SK Bioscience and Sanofi Pasteur said they have submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration to conduct phase 2 clinical trials of their new pneumococcal vaccine.
|SK Bioscience's vaccine plant in Andong, North Gyeongsang Province|
The two companies started developing the new vaccine after SK Chemicals, the parent company of SK Bioscience, signed a joint development and sales contract with Sanofi Pasteur in 2014 to enter the global market with the new vaccine.
They completed phase 1 clinical trials at the end of last year, and SK Bioscience received a milestone of $11 million from Sanofi Pasteur.
The pneumococcal vaccine under development is a protein-conjugated product made by binding a specific protein to the surface polysaccharide of pathogens, causing pneumonia. According to SK Bioscience, the protein conjugation method is known to provide the highest preventive effect among pneumococcal vaccines developed so far.
“A locally developed vaccine that can create high added value for global patients is moving toward success,” SK Bioscience CEO Ahn Jae-yong said. “We still have to complete phase 2 and 3 clinical trials for the vaccine and do our best to launch the product successfully.
According to Allied Market Research, a global market research firm, the pneumococcal vaccine market reached worldwide sales of about $6.3 billion in 2017, which will grow to about $9 billion by 2025.
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