{"id":67932,"date":"2026-06-10T21:28:53","date_gmt":"2026-06-10T13:28:53","guid":{"rendered":"https:\/\/flcube.com\/?p=67932"},"modified":"2026-06-10T21:28:54","modified_gmt":"2026-06-10T13:28:54","slug":"henlius-biotechs-serplulimab-becomes-worlds-first-pd-1-inhibitor-approved-for-perioperative-gastric-cancer-treatment-following-landmark-phase-iii-results","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=67932","title":{"rendered":"Henlius Biotech&#8217;s Serplulimab Becomes World&#8217;s First PD-1 Inhibitor Approved for Perioperative Gastric Cancer Treatment Following Landmark Phase III Results"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>Shanghai Henlius Biotech Inc.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/2696:HKG\">HKG: 2696<\/a>) announced that China&#8217;s <strong>National Medical Products Administration (NMPA)<\/strong> has granted <strong>priority review approval<\/strong> for an additional indication for its <strong>PD-1 inhibitor HanSiZhuang\u2122 (serplulimab)<\/strong>, commercially known as <strong>Hetronifly\u00ae in Europe<\/strong>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The approval authorizes serplulimab for <strong>perioperative treatment of resectable gastric cancer<\/strong> in patients with <strong>tumor PD-L1 expression CPS \u22655<\/strong>, specifically for <strong>neoadjuvant treatment combined with oxaliplatin and S-1 chemotherapy<\/strong>, followed by <strong>adjuvant monotherapy<\/strong>. This makes serplulimab the <strong>first and only PD-1 inhibitor globally approved for perioperative gastric cancer treatment<\/strong>, representing a significant advancement in the standard of care for this challenging malignancy.<\/p>\n\n\n\n<h2 id=\"h-regulatory-approval-details\" class=\"wp-block-heading\">Regulatory Approval Details<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Parameter<\/th><th>Specification<\/th><\/tr><\/thead><tbody><tr><td><strong>Drug Name<\/strong><\/td><td>HanSiZhuang\u2122 (serplulimab) \/ Hetronifly\u00ae<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>Perioperative treatment of resectable gastric cancer<\/td><\/tr><tr><td><strong>Patient Population<\/strong><\/td><td>PD-L1 CPS \u22655, surgically eligible<\/td><\/tr><tr><td><strong>Regimen<\/strong><\/td><td>Neoadjuvant: serplulimab + oxaliplatin\/S-1 \u2192 Adjuvant: serplulimab monotherapy<\/td><\/tr><tr><td><strong>Review Pathway<\/strong><\/td><td>NMPA Priority Review<\/td><\/tr><tr><td><strong>Global Status<\/strong><\/td><td>First PD-1 inhibitor approved for perioperative gastric cancer worldwide<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 id=\"h-pivotal-phase-iii-astrum-006-trial-results\" class=\"wp-block-heading\">Pivotal Phase III ASTRUM-006 Trial Results<\/h2>\n\n\n\n<h3 id=\"h-study-design-amp-population\" class=\"wp-block-heading\">Study Design &amp; Population<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Design<\/strong>: Randomized, double-blind, placebo-controlled, multicenter Phase III<\/li>\n\n\n\n<li><strong>Enrollment<\/strong>: 588 patients with locally advanced gastric\/gastroesophageal junction adenocarcinoma<\/li>\n\n\n\n<li><strong>Inclusion Criteria<\/strong>: PD-L1 CPS \u22655, surgical eligibility<\/li>\n\n\n\n<li><strong>Primary Endpoint<\/strong>: Event-free survival (EFS)<\/li>\n\n\n\n<li><strong>Data Cutoff<\/strong>: August 19, 2025<\/li>\n<\/ul>\n\n\n\n<h3 id=\"h-efficacy-outcomes-pd-l1-cps-5-population\" class=\"wp-block-heading\">Efficacy Outcomes (PD-L1 CPS \u22655 Population)<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Endpoint<\/th><th>Serplulimab Group<\/th><th>Control Group<\/th><th>Hazard Ratio<\/th><\/tr><\/thead><tbody><tr><td><strong>Event-Free Survival<\/strong><\/td><td>Significantly prolonged<\/td><td>Standard chemotherapy<\/td><td>HR 0.67 (33% risk reduction)<\/td><\/tr><tr><td><strong>Pathological Complete Response (pCR)<\/strong><\/td><td>21.6%<\/td><td>6.5%<\/td><td>&gt;3x improvement<\/td><\/tr><tr><td><strong>R0 Resection Rate<\/strong><\/td><td>96.7%<\/td><td>Not specified<\/td><td>High surgical success<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 id=\"h-safety-profile\" class=\"wp-block-heading\">Safety Profile<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Grade \u22653 TRAEs<\/strong>: 46.6% (serplulimab) vs. 58.5% (control)<\/li>\n\n\n\n<li><strong>Permanent Discontinuation<\/strong>: 6.5% (serplulimab) vs. 10.5% (control)<\/li>\n\n\n\n<li><strong>Tolerability Assessment<\/strong>: Generally manageable safety profile with improved tolerability versus chemotherapy alone<\/li>\n<\/ul>\n\n\n\n<h2 id=\"h-strategic-market-implications\" class=\"wp-block-heading\">Strategic Market Implications<\/h2>\n\n\n\n<h3 id=\"h-gastric-cancer-treatment-landscape\" class=\"wp-block-heading\">Gastric Cancer Treatment Landscape<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Global Burden<\/strong>: Gastric cancer represents the 5th most common cancer worldwide with poor prognosis in advanced stages<\/li>\n\n\n\n<li><strong>Chinese Market<\/strong>: China accounts for approximately 40% of global gastric cancer cases<\/li>\n\n\n\n<li><strong>Treatment Gap<\/strong>: Limited effective perioperative options prior to this approval<\/li>\n\n\n\n<li><strong>Standard of Care Evolution<\/strong>: Paradigm shift from chemotherapy-only to immunotherapy-enhanced perioperative approach<\/li>\n<\/ul>\n\n\n\n<h3 id=\"h-competitive-positioning\" class=\"wp-block-heading\">Competitive Positioning<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>First-Mover Advantage<\/strong>: Exclusive global position as only approved PD-1 inhibitor for perioperative gastric cancer<\/li>\n\n\n\n<li><strong>BICR Validation<\/strong>: Independent radiological assessment strengthens credibility of results<\/li>\n\n\n\n<li><strong>Combination Strategy<\/strong>: Leverages established chemotherapy backbone while adding immunotherapy benefit<\/li>\n\n\n\n<li><strong>Biomarker-Driven<\/strong>: PD-L1 CPS \u22655 selection ensures optimal patient targeting<\/li>\n<\/ul>\n\n\n\n<h2 id=\"h-commercial-outlook-amp-revenue-potential\" class=\"wp-block-heading\">Commercial Outlook &amp; Revenue Potential<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Addressable Population<\/strong>: Estimated 50,000-70,000 eligible patients annually in China<\/li>\n\n\n\n<li><strong>Pricing Strategy<\/strong>: Premium positioning based on first-in-class status and significant efficacy improvement<\/li>\n\n\n\n<li><strong>Market Penetration<\/strong>: Expected rapid adoption given priority review status and compelling clinical data<\/li>\n\n\n\n<li><strong>Global Expansion<\/strong>: European approval (as Hetronifly) provides foundation for international market access<\/li>\n\n\n\n<li><strong>Revenue Projection<\/strong>: Analysts estimate peak annual sales of $400-600 million globally for this indication<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">This approval represents a major milestone for Henlius Biotech, establishing serplulimab as a cornerstone therapy in gastric cancer management and demonstrating China&#8217;s growing leadership in innovative oncology drug development.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Forward-Looking Statements<\/strong><br>This brief contains forward-looking statements regarding market adoption, regulatory pathways, competitive dynamics, and revenue projections. Actual results may differ due to reimbursement challenges, competitive pressures, and evolving treatment guidelines.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Shanghai Henlius Biotech Inc. (HKG: 2696) announced that China&#8217;s National Medical Products Administration (NMPA) has&#8230;<\/p>\n","protected":false},"author":1,"featured_media":67934,"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":[270,862,18,15],"class_list":["post-67932","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-henlius-biotech","tag-hkg-2696","tag-pd-1-l1","tag-product-approvals"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.5 (Yoast SEO v27.8) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Henlius Biotech&#039;s Serplulimab Becomes World&#039;s First PD-1 Inhibitor Approved for Perioperative Gastric Cancer Treatment Following Landmark Phase III Results - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Shanghai Henlius Biotech Inc. 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(HKG: 2696) announced that China&#039;s National Medical Products Administration (NMPA) has granted priority review approval for an additional indication for its PD-1 inhibitor HanSiZhuang\u2122 (serplulimab), commercially known as Hetronifly\u00ae in Europe.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=67932\" \/>\n<meta property=\"og:site_name\" content=\"Insight, China&#039;s Pharmaceutical Industry\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/profile.php?id=61566606313834\" \/>\n<meta property=\"article:published_time\" content=\"2026-06-10T13:28:53+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-06-10T13:28:54+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/06\/1002-2.webp\" \/>\n\t<meta property=\"og:image:width\" content=\"1080\" \/>\n\t<meta property=\"og:image:height\" content=\"608\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Fineline Cube\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. 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