SK bioscience, a global innovative vaccine and biotech company committed to promoting human health from prevention to cure has entered a new phase of collaboration with Sanofi, a major player in the pharmaceutical industry. This partnership aims to position the company a leading position in a global pneumococcal vaccine market worth trillions of won in annual sales.

SK bioscience and Sanofi announced today the signing of an expanded agreement to co-develop next-generation pneumococcal conjugate vaccines (PCVs) for both pediatric and adult populations, with the potential to provide broader protection than those currently licensed.

This agreement builds on the companies’ existing collaboration to develop and commercialize the GBP410, a 21-valent pneumococcal conjugate pediatric vaccine candidate. Together, the companies aim to develop innovative next-generation PCVs beyond GBP410.

At the same time, SK bioscience and Sanofi are one step closer to commercializing GBP410 by initiating the phase 3 clinical program. GBP410 is the first pneumococcal conjugate vaccine candidate with more than 20 serotypes to enter phase 3 in infants and toddlers, making it a highly anticipated innovation in the market.

■Extended agreement, including KRW 75.5 billion upfront and potential milestones, allows broader development scope from pediatric vaccines to adult vaccines.

Under the terms of the agreement to co-develop next-generation PCVs, Sanofi will pay SK bioscience an upfront payment of EUR 50 million (KRW 75.5 billion) followed by development and commercial milestone payments.

The research and development costs for the vaccine will be shared equally by the two companies, while Sanofi will bear all costs related to commercialization. Once registered, SK bioscience will have commercial exclusivity in Korea, while Sanofi will commercialize the vaccines in all other markets. SK bioscience will receive royalty payments on product sales outside South Korea.

The two companies also agreed to co-develop next-generation PCVs for not only pediatric but also adult populations. Pneumococcal conjugate vaccines are well known to provide the effective protection against pneumococcal infections among the pneumococcal vaccines developed to date. The PCVs dominated the market, accounting for 94 percent of global revenue, highlighting their critical role in preventing pneumococcal diseases.

According to Evaluate Pharma data (June 2024), the global pneumococcal vaccine market is projected to grow from KRW 11.9 trillion in 2024 to KRW 14.2 trillion in 2028, with an average annual growth rate (CAGR) of 4.7%. The pediatric market represents 65 to 70 % of the PCV market. By targeting this rapidly expanding market, SK bioscience aims to secure new growth engines and solidify its position as a leading global vaccine and biotech company.

■ Initiation of phase 3 program for GBP410

Meanwhile, SK bioscience and Sanofi have commenced the phase 3 program for GBP410, with the first participant dosed last week.

The global phase 3 studies will evaluate the immunogenicity and safety of GBP410 in more than 7,700 healthy infants, toddlers, young children, and adolescents aged 6 weeks to 17 years after up to four doses, depending on the age at enrollment.

GPB410 is the first pneumococcal conjugate vaccine candidate with more than 20 serotypes to enter phase 3 in infants and toddlers. With this broader coverage, GBP410 is expected to make a significant contribution to reducing cases of invasive pneumococcal disease (IPD), which remains a serious health concern in infants and young children.

According to the World Health Organization (WHO), approximately 300,000 children under the age of five worldwide die every year due to Streptococcus pneumoniae which is the leading cause of vaccine-preventable fatalities in this age group. This underscores the critical need for improved pneumococcal vaccines like GBP410.

In June 2023, SK bioscience and Sanofi successfully completed a phase 2 study of GBP410, showing comparable immunogenicity compared to the control vaccine Prevnar 13, following the primary vaccination at 2, 4, and 6 months of age as well as the booster vaccination administered at 12-15 months. The study enrolled 140 toddlers aged 12 to 15 months and 712 infants aged 42 to 89 days.

In terms of safety, there were no vaccine-related serious adverse events. Furthermore, when co-administered with recommended childhood vaccines such as tetanus, diphtheria, pertussis, polio, and Haemophilus influenzae type b (Hib) vaccine, GBP410 demonstrated comparable immunogenicity and safety to the control vaccine.

SK bioscience is proactively preparing for the commercialization of GBP410, having initiated the expansion of its vaccine manufacturing plant ‘L House’ in March through a joint investment with Sanofi.

Thomas Triomphe, Executive Vice President, Vaccines, Sanofi, said, “Given the vast unmet public health needs in IPD, we’re delighted to extend this collaboration and continue our pursuit of innovative work in PCV. Our collaboration leverages SK bioscience’s capabilities and Sanofi’s expertise in developing and brining innovative vaccines to people worldwide with the collective aim of reducing the global impact of pneumococcal disease.”

Jaeyong Ahn, CEO of SK bioscience, said, “Our decision to develop next-generation PCVs and simultaneously initiate phase 3 clinical program for GBP410 reflects the GBP410’s high potential for success, a promising market outlook, and our strong mutual trust. As Korea’s leading company in the vaccine and bio industry, we are committed to successfully bringing vaccines with blockbuster potential to market that will secure vaccine sovereignty, contribute to global health, and lead the global market.”