Following the recent release of the “New Approach Methodologies (NAMs)” roadmap by the U.S. Food and Drug Administration (FDA), the global bio R&D market is entering a period of significant transformation.

 

The FDA has highlighted the limitations and ethical issues of animal testing, announcing that within the next three to five years, non-animal testing methods using human-derived cell technologies—such as organoids and organ-on-a-chip—will serve as new standards for preclinical toxicity evaluations.

 

As a result, organoid platforms that simulate key human organs such as the heart, liver, and nervous system are expected to become core technologies in future drug development. Organoids are three-dimensional mini-organs or tissue analogs created from stem cells, possessing structural and functional characteristics similar to human organs.

 

Amid this shift, Nexel is taking the lead on the FDA roadmap by leveraging its technological capabilities in human-induced pluripotent stem cells (hiPSC) to advance organoid and drug candidate research. The company is also securing related intellectual property rights.

 

Nexel has obtained patents in Korea and Japan for its “method for producing cardiac organoids” and has filed applications in the United States, Europe, and China. In March, the company completed registration of a “drug evaluation method using cardiac organoids” and is now securing international rights through a Patent Cooperation Treaty (PCT) application, it announced on the 21st.

 

The company also reported progress in the area of disease modeling using hiPSC-derived organoids, capable of replicating pathological phenomena. Nexel has completed both domestic and PCT applications for a “method for inducing heart failure models caused by myocardial infarction and cardiac fibrosis.” Additionally, in collaboration with the Korea Institute of Toxicology (KIT), the company has finalized a patent registration for a Wilson’s disease model using liver organoids.

 

A Nexel official stated, “This marks the foundation for leading the NAMs-centered era, as we have secured patents not only for organoid production and functional evaluation, but also for disease simulation—covering the full cycle of organoid technologies.”

 

Nexel is also building a new growth engine through new drug development by securing domestic and international patent rights for hiPSC-derived drug candidates (NP-011 and NPT-0025).

 

The company’s NP-011 candidate, which has obtained patent registrations in the U.S. and Japan as of April this year, covers various indications including liver diseases, heart diseases, and pulmonary fibrosis. The patent is currently under examination in the EU and China. In January, the company secured a domestic patent for use in treating ulcerative colitis and has since filed a PCT application.

 

NPT-0025, another drug candidate, has received patent registrations in Korea and Japan for compositions targeting idiopathic pulmonary fibrosis, and is currently under review in the EU and China.

 

These patents represent the global protection of drug candidates discovered through hiPSC-based technologies, with the mechanisms of action and efficacy precisely demonstrated using hiPSC-based evaluation models.

 

A Nexel representative added, “We are focusing our pipeline on serious diseases with established market sizes such as liver disease, heart disease, pulmonary fibrosis, and ulcerative colitis, and we are expanding indications around diseases with high commercialization potential. Based on broad partnerships, Nexel pursues an efficient and flexible strategy that enables timely technology transfers and rapid results.”