Court "Can revoke permission for invoicing company"... Kolon loses to the Food and Drug Administration (Comprehensive 2 steps)

“Kolon, Invossa Do Not Honestly Disclose Data That Makes You Suspicious”

Invossa recognized as a’significant defect’ that could cancel product permission

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Kolon Life Science Invossa (CG)

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(Seoul = Yonhap News) Reporter Hwang Jae-ha and Park Hyeong-bin = Kolon Life Sciences lost the first trial of an administrative lawsuit filed against the disposition of the authorities that canceled the permission of Invossa Kayju (hereinafter referred to as Invossa), an osteoarthritis gene therapy.

The 12th administrative division of the Seoul Administrative Court (Deputy Judge Hong Soon-wook) ruled on the 19th that Kolon Life Science lost the plaintiff in a lawsuit filed against the Minister of Food and Drug Safety, saying, “Please cancel the disposition for canceling the license for manufacturing and selling items.”

The court first admitted that “the evidence submitted by the defendant deliberately manipulated the experimental results or submitted only unfavorable experimental results even though the plaintiff knew that the Invossa 2 fluid cells were not cartilage-derived cells but cells with tumorigenicity problems. Is not enough.”

However, the court continued, “The plaintiff knew data that could doubt the identity of Invossa 2, which should be cartilage-derived cells at the time of filing for the item permission.” “On the other hand, the defendant did not know such information, so information on Invossa. Was only in the plaintiff,” he pointed out.

“The plaintiff did not honestly and openly inform the defendant of some matters, and did not sufficiently share with the defendant the data necessary for the item permission examination under his own judgment, so he lost the opportunity to correct the error regarding the identity and safety of Invossa 2 amount. I pointed out.

It is unclear whether Kolon Life Sciences intentionally concealed the ingredients of Invossa, knowing that the ingredients were wrong, but it is clear that it did not provide adverse matters to the KFDA.

Regarding the safety of Invossa, the Ministry of Justice said, “It is insufficient to admit that Invossa is a drug that lacks safety to the extent that there is a risk of harm to public health,” but said, “Invossa clinical trials and product approval review have sufficiently verified the safety and effectiveness. It is difficult to reject the defendant’s claim that it has not been made enough.”

In addition, “Drugs have a direct impact on human life and health, so if it is found that important parts of the main ingredient are different from those listed in the product approval application, it should be considered that there is an important defect.” It was confirmed that this product is not a cartilage-derived cell, but a kidney-derived cell, which is the subject of permission for this product, so the defendant can revoke the permission ex officio.”

Kolon Life Science’s litigation representative said, “As the result of a long-term court hearing, we respect the court’s judgment, but in criminal cases, we were innocent,” and said, “I will examine the reason for the judgment in a cool and legal manner.”

Earlier, the Seoul Central District Court Criminal Agreement 25-3 (Director Judge Kwon Seong-su, Kim Sun-hee and Lim Jeong-yeop), an executive of this company, was charged with filing false documents (obstruction of hierarchical public affairs) while Kolon Life Sciences obtained Invossa’s KFDA license. Most of them were found not guilty.

Invossa is an injection solution for osteoarthritis gene therapy consisting of 1 solution containing human chondrocytes and 2 solutions containing transformed cells introduced with chondrocyte growth factor (TGF-β1).In 2017, it was approved by the Ministry of Food and Drug Safety as the first gene therapy product in Korea. received.

However, when it turned out that the two-solution transformed cells were not cartilage cells, but kidney cells that could induce tumors, the Ministry of Food and Drug Safety canceled the product license in 2019. In response, Kolon Life Science filed a lawsuit asking for the cancellation of the cancellation.

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