Hengrui Scores Phase III Wins for HER2 ADC, ANGPTL3 mAb

China's Hengrui has reported positive Phase III results across two programmes. In the SHR-A1811-307 study, the HER2-directed ADC trastuzumab rezetecan combined with or without pertuzumab significantly extended progression-free survival versus docetaxel plus trastuzumab and pertuzumab (THP) in first-line HER2-positive breast cancer, meeting the primary endpoint at a prespecified interim analysis. The asset, which carries a TopI inhibitor payload with bystander activity, already holds three China approvals – HER2-mutant NSCLC (May 2025), HER2-positive breast cancer (March 2026), and HER2-positive colorectal cancer (August 2026) – with a fourth filing under review for HER2-low breast cancer.

Meanwhile, the Phase III readout for ANGPTL3 monoclonal antibody (mAb) SHR-1918 in homozygous familial hypercholesterolaemia showed a 58.8% LDL-C reduction at week 12 versus a 5.5% increase on placebo (between-group difference −64.2%, p<0.0001), with 83.3% of treated patients achieving ≥50% LDL-C reduction regardless of LDLR residual function. A China NDA filed in February 2026 has been granted priority review.

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