Henlius’ Hansizhuang Plus Chemotherapy Meets Primary Endpoint in Phase III Gastric Cancer Trial

Shanghai Henlius Biotech has announced that its anti-PD-1 antibody Hansizhuang (serplulimab, marketed as Hetronifly in Europe), combined with chemotherapy, has met the primary endpoint of event-free survival (EFS) in the Phase III ASTRUM-006 trial for gastric cancer. The multi-centre, double-blind, randomised study evaluated the safety and efficacy of Hansizhuang or placebo with chemotherapy as a neoadjuvant/adjuvant treatment for early-stage gastric cancer.

According to an interim analysis by the Independent Data Monitoring Committee (IDMC), the Hansizhuang-based regimen achieved a pathological complete response rate over three times higher than the control group and significantly reduced recurrence risk. The treatment also demonstrated a favourable safety profile with no new safety concerns identified.

Based on these positive findings, the IDMC has recommended early submission of a New Drug Application, marking a major milestone for Henlius’ gastrointestinal oncology pipeline.

14-10-2025