{"id":59090,"date":"2026-03-09T13:20:15","date_gmt":"2026-03-09T05:20:15","guid":{"rendered":"https:\/\/flcube.com\/?p=59090"},"modified":"2026-03-09T13:20:16","modified_gmt":"2026-03-09T05:20:16","slug":"hengruis-adebrelimab-wins-nmpa-approval-for-two-perioperative-cancer-trials-pd-l1-ctla-4-combo-targets-rectal-and-gastric-gej-cancers","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=59090","title":{"rendered":"Hengrui’s Adebrelimab Wins NMPA Approval for Two Perioperative Cancer Trials \u2013 PD-L1\/CTLA-4 Combo Targets Rectal and Gastric\/GEJ Cancers"},"content":{"rendered":"\n

Jiangsu Hengrui Pharmaceuticals Co., Ltd.<\/strong> (SHA: 600276<\/a>, HKG: 1276<\/a>) announced NMPA clearance<\/strong> for two pivotal clinical studies<\/strong> evaluating adebrelimab<\/strong>, its anti-PD-L1 monoclonal antibody<\/strong>, in perioperative settings<\/strong> for gastrointestinal malignancies<\/strong>. The approvals enable a Phase II\/III trial<\/strong> in locally advanced resectable rectal cancer<\/strong> (adebrelimab + SHR-8068 + chemoradiotherapy) and a Phase III trial<\/strong> in resectable gastric\/gastroesophageal junction (GEJ) cancer<\/strong> (adebrelimab + SOX chemotherapy vs. placebo), expanding the PD-L1 franchise beyond its 2023 SCLC approval into curative-intent solid tumor indications<\/strong>.<\/p>\n\n\n\n

Regulatory Milestone<\/h2>\n\n\n\n
Study<\/th>Phase<\/th>Design<\/th>Indication<\/th>Combination<\/th><\/tr><\/thead>
Study 1<\/strong><\/td>Phase II\/III<\/td>Randomized, double-blind, placebo-controlled, multicenter<\/td>Locally advanced resectable rectal cancer<\/strong><\/td>Adebrelimab + SHR-8068 + chemoradiotherapy<\/td><\/tr>
Study 2<\/strong><\/td>Phase III<\/td>Randomized, double-blind, multicenter<\/td>Resectable gastric\/GEJ cancer<\/strong><\/td>Adebrelimab + S-1\/Oxaliplatin (SOX) vs. placebo + SOX<\/td><\/tr>
Agency<\/strong><\/td>NMPA (China)<\/td>\u2014<\/td>\u2014<\/td>\u2014<\/td><\/tr>
Approval Date<\/strong><\/td>March 2026<\/td>\u2014<\/td>\u2014<\/td>\u2014<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Product Profiles<\/h2>\n\n\n\n

Adebrelimab (Anti-PD-L1 mAb)<\/h3>\n\n\n\n
Attribute<\/th>Specification<\/th><\/tr><\/thead>
Target<\/strong><\/td>PD-L1 (programmed death-ligand 1)<\/td><\/tr>
Mechanism<\/strong><\/td>Blocks PD-1\/PD-L1 interaction; restores anti-tumor T-cell immunity<\/td><\/tr>
Approved Indication<\/strong><\/td>First-line extensive-stage small cell lung cancer (ES-SCLC) \u2013 2023 China approval<\/strong> (combo with carboplatin\/etoposide)<\/td><\/tr>
Development Strategy<\/strong><\/td>Perioperative (neoadjuvant + adjuvant) expansion in GI cancers<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

SHR-8068 (Anti-CTLA-4 mAb)<\/h3>\n\n\n\n
Attribute<\/th>Specification<\/th><\/tr><\/thead>
Origin<\/strong><\/td>Licensed by Hengrui (fully human anti-CTLA-4)<\/td><\/tr>
Mechanism<\/strong><\/td>Enhances anti-tumor immune effects via CTLA-4 checkpoint blockade<\/td><\/tr>
Global Comparators<\/strong><\/td>Ipilimumab (BMS), tremelimumab (AstraZeneca)<\/td><\/tr>
Combo Rationale<\/strong><\/td>Dual checkpoint blockade (PD-L1 + CTLA-4) for enhanced priming and activation of anti-tumor immunity<\/td><\/tr>
Prior Approvals<\/strong><\/td>Multiple clinical trial clearances (NSCLC, colorectal cancer)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Clinical Strategy & Scientific Rationale<\/h2>\n\n\n\n
Cancer Type<\/th>Current Standard<\/th>Adebrelimab Value Proposition<\/th><\/tr><\/thead>
Rectal Cancer<\/strong><\/td>Chemoradiotherapy \u2192 surgery \u2192 adjuvant chemo<\/td>Neoadjuvant immunotherapy to increase pathologic complete response (pCR) rates; potential for organ preservation (watch-and-wait)<\/td><\/tr>
Gastric\/GEJ Cancer<\/strong><\/td>Perioperative chemotherapy (FLOT or SOX)<\/td>Addition of PD-L1 blockade to SOX backbone; improved R0 resection rates and recurrence-free survival<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Perioperative Immunotherapy Trend:<\/strong><\/p>\n\n\n\n