Lee Woong-yeol, honorary chairman of Kolon Group, was put on trial on charges of manipulating the ingredients of the osteoarthritis gene therapy "Invossa-K Inj. (Invossa)" and selling it, but was acquitted on appeal.
The Seoul High Court's Criminal Division 13 (Presiding Judge Baek Kang-jin) on the 5th acquitted the honorary chairman, who was indicted on charges including violating the Pharmaceutical Affairs Act, as in the first trial. Lee Woo-seok, former Kolon Life Science CEO, who was indicted together, was also acquitted as in the first trial.
Invossa is an arthritis gene therapy injection composed of Solution 1 containing human chondrocytes and Solution 2 containing transfected cells introduced with a chondrocyte growth factor. It received approval from the Ministery of Food and Drug Safety (MFDS) in 2017.
However, when Kolon TissueGene, which developed Invossa, was conducting Phase 3 clinical trials in the United States in Mar. 2019, it was revealed that the ingredients disclosed at the time of domestic approval differed from the actual ingredients. The cells used to make Solution 2 were not the approved "chondrocytes" but "kidney-derived cells," which are known to carry a risk of tumorigenesis. The Ministery of Food and Drug Safety revoked the approval in Jul. 2019.
Prosecutors indicted the chairman in Jul. 2020 on charges including manufacturing and selling Invossa with ingredients different from those approved from Nov. 2017 to Mar. 2019, generating 16 billion won in sales.
The appellate court said, "We do not acknowledge any of the charges that they recognized the error in the origin of Solution 2 cells of Invossa and nonetheless omitted that entry."
The court of first instance found that Lee and others recognized that the ingredients of Solution 2 differed from those disclosed at the time of approval by the Ministery of Food and Drug Safety after manufacturing and sales had begun, in Mar. 2019. The appellate court said it could accept this determination.