SK Bioscience applies Phase 3 trials in US for pneumococcal vaccine

It submitted the clinical trial plan of the vaccine candidate GBP410 to the FDA, developed in collaboration with Sanofi

SK Bioscience applies Phase 3 trials in US for pneumococcal vaccine
Ji-Hyun Lee 1
2023-12-11 16:24:23 bluesky@hankyung.com
Bio & Pharma

South Korea's SK Bioscience Co. announced on Monday that it submitted the Investigational New Drug (IND) application for the Phase 3 clinical trial plan of the 21-valent pneumococcal protein conjugate vaccine candidate GBP410, developed in collaboration with Sanofi SA, to the US Food and Drug Administration (FDA).

In August this year, SK Bioscience and Sanofi completed the Phase 2 clinical trial of GBP410. The trial involved administering GBP410 and a comparator vaccine (Prevenar 13) to 140 infants aged 12-15 months and 712 infants aged 42-89 days, confirming the immunogenicity of GBP410. No vaccine-related serious adverse events were reported.

SK Bioscience and Sanofi plan to complete Phase 3 clinical trials targeting infants in multiple countries, including the United States, Europe, and South Korea by 2027.

"Annually, 740,000 infants, children and adolescents die from pneumonia worldwide," Ahn Jae-yong, CEO of SK Bioscience said. "Through the development of GBP410, we aim to contribute to global public health and grow into a leading company in the market."

Write to Ji-Hyun Lee at bluesky@hankyung.com
#SK Bioscience #IND application #21-valent pneumococcal vaccine #GBP410 #Sanofi #immunogenicity #Prevenar 13

SK Bioscience to develop 2nd-generation Ebola vaccine

SK Bioscience to develop 2nd-generation Ebola vaccine

South Korea's SK Bioscience Co. announced on Wednesday that it signed a business agreement with the international non-profit research organization Hilleman Laboratories for the joint development of a second-generation Ebola Zaire virus vaccine. Under the agreement, SK Bioscience and Hilleman

SK Bioscience resumes output of flu vaccine after two years

SK Bioscience resumes output of flu vaccine after two years

SK Bioscience Co., the drug-making unit of South Korea’s SK Group, on Wednesday shipped SKYCellflu, its vaccine for the common flu, for the first time in two years.By early next year, the domestic market will get about five million doses of SKYCellflu, the world's first cell culture-base

SK Bioscience to export $51 bn flu vaccine to Thailand

SK Bioscience to export $51 bn flu vaccine to Thailand

SK Bioscience's flu vaccine Skycellflu SK Bioscience Co., the drug-making unit of South Korea’s SK Group, announced on Monday that it has signed a deal with Thailand's state-owned Government Pharmaceutical Organization (GPO) to supply the cell-cultured influenza vaccine "Sky Cell Flu" bul

SK Bioscience buys 6.5 million Novavax shares for $83.4 million

SK Bioscience buys 6.5 million Novavax shares for $83.4 million

SK Bioscience CEO Ahn Jae-yong (left) and Novavax CEO John C. Jacobs pose for a photo after signing a strategic partnership agreement SK Bioscience Co., the drug-making unit of South Korea’s SK Group, said on Wednesday it has signed a deal to buy 6.5 million shares in US vaccine maker Nov

SK Bioscience, Thai’s GPO to jointly boost vaccine infrastructure

SK Bioscience, Thai’s GPO to jointly boost vaccine infrastructure

SK Bioscience Co., the drug-making unit of South Korea’s SK Group, announced on Wednesday that it has signed a memorandum of understanding (MOU) with Thailand's state-owned pharmaceutical company, Government Pharmaceutical Organization (GPO), aiming to bolster local vaccine production an
(* comment hide *}