Hansoh Pharma's B7-H3-Targeted ADC HS-20093 Granted Breakthrough Therapy Designation by NMPA for Non-Squamous Non-Small Cell Lung Cancer

Hansoh Pharma (03692) announced that on April 17, 2025, HS-20093, a self-developed B7-H3-targeted antibody-drug conjugate (ADC) for injection, was approved by the National Medical Products Administration (NMPA) of China for inclusion in the breakthrough therapy designation. The proposed indication is for locally advanced or metastatic non-squamous non-small cell lung cancer that is driver gene-negative and has progressed or relapsed after prior platinum-based chemotherapy.

HS-20093 is a B7-H3-targeted ADC covalently linked by a fully human anti-B7-H3 monoclonal antibody and a topoisomerase inhibitor (TOPOi) payload. It is currently undergoing multiple clinical trials in China for the treatment of lung cancer, sarcoma, head and neck cancer, and other solid tumors, with the highest stage of research being Phase III clinical trials. On November 1, 2024, HS-20093 was designated as a breakthrough therapy by the NMPA for the indication of extensive-stage small cell lung cancer (ES-SCLC) that has progressed after standard first-line treatment (platinum doublet chemotherapy combined with immunotherapy). On February 25, 2025, HS-20093 was designated as a breakthrough therapy by the NMPA for the indication of treating osteosarcoma patients who have progressed after at least two prior lines of therapy.