Hansoh Pharmaceutical’s HS-20093 injection marketing authorization application for SCLC accepted by China’s NMPA

CAR-T Digest - August 2020

02 September 2026: Hansoh Pharmaceutical’s HS-20093 injection marketing authorization application for SCLC accepted by China’s NMPA

Hansoh Pharma announced that the NMPA has formally accepted the marketing authorization application for HS-20093, for the treatment of adult patients with small cell lung cancer who have progressed following platinum-based chemotherapy
The application is based on the phase 3 ARTEMIS-008 study, which met its primary overall survival endpoint, marking the first positive phase 3 result demonstrating a significant OS benefit with a B7-H3-directed ADC in a solid tumor setting
The application addresses a major unmet need in SCLC, an aggressive and rapidly progressing form of lung cancer in which most patients relapse or develop resistance following first-line platinum-based chemotherapy, leaving limited treatment options in later lines
HS-20093 is a B7-H3-directed ADC comprising a fully human B7-H3 monoclonal antibody conjugated to a topoisomerase I inhibitor payload, enabling targeted delivery of the cytotoxic agent to B7-H3-expressing tumor cells
Strategically, the NMPA acceptance advances HS-20093 toward potential approval in SCLC while strengthening Hansoh Pharma’s B7-H3 ADC franchise, with the asset also in phase 3 development for osteosarcoma and NSCLC and being evaluated across multiple additional solid tumors