Shanghai Henlius Biotech's Gastric Cancer Treatment Meets Primary Endpoint In Phase 3 Study

(RTTNews) - Shanghai Henlius Biotech, Inc. (2696.HK) on Thursday announced that HANSIZHUANG, used in combination with chemotherapy, has successfully met the primary endpoint of event-free survival (EFS) in an interim analysis of its phase 3 study.

The study, dubbed ASTRUM-006, is designed to evaluate the efficacy and safety of HANSIZHUANG , used in combination with chemotherapy, as a neoadjuvant/adjuvant monotherapy treatment for patients with early-stage gastric cancer, compared to a placebo plus chemotherapy regimen.

Based on the positive results, the Independent Data Monitoring Committee has recommended that the company submit an early New Drug Application (NDA) for HANSIZHUANG.