TAIPEI and GENEVA, Jan. 9, 2025 /PRNewswire/ — Medigen Vaccine Biologics Corp (MVC) has signed a regional distribution agreement with the pharmaceutical company Substipharm Biologics to expand the market reach of enterovirus vaccine products in Southeast Asia. The two companies have finalized an exclusive distribution agreement for ENVACGEN® Enterovirus A71 (EV-A71) vaccine in Vietnam as the first country of launch. Collaboration includes other countries in South-East Asia: Thailand, the Philippines, Indonesia, Malaysia, and Singapore. Both parties are committing resources to accelerate the introduction of this high-quality and safe EV-A71 vaccine in these ASEAN markets with significant demand.
Enterovirus 71 (EV-A71) is one of the most severe enterovirus pathogens affecting the health of infants and young children since the eradication of poliovirus. EV-A71 is highly contagious and can cause outbreaks in pediatric populations. Clinically, it is commonly presented with hand, foot, and mouth disease (HFMD) or herpangina. However, EV-A71 has a strong neurotropic propensity, making it capable of invading the nervous system and leading to severe complications such as acute flaccid myelitis, encephalitis, meningitis, and even death. Severe outbreaks have been reported in countries including Malaysia, Taiwan, China, Thailand, Vietnam, Singapore, Indonesia, the Philippines, Australia, South Korea, and Japan. The most recent major EV-A71 epidemic occurred in Vietnam in 2023, where over 180,000 children were infected, and 31 fatalities were reported.
About ENVACGEN® Enterovirus A71 Vaccine
Developed by MVC, ENVACGEN® has shown outstanding results in multinational Phase III clinical trials conducted in Taiwan and Vietnam. Vaccinated children showed 100% protection against EV-A71 infections, with a statistical regression model calculating an efficacy rate of 96.8%. The vaccine is effective against currently circulating EV-A71 subgenotypes and is the only vaccine officially approved for administration starting from two-month-old infant. Results of the clinical trials have been published in The Lancet, a leading medical journal. Long-term follow-up studies have also demonstrated that immunity persists for at least five years. ENVACGEN® was launched in Taiwan in August 2023 and has already captured over 95% of the enterovirus vaccine market share in Taiwan, solidifying its position as the best-in-class product in its category.
Statements from Leadership
Fabrice Baschiera, CEO of Substipharm Biologics, stated:
"We are dedicated to providing high-quality vaccines to protect children from life-threatening diseases. With Vietnam facing a severe enterovirus epidemic, we are going to address this important unmet medical need by ensuring that ENVACGEN® will be available to the Vietnamese population in a timely manner before expanding in other ASEAN countries. Alongside Substipharm Biologics’ IMOJEV® Japanese Encephalitis Vaccine, the introduction of ENVACGEN® will provide comprehensive protection for Vietnamese children."
Leo Lee, CEO of Medigen Vaccine, remarked:
"Our partnership with Substipharm Biologics is a critical milestone. Substipharm Biologics brings expertise, credibility, and a strong reputation in the vaccine market. This collaboration will offer Vietnamese children greater access to ENVACGEN®, addressing the long-standing public health issue of enterovirus outbreaks and helping protect children from the threats of this disease."
The collaboration between Medigen Vaccine and Substipharm Biologics is expected to create synergies by leveraging the strengths of both organizations, accelerating the delivery of high-quality and safe vaccines to those in need, and ensuring timely access to vaccination for more individuals.
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