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
Filing: Major Management Matters Related to Investment Decision (Application for Addition of European Formulation of CTP6 SC (Herzuma Subcutaneous Injection Formulation))