The U.S. Food and Drug Administration (FDA) has announced a roadmap for reducing animal testing during preclinical stages, emphasizing the adoption of "New Approach Methodologies (NAMs)." This move is expected to elevate NEXEL a leading provider company of human cell-based toxicity testing platform, as a key partner in the global pharmaceutical and biotech industries.

 

According to international reports on April 15, the FDA’s roadmap highlights the limitations of conventional animal testingand prioritizes the implementation of human-centered technologies such as organoids derived from human tissues, Organ-on-a-Chip platforms, and AI-based toxicity prediction models.

 

In particular, the FDA encourages the use of NAMs-based evaluation technologies from the early stages of drug development, It specifically identifies high-throughput cell-based screening as one of the key approaches and explicitly mentions the use of human induced pluripotent stem cell (hiPSC)-derived cells. The roadmap sets a clear goal to shift the basic framework of preclinical toxicology toward human-based models within the next 3 to 5 years.

 

NEXEL, a pioneering Korean biotech company, was the first company to develop and commercialize a wide range of hiPSC-derived funtional cells – including cardiomyocytes, hepatocytes, and neurons – which are already being supplied to multiple global pharmaceutical companies. NEXEL has also established organoid technology based on these cells, directly targeting the alternative testing market outlined in the FDA’s roadmap.

 

A NEXEL representative stated, "NEXEL was founded with the belief that hiPSC could be a game changer for NAMs. We provide a variety of functional cell products and platforms designed to replace animal testing in drug development." The representative added, "We already have established global partnerships across the U.S., Japan, and Europe. This new FDA roadmap represents not just a policy shift, but a pradigm shift in global biotech R&D. This could be the opportunity we have been preparing for, and we expect it to drive significant growth in sales of our cell products.“

 

NEXEL, which is targeting a KOSDAQ IPO by 2025, is the only Korean company to have contributed directly to the revision of the ICH S7B guidelines which recommend the use of hiPSC-derived cardiomyocytes for assessing cardiac toxicity. The company is also reportedly in strategic alliance discussion with a major Japanese corporation to further expand its cardiomyocyte-related technologies.