- SK bioscience will apply for a certification for export from the Ministry of Food and Drug Safety(KMFDS), allowing in January 2021

- Immunogenicity and safety confirmed through Phase III clinical trial results

- SK bioscience will submit the WHO PQ certification process immediately after obtaining the certification for export

SK bioscience announced on the 17th that the company’s, typhoid vaccine candidate developed jointly with International Vaccine Institute(IVI), ‘NBP618’ was shown acceptable immunogenicity and safety in Phase III clinical trial results. The company plans to submit an application for an export to the Ministry of Food and Drug Safety(KMFDS) in January.

´NBP618´ is a typhoid vaccine being developed by SK bioscience and IVI since 2013 by utilizing conjugate vaccine production technology. The Bill & Melinda Gates Foundation has been involved from the early stages of research and development of NBP618, supporting about 25.6 million USD in research funds through IVI.

The conjugate vaccine technology applied to NBP618 is characterized by a form of conjugated polysaccharides of typhoid bacteria to diphtheria toxin, which shows acceptable immunogenicity even with a single administration.

In addition,compared to the existing oral live vaccines or polysaccharide vaccines, the prophylactic effect lasts for a long period and can even be administered to infants aged 6 months to 2 years old.

SK bioscience and IVI confirmed an immune response comparable to that of the conjugate vaccine used as a control in the global Phase III clinical trial of NBP618, conducted with 1,350 healthy adults aged 6 months to 45 years old.

The candidate demonstrated safety in all age groups of the clinical trial, showing no adverse reactions after the administration.

SK bioscience plans to submit the WHO PQ (Pre-qualification) certification after acquiring the approval from the KMFDS to export the product, based on its high safety and immunogenicity secured through the clinical trials. Typhoid vaccines are supplied mainly through international bidding by UN-affiliated organizations and the PQ certification is required for bidding.

SK bioscience aims to secure the necessary qualifications in collaboration with IVI and supply NBP618 globally by 2022 at the earliest. The production and supply of the completed NBP618 will be proceeded at L HOUSE, SK bioscience’s vaccine manufacturing plant in Andong

Dr.Sushant Sahastrabuddhe, IVI´s Director of typhoid vaccine developmentsaid, “Following the success of Phase I and Phase II clinical trials in the Philippines, we have obtained satisfactory data from Phase III clinical trials.”

Jaeyong Ahn, CEO of SK bioscience said, “We have taken a step closer to commercializing vaccines by obtaining inspiring data through Phase III clinical trials. This vaccine will be universally accessible, so children in developing countries will no longer have to suffer from typhoid disease.”