Fact Source: Financial Supervisory Service DART
💡 3-Second Summary
Celltrion announced that it has obtained marketing authorization from the Ministry of Food and Drug Safety (MFDS) of South Korea for Steqeyma (CT-P43), a biosimilar to Stelara, covering all approved indications of the original drug, including plaque psoriasis, Crohn’s disease, and ulcerative colitis.
📊 [Key Disclosure Details & Financial Highlights]
- Overview
- Title: Marketing Authorization Granted by South Korean MFDS for Steqeyma (CT-P43, Stelara Biosimilar)
- Product Name: Steqeyma (CT-P43, Active Ingredient: Ustekinumab)
- Regulatory Authority: Ministry of Food and Drug Safety (MFDS), South Korea
- Board Resolution or Fact Confirmation Date: June 12, 2024
- Key Regulatory Timeline
- Application Date: June 15, 2023
- Approval Date: June 12, 2024
- Approved Indications
- Plaque psoriasis
- Pediatric plaque psoriasis
- Psoriatic arthritis
- Crohn’s disease
- Ulcerative colitis
- Future Plans & Expected Effects
- Having secured approval for all indications authorized for the reference drug, Celltrion expects to expand treatment options for patients in South Korea.
📝 Editor’s Comment (Key Follow-up Checkpoint)
📌 Verification of Domestic Sales Launch and Subsequent Disclosures
This disclosure confirms that marketing authorization has been obtained from the Ministry of Food and Drug Safety (MFDS), establishing regulatory approval for domestic commercialization. Tracking post-approval steps such as the actual initiation of domestic sales and product launch is important for assessing the commercialization performance of the biosimilar pipeline. Detailed updates can be verified in subsequent disclosures and upcoming periodic reports (Quarterly, Half-Yearly, or Annual Reports).
📢 Disclaimer & Source Notice
Source: This content has been newly structured and created based on official submission data from the Financial Supervisory Service’s Data Analysis, Retrieval and Transfer System (DART).
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