● SK chemicals Acquires Marketing Authorization for Chickenpox Vaccine “Sky Varicella Inj.”
- Clinical studies were conducted at 19 domestic/overseas sites including the Catholic University of Korea St. Vincent＇s Hospital to prove the drug’s efficacy and safety.- SK chemicals is aiming to enter the global bid market by establishing the domestic market as a foothold.
With the successive introduction of the world’s first quadrivalent cell culture flu vaccine and the world’s second herpes zoster vaccine, SK chemicals has become a vaccine powerhouse and is now about to market the fourth vaccine that the company has developed with its own technology.
On June 5th, SK chemicals announced that it has finally acquired the marketing approval for Sky Varicella Inj. (NBP608), a varicella zoster vaccine, from the Ministry of Food and Drug Safety.
As the company passed through the final stage for the drug’s commercialization, it is planning to supply the drug to local hospitals and clinics in the second half of this year after completing the remaining stages including the acquisition of the national release approval.
SK chemicals is also planning to enter the global market by utilizing the benefits of the approval. As more developing countries are streamlining the approval process by shortening the review period and exempting the inspection of the drugs that are already approved by the Ministry of Food and Drug Safety, overseas markets are increasingly welcoming domestically developed drugs.
The company confirmed the high immunogenicity of the vaccine by conducting a phase III multinational clinical trial to confirm the efficacy and safety of the drug in 499 children aged from 12 months to 12 years at 19 domestic and overseas sites including the Catholic University of Korea St. Vincent＇s Hospital.
“After we commercialize the varicella vaccine, one of the mandatory inoculation vaccines, we will be able to diversify our revenue sources and accelerate our share in the overseas markets,” says SK chemicals CEO, Park Man-hoon. “SK chemicals will continue to contribute to Korea’s self-sufficiency of vaccines by developing various premium vaccines as well as mandatory inoculation vaccines, thereby growing into a global vaccine company.”
SK chemicals has been focusing on vaccine development since 2008, investing a total of 400 billion won. The company’s vaccine factory called “L HOUSE” is one of the world’s top vaccine factories located in Andong, North Gyeongsang Province, which has foundational technologies such as cell culture, bacteria culture, gene recombination and protein vaccine, and facilities which consist of the infrastructure that the company can manufacture most of the vaccines available for development in South Korea. Meanwhile, SK chemicals plans to split off its vaccine business to enhance its business expertise and management efficiency on July 1st.
# Image caption : the SK chemicals headquarters, “Eco-Lab”, located in Pangyo, Seongnam-si, Gyeonggi-do