"Invossa (TG-C) scandal" shackled Kolon Group for the past six years, but it has thrown off the heavy burden of legal risk. That is because Honorary Chairman Lee Woong-yeul of Kolon Group, who faced allegations of ingredient manipulation, was acquitted again on appeal. With legal uncertainty resolved, Kolon plans to stake everything on launching a new drug in the United States, the world's largest pharmaceuticals market, and restoring its reputation.
On Feb. 5, the Seoul High Court's Criminal Division 13 (Presiding Judge Baek Kang-jin) acquitted the honorary chairman of charges including violations of the Pharmaceutical Affairs Act, upholding the lower court's verdict. Former Kolon Life Science CEO Lee Woo-seok was also acquitted. The bench said, "The lower court's judgment is proper," and dismissed the prosecution's appeal.
Lee's side has consistently pleaded unfairness throughout the trial. Lee has argued, "I only trusted the research team's reports, and there was absolutely no reason to knowingly obtain approval or deceive investors despite knowing about the ingredient change."
The court likewise determined that Lee did not receive a specific report from working-level staff about the ingredient error. After six years of legal battles since the prosecution's investigation began in 2019, Lee has finally shed the unjust label of having "ordered ingredient manipulation" and is set to reclaim reputation.
With this, Kolon can concentrate its full corporate capabilities on securing U.S. approval for Invossa. Invossa was approved in 2017 as Korea's first gene therapy, but in 2019 its main ingredient was found to be kidney-derived cells rather than chondrocytes, leading to the cancellation of its domestic approval and a crisis over its very existence.
However, the U.S. Food and Drug Administration (FDA) in 2020 said there were no safety issues and approved the resumption of clinical trials, and Kolon TissueGene named the product "TG-C" and continued the trials.
Kolon TissueGene has already completed dosing for patients in its U.S. phase 3 trial. It is now in the follow-up observation stage and plans to announce key clinical results in July. Based on these results, the company finalized a roadmap to apply to the FDA for approval in the first quarter of next year.
A Kolon TissueGene official said, "Considering that it takes about a year from filing for Invossa's approval to launch, we plan to introduce the product in the second half of 2028."
Once marketing is confirmed, exclusivity will be guaranteed for 12 years in the United States and 10 years in Europe. Kolon TissueGene holds the U.S. and European rights, while Kolon Life Science holds the domestic as well as Asia and Africa rights.
The growth of the global osteoarthritis therapeutics market is also encouraging. According to market research firm Research Nester, the global osteoarthritis therapeutics market is expected to surge from $10.83 billion (about 16 trillion won) last year to $36.6 billion (about 54 trillion won) by 2035. Invossa's strategy is to rapidly increase market share by absorbing soaring patient demand driven by aging populations. Production will be handled exclusively by Lonza's Singapore plant in Switzerland's Lonza.
Expansion of indications is also proceeding smoothly. Kolon TissueGene is widening its treatment scope, previously limited to the knee, to the hip and spine. It recently received FDA approval for a phase 1 trial plan to expand to spinal indications and intends to soon begin dosing procedures for patients with spinal diseases.