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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.:
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