{"id":43028,"date":"2025-10-10T16:58:35","date_gmt":"2025-10-10T08:58:35","guid":{"rendered":"https:\/\/flcube.com\/?p=43028"},"modified":"2025-10-10T16:58:36","modified_gmt":"2025-10-10T08:58:36","slug":"shanghai-henlius-biotech-achieves-primary-endpoint-in-phase-3-trial-of-serplulimab-for-early%e2%80%91stage-gastric-cancer","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=43028","title":{"rendered":"Shanghai Henlius Biotech Achieves Primary Endpoint in Phase\u202f3 Trial of Serplulimab for Early\u2011Stage Gastric Cancer"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">Shanghai Henlius Biotech Inc. (<a href=\"https:\/\/www.google.com\/finance\/quote\/2696:HKG\">HKG: 2696<\/a>) today announced that its phase\u202f3, randomized, double\u2011blind, multi\u2011center study of <strong>serplulimab<\/strong> (HANSIZHUANG) plus standard SOX chemotherapy has met the primary endpoint of event\u2011free survival (EFS) at a planned interim analysis, as confirmed by the Independent Data Monitoring Committee (IDMC). The data support an early New Drug Application (NDA) submission for serplulimab in the adjuvant setting for early\u2011stage gastric cancer.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-clinical-highlights\">Clinical Highlights<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Primary Endpoint Met<\/strong> \u2013 In the interim analysis, serplulimab\u202f+\u202fSOX achieved a statistically significant improvement in EFS versus placebo\u202f+\u202fSOX, satisfying the pre\u2011defined efficacy criteria set by the IDMC.<\/li>\n\n\n\n<li><strong>Pathologic Complete Response (pCR)<\/strong> \u2013 The pCR rate in the serplulimab arm exceeded that of the control group by over threefold, translating into a markedly lower risk of recurrence.<\/li>\n\n\n\n<li><strong>Safety Profile<\/strong> \u2013 No new safety signals were observed; the adverse event profile was consistent with that seen in serplulimab\u2019s approved indications for squamous non\u2011small\u2011cell lung cancer and other solid tumors.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-strategic-implications\">Strategic Implications<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Regulatory Momentum<\/strong> \u2013 The early positive data position Henlius to file an expedited NDA in China, potentially accelerating patient access to a novel immunotherapy for gastric cancer.<\/li>\n\n\n\n<li><strong>Portfolio Expansion<\/strong> \u2013 Serplulimab\u2019s success in a new therapeutic area strengthens Henlius\u2019s pipeline and underscores the versatility of its anti\u2011PD\u20111 platform.<\/li>\n\n\n\n<li><strong>Market Opportunity<\/strong> \u2013 With gastric cancer remaining a leading cause of cancer mortality worldwide, an effective adjuvant therapy could capture a significant share of a high\u2011growth market.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/li>\n<\/ul>\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\/2025\/10\/2025100900422_c.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 2025100900422_c.\"><\/object><a id=\"wp-block-file--media-2d59ae40-68da-44da-b14f-ede4d80fb2a0\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/10\/2025100900422_c.pdf\">2025100900422_c<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/10\/2025100900422_c.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-2d59ae40-68da-44da-b14f-ede4d80fb2a0\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Shanghai Henlius Biotech Inc. (HKG: 2696) today announced that its phase\u202f3, randomized, double\u2011blind, multi\u2011center study&#8230;<\/p>\n","protected":false},"author":1,"featured_media":43031,"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":[17,270,862,18],"class_list":["post-43028","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-clinical-trial-results","tag-henlius-biotech","tag-hkg-2696","tag-pd-1-l1"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.5 (Yoast SEO v27.9) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Shanghai Henlius Biotech Achieves Primary Endpoint in Phase\u202f3 Trial of Serplulimab for Early\u2011Stage Gastric Cancer - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Shanghai Henlius Biotech Inc. 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