[E-Daily Reporter Hyera Lee ] From Bio Co., Ltd.(377220)announced on the 14th that it has begun key preclinical safety evaluations in preparation for submitting an Investigational New Drug (IND) application for its hair loss treatment based on human adipose-derived mesenchymal stem cell-derived differentiated cells (dADSCs), which is currently under development.

The company has signed a contract with Biotoxtech Co., Ltd., a domestic GLP-compliant nonclinical testing specialist, to conduct in vivo distribution and tumorigenicity studies. The data obtained from these studies will be used as key nonclinical safety data for the future submission of an Investigational New Drug (IND) application to the Ministry of Food and Drug Safety.
The in vivo distribution evaluation assesses the distribution and persistence of administered differentiated cells within the body, while the tumorigenicity test evaluates the potential for tumor development following long-term administration; both are essential non-clinical safety evaluations for cell therapy development.
From Bio Co., Ltd. is also concurrently establishing a cell bank to ensure the consistent quality and stable supply of cells for clinical trials. The company explained that no toxicity-related effects were observed in previous general toxicity tests, and that nonclinical efficacy evaluations confirmed hair regrowth and increased hair follicle formation in an alopecia animal model.
Based on the efficacy and safety data it has secured, the company plans to advance its preclinical development and pursue an IND application next year.
CEO Shim Tae-jin stated, “We will finalize our preclinical development by securing additional key safety data and proceed with the IND application without delay.”