MVC Submits NDA for ENVACGEN® in Malaysia, Extending Taiwan's Successful Experience to the ASEAN Market

TAIPEI, March 30, 2026 /PRNewswire/ -- MVC announced on March 27 that it has officially submitted a New Drug Application (NDA) for ENVACGEN^®, its Enterovirus 71 (EV71) vaccine, to the National Pharmaceutical Regulatory Agency (NPRA) of Malaysia. ENVACGEN^® currently holds a leading market position in Taiwan with a market share of over 95%. The vaccine has successfully completed a multinational, multicenter Phase 3 clinical trial in Taiwan and Vietnam and has been approved and launched in both countries. Supported by its three core advantages—100% vaccine efficacy, suitability for infants from 2 months of age, and antibody persistence for up to 5 years—the entry of ENVACGEN^® into Malaysia aims to provide local infants and young children with a high standard of protection. This milestone also marks an important step in MVC's strategic initiative to support vaccine accessibility within the ASEAN market.

The Hand, Foot, and Mouth Disease (HFMD) epidemic in Malaysia has long exhibited a pattern of cyclical outbreaks, with a recent resurgence attributed to immunity debt. Among these cases, the risk of severe complications and mortality, such as encephalitis and cardiopulmonary failure caused by EV71, has placed significant pressure on the local public health system. However, the Malaysian market currently lacks an enterovirus vaccine that can effectively prevent severe cases. Addressing this urgent Unmet Medical Need, MVC's NDA submission carries important public health value and market development potential.

The leading position of ENVACGEN^® in the Taiwanese market is built upon robust scientific evidence. In multinational Phase 3 clinical trials, ENVACGEN^® demonstrated 100% vaccine efficacy against EV71. Furthermore, positive clinical outcomes have made it one of the few vaccines globally approved for administration starting from 2 months of age, providing early protection for vulnerable populations. Long-term follow-up data have also confirmed the persistence of neutralizing antibody titers for up to 5 years, providing continuous protection during the critical window when infants and young children are at high risk of infection.

Building on the successful regulatory record and reputation of ENVACGEN^® in both Taiwan and Vietnam, MVC is steadily advancing its international commercial footprint. With the official initiation of the NDA review process in Malaysia, the company has taken a meaningful step toward deepening its presence in the ASEAN vaccine market. Looking ahead, MVC remains committed to utilizing its product strength to help enhance local epidemic prevention capacity upon regulatory approval. This initiative aims not only to establish a protective shield for children's health but also to create long-term value within the field of infectious disease prevention in Asia.

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.

SOURCE MVC