In a landmark achievement for Taiwan’s vaccine industry, Medigen Vaccine Biologics (MVC) announced that its self-developed Enterovirus 71 (EV71) vaccine, Envacgen, has received a New Drug Application (NDA) approval from Vietnamese authorities. This is the first EV71 vaccine license issued in Vietnam and represents the first successful export of a novel Taiwanese vaccine to an overseas market.

• Proven Efficacy: Multi-national Phase III trials conducted in Taiwan and Vietnam showed 100% protection against EV71. These results, published in The Lancet, demonstrate that antibody protection remains robust for at least five years, supporting its "Best-in-Class" positioning.
• The Vietnam Advantage: Vietnam records 50,000 to 100,000 cases of hand-foot-and-mouth disease annually, with a 2023 outbreak exceeding 180,000 infections. Medigen has partnered with France’s Substipharm Biologics to penetrate the ASEAN private-pay vaccine market.
• Domestic Dominance: In Taiwan, Envacgen maintains a 95% market share in the private-pay sector, with cumulative vaccinations surpassing 500,000 doses since its 2023 launch.

Resource: 高端腸病毒疫苗攻進越南 奪首張當地腸病毒新藥藥證