Fact Source: Financial Supervisory Service DART
💡 3-Second Summary
Celltrion has submitted an application for marketing authorization of CT-P6 SC, a subcutaneous formulation of Herzuma, to the Ministry of Food and Drug Safety (MFDS) in South Korea based on successful Phase 1 clinical trial results.
📊 [Key Disclosure Details & Financial Summary]
- Disclosure Title: Application for Marketing Authorization of CT-P6 SC (Herzuma Subcutaneous) in South Korea
- Filing Date & Agency: May 28, 2026, Ministry of Food and Drug Safety (MFDS)
- Product Name: CT-P6 SC (Herzuma Subcutaneous Formulation)
- Target Indications: Early Breast Cancer, Metastatic Breast Cancer
- Clinical Trial Details:
- Approval Date & Agency: February 27, 2025, MFDS
- 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 (AUC0−inf, Cmax) 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 reported.
- Immunogenicity: Incidence of ADA/NAb against trastuzumab and rHuPH20 was generally low and similar across groups, with no clinically meaningful impact on safety.
- Expected Effects: Provide broader treatment options to patients across all indications approved for the reference product.
- Board Resolution / Fact Confirmation Date: May 28, 2026
- Investment Caution: Submission of approval application does not guarantee final regulatory approval, and commercialization plans may change or be withdrawn during evaluation.
📝 Editor’s Comment (Key Follow-up Checkpoint)
📌 MFDS Final Approval Status and Global Regulatory Submissions
This disclosure relates to Celltrion’s filing for marketing authorization of CT-P6 SC with the Korean MFDS, making it essential to monitor whether final regulatory approval is granted. Tracking official approval in South Korea and subsequent filings in key global markets is critical to assessing the product’s ultimate timeline to market and commercial impact. Progress updates and future applications can be verified in subsequent regulatory filings or under the ‘Ongoing Research and Development Activities’ section in upcoming periodic reports (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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