SK bioscience's GBP510 one step closer to being country's first vaccine

Industry

Published: 25 Apr. 2022, 17:28 Updated: 25 Apr. 2022, 17:56

SK bioscience's GBP510 one step closer to being country's first vaccine

President-elect Yoon Suk-yeol, right, shakes hands with SK Group Chairman Chey Tae-won during his visit to SK bioscience headquarters in Seongnam, Gyeonggi, on Monday. [YONHAP]

SK bioscience's Covid-19 vaccine candidate GBP510 demonstrated statistically meaningful results confirming its immunogenicity in Phase 3 trials, the company said Monday, bringing it one step closer to becoming the country's first homegrown Covid vaccine.

The Seongnam, Gyeonggi-based vaccine maker said it will announce its safety data within the week and will request authorization from the Ministry of Food and Drug by the end of the month.

The Phase 3 clinical trials were conducted on a total of 4,037 people aged 18 or older in 16 institutions in Korea and five other countries including Thailand, New Zealand and Ukraine. Divided into two groups, one group was administrated with GBP510 and the other with AstraZeneca vaccines.

The results showed that GBP510 demonstrated higher immunogenicity than the already authorized vaccine. It also had higher titers of neutralizing antibodies against the virus, according to SK bioscience.

Co-developed with the University of Washington’s Institute for Protein Design and funded by the Bill & Melinda Gates Foundation and the Coalition for Epidemic Preparedness Innovations, GBP510 is a recombinant vaccine that uses protein antigens. Inside the body, the antigens stimulate an immune response that creates antibodies to fight off the virus in case of infection.

The Ministry of Food and Drug Safety on April 15 began an advance review of the candidate. SK bioscience predicts the authorization will be announced in the first half of the year.

In March, SK bioscience signed a 200-billion-won ($160 million) deal with the Korea Disease Control and Prevention Agency (KDCA) to secure 10 million doses of GBP510 to be administered in the country. If commercialized, the vaccines will also be supplied to countries worldwide through the Covax Facility, a global vaccine distribution platform launched by the World Health Organization, SK said.

"We could not have achieved these results without the cooperation of the government, international organizations, global companies and the support from the Korean public," SK bioscience CEO Ahn Jae-yong said Monday. "Through the successful development of GBP510, we will endeavor to carry out our mission to make Korea a country that has vaccine sovereignty."

GBP510, Korea's first homegrown Covid-19 vaccine [SK BIOSCIENCE]

On Monday, President-elect Yoon Suk-yeol visited the SK bioscience headquarters in Gyeonggi and promised full support for the company.

“The [vaccine] labs contain not only the huge potential of the country, but also our economy, welfare and security,” Yoon said during the visit. “When I take the reins of the administration, the government will spare no support for companies that develop vaccines and treatment during the pandemic, including SK bioscience.”

Yoon visited the SK bioscience headquarters with Ahn Cheol-soo, chairman of the presidential transition team, to review the company’s vaccine manufacturing facilities and listen to workers at the sites. Yoon took a tour of the company's lab with SK Group Chairman Chey Tae-won and SK bioscience CEO Ahn.

This is the second visit by Yoon to SK bioscience, after visiting L House, the company’s vaccine manufacturing site in Andong, North Gyeongsang, in September last year.

Yoon also hinted that he would review easing regulations on the biopharmaceutical industry in a bid to help the country achieve vaccine sovereignty.

SK bioscience rose 6.7 percent to close at 136,000 won on Monday.

BY SARAH CHEA [chea.sarah@joongang.co.kr]