HENLIUS (02696) announced that a Phase 3 clinical trial comparing the company's proprietary Hansizhuang® (serplulimab injection) or placebo combined with chemotherapy (oxaliplatin + tegafur) for neoadjuvant/adjuvant treatment of gastric cancer has achieved its primary endpoint of event-free survival (EFS) in a planned interim analysis, as evaluated by the Independent Data Monitoring Committee (IDMC), supporting early marketing application submission.

This is a randomized, double-blind, multicenter Phase 3 clinical trial conducted in early-stage gastric cancer patients, designed to compare the clinical efficacy and safety of Hansizhuang® combined with chemotherapy versus placebo combined with chemotherapy for neoadjuvant/adjuvant treatment of early-stage gastric cancer patients.

Based on the results of the preset interim analysis conducted by the IDMC, Hansizhuang® combined with chemotherapy demonstrated significant improvement in event-free survival (EFS) compared to placebo combined with chemotherapy, meeting the preset superiority criteria. The pathological complete response (pCR) rate was more than three times higher than the control group, with significantly reduced patient recurrence risk and good safety profile, with no new safety signals identified.