-The world-second developed shingles vaccine ‘SKYZoster®’ is approved by the National Pharmaceutical Regulatory Agency (NPRA)
-SK bioscience plans to launch the zoster
vaccine with proven efficacy and safety starting in Southeast Asian market
[Jan.9,2023]Seoul, South Korea- SK bioscience, a global innovative vaccine and biotech company committed to promoting human health from prevention to cure across the globe, announced that the company has received a biologics license application approval of the ‘SKYZoster’ from the National Pharmaceutical Regulatory Agency (NPRA) in Malaysia.
This is the second overseas approval of SKYZoster after Thailand in May 2020.
SKYZoster is the world´s second developed shingles vaccine. It is a live
vaccine that attenuates varicella zoster virus. The vaccine was approved in
South Korea from the Ministry of Food and Drug Safety (KMFDS) in September 2017
based on results of clinical trials conducted in domestic and global institutions..
SKYZoster is shown clinically acceptable immunogenicity and safety at Phase
III clinical trial. As evaluating immunogenicity by enrolling 824 healthy
adults over the age of 50, the result shows that the antibody titer against the
varicella zoster virus increased 2.75 times after inoculating SKYZoster compared to before vaccination. Furthermore, the result shows
that SKYZoster is non-inferior compared to the control
vaccine (MSD Zostavax), and the cell-mediated immune response was also shown to
be at an equal level, proving SKYZoster effectively
induces immunogenicity against shingles.
In terms of safety, the incidence of adverse
reactions that occurred 6 weeks after SKYZoster vaccination was similar to that of the control vaccine group, and
there were no serious adverse reactions that showed any relationship with the study
drug reported during 26 weeks after vaccination. In addition, a post-marketing
survey of 651 people for 4 years after the launching of SKYZoster, the KMFDS’ safety evaluation result was recently announced,
indicating that no serious adverse reactions occurred after the vaccination
SKYZoster is steadily expanding the market position in the South Korean domestic
market. According to the IMS data, a global market research institute, SKYZoster´s market share in the third quarter of 2022 reached 56% (based on
the number of doses), the highest ever. In particular, the vaccine gradually
expanded its influence in the market with a 51% share in the first quarter and
a 52% share in the second quarter, proving the efficacy and safety.
SK bioscience plans to submit for SKYZoster’s Pre-Qualification(PQ) to the WHO next year to further accelerate the
vaccine’s approval for overseas emerging markets, such as Southeast Asia and
Jaeyong Ahn, CEO of SK
bioscience, said, “It is encouraging that vaccines made with our own technology are
gradually expanding their influence in the global vaccine market where big
pharmaceutical companies mainly dominate. With the experience of CMO/CDMO and
self-development of various vaccines, we will further expand our products to low-
and middle-income countries to contribute global public health."