[Edaily Reporter NA EUN-KYUNG ] KANGSTEM BIOTECH CO., LTD.(217730)has moved to reassure shareholders by disclosing long-term follow-up data for its knee osteoarthritis treatment “OSCA” and the progress of its global business development (BD) efforts. Following the announcement of the 6-month results from the Phase 2a clinical trial, investor interest in follow-up data and the status of technology transfer continued, prompting the company to directly report on the 12-month follow-up results and the status of discussions with global pharmaceutical companies.

Following an update on the progress of its key business initiatives, including OSCA, posted on its website on September 14, KANGSTEM BIOTECH CO., LTD. issued an additional shareholder notice on the 28th—approximately two weeks later.

According to KANGSTEM BIOTECH CO., LTD., it recently received 12-month magnetic resonance imaging (MRI) data from 43 patients who received OSCA in the Phase 2a clinical trial. The company is currently preparing to analyze this data and plans to complete the analysis once it obtains the 12-month MRI results for the remaining patients.

The company is focusing on the 12-month MRI results to determine whether the structural changes previously identified are sustained over the long term. The 6-month MRI evaluation revealed meaningful results in certain indicators related to structural changes in cartilage and subchondral bone. Through this analysis, the company plans to confirm whether the changes observed at the 6-month mark are maintained or further improved at the 12-month mark.

Long-term follow-up for Phase 2a clinical trial patients is also underway. Long-term follow-up visits have been completed for approximately 70 patients—including the 43 who have received their MRI results—12 months after dosing. The company plans to evaluate whether the improvements in pain and joint function observed at the 6-month mark persist at the 12-month mark.

In particular, KANGSTEM BIOTECH CO., LTD. plans to utilize this long-term follow-up data for global business development. Based on the current 6-month results from the OSCA Phase 2a clinical trial, the company is discussing potential collaborations—including licensing-out—with global partners. The company stated, “We are regularly sharing clinical results with representatives in Europe and the U.S. to discuss collaboration opportunities, and we plan to use the 12-month follow-up data as important material in future global business development discussions.”

KANGSTEM BIOTECH CO., LTD. has previously discussed various collaboration options with global pharmaceutical companies, including the co-development and technology transfer of OSCA. Whether these 12-month follow-up results can provide additional evidence regarding the durability of therapeutic effects and structural changes is expected to be a key factor in future partnering discussions.

KANGSTEM BIOTECH CO., LTD. stated, “While diligently securing additional follow-up clinical data, we will continue to review the commercialization potential of OSCA in detail through ongoing consultations with global partners.”