Medigen Vaccine Biologics : The manufacturing facility of MVC EV71 Vaccine obtained PIC/S GMP certificate from the Ministry of Health and Welfare (MOHW)

Close

Today's Information

Provided by: Medigen Vaccine Biologics Corporation
SEQ_NO	1	Date of announcement	2022/06/07	Time of announcement	22:28:02
Subject	The manufacturing facility of MVC EV71 Vaccine obtained PIC/S GMP certificate from the Ministry of Health and Welfare (MOHW)
Date of events	2022/06/07	To which item it meets	paragraph 53
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