20-valent Pneumococcal Conjugate Vaccine(Pfizer)

No patent infringement found in exports of individual conjugate bulk substances and research-use finished products of PCV13 to Russia Company plans to export PCV13 vaccine components "We aim for the global PCV market with our 21-valent and next-generation pneumococcal vaccines currently under development." SEONGNAM, South Korea, May 21, 2025 /PRNewswire/ -- SK bioscience, a global innovative vaccine and biotech company committed to promoting human health from prevention to cure, today announced that it the Supreme Court of Korea has ruled in its favor in a patent infringement lawsuit filed by large global pharmaceutical giant Pfizer over its 13-valent pneumococcal conjugate vaccine (PCV13). In 2020, Pfizer claimed that SK bioscience's export of PCV13 individual conjugate bulk substances and research-use finished products to Russia infringed on the composition patent of its vaccine, Prevnar 13. Continue Reading SK bioscience L HOUSE manufacturing plant However, the Supreme Court ruled that the individual conjugates comprising PCV13 do not fall within the scope of Pfizer's patent claims, thereby upholding the lower court's ruling in favor of SK bioscience. The Court also confirmed that the production and supply of PCV13 finished products for research purposes did not constitute patent infringement. SK bioscience successfully developed Korea's first 13-valent pneumococcal conjugate vaccine, SKYPneumo, in 2016. However, due to the ongoing patent dispute with Pfizer, the company has been prohibited from manufacturing and selling the vaccine in Korea until 2027, when the related patents set to expire. Following the ruling, SK bioscience now plans to initiate new business in pneumococcal conjugate vaccines by exporting individual components of PCV13 to countries with high vaccine demand, such as those in Southeast Asia and Latin America. Technology transfers through local partnerships are also being pursued in parallel. Looking ahead, SK bioscience aims to expand its presence in the global pneumococcal vaccine market. From 2027, the company will be able to manufacture and sell SKYPneumo domestically. In addition, the company is developing a 21-valent pneumococcal conjugate vaccine with global pharmaceutical company Sanofi, which entered Phase 3 global clinical in late 2024. Simultaneously, the two companies are also working on a next-generation pneumococcal vaccine that is expected to offer broader protection than current options. The global pneumococcal vaccine market continues to grow. According to Global Market Insights, the market is projected to grow at a compound annual rate of approximately 5.6% to reach USD 15.1 billion (approximately KRW 21.55 trillion) by 2034. This growth is driven by expanded vaccination programs and support from governments and international organizations like WHO and Gavi. SK bioscience's strong track record in public vaccine supply and cooperation with global health organizations positions it well for future expansion. Jaeyong Ahn, CEO of SK bioscience, said, "This latest court decision is meaningful in that it ensures a competitively developed vaccine in Korea does not go to waste but instead finds new opportunity. We will leverage this momentum to improve access to premium vaccines, contribute to a stable global vaccine supply, and achieve sustainable growth." Meanwhile, SK bioscience recently secured a definitive legal victory in a patent invalidation suit against Moderna, successfully challenging the biotech giant's Korean patent related to messenger RNA (mRNA) vaccine technology. The contested patent covers 'modified nucleosides, nucleotides, and nucleic acids and their uses.' This case, which invalidated the only registered mRNA manufacturing patent in Korea, regarded as a major step in reducing patent-related risks and removing barriers to innovation for domestic companies engaged in mRNA research and development. 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

Merck & Co – known as MSD outside the US and Canada – has received approval from the Medicines and Healthcare products Regulatory Agency (MHRA) for its adult-specific pneumococcal vaccine Capvaxive. The vaccine has been authorised to help protect adults aged 18 years and older against illnesses caused by Streptococcus pneumoniae bacteria, including pneumonia and meningitis, which are currently considered a “major public health problem” by the World Health Organization (WHO). There are over 100 different types of pneumococcal bacteria and Merck’s Capvaxive, a single-dose 21-valent-vaccine, is specifically designed to help protect against the ones that are responsible for the majority of adult invasive pneumococcal disease. The MHRA’s decision on Capvaxive occurred through the International Recognition Procedure, a fast-track approval process that takes into account prior authorisations from other regulatory partners, and follows the European Commission’s approval of the vaccine in March. Among the evidence supporting the EU regulator’s decision were results from a phase 3 trial comparing Capvaxive to Pfizer’s 20-valent vaccine (PCV20) in adults who had not previously received a pneumococcal vaccine. Capvaxive was shown to induce non-inferior immune responses compared to PCV20 for all ten serotypes common to both vaccines in adults aged 50 years and older, and generated superior immune responses for ten of its 11 unique serotypes. Merck’s vaccine was also shown to elicit non-inferior immune responses in adults aged 18 to 49 years compared to those aged 50 to 64 years and had a safety profile comparable to PCV20. “As with any medicine, the MHRA will keep the safety and effectiveness of this vaccine under close review,” the UK regulator said. Emma Cerrone, vaccines business unit director, MSD UK, said: “We are delighted with this decision. Pneumococcal infections can lead to serious complications requiring hospital treatment, however immunisation plays a vital role in prevention and can help adults live longer, healthier lives.” Alongside the EU, Capvaxive is approved in the US, Canada and Australia.