Kolon Life Science Lost Again in Second Trial of Administrative Lawsuit Over 'Invossa Approval Revocation'

Kolon Life Science also lost the second trial in the administrative lawsuit it filed in opposition to the authorities' decision to revoke the approval of the osteoarthritis gene therapy Invossa KJ (hereinafter Invossa).

The Seoul High Court Administrative Division 10 (Presiding Judges Seong Suje, Yang Jinsu, Ha Taehan) ruled on the 7th that Kolon Life Science's lawsuit against the Minister of Food and Drug Safety, demanding the cancellation of the decision to revoke the manufacturing and sales approval, was dismissed, just as in the first trial.

Invossa is an osteoarthritis gene therapy injection composed of two components: Component 1 containing human chondrocytes and Component 2 containing genetically modified cells introduced with the chondrocyte growth factor (TGF-β1). It was approved by the Ministry of Food and Drug Safety in 2017 as the first gene therapy in Korea.

However, when it was revealed that the genetically modified cells in Component 2 were not chondrocytes but kidney cells that could potentially cause tumors, the Ministry of Food and Drug Safety revoked the product approval in 2019. Kolon Life Science filed a lawsuit opposing this decision.

Earlier, the first trial court ruled against the plaintiff, judging that although it was unclear whether Kolon Life Science intentionally concealed the fact that Invossa's components were incorrect, it was clear that they did not provide unfavorable information to the Ministry of Food and Drug Safety during the approval process.

This content was produced with the assistance of AI translation services.