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- This approval paves the way for exports to the world's fourth most populous country.
- SK bioscience aims to continue to grow as a global vaccine brand beyond Korea.
SEONGNAM, South Korea, Oct. 23, 2024 /PRNewswire/ -- SK bioscience, a global innovative vaccine and biotech company committed to promoting human health from prevention to cure, today announced that Indonesia's Food and Drug Agency, BPOM (Badan Pengawas Obat dan Makanan), has approved the Biologics License Application (BLA) for the SKYCellflu Quadrivalent prefilled syringe, the world's first quadrivalent cell-cultured influenza vaccine. This is the first time a domestically made influenza vaccine has received approval in Indonesia.
Indonesia, the world's fourth most populous nation with over 280 million people, is impacted by the World Health Organization's flu vaccination guidelines for both regions due to its elongated geography, spanning both the Northern and Southern Hemispheres.
Following this approval of SKYCellflu for the Northern Hemisphere influenza strains, SK bioscience anticipates fast-tracked approval of flu vaccine for the Southern Hemisphere in Indonesia.
SKYCellFlu is the world's first cell culture-based influenza vaccine to achieve WHO Prequalification (PQ) certification, demonstrating acceptable immunogenicity and safety across clinical trials. It is the only cell-cultured influenza vaccine currently available in Korea.
Compared to the egg-based vaccines, its shorter production timeline makes it more suited for rapid response to pandemics or the emerging variants. SKYCellflu also doesn't require antibiotic or preservative administration.
In addition, cell-cultured vaccines are less likely to mutate during the production process than those produced in fertilized eggs, allowing for a more accurate match to circulating influenza strains.
In SK bioscience's research, the company conducted subcultures 15 times by employing cells for SKYCellflu production and fertilized eggs. Subculturing is the removal of the medium and transfer of cells from a previous culture into fresh growth medium, a procedure that enables the further propagation of the cell line or cell strain.
The study results showed that mutations were found in three proteins within the virus in the fertilized egg method, while no mutations were found in the cells used for SKYCellflu production. These findings were presented at the 2019 Korea Interscience Working Group on Influenza (KIWI) Symposium.
SKYCellflu has already been approved in multiple Asian countries, including Malaysia, Thailand, Myanmar, Iran, Singapore, Pakistan, Mongolia, and Brunei. Last year, it was granted in Chile, marking its first approval in the South American market. SK bioscience plans to pave the way for a full-scale expansion into global export markets.
Jaeyong Ahn, CEO of SK bioscience, said, "It is very encouraging that our own developed vaccines are receiving approvals worldwide, a significant step for expanding our global export market." He added, "We are confident that SK bioscience continues to grow into a global vaccine brand beyond Korea, as our vaccines, including shingles, chickenpox, and typhoid vaccines, secures WHO PQ certifications and global approvals one after another."
SK bioscience Communications Team
Changhyun Jin (jin99@sk.com)
Jeannie S. Pak (j.pak@sk.com)
- This approval paves the way for exports to the world's fourth most populous country.
- SK bioscience aims to continue to grow as a global vaccine brand beyond Korea.
SEONGNAM, South Korea, Oct. 23, 2024 /PRNewswire/ -- SK bioscience, a global innovative vaccine and biotech company committed to promoting human health from prevention to cure, today announced that Indonesia's Food and Drug Agency, BPOM (Badan Pengawas Obat dan Makanan), has approved the Biologics License Application (BLA) for the SKYCellflu Quadrivalent prefilled syringe, the world's first quadrivalent cell-cultured influenza vaccine. This is the first time a domestically made influenza vaccine has received approval in Indonesia.
Indonesia, the world's fourth most populous nation with over 280 million people, is impacted by the World Health Organization's flu vaccination guidelines for both regions due to its elongated geography, spanning both the Northern and Southern Hemispheres.
Following this approval of SKYCellflu for the Northern Hemisphere influenza strains, SK bioscience anticipates fast-tracked approval of flu vaccine for the Southern Hemisphere in Indonesia.
SKYCellFlu is the world's first cell culture-based influenza vaccine to achieve WHO Prequalification (PQ) certification, demonstrating acceptable immunogenicity and safety across clinical trials. It is the only cell-cultured influenza vaccine currently available in Korea.
Compared to the egg-based vaccines, its shorter production timeline makes it more suited for rapid response to pandemics or the emerging variants. SKYCellflu also doesn't require antibiotic or preservative administration.
In addition, cell-cultured vaccines are less likely to mutate during the production process than those produced in fertilized eggs, allowing for a more accurate match to circulating influenza strains.
In SK bioscience's research, the company conducted subcultures 15 times by employing cells for SKYCellflu production and fertilized eggs. Subculturing is the removal of the medium and transfer of cells from a previous culture into fresh growth medium, a procedure that enables the further propagation of the cell line or cell strain.
The study results showed that mutations were found in three proteins within the virus in the fertilized egg method, while no mutations were found in the cells used for SKYCellflu production. These findings were presented at the 2019 Korea Interscience Working Group on Influenza (KIWI) Symposium.
SKYCellflu has already been approved in multiple Asian countries, including Malaysia, Thailand, Myanmar, Iran, Singapore, Pakistan, Mongolia, and Brunei. Last year, it was granted in Chile, marking its first approval in the South American market. SK bioscience plans to pave the way for a full-scale expansion into global export markets.
Jaeyong Ahn, CEO of SK bioscience, said, "It is very encouraging that our own developed vaccines are receiving approvals worldwide, a significant step for expanding our global export market." He added, "We are confident that SK bioscience continues to grow into a global vaccine brand beyond Korea, as our vaccines, including shingles, chickenpox, and typhoid vaccines, secures WHO PQ certifications and global approvals one after another."
SK bioscience Communications Team
Changhyun Jin (jin99@sk.com)
Jeannie S. Pak (j.pak@sk.com)
** The press release content is from PR Newswire. Bastille Post is not involved in its creation. **
SK bioscience Announces Approval of Its Quadrivalent Influenza Vaccine in Indonesia
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Holistic Health Tracking
RingConn Gen 3 Smart Ring delivers comprehensive health tracking across multiple key dimensions, including sleep, sleep apnea, heart rate, blood oxygen, activity, stress, and women's health management such as menstrual cycle tracking and pregnancy preparation-related insights. Through continuous monitoring and long-term analysis, the device provides users with a more complete understanding of their health status over time, supporting more informed daily lifestyle decisions.
The system is powered by an advanced VCSEL infrared sensing solution, designed to enhance data stability and accuracy across a wide range of wearing conditions and real-world scenarios, strengthening the foundation for long-term health trend analysis. In internal testing, the system achieved a resting heart rate accuracy of ≥98.58%, a blood oxygen mean absolute error (MAE) of ≤0.95%, a step count accuracy of ≥97.20%, and a temperature accuracy of ±0.08°C, demonstrating strong performance in multi-dimensional health data capture.
Subtle Smart Alert
RingConn Gen 3 Smart Ring introduces subtle smart alerts to provide timely feedback when key health changes are detected. Through gentle vibration-based notifications, the device can also prompt users in scenarios such as prolonged inactivity or low battery, helping support more balanced daily usage and awareness. In quiet environments — such as during meetings or conversations — these silent notifications allow users to stay informed without disruptive sounds or attention-grabbing screen notifications.
The alert system is fully customizable, allowing users to enable or disable notifications based on personal preference. By prioritizing minimal disruption and silent vibration cues over intrusive alerts, RingConn ensures that health reminders remain discreet, context-aware, and seamlessly integrated into everyday life.
*Pre-order offer: The 10% limited-time discount is available exclusively at the RingConn official website from May 5 through June 10, 2026.
*This product is not intended to diagnose, treat, cure, or prevent any disease or medical condition. As a pre-diagnostic tool, the Gen 3 does not replace the diagnosis or treatment by a qualified healthcare professional.
For more information or to place a pre-order, visit:
https://bit.ly/ringconngen3
Follow RingConn on social media:
Instagram: https://bit.ly/ringconninstagram
TikTok: https://bit.ly/ringconntiktok
About RingConn
Established in 2021, RingConn is a user-centric company, driven by continuous innovation, to provide professional, continuous, and thoughtful health monitoring products and services. RingConn is dedicated to becoming users' most trusted guardian for their physical and mental well-being.
** This press release is distributed by PR Newswire through automated distribution system, for which the client assumes full responsibility. **
RingConn Gen 3 Smart Ring Opens for Pre-Order: Bringing Vascular Insights to Effortless Everyday Wear
RingConn Gen 3 Smart Ring Opens for Pre-Order: Bringing Vascular Insights to Effortless Everyday Wear
RingConn Gen 3 Smart Ring Opens for Pre-Order: Bringing Vascular Insights to Effortless Everyday Wear
