Lee Woong-yeol, the honorary chairman of Kolon Group, along with the corporation itself, have been indicted on charges related to the tampering of the ingredient of Invossa Injection, a treatment for osteoarthritis. The first trial is anticipated to conclude in the first half of the year, with a decision expected by year-end.
According to multiple reports, the 24th Criminal Division of the Seoul Central District Court held a preparatory session on Feb. 26 for the trial of the Honorary Chairman and others, charged with violations of the Capital Market and Financial Investment Business Act, among others.
During this session, the court organized opinions on the evidence previously submitted by both parties and coordinated the schedule for upcoming trial dates.
The prosecution announced plans to submit the appellate decision from the Seoul High Court on Feb. 7 as evidence. This decision upheld the original ruling against Kolon Life Science in its appeal against the revocation of its product license by the Ministry of Food and Drug Safety, a case that was filed in March 2021 and concluded after nearly three years.
The court stated, “To date, the harmfulness of the second component of Invossa has not been properly verified, and it is reasonable to consider there is a risk to the public.” It added, “Even if a significant amount of radiation treatment is conducted and it is expected to be eliminated after a certain period, the selected dosage of radiation was not chosen with consideration of its harmfulness, and thus, concerns regarding its potential harm to public health have not been alleviated.”
Meanwhile, Kolon Group is seeking to sustain Invossa’s viability internationally, so its Phase 3 clinical trials in the United States can continue. The U.S. Food and Drug Administration (FDA) had halted the Phase 3 trials in 2019 after discovering that the second component of Invossa differed through genetic lineage analysis (STR testing). After reviewing additional experimental data for over a year, the FDA has since allowed the trials to resume.