SK Chemicals said Tuesday that it has gained marketing approval for Sky Varicella Inj., a varicella zoster vaccine, from the Ministry of Food and Drug Safety.
As the company passed the final stage for commercialization, it plans to supply the treatment to local hospitals and clinics in the second half of this year. The company also plans to use the agency’s approval as a stepping stone to market its treatment worldwide.
The company expects fast entry into foreign markets as developing countries have recently implemented systems shortening the review period and exempting the inspection of drugs approved by the Korean ministry.
The company confirmed the high immunogenicity of the vaccine in a clinical trial conducted at 19 domestic and foreign institutions, including the Catholic University of Korea St. Vincent's Hospital. The research confirmed the efficacy and safety of the drug in 499 children aged from 12 months to 12 years.
“The commercialization of varicella vaccine, one of the mandatory inoculation vaccines, will diversify our revenue sources and speed up overseas expansion,” SK Chemicals CEO Park Mahn-hoon said. “We will continue to contribute to establishing a vaccine stockpile and grow into a global vaccine company by developing essential vaccines.”