Exclusive Summary

• Proven Clinical Benefit: Phase III pivotal data demonstrates a median PFS of 11.33 months in HER2+ advanced breast cancer, significantly outperforming Lapatinib + Capecitabine with a 36% reduction in progression risk.
• Superior Safety Differentiator: exhibits an exceptionally low rate of Grade 3 diarrhea (0.5%) and a low discontinuation rate (4.5%) due to adverse events, positioning it as a potential Best-in-class option.
• Advanced Platform Technology: Validated non-natural amino acid site-specific conjugation ensures high drug homogeneity and in vivo stability, minimizing off-target toxicity.
• Expansion Potential: Promising efficacy confirmed in HER2-low breast cancer in combination with PD-1 (Toripalimab), showing an ORR of 42.3% and preliminary median OS of 19.6 months.

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