MVC's ENVACGEN® Receives First Marketing Authorisation for Enterovirus A71 Vaccine in Vietnam; Collaborating with Substipharm Biologics
Taipei and Geneva, (ANTARA/PRNewswire) - On 17 March, Medigen Vaccine Biologics Corp. (MVC) and Substipharm Biologics announced that ENVACGEN®, the Enterovirus 71 (EV-A71) vaccine, has obtained marketing authorisation from the Drug Administration of Vietnam (DAV). Substipharm Biologics will market and distribute the vaccine in Vietnam. Holding more than 97% market share in Taiwan, ENVACGEN® now makes history as the first EV-A71 vaccine approved in Vietnam. This achievement provides a strong foundation for both companies to expand their business reach in Southeast Asia.
Enterovirus 71 (EV-A71) is the primary cause of serious neurological complications and deaths in children in Asia. Vietnam has been significantly impacted by recurrent outbreaks, with approximately 180,000 cases and 31 reported deaths in 2023. This condition poses a serious threat to child health and places a heavy burden on the local healthcare system.
As a “best-in-class” vaccine, ENVACGEN® demonstrates excellent clinical performance: 100% efficacy[1], providing early protection for infants from two months of age, and long-term immunity for more than five years. With Vietnam’s annual birth rate reaching 1.36 million infants, the synergy between MVC’s high-quality production capabilities and Substipharm Biologics’ marketing expertise helps meet the substantial medical needs in the region.
Management Statements
Leo Lee, CEO of MVC, said: “The marketing authorisation for ENVACGEN® as the first EV71 vaccine in Vietnam is an important development in MVC’s global expansion. We are delighted to partner with our experienced partner, Substipharm Biologics, to provide high-quality vaccines to children in Vietnam. Given the high demand in Southeast Asia, MVC is beginning to plan for increased production capacity to ensure a stable vaccine supply.”
Fabrice Baschiera, CEO of Substipharm Biologics, added: “With ongoing large-scale outbreaks of hand, foot, and mouth disease (HFMD) over the past decade, EV71 has long been a serious challenge to child health in Vietnam. In 2025, the number of HFMD cases was recorded at 107,249, an increase of 28.9% from the previous year. We welcome the partnership with MVC to bring the first innovative vaccine in its class to the local market. Substipharm Biologics is committed to working with health authorities and medical personnel in Vietnam to deliver this vaccine as soon as possible to protect children from HFMD caused by the EV71 virus.”
About Medigen Vaccine Biologics Corp (MVC)
Established in 2012, MVC develops and mass-produces innovative vaccines to combat infectious diseases. With advanced cell culture technology and PIC/S GMP-certified biopharmaceutical facilities, MVC is the only domestic manufacturer in Taiwan that obtained Emergency Use Authorisation (EUA) during the COVID-19 pandemic, reflecting its research and development strengths. MVC’s current commercial products include enterovirus and seasonal influenza vaccines, with a research pipeline that includes Enterovirus D68 and multivalent enterovirus vaccines. Through global collaborations, MVC is committed to providing innovative public health solutions worldwide.
About Substipharm & Substipharm Biologics
Substipharm is a private French pharmaceutical company that develops, supplies, and distributes medicines in more than 100 countries, with a portfolio encompassing over 90 products. In the last 10 years, Substipharm has made 25 acquisitions, including the acquisition of the Japanese encephalitis vaccine IMOJEV® from Sanofi in 2022, as well as taking a 49% stake in a Japanese encephalitis vaccine factory in Bangkok, Thailand. Substipharm has offices in Geneva, Switzerland, Thailand, and Vietnam and focuses on developing vaccines. Substipharm Biologics’ IMOJEV® vaccine is available in 14 countries in the Asia-Pacific, Southeast Asia, and Australia, and is recognised as the best-in-class Japanese encephalitis vaccine.