TAIPEI and GENEVA, March 18, 2026 /PRNewswire/ -- Medigen Vaccine Biologics Corp. (MVC) and Substipharm Biologics announced on March 17 that ENVACGEN®, an Enterovirus 71 (EV-A71) vaccine, has received marketing authorization from the Drug Administration of Vietnam (DAV). Substipharm Biologics will spearhead the marketing and distribution activities in Vietnam. Maintaining a dominant market share of over 97% in Taiwan, ENVACGEN® now achieves a historic milestone as the first-ever EV-A71 vaccine authorized in Vietnam. This breakthrough sets a strong foundation for both parties to expand their commercial footprint across Southeast Asia.

Enterovirus 71 (EV-A71) is a primary cause of severe neurological complications and mortality in young children across Asia. Vietnam has been severely impacted by cyclical outbreaks, reporting approximately 180,000 cases and 31 deaths in 2023 alone. These recurring crises pose a grave threat to pediatric health and exert a heavy burden on the local healthcare system.

Standing out as a "Best-in-class" vaccine, ENVACGEN® delivers exceptional clinical performance: 100% efficacy^[1], early protection for infants from two months of age, and long-term immunogenicity lasting over five years. With Vietnam's 1.36 million annual births, the synergy of MVC's high-quality manufacturing and Substipharm Biologics' marketing expertise will rapidly address the region's significant unmet medical needs.

Statements from Leadership

Leo Lee, CEO of MVC, stated: "The successful marketing authorization of ENVACGEN® as Vietnam's first EV71 vaccine is a pivotal milestone in MVC's global expansion. We are eager to work with our experienced partner, Substipharm Biologics, to provide this high-quality vaccine to local children. Facing the vast demand in Southeast Asia, MVC has already initiated capacity expansion plans to ensure a stable supply of premium vaccines."

Fabrice Baschiera, CEO of Substipharm Biologics, commented:  "With the recurrent, large-scale outbreaks of hand, foot and mouth disease (HFMD) over the past decade , EV71 has long posed a severe challenge to pediatric health in Vietnam. In 2025, 107,249 HFMD cases were reported, a 28.9% increase compared to the previous year. We are thrilled to partner with MVC to introduce this breakthrough, first-of-its-kind vaccine to the local market. Substipharm Biologics is fully committed to collaborate with the Vietnam health authorities and health care professionals to bring the vaccine to Vietnam as early as possible to protect the Vietnamese children against HFMD caused by EV71 virus."  

[1] Vaccine Efficacy: 100%. All confirmed cases occurred in the placebo group, with no infections among the vaccinated group during the follow-up period. The statistical Poisson regression analysis showed an efficacy of 96.8% (CI: 85.5%, 100%).

About Medigen Vaccine Biologics Corp (MVC)

Founded in 2012, MVC is dedicated to combating infectious diseases through the development and mass production of innovative vaccines. Utilizing advanced cell-culture technology and a PIC/S GMP-certified biopharmaceutical facility, MVC notably served as the only domestic manufacturer to receive Emergency Use Authorization (EUA) in Taiwan during the COVID-19 pandemic, demonstrating its robust R&D capabilities. MVC's current commercial products include vaccines for enterovirus and seasonal influenza, with R&D pipelines featuring Enterovirus D68, and multivalent enterovirus vaccines. By collaborating with global partners, 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 medications in over 100 countries, offering a robust portfolio of more than 90 products. Among the last 25 acquisitions done in the last 10 years, Substipharm has acquired in 2022 IMOJEV® Japanese Encephalitis Vaccine from Sanofi, along with a 49% stake in the Japanese Encephalitis vaccine plant in Bangkok, Thailand. It has established its subsidiaries in Geneva, Switzerland, Thailand and Vietnam to focus on vaccines. Substipharm Biologics' IMOJEV® vaccine is available in 14 countries across the Asia-Pacific region, Southeast Asia, and Australia, where it is recognized as the best-in-class Japanese encephalitis vaccine.

Website: www.medigenvac.com
Website: www.substipharm.com 

Source:
Medigen Vaccine Biologics Corp
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