SK Bioscience and Sanofi sign contract to co-develop

pneumococcal conjugate vaccines

Extended scope of GBP410 co-development agreement from 2014…to develop next-generation vaccines

An upfront payment of KRW 75.5 billion…to receive technology fees at each development stage·revenue is expected after commercialization

SK Bioscience has extended the scope of vaccine development in collaboration with the global pharmaceutical company Sanofi.

 

The company aims to advance the pneumococcal conjugate vaccine currently being developed to the next-generation vaccine.

 

SK Bioscience and Sanofi announced on December 23 that they have signed an agreement to co-develop the next-generation pneumococcal conjugate vaccine for infants and young children.

 

The new vaccine will provide a broad preventive effect compared to the currently commercialized products.

 

This contract extends the scope of collaboration that both companies have previously signed for the development and commercialization of 'GBP410,' a 21-valent pneumococcal conjugate vaccine.

 

Previously, SK Bioscience signed a co-development and sales agreement with Sanofi in 2014 for the next-generation pneumococcal conjugate vaccine.

 

Based on the extended agreement, both companies plan to develop an innovative next-generation pneumococcal conjugate vaccine that is more advanced than 21-valent vaccines.

 

Given new projects, SK Bioscience will receive a 50 million euros (about KRW 75.5 billion) upfront payment from Sanofi.

 

The company will receive additional milestones per stage until the development is completed.

 

Both companies will be equally responsible for development costs.

 

Sanofi will be responsible for commercialization costs.

 

Once commercialized, SK Bioscience will sell the vaccine in South Korea, and Sanofi will be responsible for global sales.

 

Both companies will equally share revenues generated from sales at a predetermined rate.

 

A conjugate form of pneumococcal vaccine is known to offer superior preventive effects among the developed pneumococcal vaccines.

 

As of 2023, it takes 94% of the sales of the pneumococcal vaccine market worldwide.

 

According to the global pharmaceutical statistics agency Evaluate Pharma, the pneumococcal vaccine market has achieved a compound annual growth rate (CAGR) of 4.7%.

 

The market is projected to grow from KRW 11.9 trillion in 2024 to KRW 14.2 trillion by 2028.

 

SK Bioscience plans to target the global pneumococcal vaccine market with advanced technology, aiming to secure a new growth engine for the future and establish itself as a leading global vaccine and biotech company.

 

Photo of SK Bioscience

In addition to developing next-generation vaccines, the clinical trial of GBP410 conducted by both companies is progressing smoothly.

 

Last week, GBP410 entered a multinational Phase 3 clinical trial, with the first participant dosed.

 

The Phase 3 trial involves over 7,700 infants, children, and adolescents aged six weeks to 17 years, comparing the immunogenicity·safety of up to four doses of GBP410 against an already approved pneumococcal vaccine.

 

SK Bioscience and Sanofi confirmed the efficacy and safety of GBP410 in a Phase 2 clinical trial conducted last June.

 

The comparative study involved 140 children aged 12 to 15 months and 712 infants aged 42 to 89 days, evaluating GBP410 against a control vaccine (Prevenar 13) for primary and booster vaccinations.

 

The results demonstrated that the immunogenicity of GBP410 was comparable to that of the control vaccine.

 

Regarding safety, no vaccine-related serious adverse events were reported in the GBP410 group.

 

Even when co-administered with other recommended vaccines for infants and children, such as vaccines for tetanus, diphtheria, pertussis, polio, and Haemophilus influenza type B, GBP410 exhibited equivalent immunogenicity and safety to the control vaccine.

 

GBP410 was the first to include a serotype over a 20-valent among the vaccine candidates that entered a phase 3 trial targeting infants.

 

SK Bioscience anticipates that GBP410 will reduce invasive pneumococcal disease (IPD) in infants and young children.

 

"The contract extension between SK Bioscience and Sanofi was based on trust between two companies, given the potential of a 21-valent vaccine and positive market outlook," Jaeyong Ahn, CEO of SK Bioscience.

 

"As Korea's key company in the vaccine and biotech industry, SK Bioscience will secure vaccine market share and strive to launch a blockbuster vaccine successfully."