[Click eStock] "Kangstem Biotech Accelerates Skin Organoid Sales... Clinical Momentum Secured"

On December 12, independent research firm ValueFinder evaluated Kangstem Biotech as a leading regenerative medicine company, highlighting its simultaneous possession of a next-generation skin organoid platform-expected to drive alternatives to animal testing-and the osteoarthritis treatment 'OSCA.'

ValueFinder noted that Kangstem Biotech has built an organoid platform capable of evaluating transdermal drugs by applying proprietary Wnt signaling regulation and air-liquid interface (ALI) culture technology based on Seoul National University's original technology. This enables the reproduction of epidermis, dermis, hair follicle, and vascular structures similar to real human skin. The company explained that, compared to 3D printing methods, the platform offers higher human similarity and, in line with the U.S. FDA's trend toward reducing animal testing, could emerge as a leading standard model for the alternative testing market.

Additionally, ValueFinder emphasized that Kangstem Biotech's skin organoid products are already being supplied to major domestic corporations for skin absorption evaluation purposes, generating revenue and indicating that the company has moved beyond the simple research stage into commercialization.

Researcher Lee Chunghun of ValueFinder stated, "As demand for organoids expands, related product and service sales are expected to grow steadily, positioning Kangstem Biotech as a leading company in the global organoid industry."

Regarding OSCA, the company's main pipeline for osteoarthritis treatment, Lee commented, "Dosing for phase 2a clinical trials involving 113 participants was completed in November. After observation ends in the second quarter of next year, topline results are expected to be announced around July. Based on our internal simulations, there is a high probability of achieving statistical significance compared to placebo."

He added, "If the clinical trials progress smoothly, the goal is global technology transfer in the second half of 2026. Next year's U.S. FDA Pre-IND meeting is expected to be a key catalyst for strengthening technology transfer negotiations."

From a financial perspective, Lee positively assessed the company’s capital raise of 36.6 billion won through a rights offering in August, which has significantly alleviated regulatory risks stemming from accumulated past deficits. He analyzed, "With the full-scale launch of organoid sales and milestone inflows from Yuyu Pharma, it is likely that the company will easily meet the annual sales requirement of 3 billion won. In a favorable supply-demand environment for the biotech sector, multiple momentum factors-including the launch of the organoid business and the results of the OSCA phase 2a trial-are on the horizon."