Fact Source: Financial Supervisory Service DART
💡 3-Second Summary
Celltrion received marketing authorization from the Ministry of Food and Drug Safety (MFDS) for Stoboclo and Osenvelt (CT-P41), biosimilars referencing Prolia and Xgeva.
📊 Key Disclosure Content & Financial Highlights
- Overview
- Company: Celltrion, Inc. (Stock Code: 068270)
- Disclosure Type: Major Matters Report Related to Investment Decisions
- Subject: Domestic (MFDS) Marketing Authorization for Stoboclo & Osenvelt (CT-P41, Prolia & Xgeva Biosimilar)
- Regulatory Authority: Ministry of Food and Drug Safety (MFDS)
- Key Dates: Application Date 2023-12-29 / Approval Date 2024-11-21
- Confirmation Date: 2024-11-21 (Date marketing authorization was confirmed)
- Product & Indication Details
- Products:
- Stoboclo (CT-P41, Prolia Biosimilar, Active Ingredient: Denosumab)
- Osenvelt (CT-P41, Xgeva Biosimilar, Active Ingredient: Denosumab)
- Approved Indications:
- Stoboclo: Postmenopausal osteoporosis, male osteoporosis, glucocorticoid-induced osteoporosis, bone loss in prostate cancer patients on androgen deprivation therapy, bone loss in breast cancer patients on adjuvant aromatase inhibitor therapy
- Osenvelt: Prevention of skeletal-related events in patients with multiple myeloma and bone metastases from solid tumors, giant cell tumor of bone
- Key Details & Expected Effects
- Approval Scope: Secured domestic marketing authorization for Stoboclo and Osenvelt across the listed target indications
- Expected Effects: Expected to provide treatment options to more patients in the future by securing marketing authorization across all reference indications
- Additional Notes: Content will be utilized in upcoming press releases and IR materials
📝 Editor’s Comment (Key Follow-up Checkpoint)
📌 Verification of Marketing Authorization Official Reflection and Subsequent Disclosures
This disclosure serves as official notification regarding the MFDS marketing authorization for Stoboclo and Osenvelt in Korea. Following product approval, monitoring the official reflection of this marketing authorization and subsequent disclosures is important. Relevant updates can be confirmed through future disclosures 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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