Henlius' HANSIZHUANG meets primary endpoint in gastric cancer trial

Shanghai Henlius Biotech, Inc. announced that its phase 3 clinical study for HANSIZHUANG (serplulimab injection), in combination with chemotherapy for neo-/adjuvant treatment of gastric cancer, met its primary endpoint of event-free survival (EFS). This positive outcome, evaluated by the independent data monitoring committee (IDMC), supports an early new drug application submission.

The study demonstrated a significant improvement in EFS for HANSIZHUANG combined with chemotherapy compared to placebo, meeting predefined efficacy criteria. The pathological complete response (pCR) rate was over three times that of the control group, with a notable reduction in patient recurrence risk. The safety profile was deemed good, with no new safety signals observed.

HANSIZHUANG, an anti-PD-1 monoclonal antibody, is already approved in mainland China for various indications including lung and esophageal cancers, and in other regions such as the European Union and the United Kingdom. Global sales of PD-1 monoclonal antibody drugs are projected to reach approximately $45.550 bn in 2024.