Nature Cell retail investors urge approval of JointStem through prayer service

In a bizarre turn of events, the entrance of the Ministry of Food and Drug Safety (MFDS) was adorned with large placards and hundreds of flower wreaths, all cheering on Food and Drug Safety Minister Oh Yu-kyoung.

The mastermind behind this unusual sight was none other than Vision Korea, a small shareholder coalition of the bio-company Nature Cell.

Their sole wish is to obtain approval for Nature Cell's JointStem, called by shareholders as the groundbreaking stem cell therapy for severe osteoarthritis.

The rally supporting Minister Oh started on May 30, including a shareholder prayer service in front of the agency's entrance on June 10. Prior to these events, they also held protests near the headquarters of the ruling party in Yeouido in April and May, engaging in collective actions.

Retail shareholders are holding such events after the MFDS rejected the approval of JointStem, touted by Nature Cell as a treatment that can fully cure osteoarthritis with a single administration.

Nature Cell completed phase 3 clinical trials of JointStem in 2021 and applied for product approval to the MFDS.

However, the Central Pharmaceutical Affairs Advisory Committee of the agency rejected the application, stating, "While some clinical efficacy is recognized, the drug needs more data to show that it can demonstrate superiority compared to existing treatment options and explain the mechanism of action of the product."

On April 6, Nature Cell received another rejection as a result of the second deliberation for the approval of the JointStem. At that time, nine out of 10 experts who participated in the Central Pharmaceutical Affairs Advisory Committee meeting concluded that the item license was not valid.

In response, Vision Korea argued that the panel conducted the review in violation of the FDA's guidelines, which explicitly state that certain clinical indicators should not be used for drug approval decisions.

They claimed that the evaluation process contradicted the FDA's regulatory guidelines.

However, industry watchers have questioned why the retail shareholder coalition has mentioned FDA guidelines when the MFDS is reviewing the approval process.

Meanwhile, in connection with this issue, Nature's Cell officially filed an appeal to the MFDS on June 2. The ministry has the option to make a decision within 10 days of receiving the appeal or extend the review period by an additional 10 days for further examination.

The ministry has not commented on the process stating that the case is still under review.

Shareholders are now requesting that Oh personally intervene and reconsider the appeal. A Vision Korea representative stated, "We sincerely ask for a fair and impartial reevaluation of the appeal, correcting the mistakes of the Central Pharmaceutical Affairs Advisory Committee."

As the battle between Nature's Cell and the Food and Drug Safety Agency unfolds, industry watchers are keeping a close eye if the shareholder's bizarre protest methods will eventually lead to a happy ending for JointStem.