Adimmune (TWSE: 4142) and its subsidiary Enimmune (TWSE: 6564) today announced that Taiwan Food and Drug Administration (TFDA) of the Ministry of Health and Welfare has granted the Marketing Authorization for EnVAX-A71, the first Taiwan independently developed and manufactured vaccine to prevent EV71.  

The Phase 1 clinical trial of the EV71 vaccine was originally undertaken by the National Health Research Institutes (NHRI). In 2009, Adimmune carried on and completed the Phase 2 clinical trial. To ensure stable commercial production and raise purification quality, the Company developed a high capacity manufacturing process utilizing cell culture bioreactors to substitute for NHRI’s roller bottles technology, and conducted another Phase 2 clinical trial. Enimmune was then established and together with Adimmune completed the Phase 3 clinical trial as well as the manufacturing process development and quality validation indicators. 

“It took 13 years and NTD1.5 billion to develop the EV71 vaccine in our collective effort,” said Chi-Hsien Chan, Chairman and CEO of Adimmune Corporation. “This is Taiwan’s very first independently developed and manufactured human vaccine. This significant milestone represents Taiwan’s strength and our pride in the biotech industry.” 

Enimmune’s EnVAX-A71 vaccine is EV71 B4 virus-based, the circulating strain in Taiwan. The vaccine will protect children in Taiwan from enterovirus once it is available in Q1. EnVAX-A71 is also proven to be effective against the main circulating strains in Southeast Asia and China. The Vietnam’s Phase 3 clinical trial is soon to be completed and Enimmune has signed a marketing and sales MOU with Vietnam’s largest state-owned vaccine company. The vaccine market of the newborns in Southeast Asia is estimated over 20 million doses per year. Submissions for regulatory approvals in Southeast Asia, China, Korea, and Japan are planned. 

About Enterovirus 

Enterovirus is a prevalent infectious disease in Asia. Children under five years of age, if infected with enterovirus 71, are prone to severe complications. In 1998, during the first outbreak of hand, foot and mouth disease and herpangina in Taiwan, as many as 1.4 million children were infected, 405 with severe complications, and 78 children died. The severe neurological complications were mainly caused by enterovirus 71.