Fact Source: Financial Supervisory Service DART
💡 3-Second Summary
Celltrion received final marketing approval from the U.S. FDA for Stoboclo and Osenvelt (CT-P41), biosimilars to Prolia and Xgeva, covering all indications held by the reference products.
📊 Key Disclosure Content & Financial Highlights
- Overview
- Company: Celltrion, Inc. (Stock Code: 068270)
- Disclosure Type: Major Matters Report Related to Investment Decisions
- Subject: U.S. FDA Final Marketing Approval for Stoboclo & Osenvelt (CT-P41, Prolia & Xgeva Biosimilars)
- Regulatory Body: U.S. Food and Drug Administration (FDA)
- Application & Approval Dates (Local Time): Application Date 2023-11-30 / Approval Date 2025-02-28
- Confirmation Date: 2025-03-01 (Date FDA approval was confirmed)
- Product & Indication Details
- Approved Products (Active Ingredient: Denosumab):
- Stoboclo (CT-P41, Prolia Biosimilar)
- Osenvelt (CT-P41, Xgeva Biosimilar)
- Approved Indications:
- Stoboclo: Postmenopausal osteoporosis, Male osteoporosis, Glucocorticoid-induced osteoporosis, Bone mass loss in nonmetastatic prostate cancer receiving ADT, Bone mass loss in breast cancer receiving adjuvant AI therapy
- Osenvelt: Prevention of SREs in multiple myeloma and bone metastases from solid tumors, Giant cell tumor of bone, Hypercalcemia of malignancy refractory to bisphosphonate therapy
- Key Details & Future Plans
- Approval Details: Secured final U.S. marketing authorization for all indications approved for the reference products (Prolia & Xgeva)
- Expected Effects: Expanded treatment options for patients by securing authorization across all reference indications
- Future Plans: Distribution throughout the U.S. via local subsidiary
- Additional Notes: Content will be utilized in future press releases and IR materials
📝 Editor’s Comment (Key Follow-up Checkpoint)
📌 Verification of Final FDA Approval Listing in Official Documents
This disclosure serves as official notification regarding FDA marketing approval for Stoboclo and Osenvelt across all reference drug indications. Reviewing 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.
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