Regulatory & Policy

NMPA accepts Hansoh’s B7-H3 ADC HS-20093 in post-platinum SCLC

Edited by Robert McTiernan··2 min read
NMPA accepts Hansoh’s B7-H3 ADC HS-20093 in post-platinum SCLC

China's National Medical Products Administration (NMPA) has accepted a biologics license application from Hansoh Pharmaceutical Group Company Limited (HKEX: 03692) for HS-20093, a B7-H3-directed antibody-drug conjugate (ADC), in adult patients with small cell lung cancer (SCLC) who have progressed on prior platinum-based chemotherapy. The filing, accepted September 2, 2026, marks the first regulatory submission for HS-20093 in SCLC.

The application follows the Phase III ARTEMIS-008 trial, in which HS-20093 demonstrated a statistically significant and clinically meaningful improvement in overall survival compared with topotecan at a pre-specified interim analysis. Consistent benefit was also reported across secondary endpoints including progression-free survival. Hansoh said the safety profile was consistent with prior findings, with no new signals identified. Detailed data are expected at an upcoming international oncology conference.

HS-20093 targets B7-H3 (CD276), an immune checkpoint protein broadly overexpressed across multiple solid tumor types, and delivers a topoisomerase I inhibitor payload following receptor-mediated internalization. The molecule is licensed to GSK outside Greater China.

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The SCLC filing is the first confirmed BLA submission for HS-20093. Hansoh is also preparing an approval filing in China for HS-20093 in osteosarcoma based on a positive data readout from the ARTEMIS-011 study, which met its primary endpoint of progression-free survival in relapsed or refractory osteosarcoma. The molecule had also received NMPA Breakthrough Therapy Designation in April 2026 in combination with adebrelimab for non-squamous non-small cell lung cancer after platinum-based chemotherapy, extending development of HS-20093 across a third tumor type.

In post-platinum SCLC, topotecan remains a standard second-line option despite modest efficacy, while lurbinectedin is available in some markets. No ADC is currently approved in this setting in China. HS-20093’s Phase III survival benefit against topotecan therefore gives Hansoh a clinically differentiated basis for its first regulatory filing for the drug.

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