Fact Source: Financial Supervisory Service DART
💡 3-Second Summary
Celltrion received final marketing authorization from the European Commission (EC) for Stoboclo and Osenvelt (CT-P41), biosimilars to Prolia and Xgeva, covering all reference indications across 30 European countries.
📊 Key Disclosure Content & Financial Highlights
- Overview
- Company: Celltrion, Inc. (Stock Code: 068270)
- Disclosure Type: Major Matters Report Related to Investment Decisions
- Subject: European Commission Final Marketing Authorization Approval for Stoboclo & Osenvelt (CT-P41, Prolia & Xgeva Biosimilars)
- Regulatory Authority: European Commission (EC)
- Key Dates (Local Time):
- Application Date: 2024-03-08
- CHMP Positive Opinion Date: 2024-12-12
- Final Marketing Approval Date: 2025-02-17
- Confirmation Date: 2025-02-18 (Date EC approval was confirmed)
- Product & Indication Details
- Approved Products (Active Ingredient: Denosumab):
- Stoboclo (CT-P41, Prolia Biosimilar)
- Osenvelt (CT-P41, Xgeva Biosimilar)
- Target Region: 30 European countries
- Approved Indications:
- Stoboclo: Osteoporosis in postmenopausal women and men, bone loss associated with hormone ablation in prostate cancer, bone loss associated with long-term glucocorticoid therapy
- Osenvelt: Prevention of skeletal-related events in adults with advanced malignancies involving bone, giant cell tumor of bone
- Key Details & Future Plans
- Approval Details: Secured final European marketing authorization for all indications approved for the reference products (Prolia & Xgeva)
- Expected Effects: Broadened treatment options for European patients by securing authorization across all reference indications
- Future Plans: Distribution across Europe via local sales subsidiaries
- Additional Notes: Content will be utilized in upcoming press releases and IR materials
📝 Editor’s Comment (Key Follow-up Checkpoint)
📌 Verification of EC Marketing Authorization Listing in Official Documents
This disclosure serves as official notification regarding EC marketing approval for Stoboclo and Osenvelt across 30 European countries for all reference indications. Checking whether the final marketing authorization status is accurately reflected in the company’s official periodic reporting documents is important for verifying the formal regulatory documentation. Relevant updates can be confirmed through subsequent periodic reports or official IR materials.
📢 Disclaimer & Source Notice
Source: This content was structured and generated based on official disclosure data from the Financial Supervisory Service’s DART system.
Investment Risk Warning: This material is provided for informational and language reference purposes only. Under no circumstances does it constitute financial advice or a recommendation to buy or sell specific stocks. All investment decisions and financial responsibilities rest solely with the investor.
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