Kolon Life Sciences lost in the first trial of an administrative lawsuit filed in objection to the disposition of the authorities that canceled the approval of Invossakeiju (hereinafter referred to as Invossa) for osteoarthritis gene therapy.
The 12th administrative division of the Seoul Administrative Court (Deputy Judge Hong Soon-wook) ruled on the 19th that Kolon Life Sciences defeated the plaintiff in a lawsuit against the Minister of Food and Drug Safety, saying, “Please cancel the disposition for canceling the license for manufacturing and selling items.”
The court said, “The evidence submitted by the defendant alone is insufficient to admit that the plaintiff intentionally omitted matters unfavorable for the product approval review.” However, “As (drugs) directly affect life or health, other facts are stated in the product license. If it turns out, it is a serious flaw.”
He added, “The plaintiff knew enough data that could question the stability of (Invossa), but the defendant did not seem to know it,” he explained. “There is no illegality in the disposition of the defendant’s ex officio cancellation of the item permission.”
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). received.
However, it turned out that the two-solution transformed cells were not cartilage cells but kidney cells that could induce tumors, so 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 disposition.
/yunhap news
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