SK Chemicals Co. Ltd.

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 by leveraging the advantages of cell-cultured vaccines. 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. Continue Reading SKYCellflu Quadrivalent prefilled syringe Indonesia is the world's fourth most populous nation with over 280 million people, with rapidly growing pharmaceutical market. According to global market research firm Innsight10, Indonesia's flu vaccine market is projected to grow from USD 38.5 million in 2022 to USD 69.1 million in 2030. Due to its elongated geography, spanning both Northern and Southern Hemispheres, Indonesia is impacted by the World Health Organization's flu vaccination guidelines for both regions. Following this approval of SKYCellflu for the Northern Hemisphere influenza strains, SK bioscience anticipates fast-tracked approval of flu vaccine for Southern Hemisphere influenza strains by the Indonesian Food and Drug Agency. 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 does not 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, also referred to as passaging cells, 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 will continue to grow into a global vaccine brand beyond Korea, as our vaccines, including shingles, chickenpox, and typhoid vaccines, are securing WHO PQ certifications and global approvals one after another." About SK bioscience SK bioscience is an innovative vaccine and biotech company, committed to vaccine development and manufacturing to enable more equitable access to vaccines around the world. Leveraging strengths on cutting-edge technologies, SK bioscience has been dedicated to promoting human health from prevention to cure across the globe. With the cooperation of domestic and international governments, regulatory agencies, healthcare providers, doctors, and medical experts, all of the SK colleagues are passionately committed to providing high-quality vaccines to those who need them and better public healthcare solutions. - SK bioscience Website - SK bioscience Linkedin Contact SK bioscience Communications Team Changhyun Jin([email protected]) Jeannie S. Pak([email protected]) SOURCE SK bioscience WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

SK bioscience invested USD 3 million in FinaBio, a U.S. company specializing in next-generation conjugate vaccine technology. With the agreement, SK bioscience expects to improve the immunogenicity and productivity of conjugate vaccines, including those for pneumoniae and typhoid. The company will accelerate its future growth strategies by exploring and investing in promising global companies. SEONGNAM, South Korea and ROCKVILLE, Md., Oct. 8, 2024 /PRNewswire/ -- SK bioscience, a global innovative vaccine and biotech company committed to promoting human health from prevention to cure, announced today that the company has signed an agreement to acquire a stake in Fina Biosolutions (FinaBio), a promising R&D biotechnology company based in Rockville, Maryland, United States, by investing USD 3 million. With this acquisition, SK bioscience will become FinaBio's first and sole strategic investor. Continue Reading Korea’s SK bioscience Acquires Stake in U.S. Biotech Fina Biosolutions Founded in 2006, FinaBio specializes in the research and development of conjugate vaccines for pneumoniae, meningococcal, typhoid, and other diseases. Among other assets, FinaBio has developed FinaXpress, a proprietary E. coli expression system which they use for producing proteins not previously made in these bacteria, including many carrier proteins like CRM197. Marketed as EcoCRM®, FinaBio has expanded access to this critical protein. FinaBio is also developing a next-generation conjugation technology that is site-specific and targets the desired location for antigen binding, hence boosting immunogenicity and productivity. FinaBio collaborates with a number of global biotech companies and institutions, including The Serum Institute of India, The Chengdu Institute of Biology in China, and Inventprise in the U.S. to supply conjugation technology and carrier proteins, including CRM197. Leveraging its expertise in conjugation, the company will continue to grow its business units, including conjugate vaccine development services, reagents and technologies. SK bioscience, which already manufactures conjugate vaccines such as pneumococcal and typhoid vaccines, will actively utilize FinaBio's CRM197 technology. It aims to secure the high effectiveness of diverse conjugate vaccines while increasing profitability through high-yield processes. Dr. Andrew Lees, Founder and CEO of FinaBio, said, "We appreciate SK's confidence in Fina Biosolutions. The investment will accelerate the global commercialization of EcoCRM®(CRM197). Combined with our efficient conjugation technology, this will enable the development of the next generation conjugate vaccines. It will also allow us to continue our mission of promoting affordable vaccines." Jaeyong Ahn, CEO and President of SK bioscience, said, "We are delighted to continue developing partnerships with global firms that have next-generation vaccine technology. Through our mid- to long-term collaboration with FinaBio, we will advance the vaccines we are developing to the next level and strengthen our competitiveness for global market expansion." Recently, SK bioscience has been actively investing in global companies to create synergies in business. In June 2024, the company signed an agreement to acquire the controlling stake in a German company, IDT Biologika, one of the top 10 global vaccine contract manufacturers and completed the acquisition earlier this month. In July 2024, SK bioscience inked a Simple Agreement for Future Equity (SAFE) with Sunflower Therapeutics, a U.S. biotech company known for its own yeast-based protein manufacturing technology, which facilitates the development and production of diverse antigens and antibodies. SK bioscience continues to secure its competitiveness through strategic investments in promising companies with exceptional technology and M&As to lay the foundation for a great leap forward into a leading global company. About SK bioscience SK bioscience is an innovative vaccine and biotech company, committed to vaccine development and manufacturing to enable more equitable access to vaccines around the world. Leveraging strengths on cutting-edge technologies, SK bioscience has been dedicated to promoting human health from prevention to cure across the globe. With the cooperation of domestic and international governments, regulatory agencies, healthcare providers, doctors, and medical experts, all of the SK colleagues are passionately committed to providing high-quality vaccines to those who need them and better public healthcare solutions. - SK bioscience Website - SK bioscience Linkedin Contact SK bioscience Communications Team Changhyun Jin ([email protected]) Jeannie S. Pak ([email protected]) Fina Biosolutions Andrew Lees ([email protected]) SOURCE SK bioscience WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

SK Biopharmaceuticals inked an exclusive global licensing agreement worth $571.5 million with Full-Life Technologies, gaining the latter’s radionuclide drug conjugate (RDC) candidate FL-091. As hinted last month, this marks SK Biopharm’s debut in the radiopharmaceutical space.With ambitions of blooming into a ‘Big Biotech’, SK Biopharm will “further unveil and implement business plans for radiopharmaceutical therapy this year, and actively pursue clinical development and commercialization in the near future,” said chief executive Donghoon Lee. Under the deal announced Tuesday, SK Biopharm will acquire worldwide R&D, production and commercialisation rights to FL-091 and its back-up compounds. FL-091 is a small-molecule radioligand vector designed to deliver targeted radiotherapy to neurotensin receptor 1-positive (NTSR1+) solid tumours, including colorectal, prostate, and pancreatic cancers.It has demonstrated promising biodistribution, NTSR1-binding affinity and antitumour activity in preclinical studies. According to Full-Life, the development of an alpha-emitter therapy 225Ac-FL-091 is currently under way. Moreover, SK Biopharm holds the right of first negotiation to license additional pre-selected RDC programmes. Meanwhile, Full-Life stands to receive an undisclosed upfront payment, alongside payments on development and commercial milestones, and sales royalties.