Medigen Vaccine Biologics Corporation announced on January 9 that it has signed a regional distribution agreement with French pharmaceutical company Substipharm Biologics. The partnership aims to expand the market for Medigen's enterovirus vaccine in Southeast Asia. The two companies have already finalized a distribution agreement for the "ENVACGEN Enterovirus 71 Vaccine" in Vietnam and will continue negotiations to introduce the vaccine in Thailand, the Philippines, Indonesia, Malaysia, and Singapore. This collaboration seeks to accelerate the delivery of high-quality, safe enterovirus 71 vaccines to ASEAN countries.
Medigen stated that ENVACGEN Enterovirus 71 Vaccine was developed by the company. A Phase III multinational, multicenter trial conducted in Taiwan and Vietnam showed that none of the vaccinated children contracted enterovirus 71, achieving 100% protection. Statistical regression models demonstrated an impressive protective efficacy of 96.8%. The vaccine has been confirmed to provide effective protection against the EV-A71 genetic subtypes prevalent in Southeast Asia. Notably, it is the only vaccine officially approved for administration from as early as two months of age. Results from this trial were published in the prestigious medical journal The Lancet. Long-term follow-up studies also revealed that the vaccine provides sustained immunity for at least five years. ENVACGEN was launched in Taiwan in August 2023, securing over 95% market share and earning its position as the "best-in-class" product in the enterovirus vaccine market.
Medigen highlighted Substipharm’s strengths as a private pharmaceutical company established in France in 1995. Initially focused on niche generic drugs, Substipharm has expanded through strategic collaborations and acquisitions, growing its portfolio to include over 90 products marketed across Europe, the Americas, and Southeast Asia in more than 80 countries.
In recent years, Substipharm has acquired branded drugs directly from multinational pharmaceutical companies. For instance, in 2022, it acquired the IMOJEV Japanese encephalitis vaccine from Sanofi, along with a 49% stake in the vaccine's manufacturing facility in Thailand. Substipharm subsequently established Substipharm Biologics (S-Bio), a subsidiary dedicated to developing vaccines and biologics. S-Bio focuses on identifying and commercializing "best-in-class" products. Currently, its IMOJEV® vaccine is available in 14 countries across the Asia-Pacific, Southeast Asia, and Australia, boasting a 99% market share in Taiwan’s public immunization programs.
Medigen emphasized that enterovirus 71 (EV-A71) is one of the most significant health threats to infants and young children after the poliovirus. EV-A71 is highly contagious, particularly in young children, and can cause clusters of infections. Clinical symptoms include hand, foot, and mouth disease (HFMD) and herpangina. EV-A71 also exhibits strong neurotropism, often leading to severe complications such as acute flaccid myelitis, encephalitis, meningitis, and even death. The virus frequently causes outbreaks in the Asia-Pacific region, with severe epidemics reported in countries like Malaysia, Taiwan, mainland China, Thailand, Vietnam, Singapore, Indonesia, the Philippines, Australia, South Korea, and Japan. In the latest outbreak in Vietnam in 2023, over 180,000 children were infected, and 31 fatalities were reported.
Fabrice Baschiera, CEO of Substipharm Biologics, stated: "We are committed to providing high-quality vaccines to protect children from disease threats. Vietnam is facing a severe enterovirus epidemic, and we will leverage our extensive marketing resources to expedite ENVACGEN®'s entry into the Vietnamese market. Alongside our Japanese encephalitis vaccine, IMOJEV®, the introduction of ENVACGEN® will offer more comprehensive protection for young children in Vietnam."
Leo Lee, CEO of Medigen Vaccine Biologics Corporation, remarked: "Our collaboration with Substipharm Biologics marks a significant milestone. With Substipharm Biologics' expertise in vaccines and its strong market reputation among healthcare professionals, this partnership will provide Vietnamese children with greater access to the ENVACGEN Enterovirus 71 Vaccine. Together, we aim to address Vietnam’s longstanding public health challenges posed by enterovirus and help children escape the threat of this disease."
By combining their respective strengths, Medigen and Substipharm Biologics aim to accelerate the delivery of high-quality, safe vaccines, ensuring timely protection for those in need.
Resource: 高端與法國Substipharm醫藥公司合作 腸病毒疫苗進軍東協
