Court Rules "Inbosa Approval Cancellation Justified"… Kolon Loses Appeal Lawsuit

[Image source=Yonhap News]

[Asia Economy Reporter Baek Kyunghwan] Kolon Life Science filed an administrative lawsuit claiming that the cancellation of the approval for the osteoarthritis gene therapy drug 'Invossa-K' is invalid, but the court did not accept it.

On the 19th, the 12th Administrative Division of the Seoul Administrative Court (Presiding Judge Hong Soonwook) ruled against Kolon Life Science, which had filed a lawsuit against the Minister of Food and Drug Safety demanding the cancellation of the decision to revoke the manufacturing and sales approval.

Invossa is an osteoarthritis gene therapy injection composed of two components: Component 1 containing human cartilage cells and Component 2 containing genetically modified cells introduced with cartilage cell growth factor (TGF-β1).

It was approved by the Ministry of Food and Drug Safety in 2017 as the first gene therapy in Korea, but in 2019, the Ministry revoked the product approval after it was revealed that the genetically modified cells in Component 2 were not cartilage cells but kidney cells that could potentially cause tumors.

On this day, the court stated, "Based solely on the evidence submitted by the defendant, it is insufficient to recognize that the plaintiff intentionally omitted unfavorable information during the product approval review," and added, "Since it directly affects life or health, if other facts are found to be recorded in the product approval documents, it constitutes a serious defect." The court further explained, "There is no illegality in the defendant's decision to revoke the product approval ex officio."

Meanwhile, Kolon Life Science executives who were indicted on charges of manipulating the components of Invossa-K and submitting false documents to authorities were acquitted this morning. Jo, who was the head of the clinical development team overseeing the development, and Kim, who was the director of the biopharmaceutical research institute, were indicted for submitting false data regarding Invossa's components to obtain approval from the Ministry of Food and Drug Safety. However, the court acknowledged that they included some inaccurate information in the documents but judged them not guilty, stating, "There is suspicion that the Ministry of Food and Drug Safety's verification during the Invossa product approval process was insufficient."

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