The Ministry of Food and Drug Safety (MFDS) has dismissed R Bio's appeal regarding the approval denial for Nature Cell's stem cell therapy, JointStem, to treat severe osteoarthritis.

R Bio is the largest shareholder of Nature Cell and the original developer of JointStem.

According to Vision Korea, a small shareholder coalition of Nature Cell, the MFDS recently sent a letter to R Bio dismissing the company's appeal regarding the rejection of its application for approval of JointStem.

Earlier, the MFDS had requested supplementary data on the efficacy of JointStem during the approval review in April, but rejected the application due to lack of clinical significance.

In response, R Bio filed an appeal against the rejection and submitted data on the feasibility of approval, including clinical significance, to the MFDS.

Vision Korea had also conducted a protest in front of the drug ministry urging them to reconsider and approve JointStem.

However, with the appeal again rejected, industry watchers say that R Bio's only remaining strategy for the company is to file a lawsuit against the MFDS.

Regarding the matter, the ministry said that the application was rejected due to a lack of clinical significance under the Advanced Biopharmaceuticals Act, and the appeal was also dismissed.

"If the company files an administrative lawsuit, the ministry will respond accordingly," an MFDS spokesperson told Korea Biomedical Review.

Meanwhile, Vision Korea expressed its frustration against MFDS's final rejection.

"Since 2021, R Bio has been conducting phase 2b and 3a clinical trials of JointStem in the U.S. and has successfully confirmed the clinical significance of the treatment in a phase 3 clinical trial, which was higher than Invossa, Kolon TissueGene's stem cell treatment," Vision Korea said. "Even though the company has successfully conducted four clinical trials in Korea and the U.S., but has not been able to overcome the high barrier of the MFDS' product licensing."