[Edaily Reporter Kwon Oh Seok ] On the 30th, independent research firm Value Finder assessed that KANGSTEM BIOTECH CO., LTD.(217730)had confirmed, through a placebo-controlled Phase 2a clinical trial of its core pipeline candidate OSCA, not only pain relief and anti-inflammatory effects but also structural improvement—an outcome that is notoriously difficult to demonstrate in clinical trials for osteoarthritis treatments. Furthermore, the firm analyzed that the company is accumulating commercialization references for its platform business following the recent signing of an organoid-based evaluation agreement with a major global pharmaceutical company.

KANGSTEM BIOTECH CO., LTD. is a biotech company that possesses both allogeneic umbilical cord blood-derived stem cell therapies and organoid platform technology. On the 28th, the company announced topline results from the Phase 2a clinical trial of its core pipeline, OSCA (an allogeneic umbilical cord blood-derived stem cell therapy for osteoarthritis). In a trial involving 113 participants, including a placebo group, pain, joint function, and quality of life metrics showed significant improvement compared to the placebo, with effects appearing as early as four weeks after administration.
Notably, the trial confirmed structural improvement—a difficult outcome to demonstrate in osteoarthritis clinical trials—in a placebo-controlled setting, and the results also showed favorable safety profiles with no serious adverse drug reactions. The confirmation of “Triple Action”—combining analgesia, anti-inflammation, and structural improvement—is expected to have a positive impact on the design of follow-up clinical trials and the company’s negotiating power for global technology licensing (L/O) agreements.
According to ValueFinder, the company has also finalized its follow-up roadmap based on these results. It plans to complete the Clinical Study Report (CSR) during the fourth quarter, present the findings at ACR Convergence, and, after securing 12-month MRI data in the first half of next year, commence follow-up clinical trials in South Korea. In the U.S., the company is simultaneously pursuing Regenerative Medicine Advanced Therapy (RMAT) and Breakthrough Therapy designations, with the goal of submitting an Investigational New Drug (IND) application in the fourth quarter of 2027.
The company explained that the follow-up clinical trial will feature an innovative design—rather than a conventional Phase 2b trial—to accelerate commercialization, and that the possibility of a conditional technology export deal remains open around the time the 12-month MRI data is secured. There is also speculation about the potential to benefit from the recent failure of a competing pipeline’s Phase 3 clinical trial, and expectations are growing that the global license deal could reach approximately 4 trillion won.
Results are also becoming visible in the organoid business. The company announced on the 16th that it had signed a organoid-based evaluation agreement (MTEA) with a major global pharmaceutical company. The agreement, finalized following an on-site inspection of the company’s research facility last May, is believed to involve using hair follicle organoids to evaluate the hair regrowth efficacy of new drug candidates in comparison to existing hair regrowth agents. Given the thoroughness of the on-site inspection, there is a possibility that the collaboration could expand to include direct organoid supply or platform technology transfer in the future; discussions regarding a contract with another major global pharmaceutical company are also understood to be in the final stages.
In South Korea, the company has been supplying organoids to major cosmetics and health and lifestyle product companies since last year, leading to the accumulation of commercial references both domestically and internationally. However, while the stem cell and cosmetics businesses account for the majority of revenue, sales have been on a downward trend in recent years; therefore, the clinical outcomes of the pipeline and the pace of commercialization of the organoid business are expected to be key to improving future performance.
Jeon Woo-bin, a researcher at Value Finder, explained, “The fact that the OSCA Phase 2a clinical trial demonstrated, in a placebo-controlled study, improvements not only in pain relief and anti-inflammation but also in tissue structure will have a positive impact on both the design of subsequent clinical trials and global technology export negotiations.”
He added, “As the company continues to sign organoid contracts with global big pharma and accumulates commercialization references, now is the time to pay attention to the gap between its current enterprise value and technology value.”