Zai Lab's NDA for margetuximab accepted by China NMPA for HER2+ breast cancer

Zai Lab Ltd

NMPA accepted NDA for margetuximab, a HER2-targeted monoclonal antibody, for metastatic HER2+ breast cancer with 2+ prior anti-HER2 therapies.
Margetuximab is the only HER2-targeted agent to show PFS improvement vs trastuzumab in head-to-head Phase 3 SOPHIA trial.
NDA acceptance marks Zai Lab's sixth NDA acceptance by NMPA and expands women's oncology franchise.
Bridging study in Chinese patients met primary endpoint of PFS by BICR; safety consistent with SOPHIA.

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.