Do you remember the so-called 'Invossa incident' that caused a stir in society five years ago?
It was released as the world's first degenerative arthritis gene therapy, but controversy arose when it was revealed that it contained tumor-causing substances.
Kolon Group Honorary Chairman Lee Woong-yeol, who was accused of being involved in manipulating ingredient data, was acquitted in the first trial for the first time in more than four years.
I'm reporter Kim Tae-won.
[Reporter]
Invossa K.J., a degenerative arthritis treatment developed by Kolon Life Sciences.
As the first gene therapy in Korea, it was approved for sale by the Ministry of Food and Drug Safety in 2017.
However, unlike the data submitted during the screening process, it became controversial when it was revealed that kidney-derived cells that can cause tumors were included,
[Kang Seok-yeon / Then Food and Drug Administration Bio]Director of the Biopharmaceutical Affairs Bureau (last 2019): We have decided to cancel the product license for Invossa K.J. and file a complaint against Kolon Life Sciences.]
Kolon Honorary Chairman Lee Woong-yeol and others were put on trial.
After nearly five years of hearing, the first trial court acquitted Chairman Lee.
The court judged that Kolon seems to have belatedly recognized that Invossa's actual ingredients and licensed ingredients are different.It is difficult to evaluate it as a crime because it was not intentionally hidden
.
In connection with charges of hiding and attracting funds from the U.S. FDA for suspending clinical trials,
The
process was delayed for a while, and it was not a major setback in development, and there was a lack of evidence to believe that it was trying to hide it.
[Lee Woong Yeol / Honorary Chairman of Kolon: (I'm acquitted today. Please say something.) Thank you.]
The
court explained that the safety of Invossa in the United States has been carefully reviewed from a scientific point of view and that phase 3 clinical trials have recently been conducted.
On the other hand, he pointed out that in Korea, only administrative litigation and criminal trials have been going on for several years, and that it is necessary to think about how judicial control over science should be carried out.
I'm Kim Taewon of YTN.
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