Fact Source: Financial Supervisory Service DART
💡 3-Second Summary
Celltrion received marketing authorization from the Ministry of Food and Drug Safety (MFDS) of South Korea for Avtozma (CT-P47), a biosimilar referencing Actemra, covering major indications including adult rheumatoid arthritis.
📊 Key Disclosure Content & Financial Highlights
- Overview
- Company: Celltrion, Inc. (Stock Code: 068270)
- Disclosure Type: Major Matters Report Related to Investment Decisions
- Subject: Korean MFDS Marketing Authorization Approval for Avtozma (CT-P47, Actemra Biosimilar)
- Regulatory Authority: Ministry of Food and Drug Safety (MFDS), South Korea
- Key Dates:
- Application Date: 2024-02-28
- Marketing Approval Date: 2024-12-20
- Confirmation Date: 2024-12-20 (Date MFDS approval was confirmed)
- Product & Indication Details
- Approved Product: Avtozma (CT-P47, Active Ingredient: Tocilizumab)
- Approved Indications:
- Adult Rheumatoid Arthritis
- Systemic Juvenile Idiopathic Arthritis
- Polyarticular Juvenile Idiopathic Arthritis
- Key Details & Future Plans
- Approval Details: Secured domestic marketing authorization for Avtozma across all target indications
- Future Plans: Expand therapeutic options for patients in South Korea as approval was granted for all indications approved for the reference drug
- Additional Notes: Content will be utilized in upcoming press releases and IR materials
📝 Editor’s Comment (Key Follow-up Checkpoint)
📌 Verification of Domestic Marketing Authorization Listing in Official Documents
This disclosure serves as official notification regarding MFDS marketing approval for Avtozma in South Korea. Checking whether the 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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