SK Bioscience Secures Additional 200 Billion KRW CEPI Funding for COVID-19 Vaccine Development

Secured a total of $210 million in CEPI funding
To be used for clinical trials of candidate substances and additional research against variants

An SK Bioscience researcher is conducting research and development for vaccine development. (Photo by SK Bioscience)

[Asia Economy Reporter Kim Ji-hee] SK Bioscience has secured additional funding of approximately 200 billion KRW from the international non-governmental organization Coalition for Epidemic Preparedness Innovations (CEPI) ahead of entering Phase 3 clinical trials for its COVID-19 vaccine currently under development. The funds secured this time will be used for clinical trials of the vaccine candidate, regulatory approval, and additional research and development to address variants.

On the 24th, SK Bioscience announced that it will receive up to $173.4 million (about 200 billion KRW) in additional support from CEPI for the research and development of the COVID-19 vaccine candidate ‘GBP510’, jointly developed with the Antigen Design Institute at the University of Washington in the United States. Previously, SK Bioscience had received support from CEPI for Phase 1 and 2 clinical trials, process development, and research related to variants, securing a total of $210.1 million (about 236.9 billion KRW) solely for the development of GBP510.

An SK Bioscience official stated, "This is the largest amount of international funding for a single domestic vaccine development," adding, "CEPI’s large-scale support for GBP510 reflects expectations regarding the safety and immunogenicity confirmed through Phase 1 and 2 clinical trials." The newly secured funds will be used for ▲conducting multinational Phase 3 clinical trials and obtaining regulatory approval for GBP510 ▲developing commercial-scale manufacturing processes capable of producing hundreds of millions of doses annually and procuring related raw materials ▲additional research and development to prepare for variants.

GBP510 entered Phase 1 and 2 clinical trials at the end of last year and is currently in 'Stage 2', corresponding to Phase 2 clinical trials. SK Bioscience plans to submit an Investigational New Drug (IND) application for multinational Phase 3 clinical trials to regulatory authorities, including the Korean Ministry of Food and Drug Safety, as early as the first half of this year. The company aims for commercialization by the first half of next year through expedited approval procedures such as emergency use authorization.

If GBP510, selected as the first target of CEPI’s next-generation COVID-19 vaccine project 'Wave2', is commercialized, it will be supplied worldwide, including underdeveloped countries in Africa, South America, and Southeast Asia, through the COVAX facility. SK Bioscience expects high growth rates in advanced markets once supply begins in earnest, as the COVID-19 vaccine manufacturing facility at its Andong plant recently obtained the European Union Good Manufacturing Practice (EU-GMP) certification, demonstrating excellence in manufacturing and quality control.

Richard Hatchett, CEO of CEPI, said, "Addressing COVID-19 and its variants is central to CEPI’s five-year plan," adding, "We are pleased to expand our partnership with SK Bioscience to control this deadly disease."

SK Bioscience President Ahn Jae-yong stated, "CEPI’s full support for GBP510 demonstrates the technical level and potential value of this vaccine candidate," and added, "We will complete a vaccine capable of preventing variant viruses with GBP510 and lead the end of the pandemic by supplying sufficient quantities of the vaccine worldwide through factory expansion."

This content was produced with the assistance of AI translation services.