[EirGenix] Licensing Partner Sandoz Submits Variation Application to EMA for EG12014 to Add 420mg Vial Dosage

1. Date of occurrence: April 24, 2026. 2. Name or code of the new drug: Herwenda, EG12014 (Trastuzumab Biosimilar). 3. Purpose: Treatment of early breast cancer, metastatic breast cancer, and metastatic gastric cancer. 4. R&D stages: Submission of a Type II variation application to the European Medicines Agency (EMA) for adding the 420mg vial dosage. 5. Current R&D stage: (1) Marketing authorization for the 150mg dosage in the EU has already been obtained. This application is for the additional 420mg vial. (2) Future Direction: If approved, the 420mg dosage is expected to expand market layout and have a positive impact on the company's overall operations. (3) Accumulated R&D expenses: Not disclosed due to a confidentiality agreement with Sandoz. 6. Next steps: The review schedule will follow EMA's procedures, and the final result depends on EMA's notification. 7. Market status: Breast cancer and gastric cancer are major cancer burdens in Europe. The reference drug Herceptin had sales of 1.028 billion CHF (approx. $1.3 billion) in 2025. The biosimilar market is estimated at $6.9 billion, where the 420mg vial accounts for about two-thirds of the European market share. Sandoz's addition of the 420mg vial is expected to capture the mainstream market. 8. Other matters: None. 9. Risk Warning: New drug development is long, expensive, and not guaranteed to succeed.