Lee Woong-yeol, Honorary Chairman of Kolon Group, who was indicted on charges including involvement in the manipulation of the components of the osteoarthritis treatment drug Invossa-K, was acquitted in the first trial.
Lee Woong-yeol, Honorary Chairman of Kolon, who was indicted on suspicion of manipulating the components of the osteoarthritis gene therapy drug Invossa-K (Invossa), is answering reporters' questions as he leaves the courthouse after being acquitted in the first trial held at the Seoul Central District Court in Seocho-gu, Seoul, on the morning of the 29th. Photo by Yonhap News
On the morning of the 29th, the Criminal Division 24 of the Seoul Central District Court (Presiding Judge Choi Kyung-seo) acquitted Lee, who was tried for violations of the Capital Markets Act and other charges. The court dismissed the charges related to violations of the Financial Real Name Act concerning nominee stocks of Kolon Life Science Inc. Lee Woo-seok, former CEO of Kolon Life Science, who was also indicted, was acquitted. This verdict came approximately 4 years and 10 months after the indictment in 2020.
The court ruled that Lee and the former CEO were not guilty of violating the Pharmaceutical Affairs Act and fraud charges. The court stated, “It is difficult to immediately conclude that the drug was manufactured and sold without approval simply because the components listed on the drug item and documents differ from the actual components manufactured and sold, and that such acts constitute criminal violations of related laws.”
Furthermore, the court noted, “The point at which Kolon Life Science and the defendants became aware of the origin error appears to be after March 30, 2019,” and added, “It is difficult to determine that there was intent by categorizing the manufactured and sold Invossa-K as a different drug.”
The court also addressed the safety and efficacy of Invossa-K, stating, “The prosecution has not submitted objective data regarding safety issues, and even if such data were not submitted, the court cannot make a judgment on safety concerns from a scientific perspective.”
Earlier, in the July sentencing hearing, the prosecution requested the court to sentence Lee to 10 years in prison, impose a fine of 500 billion KRW, and order the confiscation of approximately 3.4 billion KRW. The prosecution also sought a 10-year prison sentence and a 500 billion KRW fine for Lee Woo-seok, CEO of Kolon Life Science, who was indicted together.
Invossa is an osteoarthritis treatment developed and researched by Kolon TissueGene, consisting of two components: the first containing human cartilage cells and the second containing transduced cells. It was approved by the Ministry of Food and Drug Safety in 2017 as the first gene therapy in Korea.
The prosecution judged that Lee manufactured and sold the second component of Invossa from November 2017 to March 2019 using kidney-derived cells instead of the approved cartilage cells, generating sales worth about 10 billion KRW, and brought him to trial. He is also accused of hiding the fact that Kolon TissueGene received a clinical trial halt order from the U.S. FDA in June 2016 while obtaining an equity investment worth 10 million USD from the Export-Import Bank of Korea.
Finally, the court remarked, “I recall that the Invossa incident caused significant repercussions in 2019,” and added, “If the final judgment of the first trial court aligns with this court’s judgment, it is necessary to deeply consider what the meaning of this lawsuit is, which has involved a massive number of personnel over several years, and how judicial control over the scientific field is conducted.”
When asked about his stance on the first trial acquittal, Lee responded to reporters, “I am grateful.”
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