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Enimmune Enterovirus Vaccine Filed in Singapore to Capture ASEAN Market

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Enimmune's enterovirus Type 71 vaccine, EnVAX-A71, has submitted a new drug review application to Singapore's Health Sciences Authority, further expanding its Southeast Asian footprint after Vietnam and Thailand, partnering with Malaysia's Duopharma to build the Singapore-Malaysia market and capture ASEAN epidemic-prevention business opportunities.

Advancing into Singapore, Targeting ASEAN Benchmark Market

Adimmune subsidiary Enimmune Corporation announced that its EnVAX-A71 enterovirus Type 71 vaccine has submitted a new drug review application to Singapore's Health Sciences Authority, officially entering the Singapore market. The company said Singapore has mature public health and medical regulations, making it a benchmark country for entering the ASEAN market, and that no enterovirus vaccine is currently marketed locally, making this filing an important deployment for expanding into the Southeast Asian market.

Expanding Filing Footprint After Vietnam and Thailand

Enimmune's enterovirus vaccine has already obtained drug licenses in Taiwan and Macao, and is actively expanding into the Southeast Asian market through license applications. Following filings in Vietnam in 2025年7月 and Thailand in 2026年8月, this application was submitted through its EB company established in Singapore, continuing regional market development in order to narrow the regional prevention gap.

General Manager: Singapore Approval Has Demonstrative Effect

General Manager Zhang Zhewei pointed out that Singapore is an area with frequent enterovirus and hand, foot and mouth disease, and enterovirus prevention in young children has become an important public health issue. No enterovirus vaccine is yet available locally, and introducing a vaccine would provide an important epidemic-prevention tool to protect young children, with future use experience in Singapore having a demonstrative effect for Taiwan to connect ASEAN countries in building a complete enterovirus protection network. He stressed that although Singapore is small, it has a special position in ASEAN as the country with the most mature medical, public health and pharmaceutical regulations in Southeast Asia, and obtaining drug license approval in Singapore would carry greater benchmark significance for future entry into other ASEAN countries.

Partnering with Duopharma to Build Singapore-Malaysia Market, Production Capacity Secure

To expand into the key Singapore market, Enimmune has signed a sales contract with Malaysian benchmark listed pharmaceutical company Duopharma to fully build the Singapore-Malaysia market and push into the ASEAN market. Duopharma maintains a long-term cooperative relationship with Malaysia's Ministry of Health and has rich experience in public medical supply. The vaccine is produced at Adimmune's Tanzi plant using an advanced bioreactor process with stable quality and greater capacity, maintaining an annual capacity of at least 100萬劑, sufficient to supply Taiwan and ASEAN markets. The vaccine is indicated for active immunization in infants and young children aged 2個月以上至未滿6歲 to prevent diseases caused by enterovirus Type 71 infection, with vaccine efficacy reaching 99.21%. Enterovirus is an epidemic disease prevalent in the Southeast Asian region, of which EV71 has high neurotropism and high pathogenicity, easily causing severe complications such as limb paralysis, encephalitis, meningitis, pulmonary edema or hemorrhage and even death, and immunity debt after the COVID-19 pandemic has left most infants and young children lacking naturally acquired antibodies, leading to a resurgence of epidemics in Southeast Asian countries in recent years and further increasing market demand for severe-disease prevention vaccines.

FAQ

Which vaccine did Enimmune file for in Singapore?

It is the EnVAX-A71 enterovirus Type 71 vaccine, indicated for active immunization in infants and young children aged 2個月以上至未滿6歲, with vaccine efficacy reaching 99.21%.

Why is the Singapore market a benchmark?

Singapore is the country with the most mature medical, public health and pharmaceutical regulations in Southeast Asia, and no enterovirus vaccine is yet marketed locally; obtaining drug license approval there would help subsequent entry into other ASEAN countries.

What is Enimmune's current Southeast Asian deployment and production capacity?

It has obtained licenses in Taiwan and Macao, filed in Vietnam in 2025年7月 and in Thailand in 2026年8月, and signed with Malaysia's Duopharma to build the Singapore-Malaysia market; the vaccine is produced at Adimmune's Tanzi plant with annual capacity of at least 100萬劑.