Submitted extension application for CT-P6 SC (Herzuma subcutaneous) to EMA (April 30, 2026)
Indications: early and metastatic breast cancer (same as originator Herceptin SC)
Phase 1 trial (n=203): PK equivalence demonstrated (90% CI for AUC0-inf and Cmax within 80-125%)
Safety: AEs in 89.5% (mostly mild/moderate), no serious AEs, comparable between groups
Immunogenicity: low ADA/NAb incidence, similar between groups, no clinical impact
Next steps: pursue approvals in additional countries after EU decision
KOSPI Filing Information
Major Management Matters Related to Investment Decision (Application for Addition of European Formulation of CTP6 SC (Herzuma Subcutaneous Injection Formulation))