Hansoh Pharma (03692) has announced that its self-developed B7-H3-targeting antibody-drug conjugate (ADC), HS-20093, has met its primary endpoint in the pivotal Phase III clinical trial (ARTEMIS-011). The trial was conducted in patients with osteosarcoma who had progressed or relapsed after receiving at least two prior lines of systemic therapy.

Compared to chemotherapy, HS-20093 demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) as assessed by an Independent Review Committee (IRC). Consistent benefits were also observed across secondary clinical endpoints, including overall survival (OS) and investigator-assessed PFS.

The safety profile was consistent with prior studies, and no new safety signals were identified. Based on these positive results, the group will soon initiate communications with regulatory authorities to advance preparations for a New Drug Application in China.

Detailed data from the ARTEMIS-011 study is expected to be presented at a future international oncology conference.