Emerging biotech stock Enimmune announced on the 20th that its independently developed enterovirus 71 (EV71) vaccine, EnVAX-A71, has been officially submitted for marketing authorization in Vietnam. The submission was made on July 18 by its local partner, the Vietnamese state-owned company VABIOTECH, to the Drug Administration of Vietnam (DAV) under the Ministry of Health.
According to Enimmune’s announcement, the EnVAX-A71 vaccine is intended for active immunization in infants and young children aged over two months up to six years old, to prevent diseases caused by EV71 infection. Following this submission to the DAV, Enimmune also plans to apply for regulatory approvals in other Southeast Asian countries.
The company stated that this application aligns with Vietnam’s newly issued Circular No. 12/2025/TT-BYT on the Registration of Drugs and Pharmaceutical Ingredients, released by the Ministry of Health on May 16, 2025, and coming into effect on July 1, 2025.
Enimmune pointed out that the incidence of hand, foot, and mouth disease (HFMD) has been on the rise globally over the past decade, especially in Asia-Pacific countries such as mainland China, Japan, Singapore, and Vietnam. According to the World Health Organization (WHO), Vietnam reports between 50,000 and 100,000 HFMD cases annually, including several fatalities. Research further shows that Vietnam records an average of 80,000 HFMD cases per year, yet no EV71 vaccine is currently available in the country.
The global enterovirus vaccine market is valued at USD 340 million in 2024 and is projected to grow to USD 570 million by 2033, with a compound annual growth rate (CAGR) of approximately 5.8%. Should Vietnam include the vaccine in its national immunization program, the local market potential is estimated at USD 40 million annually, while the ASEAN market could exceed USD 300 million.
Enimmune added that its EV71 vaccine has successfully completed a multicenter Phase III clinical trial, demonstrating a vaccine efficacy (VE) of 99.21%, meeting key benchmarks for protective effectiveness and immune durability. The company has also initiated GMP validation for 200- and 1,000-liter scale commercial production, ensuring sufficient supply capacity to meet market demand in Vietnam. Looking ahead, Enimmune will continue its regulatory submission efforts across Southeast Asia and the global market, aiming to close the regional public health gap and safeguard infant and child health.
Resource: 安特羅腸病毒71型疫苗 正式向越南提交上市許可申請
