SK Bioscience obtains product approval for shingles vaccine 'Skyzoster' in Malaysia

"Expanding Global Market Influence Starting with Emerging Markets in Southeast Asia"

SK Bioscience's shingles vaccine 'Sky Zoster'.
Photo by SK Bioscience

[Asia Economy Reporter Myunghwan Lee] SK Bioscience announced on the 9th that its self-developed shingles vaccine, 'Skyzoster,' has obtained product approval from the Malaysian National Pharmaceutical Regulatory Agency. This marks the second overseas approval for Skyzoster, following Thailand in May 2020.

Skyzoster is the first shingles vaccine developed in Korea and the second in the world. It is a live attenuated vaccine derived from the varicella-zoster virus. After safety was verified by overseas specialized non-clinical testing institutions, it underwent five years of clinical trials in Korea and received product approval from the Korean Ministry of Food and Drug Safety in September 2017.

SK Bioscience emphasized that the excellent immunogenicity and safety of Skyzoster were demonstrated in Phase 3 clinical trials conducted at eight institutions, including Korea University Guro Hospital. The immunogenicity evaluation, which enrolled 824 healthy adults aged 50 and older, showed that antibody titers against the varicella-zoster virus increased 2.75 times after vaccination compared to before vaccination.

Excellent safety is also a strong point. Safety evaluation results showed that the incidence rate of adverse reactions within six weeks after Skyzoster vaccination was similar to that of the control vaccine group, and no serious adverse reactions related to the clinical trial drug were reported during the 26 weeks following vaccination. Recently, the Ministry of Food and Drug Safety also announced safety evaluation results from a post-marketing surveillance of Skyzoster involving 651 subjects over four years, confirming that no serious adverse events occurred after administration.

Based on excellent clinical results, SK Bioscience explained that Skyzoster is steadily expanding its position in the domestic market. According to IMS data, a global market research firm, Skyzoster's market share by dose reached a record high of 56% in the third quarter of 2022. The market share has gradually increased from 51% in the first quarter and 52% in the second quarter of last year.

SK Bioscience President Jaeyong Ahn said, "It is encouraging that a vaccine developed with our technology is gradually expanding its influence in the global vaccine market dominated by big pharma," adding, "With our elevated global status following the contract manufacturing and self-development of COVID-19 vaccines, we will continue to expand the reach of our technology-based products."

SK Bioscience plans to apply for the World Health Organization (WHO) prequalification for Skyzoster within this year and accelerate the approval registration of Skyzoster in emerging overseas markets based on this.

This content was produced with the assistance of AI translation services.