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Phase 3 Clinical Trial of HANSIZHUANG Plus Chemotherapy Meets Primary Endpoint in Neoadjuvant/Adjuvant Gastric Cancer, Greenlighting Early NDA Submission
Shanghai Henlius Biotech, Inc. (2696.HK) announced that its self-developed innovative anti-PD-1 monoclonal antibody, HANSIZHUANG (serplulimab, Hetronifly® in Europe), in combination with chemotherapy for the neoadjuvant/adjuvant monotherapy treatment of gastric cancer, has met the primary endpoint of Event-Free Survival (EFS) in an interim analysis of its phase 3 clinical study (ASTRUM-006). This outcome represents a breakthrough, making it the world-first regimen to replace adjuvant chemotherap
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[{"type":"list","items":[{"val":[{"type":"text","content":"The phase 3 clinical trial of HANSIZHUANG for perioperative gastric cancer treatment met its EFS primary endpoint, supporting an early New Drug Application (NDA) submission","length":172,"tagName":"p"}]},{"val":[{"type":"text","content":"World-first regimen in gastric cancer that replaces adjuvant chemotherapy with mono-immunotherapy in the perioperative setting","length":126,"tagName":"p"}]},{"val":[{"type":"text","content":"The ASTRUM-006 study demonstrated a significant improvement in event-free survival (EFS) and achieved a more than threefold higher pathological complete response (pCR) rate compared with the control arm, unlocking the potential for a cure","length":243,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":541,"olType":false},{"type":"text","content":"SHANGHAI, Oct. 9, 2025 /PRNewswire/ -- Shanghai Henlius Biotech, Inc. (2696.HK) announced that its self-developed innovative anti-PD-1 monoclonal antibody, HANSIZHUANG (serplulimab, Hetronifly® in Europe), in combination with chemotherapy for the neoadjuvant/adjuvant monotherapy treatment of gastric cancer, has met the primary endpoint of Event-Free Survival (EFS) in an interim analysis of its phase 3 clinical study (ASTRUM-006). This outcome represents a breakthrough, making it the world-first regimen to replace adjuvant chemotherapy with mono-immunotherapy in the perioperative treatment of gastric cancer.","length":619,"tagName":"p"},{"type":"text","content":"ASTRUM-006 is a randomized, double-blind, multi-centre phase 3 clinical study among patients with early-stage gastric cancer, aiming to compare the efficacy and safety of HANSIZHUANG or placebo in combination with chemotherapy as a neoadjuvant/adjuvant monotherapy treatment for patients with early-stage gastric cancer. According to the interim analysis conducted by the Independent Data Monitoring Committee (IDMC), the trial met its predefined efficacy criteria. Compared with placebo plus chemotherapy, HANSIZHUANG plus chemotherapy significantly prolonged EFS and achieved a more than threefold higher pathological complete response (pCR) rate compared with the control arm, with a significant reduction in the risk of recurrence. Furthermore, the combination regimen demonstrated a favorable safety profile, with no new safety signals identified....