Hansoh Pharma announces NMPA has granted Breakthrough Therapy Designated drug for B7-H3-targeted antibody-drug conjugate HS-20093 for nsNSCLC

CAR-T Digest - August 2020

Weekly Digest - April 2025

17 Apr 2025: Hansoh Pharma announces NMPA has granted Breakthrough Therapy Designated drug for B7-H3-targeted antibody-drug conjugate HS-20093 for nsNSCLC

Hansoh Pharma announced that its B7-H3-targeted antibody-drug conjugate HS-20093 has been granted BTD by China’s NMPA for treating advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) without driver mutations
The designation is based on preliminary data from the ongoing ARTEMIS-001 Phase 1 trial involving over 300 patients
The trial assesses the safety, tolerability, and anti-tumor activity of HS-20093 in patients whose disease progressed after platinum-based chemotherapy
HS-20093 had previously received the same designation for extensive-stage small-cell lung cancer (ES-SCLC) after first-line treatment failure
It also holds BTD status for osteosarcoma in patients who have failed at least two prior treatments