Medigen Vaccine Biologics : MVC file provisional approval application of COVID-19 Vaccine to Therapeutic Goods Administration

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Provided by: Medigen Vaccine Biologics Corporation
SEQ_NO	1	Date of announcement	2022/06/06	Time of announcement	15:21:11
Subject	MVC file provisional approval application of COVID-19 Vaccine to Therapeutic Goods Administration
Date of events	2022/06/06	To which item it meets	paragraph 10
Statement	1.Date of occurrence of the event:2022/06/06 2.New drug name or code:MVC COVID-19 Vaccine 3.Indication:Prevention of COVID-19 infection 4.Planned development stages:apply for Emergency Use Authorization (EUA) in various countries; pursue relative clinical studies and post-marketing surveillance 5.Current development stage: (1)Application submission/approval/disapproval/each of clinical trials (include interim analysis): file provisional approval (similar with EUA) application to Therapeutic Goods Administration (2)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 (3)After obtaining official approval or the results of statistically significant sense, the future strategy: N/A (4)Accumulated investment expenditure incurred: Based on business strategy considerations, it will not be disclosed for the time being. 6.Upcoming development plan: (1)Estimated date of completion: Depends on the review progress by the regulatory authority. (2)Estimated responsibilities: All relevant fees for the application. 7.Market situation: TGA is very convincing in global pharmaceutical regulatory authorities. It is not only one of the Stringent Regulatory Authority (SRA) defined by WHO, but also one of the top ten advanced medical countries in Taiwan's Regulations for Medicinal Products Registration. In the process of formulating international medical regulations for COVID-19, TGA is also the members of "International Coalition of Medicines Regulatory Authorities (ICMRA)", "Access Consortium", and "COVID-19 Vaccines and Therapeutics Committee of EMA". According to Our World in Data statistics, 67.6% of the world's population has completed at least one dose of COVID-19 vaccine, 62% of the population has completed fully vaccination, and 26% has received a third dose for booster vaccination; the total dose of vaccination have been more than 11.8 billion doses. At present, in addition to the large-scale vaccination of the third booster dose in developed countries, Israel, the United States and other countries have also begun to conduct the fourth booster dose or assessments for the elderly and high-risk groups. Based on the demand for primary series and the third booster dose, there is still a global demand gap of more than ten billion doses of COVID-19 vaccine. 8.Any other matters that need to be specified:None 9.New drug development requires long process, vast investments and with no guarantee in success which may pose investment risks.The investors are advised to exercise caution and conduct thorough evaluation.: