Hansoh Pharma has submitted a China marketing application for risvutatug rezetecan (HS-20093), a B7-H3-directed antibody-drug conjugate (ADC) with a TopI inhibitor payload, for small cell lung cancer (SCLC) after platinum-based therapy failure.

The filing follows the Phase III ARTEMIS-008 study, which met its overall survival (OS) primary endpoint at a prespecified interim analysis versus topotecan, with consistent progression-free survival (PFS) benefit and a safety profile aligned with prior studies and no new signals – the first Phase III evidence that a B7-H3 ADC confers a significant OS advantage in SCLC. Hansoh out-licensed ex-Greater China rights to GSK in December 2023, and GSK is advancing overseas Phase III development.

SCLC accounts for roughly 15% of lung cancers and carries a poor prognosis, with most patients relapsing quickly after first-line platinum-based chemo and facing limited second-line options beyond topotecan or lurbinectedin.