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 Eydenzelt (CT-P42), a biosimilar to Eylea, covering all approved indications of the reference drug, including neovascular (wet) age-related macular degeneration and diabetic macular edema.
📊 [Key Disclosure Details & Financial Highlights]
- Overview
- Title: Marketing Authorization Granted by South Korean MFDS for Eydenzelt (CT-P42, Eylea Biosimilar)
- Product Name: Eydenzelt (CT-P42, Active Ingredient: Aflibercept)
- Regulatory Authority: Ministry of Food and Drug Safety (MFDS), South Korea
- Board Resolution or Fact Confirmation Date: May 29, 2024
- Key Regulatory Timeline
- Application Date: July 26, 2023
- Approval Date: May 29, 2024
- Approved Indications
- Treatment of neovascular (wet) age-related macular degeneration
- Treatment of visual impairment due to macular edema secondary to retinal vein occlusion (branch RVO or central RVO)
- Treatment of visual impairment due to diabetic macular edema
- Treatment of visual impairment due to myopic choroidal neovascularization
- 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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