Medigen Vaccine Biologics Corporation filed new drug Application of MVC Trivalent Influenza Vaccine to Taiwan Food and Drug Administration. New drug name or code:MVC FLU Trivalent pre-filled syringe injection. Indication: Prevention of influenza-related diseases caused by two types of influenza A and one type of influenza B viruses.

Planned development stages: File New Drug Application (NDA) to Taiwan Food and Drug Administration. Current development stage: Application submission/approval/disapproval/each of clinical trials (include interim analysis): File New Drug Application (NDA) to Taiwan Food and Drug Administration. Once disapproved by competent authority or each of clinical trials (include interim analysis) results less than statistically significant sense, the risks & the associated measures the Company.

Upcoming development plan: Estimated date of completion: Depends on the review progress by the regulatory authority. Estimated responsibilities: All relevant fees for the registration of new drug application. Market situation: The World Health Organization (WHO) recommended on February 23, 2024, to remove the B/Yamagata strain antigen from quadrivalent influenza vaccines.

The United States, Europe, and other countries are also gradually transitioning their publicly funded influenza vaccines to trivalent influenza vaccines. To complete company's influenza vaccine product line and to align with regulatory trends, they have submitted a New Drug Application (NDA) of trivalent influenza vaccines to meet future market demands.