24 May, 2023, Taipei, Taiwan Medigen Vaccine Biologics Corp (TPEx 6547.TWO, MVC), a biopharmaceutical company focused on developing and producing vaccines and biologics, announced today that it has filed for New Drug Application (NDA) for its enterovirus-71 (EV-71) vaccine with the Drug Administration of Vietnam (DAV). The NDA filing follows the successful approval obtained on April 12th, 2023 by the Taiwan Food and Drug Administration (TFDA) and the Certificate of Pharmaceutical Product (CPP) from the Taiwan Ministry of Health and Welfare (MOHW) in May, 2023. This is a significant milestone in the ongoing efforts to combat EV-71, a significant contributor to hand-foot-and-mouth disease in children and infants.
The EV-71 vaccine is the result of a technology transfer from the Taiwan National Health Research Institutes (NHRI). After the technology transfer, MVC pursued a Phase II clinical validation of safety, dose exploration, and cross-protection with subtypes in 2-month-old infants and children up to the age of 11. The results of the Phase II study were peer-reviewed and published in Vaccine, confirming a strong vaccine candidate. In parallel to the clinical studies, MVC has successfully developed a commercial-scale production capacity in its Hsinchu Biomedical Park factory.
Further to the Phase II study, MVC completed a Phase III clinical trial in Taiwan and Vietnam in 2-month-old infants and children up to the age of 6. To date, the MVC EV-71 vaccine is the only EV-71 vaccine that has obtained clinical efficacy data in the crucial age group of 2 months to 6 months of age. The Phase III study achieved excellent results, with 100% vaccine efficacy during the study period. The results have been peer-reviewed and published in the prestigious academic journal, The Lancet. MVC intends to market the EV-71 product in Vietnam, Taiwan and other target markets where EV-71 vaccines are a significant unmet medical need.
“MVC is committed to providing safe and effective vaccines to protect the health of people worldwide,” said Charles Chen, CEO of MVC. “We hope that our EV-71 vaccine can contribute to reducing the medical and economic burden of hand-foot-and-mouth disease caused by EV-71. It is fitting that the first regulatory submissions of our EV-71 vaccine would take place in the countries where we conducted our Phase III clinical study: Vietnam and Taiwan. We are immensely proud to bring this product to market during a tumultuous COVID-19 period. We thank the participants and their families for partaking in our studies, making it possible to bring this vaccine to market and in turn assist others in their fight against this disease.”
About EV-71
EV-71, also known as Enterovirus 71, is a type of virus that belongs to the Picornaviridae family. It is a highly infectious virus that is primarily transmitted through fecal-oral or oral-oral routes, and is commonly associated with outbreaks of hand, foot, and mouth disease (HFMD). EV-71 infections can lead to severe neurological and cardiovascular complications, especially in children under the age of five. The virus is prevalent in many parts of the world, particularly in Asia.
About Medigen Vaccine Biologics (MVC) Corporation
MVC is a biopharmaceutical company using cell-based technologies for the development of vaccines and biosimilars. In addition to the EV-71 vaccine, MVC has developed and manufactured the first SARS-CoV-2 vaccine in Taiwan with emergency use approval granted in 2021. MVC also has an approved quadrivalent influenza vaccine entering the seasonal National Immunization Program in 2023. With a goal of national self-sufficiency, MVC also aims to provide vaccines and biopharmaceuticals to meet regional needs and with a desire to help globally against the threats of infectious diseases. MVC will continue to collaborate with international partners to develop promising vaccines. MVC’s large-scale production facility is state-of-the-art and adherent to international PIC/s GMP requirements. For more information, visit www.medigenvac.com.
MVC's Forward Looking Statements
This press release contains certain forward-looking statements relating to the business of Medigen Vaccine Biologics Corporation (MVC, TPEx: 6547.TWO) including with respect to the progress, timing and completion of research, development and clinical trials for MVC's vaccine candidates and the ability to manufacture, market, commercialize and achieve market acceptance thereof. These forward-looking statements are based largely on the current expectations of MVC as applicable, as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In particular, such could be affected by, among other things, uncertainties involved in the development and manufacture of MVC's vaccines, unexpected clinical trial results, unexpected regulatory actions or delays, competition in general, currency fluctuations, changes in global financial markets and the ability to obtain or maintain patent or other proprietary intellectual property protection. In light of these risks and uncertainties, there can be no assurance that such forward-looking statements will in fact be realized. MVC is providing the information in this press release as the date hereof, and disclaim any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
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