Fact Source: Financial Supervisory Service DART
💡 3-Second Summary
Celltrion received final marketing authorization from the US Food and Drug Administration (FDA) for Steqeyma (CT-P43), a Stelara biosimilar, for key indications including plaque psoriasis and Crohn’s disease across the United States.
📊 Key Disclosure Content & Financial Highlights
- Overview
- Company: Celltrion, Inc. (Stock Code: 068270)
- Disclosure Type: Major Matters Report Related to Investment Decisions
- Subject: US FDA Final Marketing Authorization Approval for Steqeyma (CT-P43, Stelara Biosimilar)
- Regulatory Authority: US Food and Drug Administration (FDA)
- Key Dates (Local Time):
- Application Date: 2023-06-30
- Marketing Approval Date: 2024-12-17
- Confirmation Date: 2024-12-18 (Date official FDA approval document was received)
- Product & Indication Details
- Approved Product: Steqeyma (CT-P43, Active Ingredient: Ustekinumab)
- Approved Indications:
- Plaque psoriasis
- Pediatric plaque psoriasis
- Psoriatic arthritis
- Pediatric psoriatic arthritis
- Crohn’s disease
- Ulcerative colitis
- Key Details & Future Plans
- Approval Details: Secured final US marketing authorization across all indications approved for the reference product
- Expected Effects: Expanded therapeutic options for US patients suffering from target inflammatory conditions
- Future Plans: Commercial distribution across the US 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 US FDA Marketing Authorization Listing in Official Documents
This disclosure serves as official notification regarding US FDA marketing approval for Steqeyma for specified 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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