Fact Source: Financial Supervisory Service DART
💡 3-Second Summary
Alteogen obtained final marketing authorization approval from the Ministry of Food and Drug Safety (MFDS) for Tergase Injection (ALT-BB4, berahyaluronidase alfa), a recombinant human hyaluronidase stand-alone product.
📊 [Key Disclosure Details & Financial Highlights]
- Product Name: Tergase Injection (berahyaluronidase alfa (hyaluronidase, recombinant))
- Target Indications: Increasing the permeability of subcutaneous or intramuscular injections, local anesthetics, and subcutaneous infusions
- Marketing Authorization Timeline & Authority:
- Application Date: February 07, 2023
- Approval Date: July 05, 2024
- Regulatory Authority: Ministry of Food and Drug Safety (MFDS)
- Date of Fact Confirmation: 2024-07-05 (Date of notification of marketing authorization approval from the MFDS)
- Additional Notes: Disclosed information will be utilized for press releases and IR materials
- Related Disclosures:
- 2023-02-07 Major Management Matters Related to Investment Decision (Application for Marketing Authorization for ALT-BB4 (Tergase) Injection)
- 2023-02-08 Major Management Matters Related to Investment Decision (Application for Marketing Authorization for ALT-BB4 (Tergase) Injection)
📝 Editor’s Comment (Key Follow-up Checkpoint)
📌 Why Verifying Marketing Authorization Approval and Integration Is Necessary
This filing is an informational disclosure notifying that final marketing authorization from the Ministry of Food and Drug Safety (MFDS) has been granted for Tergase Injection (ALT-BB4).
Checking this follow-up item is necessary because the regulatory approval status for the product has been officially established following the final authorization decision by the MFDS. Verifying that the approved marketing authorization status and its details are accurately reflected in upcoming periodic reports or future disclosures is essential to confirm the final verification of the disclosed facts.
The details can be verified in future disclosures or upcoming periodic reports on DART.
📢 Disclaimer & Source Information
Source: This content was structured and generated based on official submission data from the Financial Supervisory Service’s Data Analysis, Retrieval and Transfer System (DART).
Investment Risk Warning: This content is provided solely for informational and linguistic reference purposes. Under no circumstances does it constitute financial advice or a recommendation to buy or sell specific stocks. All investment decisions and financial responsibilities rest entirely with the investor.
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