(Health Korea News / Lim Doi) SK Bioscience announced on the 17th that it received approval from the FDA for the U.S. Phase 3 Clinical Trial (IND) for the 21-valent pneumococcal vaccine (GBP410), which is being jointly developed with Sanofi. revealed. Previously, SK Bioscience received approval for a phase 3 IND with the same content from the Korean Ministry of Food and Drug Safety on the 14th. (See related article below)
The global phase 3 clinical trial of GBP410, which began the first phase 3 administration in Australia last month, will be administered up to 4 doses (3 basic doses and 1 booster dose) to approximately 7,700 infants, toddlers, children, and adolescents from 6 weeks of age to 17 years of age. This is to compare and evaluate the immunogenicity and safety with the late-approved pneumococcal vaccine.
SK Bioscience and Sanofi successfully secured the phase 2 results of GBP410 in June 2023. Comparative clinical results of basic and booster vaccinations with GBP410 and the control vaccine (Prevenar 13) in 140 children aged 12 to 15 months and 712 infants and toddlers aged 42 to 89 days. Immunogenicity of the control vaccine and GBP410. It was confirmed that this was at the same level.
In terms of safety, no serious adverse events related to the vaccine were reported in the GBP410 vaccination group. Even when administered in combination with vaccines recommended for infants, toddlers and children, such as tetanus, diphtheria, pertussis, polio, and Haemophilus influenzae type B vaccines, an equivalent level of immunogenicity and safety was confirmed compared to the reference vaccine.
GBP410 is the first vaccine candidate to enter phase 3 clinical trials for infants and young children and includes serotypes exceeding 20. Through this, GBP410 is expected to significantly contribute to reducing the incidence of invasive pneumococcal disease (IPD), one of the serious health problems in infants and young children.
According to WHO, about 700,000 children under 5 years of age worldwide suffer from pneumonia, and about 300,000 of them die from pneumococcal disease. As pneumococcal disease is the leading cause of vaccine-preventable death in this age group, there is also high demand for pneumococcal vaccines that provide a wider range of protection, such as GBP410.
SK Bioscience is actively preparing for the commercialization of GBP410 by beginning construction to expand its vaccine manufacturing plant ‘L House’ in March of last year through a joint investment with Sanofi.
At the same time, the two companies decided to expand the scope of cooperation for the development and commercialization of GBP410 and proceed with a new joint development project, raising market expectations. The contract signed last month aims to develop a next-generation pneumococcal conjugate vaccine for infants, toddlers, children and adults, which is expected to provide potentially broader protection than currently commercialized products.
According to the new project of the two companies, SK Bioscience will receive 50 million euros (about KRW 75.5 billion) as an upfront payment from Sanofi and up to 300 million euros (about KRW 452.9 billion) in milestone payments in each stage until the completion of development. You will receive additional payment.
The research and development costs of the vaccine will be shared equally by both companies, and all costs related to commercialization will be borne by Sanofi. After commercialization, SK Bioscience will handle sales in Korea and Sanofi will handle global sales. Depending on product sales, profits will be divided between the two companies at a set ratio.
The protein-conjugated pneumococcal vaccine is known to have excellent preventive effects among the pneumococcal vaccines developed so far, and plays an important role in preventing pneumococcal disease, accounting for 94% of sales in the global pneumococcal vaccine market as of 2023. .
According to Evaluate Pharma, a global pharmaceutical statistics agency, the pneumococcal conjugate vaccine market is growing at a CAGR of 4.7%, from KRW 11.9 trillion in 2024 to KRW 14.2 trillion in 2028. It is expected to grow. SK Bioscience plans to secure new future growth engines and establish itself as a global vaccine and bio company by targeting the 14 trillion won global pneumococcal vaccine market with advanced technology.
SK Bioscience President Ahn Jae-yong said, “The completion of the FDA’s review of the phase 3 trial plan is a very important step forward in the development of GBP410,” adding, “We will meet unmet medical needs through GBP410 and an innovative next-generation pneumococcal vaccine with 21 or more valent values that will be developed in the future.” “We will do our best to resolve this issue and provide safe and effective protection to more people.”
Copyright © Health Korea News Unauthorized reproduction and redistribution prohibited
Source: www.hkn24.com
