{"id":50833,"date":"2025-12-15T20:52:30","date_gmt":"2025-12-15T12:52:30","guid":{"rendered":"https:\/\/flcube.com\/?p=50833"},"modified":"2025-12-15T20:52:30","modified_gmt":"2025-12-15T12:52:30","slug":"henlius-serplulimab-nda-wins-priority-review-for-gastric-cancer-as-adjuvant-therapy","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=50833","title":{"rendered":"Henlius Serplulimab NDA Wins Priority Review for Gastric Cancer as Adjuvant Therapy"},"content":{"rendered":"\n

Shanghai Henlius Biotech, Inc.<\/strong> (HKG: 2696<\/a>) announced that the NMPA accepted its New Drug Application (NDA) for HANSIZHUANG (serplulimab, trade name in Europe: Hetronifly)<\/strong> as neoadjuvant\/adjuvant treatment for PD\u2011L1 positive, operable gastric cancer<\/strong>, granting Priority Review<\/strong> status. The filing is supported by the pivotal ASTRUM\u2011006 Phase\u202f3 trial<\/strong>, which demonstrated significant improvements in Event\u2011Free Survival (EFS)<\/strong> and pathological complete response (pCR)<\/strong> rates vs. chemotherapy alone.<\/p>\n\n\n\n

Regulatory Milestone<\/h2>\n\n\n\n
Item<\/th>Details<\/th><\/tr><\/thead>
Submission Date<\/strong><\/td>12\u202fDec\u202f2025<\/td><\/tr>
Agency<\/strong><\/td>NMPA (China)<\/td><\/tr>
Product<\/strong><\/td>HANSIZHUANG (serplulimab)<\/td><\/tr>
Indication<\/strong><\/td>PD\u2011L1 positive, operable gastric cancer (neoadjuvant + adjuvant)<\/td><\/tr>
Review Status<\/strong><\/td>Priority Review granted<\/td><\/tr>
Trial Basis<\/strong><\/td>ASTRUM\u2011006 Phase\u202f3 study met primary EFS endpoint and pCR superiority<\/td><\/tr>
Safety Profile<\/strong><\/td>Manageable and consistent with prior serplulimab data<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Drug Profile & Commercial Reach<\/h2>\n\n\n\n
Attribute<\/th>Serplulimab<\/th>Global Launch Status<\/th><\/tr><\/thead>
Mechanism<\/strong><\/td>Anti\u2011PD\u20111 monoclonal antibody<\/td>Approved in 40+ countries<\/td><\/tr>
Approved Indications<\/strong><\/td>sqNSCLC, ES\u2011SCLC, ESCC, nsNSCLC<\/td>China, UK, Germany, Singapore, India<\/td><\/tr>
New Indication<\/strong><\/td>Adjuvant\/neoadjuvant gastric cancer<\/td>Filing under Priority Review<\/td><\/tr>
Market Opportunity<\/strong><\/td>450,000+ new gastric cancer cases annually in China<\/td>PD\u2011L1 positive subset ~40\u201150% of operable patients<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

ASTRUM-006 Efficacy Data<\/h2>\n\n\n\n
Endpoint<\/th>Serplulimab + Chemotherapy<\/th>Placebo + Chemotherapy<\/th>Statistical Significance<\/th><\/tr><\/thead>
Event\u2011Free Survival (EFS)<\/strong><\/td>Primary endpoint met<\/td>Control arm<\/td>Superiority demonstrated<\/td><\/tr>
Pathological Complete Response (pCR)<\/strong><\/td>Significantly higher<\/td>Baseline comparator<\/td>Clinically meaningful improvement<\/td><\/tr>
Recurrence Risk Reduction<\/strong><\/td>Substantial risk reduction<\/td>\u2014<\/td>p < 0.05 (pre\u2011specified)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Forward\u2011Looking Statements<\/strong>
This brief contains forward\u2011looking statements regarding serplulimab\u2019s NDA review timeline, market penetration in gastric cancer, and potential NRDL negotiations. Actual results may differ due to regulatory feedback, competitive dynamics, or pricing pressures.-Fineline Info & Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that the NMPA accepted its New Drug Application…<\/p>\n","protected":false},"author":1,"featured_media":50834,"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":[270,862,38,18],"class_list":["post-50833","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-henlius-biotech","tag-hkg-2696","tag-market-approval-filings","tag-pd-1-l1"],"yoast_head":"\nHenlius Serplulimab NDA Wins Priority Review for Gastric Cancer as Adjuvant Therapy - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that the NMPA accepted its New Drug Application (NDA) for HANSIZHUANG (serplulimab, trade name in Europe: Hetronifly) as neoadjuvant\/adjuvant treatment for PD\u2011L1 positive, operable gastric cancer, granting Priority Review status. The filing is supported by the pivotal ASTRUM\u2011006 Phase\u202f3 trial, which demonstrated significant improvements in Event\u2011Free Survival (EFS) and pathological complete response (pCR) rates vs. chemotherapy alone.\" \/>\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=50833\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Henlius Serplulimab NDA Wins Priority Review for Gastric Cancer as Adjuvant Therapy\" \/>\n<meta property=\"og:description\" content=\"Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that the NMPA accepted its New Drug Application (NDA) for HANSIZHUANG (serplulimab, trade name in Europe: Hetronifly) as neoadjuvant\/adjuvant treatment for PD\u2011L1 positive, operable gastric cancer, granting Priority Review status. 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