CT-P6 SC (Herzuma subcutaneous) EU extension application - Phase 1 success
- 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
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KOSPI Filing Information
- Filing: Major Management Matters Related to Investment Decision (Application for Addition of European Formulation of CTP6 SC (Herzuma Subcutaneous Injection Formulation))
- Company: Celltrion (068270)
- Submission: Celltrion, Inc.
- Receipt: 04-30-2026
- Under KRX KOSPI Market Division