Fact Source: Financial Supervisory Service DART
💡 3-Second Summary
Celltrion has submitted an extension application for CT-P6 SC, a subcutaneous formulation of Herzuma, to the European Medicines Agency (EMA) and the European Commission (EC) based on Phase 1 clinical trial results.
📊 [Key Disclosure Details & Financial Summary]
- Disclosure Title: Application for Extension of Marketing Authorization for CT-P6 SC (Herzuma Subcutaneous Formulation) in Europe
- Filing Date & Regulatory Agency: April 30, 2026 (Local time), European Medicines Agency (EMA) / European Commission (EC)
- Product Name: CT-P6 SC (Herzuma Subcutaneous Formulation)
- Target Indications: Early breast cancer, Metastatic breast cancer
- Clinical Trial Details:
- Trial Identifier: NCT06687928 (ClinicalTrials.gov)
- Subject Scale & Design: 203 healthy adult male subjects / Double-blind, randomized, active-controlled Phase 1 clinical trial
- Key Results:
- Pharmacokinetics (PK): 90% confidence intervals for primary endpoints ($AUC_{0-inf}$, $C_{max}$) fell within the predefined equivalence margin (80%–125%), demonstrating PK equivalence to reference Herceptin SC.
- Safety: Treatment-emergent adverse events were reported in 89.5% of subjects (comparable between groups, mostly mild to moderate) with no serious adverse events.
- Immunogenicity: Incidence of ADA/NAb against trastuzumab and rHuPH20 was low and similar across groups, showing no safety impact.
- Expected Effects: Expand treatment options across all approved indications of the reference product.
- Board Resolution / Fact Confirmation Date: April 30, 2026
- Investment Caution: Submission of application does not guarantee final approval, and commercialization plans remain subject to change during regulatory evaluation.
📝 Editor’s Comment (Key Follow-up Checkpoint)
📌 Verification of European Regulatory Review Progress and Approval Outcomes
This disclosure relates to Celltrion’s extension application submitted to the EMA and EC for CT-P6 SC, making it important to monitor the ongoing regulatory evaluation and final approval decision. Tracking official regulatory outcomes is necessary to verify the completion of the authorization process. Review progress and final decision updates can be tracked through subsequent regulatory filings or under ‘Ongoing Research and Development Activities’ in upcoming periodic filings (Quarterly, Half-Yearly, or Annual Business Reports).
📢 Disclaimer & Source Information
Source: This content was newly generated and structured based on official data submitted to the Data Analysis, Retrieval and Transfer System (DART) of the Financial Supervisory Service.
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