"I Will Not Evade Responsibility for the Invossa Incident"
Prosecution Seeks 10-Year Prison Sentence for Chairman Lee Woongyeol
Appellate Court Ruling Set for February 5 Next Year
Lee Woong-yeol, Honorary Chairman of Kolon Group, delivered his final statement in the 'Invossa Incident' trial, saying, "I have no intention of evading responsibility," and added, "I am striving to put an end to the concerns and controversies that have arisen, and to restore trust." On November 17, Lee appeared at the sentencing hearing (2024No3771) held by the 13th Criminal Division of the Seoul High Court (Presiding Judge Baek Kangjin) and made these remarks.
Former Kolon Group Chairman Lee Woong-yeol, who was indicted on charges including involvement in the manipulation of the components of Invossa K Injection (Invossa). The Asia Business Daily database.
View original imageThe Invossa Incident refers to the controversy over the manipulation of the components of Invossa K Injection, an osteoarthritis treatment, which emerged in March 2019. Lee stated, "Kolon Group did its utmost to address the Invossa Incident," and emphasized, "We prioritized trust in Invossa's safety and efficacy, and I can say that at no point during the development process did we deviate from the right path." He continued, "Although progress has been gradual, we are seeing tangible results with Invossa," and added, "If the Phase 3 clinical trials for Invossa are successfully completed and we receive approval from the United States Food and Drug Administration (FDA), my colleagues at Kolon Group and I believe that we will be able to free many people from pain." Lee concluded, "I will do my utmost to fulfill my responsibilities and live up to expectations," and said, "I apologize to everyone who has supported Kolon Group."
The prosecution requested a 10-year prison sentence for Lee, stating, "As the highest authority in the decision-making structure for Invossa investments and the listing of Kolon TissueGene, Lee used illicit methods to disrupt the Capital Markets Act." Kolon TissueGene is the United States-based Kolon Group affiliate that led the development of Invossa.
The prosecution also requested a 10-year prison sentence for Lee Wooseok, former CEO of Kolon Life Science. Lee Wooseok stated in his final statement, "The prosecution claims that in October 2017, a foreign executive reported to me that kidney-derived cells were included in Invossa's second component (contrary to the approval), but it was a passing comment and not at all a serious context," and added, "After becoming aware of the issue regarding the origin of the cells in Invossa's second component in March 2019, I immediately instructed an official report to the FDA and personally visited the Ministry of Food and Drug Safety to make a report." Kolon Life Science is the company responsible for the production and development of Invossa in Korea.
The prosecution requested a five-year prison sentence each for Kwon Soonwook, Head of Kolon TissueGene's Korea branch (Director), and Yang Yooncheol, former Executive Director of Kolon Life Science, and a three-year prison sentence for Song Moonsu, CEO of TNP Logistics.
In November 2024, the first trial acquitted Lee and former CEO Lee, among others. The court determined that, based on the evidence submitted, it was difficult to conclude that the defendants knowingly concealed the change in the cell type of Invossa's second component. The court also found it hard to recognize as guilty the charges related to receiving an equity investment of approximately 10 million dollars from the Export-Import Bank of Korea while concealing the FDA's clinical hold (CH) order, as well as the allegations of artificially inflating affiliate stock prices through false disclosures during the process of listing Kolon TissueGene on KOSDAQ and raising about 200 billion won.
The appellate court's sentencing is scheduled for February 5, 2026.
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Reporter Lee Sangwoo, The Law Journal
※This article is based on content supplied by Law Times.
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