[Incheon, S. Korea, October 29, 2026] SK bioscience announced on 29 that it has joined forces with IAVI, a global nonprofit biomedical research organization, Hilleman Laboratories and other partners in a project supported by USD 36 million of a contract valued up to USD 99 million (approximately KRW 130 billion) from the Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services (HHS), to advance development, manufacturing, and clinical evaluation of a Bundibugyo Ebola vaccine.

The project is aimed at responding to infections caused by Bundibugyo virus (BDBV), which have recently been spreading primarily in the Democratic Republic of the Congo (DRC). As of October 25, the outbreak had recorded 10,060 confirmed cases and 4,887 deaths, representing a case fatality rate of 48%, making it the second-largest Ebola outbreak on record and the largest ever involving Bundibugyo virus. Despite the growing threat, there are currently no approved vaccines or specific treatments for BDBV infection. The participating organizations therefore aim to develop a vaccine capable of rapidly inducing immunity with a single dose while establishing a reliable global supply system.

Each organization will contribute its specialized capabilities to the program. IAVI will oversee the overall program, clinical development, regulatory engagement with agencies including the U.S. Food and Drug Administration (FDA), and outbreak preparedness strategy. Hilleman Laboratories will manufacture initial clinical vaccine supplies using an advanced manufacturing process and lead the subsequent technology transfer.

SK bioscience will lead process scale-up and large-scale manufacturing of investigational vaccine doses. Its German contract development and manufacturing organization (CDMO) subsidiary, IDT Biologika (IDT), will contribute its long-standing expertise in vaccine manufacturing by taking responsibility for the fill-and-finish activities within the project, leveraging its extensive capabilities in aseptic filling, processing, and final product manufacturing.

ASPR/BARDA funding will support clinical and regulatory activities, including a Phase 1 clinical trial, as well as production of vaccines for outbreak response and supply to strengthen health security. The program will also support the development of an updated vaccine based on a 2026 variant strain.

This ASPR/BARDA-supported program complements ongoing development activities by IAVI and Hilleman, funded by the Coalition for Epidemic Preparedness Innovations (CEPI). CEPI’s funding supports activities intended to accelerate the development and manufacturing of BDBV vaccine candidate doses for Bundibugyo virus outbreak control and response. The BARDA award, in addition to bolstering outbreak response, focuses on strengthening longer-term preparedness. Both investments seek to strengthen longer-term preparedness for Bundibugyo virus outbreaks.

The participating organizations plan to accelerate development by leveraging the recombinant vesicular stomatitis virus (rVSV) platform, the same platform used for the Zaire ebolavirus vaccine whose safety and efficacy have been demonstrated and which has received World Health Organization (WHO) prequalification.

SK bioscience has also been working with MSD, Hilleman Laboratories, CEPI and other global partners on the development of a next-generation Zaire Ebola vaccine and improvements to its manufacturing process.

Dr. Mark Feinberg, president and CEO of IAVI, said, “By supporting efforts to address the current Bundibugyo virus epidemic and strengthen preparedness for future outbreaks, this BARDA award strengthens partnerships, capabilities, and this vaccine candidate. IAVI is bringing together organizations with highly complementary capabilities to accelerate development of a vaccine candidate that addresses a critical unmet public health need. By combining IAVI´s expertise in rVSV vaccine development, clinical advancement, regulatory engagement, and outbreak preparedness with our partners´ manufacturing capabilities, we are working to strengthen preparedness for future Bundibugyo virus outbreaks.”

Raman Rao, CEO of Hilleman Laboratories, said, “Vaccine manufacturing is incredibly complex, and it takes a village to make the entire value chain work. Working closely with IAVI, SK bioscience, IDT Biologika, and MSD, Hilleman Laboratories is focused on supplying clinical trial material and advancing technology transfer for manufacturing at scale. The strength of this partnership lies in the diversity of expertise each organization brings, united by the commitment to delivering an effective single-dose vaccine for outbreak response.”

Dr. Sally Choe, CEO of IDT Biologika, said, “IDT Biologika is proud to be part of this important initiative. Together with our partners, we are helping to strengthen global preparedness for Ebola outbreaks and ensure access to potentially life-saving vaccines.”

Jaeyong Ahn, President and CEO of SK bioscience, said, “Proactively preparing for infectious disease threats requires sustained efforts to strengthen vaccine development and manufacturing capabilities. This project brings together SK bioscience’s vaccine development expertise and IDT’s manufacturing capabilities with the complementary strengths of our global partners. By working closely with our partners to accelerate vaccine development and strengthen reliable supply capacity, we aim to contribute to global preparedness for future infectious disease outbreaks.”

SK bioscience continues to expand its infectious disease response pipeline through extensive partnerships with global organizations and leading pharmaceutical companies.

The global Phase 3 clinical trial of its 21-valent pneumococcal conjugate vaccine, being jointly developed with Sanofi, is progressing as planned. The company has also entered into a technology license agreement for an injectable rotavirus vaccine candidate developed by the U.S. Centers for Disease Control and Prevention (CDC) and is advancing subsequent clinical development and commercialization.

In addition, SK bioscience is diversifying its next-generation public health portfolio through collaborations with the Gates Foundation, CEPI, the Korea Disease Control and Prevention Agency (KDCA) and other partners on programs including an RSV preventive antibody and a broadly protective coronavirus vaccine, further strengthening its contribution to global infectious disease preparedness and health security.

[This project has been funded in whole or in part with federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under Other Transaction Number: 75A50123D00005.]

SK bioscience is an innovative vaccine and biotech company, committed to vaccine development and manufacturing to enable more equitable access to vaccines around the world. Leveraging strengths on cutting-edge technologies, SK bioscience has been dedicated to promoting human health from prevention to cure across the globe. With the cooperation of domestic and international governments, regulatory agencies, healthcare providers, doctors, and medical experts, all of the SK colleagues are passionately committed to providing high-quality vaccines to those who need them and better public healthcare solutions

IAVI is a global nonprofit biomedical research organization dedicated to translating scientific discoveries into vaccines, antibodies, and other interventions that address urgent global health challenges. IAVI works with partners in Africa, India, Europe, and the U.S. to advance research and development for HIV, tuberculosis, and emerging infectious diseases, and to strengthen the scientific and clinical capabilities needed to make biomedical innovation accessible to the people and communities who need it most. For more information, visit www.iavi.org.

Hilleman Laboratories was established in 2009 as a joint venture between MSD, a global research-driven biopharmaceutical company, and Wellcome, a global charitable foundation dedicated to human and animal health. Hilleman Laboratories’ mission is to develop affordable vaccines and biologics against infectious diseases that affect low- and middle-income countries.

The company’s expertise in end-to-end product development is targeted at creating novel vaccines and biologics in areas of high unmet need as well as adapting existing vaccines and biologics with more effective delivery tools to meet challenging environments in developing countries. Hilleman Laboratories also seeks to collaborate with local, regional, and global partners and stakeholders, including policymakers and governments, to facilitate wider, affordable access to life-saving vaccines and biologics.

About IDT Biologika

IDT Biologicska was founded in 1921 and is one of the world’s leading contract development and manufacturing organizations (CDMOs), specializing in the development and manufacture of vaccines and complex biologics. The company’s extensive expertise encompasses viral vector technologies, live and recombinant vaccines, and other biologics with high safety requirements, making IDT a preferred partner for global vaccine programs and public health initiatives. Over the past two decades, IDT Biologika has played a central role in addressing international health emergencies and vaccine shortages.