Medigen Vaccine Biologics Corporation received the NDA approval letter of MVC quadrivalent influenza vaccine from Taiwan Food and Drug Administration. Indication: Prophylaxis against influenza caused by influenza A subtype viruses and type B viruses in adults and children aged 3 years and older. Current development stage: Application submission/approval/disapproval/each of clinical trials (include interim analysis): MVC FLU Quadrivalent pre-filled syringe injection received the NDA approval letter from TFDA.

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 may occur: N/A. After obtaining official approval or the results of statistically significant sense, the future strategy: Vaccine product launch and sales. Accumulated investment expenditure incurred: Based on business strategy considerations, it will not be disclosed for the time being. Taiwan's quadrivalent influenza vaccine is dominated by the government- funded market.

The purchase quantity of public-funded quadrivalent influenza vaccine in Taiwan each year is about 6 million doses with a budget of about TWD 1.5 billion. There are currently 3 suppliers (including local or imported companies) to provide the public-funded influenza vaccine market, and there is another 0.5approximately 1 million doses for self-paid vaccine market. MVC quadrivalent influenza vaccine is cooperated by the company and GC Pharma in South Korea.

GC Pharma produces the vaccine bulk, and then the company (MVC) conducts fill-and-finish, sub-packaging and quality control release. MVC will invest in the domestic annual quadrivalent influenza vaccine supply.