Medigen Vaccine Biologics Corp. (MVC, 6547.TWO) today announced the official initiation of the first phase of domestic antigen process development collaboration for its “Second-Generation Multivalent Enterovirus Vaccine”. Driven by MVC’s core technological roadmap, the company has signed two independent agreements with Taiwan Bio-Manufacturing Corp. (TBMC) and TFBS Bioscience Inc. (TFBS, 6939.TWO). This parallel collaboration aims to develop antigen processes for multiple viral serotypes, accelerating development timelines and further strengthening the self-reliant development and manufacturing capabilities of Taiwan's vaccine industry.
Building on the First-Generation EV-71 Vaccine to Tackle the Technical Barriers of a Second-Generation Multivalent Product
As one of the few domestic vaccine manufacturers with a proven track record of successfully advancing novel vaccines from the laboratory to commercial mass production (Bench-to-Market), MVC has already achieved outstanding results in the domestic market with its first-generation enterovirus 71 (EV-71) vaccine, ENVACGEN®, of which the first batch has already been exported to Vietnam. To address the rapidly changing epidemiological patterns of enteroviruses, MVC is leveraging the success of its first-generation vaccine to invest in a broader-protection second-generation multivalent vaccine, continuing to deepen its technological barriers and laying a solid foundation for subsequent clinical development and commercialization.
Leading the R&D Roadmap and Precisely Orchestrating Scarce Domestic BSL-2 Capacity
Enterovirus vaccine process development requires specialized facilities compliant with stringent biosafety standards, and Biosafety Level 2 (BSL-2) facilities and production capacity are relatively scarce in Taiwan. In addition to actively constructing its own second manufacturing plant to expand long-term capacity, MVC’s collaboration with TBMC and TFBS integrates over half of Taiwan's currently available BSL-2 R&D capacity, creating a comprehensive support system for vaccine development.
In this collaboration, TBMC leverages the strengths of its integrated CRDMO platform to connect R&D, analytics, process development, and GMP manufacturing. By utilizing data-driven process decisions, it helps accelerate the product’s progression toward clinical trials and commercialization. TFBS, meanwhile, has deep-rooted expertise in virology and analytical technologies and has expanded into CDMO services, with particular expertise in virus-based products. Through a clear division of expertise and the integration of resources, the three parties connect the technologies and capacities of different domestic enterprises to enhance the efficiency of vaccine development.
Integrating Domestic Vaccine Development Capacity for Shared Industry Growth
Leo Lee, Chief Executive Officer of MVC, stated: “To develop an internationally competitive second-generation multivalent enterovirus vaccine, the key is to elevate the technical barriers early in development. We have specifically integrated the expertise and capabilities of TBMC and TFBS, and hope that through this collaboration among domestic biopharmaceutical industry players we can accelerate the development of a new-generation vaccine. The process experience and technical achievements accumulated during this stage will also subsequently connect with MVC's second manufacturing plant, continuously expanding Taiwan's vaccine research, development, and manufacturing capabilities.”
David Chang, Chief Executive Officer of TBMC, stated: “We are delighted to work with MVC to advance the development of the second-generation multivalent enterovirus vaccine. TBMC possesses facilities and a technical team that comply with PIC/S GMP standards. In this collaboration, we will contribute our high-throughput integrated process development and manufacturing capabilities to help MVC accelerate vaccine development and subsequent scale-up, jointly strengthening the resilience of Taiwan's self-reliant vaccine supply and contributing to domestic public health.”
Tatung Yuan, Chief Executive Officer of TFBS, stated: “MVC’s successful experience with its first-generation EV-71 vaccine and its international market expansion demonstrate the strength of Taiwan’s vaccine research and development capabilities. TFBS is pleased to continue our long-standing collaboration with MVC and apply our expertise in virology, analytics, process development, and GMP manufacturing to support the development of this second-generation multivalent vaccine. Together, we aim to further strengthen the connectivity of Taiwan’s vaccine development ecosystem.”
About Medigen Vaccine Biologics Corporation
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 vaccine manufacturer to receive Emergency Use Authorization (EUA) in Taiwan during the COVID-19 pandemic, demonstrating its robust R&D capabilities. MVC's commercialized ENVACGEN®, an Enterovirus 71 Vaccine, has obtained regulatory approvals in Taiwan and Vietnam, with active market expansion in Southeast Asia. Building on this foundation, MVC continues to deepen its research in enterovirus vaccines by actively driving the development of a second-generation multivalent enterovirus vaccine. By aligning with global strategic partners, MVC aims to build a comprehensive enterovirus vaccine portfolio with the vision of becoming a global leader in enterovirus vaccine innovation.
About Taiwan Bio-Manufacturing Corporation (TBMC)
Taiwan Bio-Manufacturing Corporation (TBMC) is a Contract Research, Development, and Manufacturing Organization (CRDMO) specializing in advanced therapies, offering integrated, end-to-end solutions spanning drug discovery support and process development through commercialization.TBMC’s multi-platform capabilities include Nucleic Acids, Viral Vectors, Cell Therapies, and Biologics. By combining advanced technologies, scalable manufacturing processes, and a rigorous quality management system, TBMC provides high-quality and reliable CRDMO solutions that help clients shorten development timelines and accelerate advanced therapies toward clinical development and commercialization. TBMC is committed to becoming a trusted long-term strategic partner to the global biotech and pharmaceutical industries.
About TFBS Bioscience Inc.
TFBS Bioscience Inc. (TFBS) was founded in 2016 as the first contract research organization providing biological testing in Taiwan after its spin-off from Development Center for Biotechnology, a government-sponsored research institute. TFBS has established strong track records in several regulatory submissions, winning trust from the international regulatory agencies and biopharmaceutical industry. TFBS has launched the first viral vector contract development and manufacturing facility in Taiwan, providing fully integrated end-to-end contract development and manufacturing services for the needs of clinical trials. TFBS offers manufacturing expertise in adeno-associated virus, lentivirus, and retrovirus. With the customization specialty and state-of-the-art facility, TFBS is the best partner offering clients a one-stop-shop solution for gene and cell therapy.