Corestem ChemOn Selected for Ministry of Food and Drug Safety's National Project on Animal Alternative Toxicity Assessment

Proactive Response to the FDA's Shift Away from Animal Testing

Corestem ChemOn, a company specializing in non-clinical CRO (Contract Research Organization) services, announced on January 27 that it has been selected as the lead research institution for the project "Development of Embryogenesis-Based Animal Alternative Toxicity Testing Methods Using Stem Cells," overseen by the Ministry of Food and Drug Safety. As a result of this selection, Corestem ChemOn will receive a total of 600 million won in research funding over the next two years starting this year, and will work to secure next-generation toxicity assessment platform technology that can replace animal testing.

Recently, the global pharmaceutical and biotech industries have adopted the "3R Principle" (Replacement, Reduction, Refinement) as a standard, aiming to minimize animal testing due to animal welfare and ethical concerns. In particular, the field of "reproductive and developmental toxicity," which assesses the effects of drugs on fetal development in pregnant animals, has been considered the most challenging area for developing alternative technologies due to its biological complexity.

Through this research, Corestem ChemOn plans to establish a toxicity assessment method that precisely simulates the human embryogenesis process in vitro using stem cell and spheroid (3D cell aggregate) technologies. This approach is innovative in that it reduces errors caused by interspecies differences in animal models and enables more accurate prediction of human responses.

The company expects that this technology development will not be limited to research but will also lead to immediate business results. First, the developed testing method can serve as a key supporting document for proving drug safety during Investigational New Drug (IND) applications by new drug developers. In addition to drug development, it can also be applied in fertility (reproductive) centers to precisely analyze the health status of embryos and the toxic effects of environmental hormones, thus enabling Corestem ChemOn to diversify its revenue streams beyond the existing non-clinical CRO market into the field of reproductive medicine.

During the two-year research period, Corestem ChemOn plans to ▲ optimize the standard operating protocol (SOP) for the testing method ▲ ensure reproducibility through inter-laboratory validation ▲ and secure statistical validation data such as sensitivity and specificity. Based on this, the company ultimately aims to propose this testing method as an OECD (Organisation for Economic Co-operation and Development) internationally recognized guideline and lead the global standard for toxicity assessment.

Industry experts believe that this national project selection will be a decisive turning point for enhancing Corestem ChemOn's corporate value. This is because the global regulatory paradigm is rapidly shifting to "non-animal" alternatives, as evidenced by the Biden administration in the United States enacting the "FDA Modernization Act 2.0" at the end of 2022, which abolished the animal testing mandate after more than 80 years.

Accordingly, the market size is also experiencing explosive growth. According to global market research firms Grand View Research and Allied Market Research, the global animal alternative testing market grew from approximately $9.8 billion (about 13 trillion won) in 2021 at a compound annual growth rate of 13.5%, and is projected to reach around $29.4 billion (about 40 trillion won) by 2030. In particular, the organoid sector, which is Corestem ChemOn's main focus, is considered a blue ocean with expected annual growth rates exceeding 20%.

Additionally, the surge in demand from global pharmaceutical companies (Big Pharma) strengthening ESG management is also a positive factor. As the trend toward ethical consumption accelerates efforts to reduce animal testing, the value of CROs capable of providing reliable alternative testing data is soaring. The company plans to leverage OECD-level standard data acquired through this research to capture a share of the 40 trillion won global market.

Kim Seondon, Head of the Advanced Testing Center at Corestem ChemOn, stated, "Being selected for this national project means our non-clinical technology has been recognized at the national level," and added, "By proactively securing animal alternative testing methods in line with changes in international regulatory guidelines (ICH S5), we aim to become a global CRO that provides the most efficient and ethical solutions to pharmaceutical companies both domestically and internationally."