● Marketing Authorization for SKYZoster, the World`s Second Zoster Vaccine

- Breaks monopoly in herpes zoster market
- Entry into ₩80 billion domestic market with release in 2017
- 50% of 28 essential vaccines now capable of being produced in South Korea.



A Korean pharmaceutical company has entered the herpes zoster (commonly known as ‘shingles’) vaccine market, adding another vital option for patients in a market traditionally dominated by a single company.

SK chemicals announced on the 9th that SKYZoster Injection (project name NBP608), a herpes zoster vaccine developed through proprietary technologies, has obtained final marketing authorization from the Ministry of Food and Drug Safety.

SK chemicals plans to supply SKYZoster, which passed the final stage for commercialization, to domestic hospitals and clinics within this year after commencing with full-scale commercial production and obtaining nationwide shipping approval.

This marketing authorization of SKYZoster marks the first time that half of all 28 essential and counter-terrorism vaccines are capable of being produced in South Korea.

SK chemicals` SKYZoster is a live attenuated vaccine (LAV) prepared with the varicella-herpes zoster virus (VZV). The vaccine has undergone 5 years of clinical trials domestically after having demonstrated strict safety in professional non-clinical testing institutions overseas.

A total of 842 adult patients over 50 years of age participated in clinical trials conducted by eight clinical institutions including Korea University Guro Hospital, proving the efficacy, safety, and non-inferiority of the vaccine.

Until now, Zostavax, the vaccine introduced by global pharmaceutical company MSD in 2006 (2013 in Korea), was the only available herpes zoster vaccine in what was essentially a market monopoly. SK chemicals was able to accelerate their product development with support from the Ministry of Food and Drug Safety`s Global Vaccine Commercialization Team.

With the recent marketing authorization, SK chemicals will enter the domestic herpes zoster vaccine market estimated at about ₩80 billion, with plans to expand into the global market. According to Data Monitor, a market research firm, the global market for herpes zoster vaccines is estimated at about $685 million (₩800 billion) as of 2016.

SK chemicals President Man-hun Park stated, "Following SKYCellflu, the world`s first cell-culture quadrivalent influenza vaccine, we`ve succeeded in creating another global-level vaccine purely with domestic technology." He added, "We will do our part in establishing vaccine independence by pouring our efforts into the development of various premium vaccines in the future."

To realize domestic vaccine self-sufficiency, SK chemicals has focused on vaccine research and development, investing a total of ₩400 billion, since in 2008. Notably, the company has established an infrastructure capable of producing most vaccines domestically, including their world-leading vaccine factory L-House in Andong, North Gyeongsang Province, which houses production facilities and fundamental technologies for cell culture, bacterial culture, genetic recombinant, and protein conjugate vaccines, to name a few.





[Photo]
SKYZoster, Korea`s first and world`s second herpes zoster vaccine, recently obtained marketing authorization from the Ministry of Food and Drug Safety


[Glossary]
* Herpes zoster
A disease that occurs when dormant varicella-herpes zoster virus (VZV) is activated after having chickenpox in childhood
* Live vaccine
Attenuated mutant strains of live cells or viruses used as a vaccine
* Non-inferiority
Demonstrating equal or greater efficacy
* SKYZoster
Portmanteau of brand name `SKY,` applied to drugs produced by SK chemicals, and `zoster` from the varicella-herpes zoster virus.