[Special Stock] FDA "AI Instead of Animal Testing"...Related Stocks Surge

As of 9:30 a.m. on the 11th, in the KOSDAQ market, Tomocube surged 12.92%, Oncocross rose 27.53%, and Syntekabio jumped 15.68% compared to the previous day's closing prices. This was due to the U.S. Food and Drug Administration (FDA) announcing the day before that it plans to replace animal testing in monoclonal antibody therapies and other drug developments with new AI-based models.

The new drug development process consists of non-clinical (or preclinical) experiments using animals such as mice, dogs, and monkeys, clinical phase 1, 2, and 3 trials involving drug administration to humans, and the FDA approval stage.

According to Reuters on the 10th (local time), the FDA stated that animal testing will be reduced, improved, or potentially replaced by using NAMs (New Approach Methods), a new methodology that employs AI-based models to predict drug efficacy and side effects and includes testing on lab-grown human organ-like structures. The FDA explained that this new approach will help improve drug safety and reduce research and development costs as well as drug prices. The FDA plans to launch a pilot program next year allowing some antibody-based drug developers to use non-animal testing strategies.

Domestically, Organoid Science, which researches and develops organoids?one of the human organ-like structures?is set to receive public subscription for its KOSDAQ listing from the 25th to the 28th.

Tomocube, a cell imaging specialist company, possesses imaging technology based on holotomography (a laser that measures three-dimensional refractive index tomograms) that enables real-time observation of living organoids. This technology does not require additional preprocessing such as fluorescent staining and allows dynamic changes to be observed over long periods without cell damage. Tomocube equipment is used by 200 institutions in over 50 countries worldwide.

Oncocross has developed and operates RAPTOR AI, which is the first in Korea to analyze gene expression data (transcriptome) changes caused by drug administration or disease occurrence using AI, matching optimal diseases and treatments.

Syntekabio owns an AI platform that processes 3D protein structures and genomic big data, which can be utilized not only for synthetic drugs but also for antibody therapeutics, vaccines, and other biopharmaceutical research and development.

However, unlike new drug development bio companies, these companies mostly generate revenue from services and product sales, so it is necessary to carefully examine their sales and cost trends. Last year’s sales were 6 billion KRW for Tomocube, 1.1 billion KRW for Oncocross, and 100 million KRW for Syntekabio.