SK bioscience’s Zoster Vaccine Receives Biologics License Utility Approval in Malaysia

SK bioscience’s Zoster Vaccine Receives Biologics License Utility Approval in Malaysia
  • The world-second developed shingles vaccine ‘SKYZoster™’ is authorized by the Nationwide Pharmaceutical Regulatory Company (NPRA)
  • SK biosciences plans to launch the zoster vaccine with confirmed efficacy and security beginning in Southeast Asian market

SEOUL, South Korea, Jan. 9, 2023 /PRNewswire/ — SK bioscience, a world modern vaccine and biotech firm dedicated to selling human well being from prevention to treatment throughout the globe, introduced that the corporate has obtained a biologics license software approval of the ‘SKYZoster™’ from the Nationwide Pharmaceutical Regulatory Company (NPRA) in Malaysia.

That is the second abroad approval of SKYZoster™ after Thailand in Could 2020.

SKYZoster™ is the world’s second developed shingles vaccine. It’s a reside vaccine that attenuates varicella zoster virus. The vaccine was authorized in South Korea from the Ministry of Meals and Drug Security (KMFDS) in September 2017 primarily based on outcomes of medical trials performed in home and international establishments.

SKYZoster™ is proven clinically acceptable immunogenicity and security at Part III medical trial. As evaluating immunogenicity by enrolling 824 wholesome adults over the age of fifty, the end result reveals that the antibody titer towards the varicella zoster virus elevated 2.75 occasions after inoculating SKYZoster™ in comparison with earlier than vaccination. Moreover, the end result reveals that SKYZoster™ is non-inferior in comparison with the management vaccine (MSD Zostavax), and the cell-mediated immune response was additionally proven to be at an equal degree, proving SKYZoster™ successfully induces immunogenicity towards shingles.

By way of security, the incidence of hostile reactions that occurred 6 weeks after SKYZoster™ vaccination was just like that of the management vaccine group, and there have been no severe hostile reactions that confirmed any relationship with the examine drug reported throughout 26 weeks after vaccination. As well as, a post-marketing survey of 651 individuals for 4 years after the launching of SKYZoster™, the KMFDS’ security analysis end result was lately introduced, indicating that no severe hostile reactions occurred after the vaccination.

SKYZoster™ is steadily increasing the market place within the South Korean home market. In response to the IMS information, a world market analysis institute, SKYZoster™’s market share within the third quarter of 2022 reached 56% (primarily based on the variety of doses), the best ever. Particularly, the vaccine progressively expanded its affect out there with a 51% share within the first quarter and a 52% share within the second quarter, proving the efficacy and security.

SK bioscience plans to submit for SKYZoster™’s Pre-Qualification(PQ) to the WHO subsequent yr to additional speed up the vaccine’s approval for abroad rising markets, equivalent to Southeast Asia and creating international locations.

Jaeyong Ahn, CEO of SK bioscience, stated, “It’s encouraging that vaccines made by our personal know-how are progressively increasing their affect within the international vaccine market the place huge pharmaceutical corporations primarily dominate. With the expertise of CMO/CDMO and self-development of varied vaccines, we are going to additional broaden our merchandise to low- and middle-income international locations to contribute international public well being.”

Contact
SK bioscience Communications Group
Changhyun Jin ([email protected])
Jeannie S. Pak ([email protected])
Tae-Gyun Kim ([email protected])

About SK bioscience
SK bioscience is a world modern vaccine and biotech firm, dedicated to international pandemic preparedness in vaccine growth and manufacturing for extra equitable entry. In leveraging the strengths of cutting-edge vaccine growth applied sciences, SK bioscience is devoted to selling human well being from prevention to treatment throughout the globe. Via collaborations with home and worldwide governments, regulatory businesses, healthcare suppliers, medical doctors and medical specialists, SK bioscience has firmly established globally licensed R&D and manufacturing applied sciences. All SK colleagues are passionately dedicated to offering higher public healthcare options and providing high-quality vaccines and therapeutics to those that want them.
For additional data, please go to: https://www.skbioscience.co.kr/en/essential

SOURCE SK bioscience

SK bioscience’s Zoster Vaccine Receives Biologics License Utility Approval in Malaysia