Adimmune Corp. and its subsidiary Enimmune Corp. announced that the first locally developed and produced enterovirus 71 vaccine (EnVAX-A71) has been approved by TFDA and is expected to be marketed in the first quarter of this year. 

It took 13 years and NT$1.5 billion to develop the enterovirus vaccine, and a large number of team members were mobilized to overcome many difficulties and write a new record for the successful launch of the domestic vaccine from research and development to mass production. In addition to giving priority to the supply of vaccinations for children in Taiwan, it will also go to Southeast Asia, South Korea, Japan, and mainland China.

In order to improve the quality and production technology of the vaccine to meet the market demand for mass production, Adimmune further researched and developed the original NHRI vial production technology and refined it to the Bioreactor process. The company then invested in a subsidiary, Enimmune, to jointly complete the Phase III human clinical trial and complete the process development and quality control validation targets.

According to the company, the vaccine took 13 years to develop, mobilised a large number of team members and resources, and cost NT$1.5 billion. It is the first human vaccine to be developed and marketed purely by Taiwanese, representing the energy and pride of Taiwan's biotechnology industry and an important milestone.

Enimmune's successfully licensed enterovirus 71 vaccine is based on the B4 subgenotype strain of the virus prevalent in Taiwan, and is combined with Adimmune's new generation of high-capacity cell culture bioreactor process; after its launch, it will give priority to protecting Taiwan's young children from the threat of enterovirus, adding another important tool for epidemic prevention.

Enimmune pointed out that since the enterovirus vaccine has cross-protection against epidemic strains in Southeast Asia and China, it will soon complete a Phase III clinical trial in Vietnam and sign a memorandum of understanding with Vietnam's largest state-owned vaccine company for the sale of enterovirus vaccines in order to expand into the Southeast Asian market.

In 1998, the first outbreak of severe hand, foot and mouth disease (HFMD) and herpangina occurred in Taiwan, infecting 1.4 million children, causing 405 severe complications and 78 deaths, including The main cause of severe neurological complications was enterovirus 71. The enterovirus 71 vaccine by Enimmune has excellent cross-protection potential in the international market.