Fact Source: Financial Supervisory Service DART
💡 3-Second Summary
Celltrion announced that it has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) for CT-P39 (Omalizumab), a biosimilar to Xolair, covering 30 European countries.
📊 [Key Disclosure Details & Financial Highlights]
- Overview
- Title: Acquisition of Positive Opinion from EMA CHMP for CT-P39 (Xolair Biosimilar)
- Product Name: CT-P39 (Active Ingredient: Omalizumab)
- Regulatory Authority: Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA)
- Board Resolution or Fact Confirmation Date: March 23, 2024 (Date of confirming CHMP positive opinion)
- Key Regulatory Timeline
- Application Date: April 24, 2023 (Local Time)
- CHMP Positive Opinion Date: March 21, 2024 (Local Time)
- Approved Indications & Scope
- Indications: Allergic asthma, Chronic rhinosinusitis with nasal polyps, Chronic spontaneous urticaria
- Scope of Recommendation: Positive opinion for marketing authorization covering 30 European countries
- Future Plans & Expected Effects
- Secured positive opinion for all indications approved for the reference drug.
- Following the CHMP recommendation, Celltrion expects to obtain final marketing authorization from the European Commission (EC) in the near future.
📝 Editor’s Comment (Key Follow-up Checkpoint)
📌 Verification of Final Marketing Authorization from the European Commission (EC)
This disclosure details the receipt of a positive CHMP opinion from the EMA for CT-P39. Tracking the subsequent final marketing authorization decision by the European Commission (EC) is key to assessing the pipeline’s progress toward commercial launch in Europe. 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).
Investment Risk Warning: This content is provided for informational and linguistic 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.
Contact: For compliance inquiries or copyright requests, please contact ksb220805@gmail.com.
