmaceuticals","tag-hkg-1276","tag-multi-specific-antibodies","tag-pd-1-l1","tag-product-approvals","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&#039;s Retlirafusp \u03b1 Wins NMPA Approval for First-Line Gastric 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 self-developed Category\u202f1 drug, Retlirafusp \u03b1 Injection, has received marketing approval from China\u2019s National Medical Products Administration (NMPA). The drug is indicated for first\u2011line treatment of locally advanced unresectable, recurrent, or metastatic gastric and gastroesophageal junction adenocarcinoma (GC\/GEJC) that is PD\u2011L1 positive (CPS\u202f\u2265\u202f1), representing the world\u2019s first approved anti\u2011PD\u2011L1\/TGF\u2011\u03b2RII bispecific antibody fusion protein.\" \/>\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=53348\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Hengrui&#039;s Retlirafusp \u03b1 Wins NMPA Approval for First-Line Gastric Cancer\" \/>\n<meta property=\"og:description\" content=\"Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276, HKG: 1276) announced that its self-developed Category\u202f1 drug, Retlirafusp \u03b1 Injection, has received marketing approval from China\u2019s National Medical Products Administration (NMPA). 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