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Statement
| 1.Date of occurrence of the event:2022/06/07
2.Company name:MEDIGEN VACCINE BIOLOGICS CORPORATION
3.Relationship to the Company (please enter "head office" or
"subsidiaries"):head office
4.Reciprocal shareholding ratios:non applicable
5.Cause of occurrence:
MVC EV71 vaccine is currently under review for New Drug Application by
Taiwan Food and Drug Administration (TFDA), and simultaneously applies for
PIC/S GMP inspection.
Today (6/7), MVC obtained the official letter from MOHW, confirming that
full-line operations (including antigen production, formulation, sterile
filling, packaging, release testing, GDP cold chain storage and
transportation) of MVC EV71 vaccine manufacturing facility are in compliance
with the Good Manufacturing Practice for Medicinal Products. MOHW granted
and renewed the PIC/S GMP certificate, the license number: (AP) 0460161.
6.Countermeasures:
At present, there are only three companies have launched EV71 vaccines in
China, and the vaccines are suitable for over 6 months old babies. The
average sales volume in the last three years is about 21 million doses per
year, and the annual sales is about NT$30 billion.
MVC EV71 vaccine is currently the only project in the world that obtained
the multi-regional clinical trial validation, the vaccine efficacy data of
high-risk population aged 2 to 6 months infants, and with PIC/S GMP
certificate.
In the follow-up, MVC will target to the markets in Taiwan, Southeast Asia
, etc., where with high demand and there are no enterovirus vaccines on the
markets. Also, MVC will file new drug application registration in the
target markets and international regulatory authorities.
7.Any other matters that need to be specified:none
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