Prosecutors have dropped their appeal to the Supreme Court against Kolon Honorary Chairman Lee Woong-yeol and others, who were acquitted on appeal in the "Invossa scandal."
The Seoul High Prosecutors' Office said on the 11th that it decided not to appeal to the Supreme Court against all the deceased defendants, including Honorary Chairman Lee, in the Invossa case, in which not-guilty verdicts were handed down on appeal, after considering the evidentiary record and the likelihood of the appeal being granted. As a result, the Invossa-related case concluded 5 years and 7 months after prosecutors filed charges.
Earlier, the Seoul High Court's Criminal Division 13 (Presiding Judge Baek Kang-jin) on the 5th acquitted, as in the first trial, Honorary Chairman Lee and former Kolon Life Science CEO Lee Woo-seok, who were indicted on charges including violations of the Pharmaceutical Affairs Act.
Invossa is an injectable gene therapy for arthritis composed of Solution 1, which contains human chondrocytes, and Solution 2, which contains transfected cells introduced with a chondrocyte growth factor (TGF-β1).
It received approval from the Ministery of Food and Drug Safety in 2017, but in Mar. 2019, while developer Kolon TissueGene was conducting phase 3 clinical trials in the United States, it became a problem when it was revealed that the components disclosed at the time of approval in Korea differed from the actual components. The cells used to make Solution 2 were not the approved "chondrocytes" but "kidney-derived cells (GP2-293)," which are known to carry a risk of tumorigenesis, and the Ministery of Food and Drug Safety revoked the approval in Jul. 2019.
Prosecutors then indicted Lee in Jul. 2020 on charges including manufacturing and selling Invossa with components different from those approved between Nov. 2017 and Mar. 2019, generating 16 billion won in sales.
In the appellate ruling, the court did not accept any of the allegations that Honorary Chairman Lee and others recognized the origin error of the cells in Invossa's Solution 2 and omitted that information from the filings. It added, "We can accept the lower court's finding that the defendants became aware around Mar. 2019, later than the time of manufacture and sale."