SK Bioscience and Sanofi: A New Era in Pneumococcal Vaccines

SK Bioscience, a global vaccine and biotech leader, has announced an expanded partnership with Sanofi to co-develop next-generation pneumococcal conjugate vaccines (PCVs) for pediatric and adult populations. This collaboration aims to address unmet needs in the global pneumococcal vaccine market, estimated to reach KRW 14.2 trillion by 2028.

Expanded Agreement Details

Under the agreement, Sanofi will pay SK Bioscience an upfront sum of EUR 50 million (KRW 75.5 billion), with potential milestone payments. Research and development costs will be shared equally, while Sanofi will handle global commercialization costs, retaining rights outside Korea. SK Bioscience will maintain exclusive rights in Korea and receive royalties on international sales.

This partnership extends the scope beyond the GBP410 pediatric vaccine candidate to include vaccines for adults, targeting a market where PCVs account for 94% of global revenue.

Phase 3 Clinical Trials for GBP410

The companies have commenced a global phase 3 clinical program for GBP410, the first pneumococcal conjugate vaccine with more than 20 serotypes to reach this stage in infants and toddlers. The trial will assess the vaccine’s immunogenicity and safety in over 7,700 participants aged 6 weeks to 17 years.

Promising Results from Phase 2 Trials

Phase 2 studies of GBP410, completed in June 2023, demonstrated comparable immunogenicity and safety to Prevnar 13, the control vaccine. No serious adverse events were reported, and GBP410 showed similar efficacy when co-administered with other recommended childhood vaccines.

Global Health Impact

Pneumococcal disease remains a leading cause of vaccine-preventable deaths among children under five, with 300,000 annual fatalities globally, according to WHO. GBP410’s broader serotype coverage aims to significantly reduce invasive pneumococcal disease cases.

Strategic Expansion and Investment

To support commercialization, SK Bioscience is expanding its vaccine manufacturing plant, “L House,” in partnership with Sanofi.

Leadership Remarks

• Thomas Triomphe, EVP, Vaccines, Sanofi: “Extending this collaboration underscores our commitment to addressing unmet public health needs and reducing the impact of pneumococcal disease.”
• Jaeyong Ahn, CEO, SK Bioscience: “Developing next-generation PCVs and advancing GBP410 reflects its high potential and our mutual trust. SK Bioscience remains dedicated to enhancing global health and leading the vaccine market.”

This collaboration solidifies SK Bioscience and Sanofi’s commitment to pioneering innovations in the pneumococcal vaccine sector.