SK bioscience(302440) will release the global phase 3 results for its pneumococcal vaccine "GBP410" in the second half of next year. After gaining name recognition during the COVID-19 pandemic, this will be the first test of whether it can move beyond being seen as a "COVID vaccine corporations."
GBP410 is a pneumococcal vaccine that includes 21 serotypes. According to the company, it is designed to prevent about 64% of the serotypes that cause invasive pneumococcal disease in the United States and about 74% in Europe.
Development has entered the final gateway to commercialization. After starting phase 1 in 2018, it moved into a global phase 3 last year, and trials are now underway in the United States, Europe and Korea with about 7,700 infants. The company aims to secure topline (key indicator) results from phase 3 in the second half of next year and launch globally in 2029.
SK bioscience plans to use GBP410 as a starting point to expand its pneumococcal vaccine portfolio. Last year it signed a joint development contract worth up to 530 billion won with France's Sanofi. The deal is to co-develop a next-generation pneumococcal vaccine that includes more serotypes than GBP410.
It is also preparing for commercialization in parallel. The company has completed an expansion of its production facilities in Andong, North Gyeongsang, and this year it secured policy funds through the Public Growth Fund.
However, it takes time for a new drug to reach commercialization. SK bioscience plans to secure a stable revenue base through IDT Biologika, which it acquired in 2023, until GBP410's results begin in earnest.
IDT is a German biopharmaceutical contract development and manufacturing (CDMO) corporations with more than 100 years of history. In addition to vaccines, it produces cancer vaccines and botulinum toxin, and counts Takeda and Amgen among its clients. Its German production facility meets the U.S. Food and Drug Administration's (FDA) current good manufacturing practice (cGMP) standards, and it recently passed the World Health Organization's (WHO) paper review.
The effects of the acquisition are starting to show. SK bioscience recently won, together with IDT, a next-generation vaccine development project led by the European Union (EU) Health and Digital Executive Agency (HaDEA). In the second-generation Zaire Ebola vaccine project involving MSD and the Hilleman Institute, SK bioscience will produce the drug substance, while IDT will handle drug product development and manufacturing.
The company has set a goal of more than doubling CDMO revenue from before the acquisition and raising the operating margin to over 20%. Recently it has expanded into the cell and gene therapy (CGT) field, further diversifying its manufacturing portfolio.
The company cites its global collaboration network as a strength that supports this strategy. SK bioscience has maintained partnerships with the World Health Organization (WHO), the Coalition for Epidemic Preparedness Innovations (CEPI), the Gates Foundation, and the U.S. Centers for Disease Control and Prevention (CDC).
The networks built during development of the typhoid vaccine and COVID-19 vaccine have led to new pipelines. Representative examples include a rotavirus vaccine license agreement with the CDC, the introduction of RSV antibody therapy technology from a research institute under the Gates Foundation, and development of the AI-based clinical decision support platform "ROTOR."
In the first quarter of this year, SK bioscience's sales rose 9% year over year to 154.6 billion won, but its operating loss widened to 44.5 billion won. That reflected both relocation expense for the new headquarters in Songdo, Incheon, and global phase 3 research and development costs for GBP410.
A SK bioscience official said, "We are in an investment phase for the future," adding, "We will build our growth base on two pillars—GBP410 and the CDMO business—and, by adding next-generation platform technologies such as artificial intelligence (AI) and messenger RNA (mRNA), we will leap forward as a global vaccine corporations."