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MVC's ENVACGEN® is Granted First Enterovirus A71 Vaccine Marketing Authorization in Vietnam; Joins Forces with Substipharm Biologics to Expand Southeast Asian Market
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 str
About this update from Medigen Vaccine Biologics Corp.
[{"type":"text","content":"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.","length":646,"tagName":"p"},{"type":"text","content":"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.","length":369,"tagName":"p"},{"type":"text","content":"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.","length":451,"tagName":"p"},{"type":"text","content":"Statements from Leadership","length":26,"tagName":"p"},{"type":"text","content":"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."","length":452,"tagName":"p"},{"type":"text","content":"Fabrice Baschiera, CEO of Substipharm Biologics, commented: "With the recurrent, large-scale outbreaks of hand, foot and mouth disease (HFMD) ...