Kolon Life Science asked to temporarily suspend the disposition of an item for the osteoarthritis gene therapy Inbosakei, but it was not accepted by the court.
The 12th administrative division of Seoul Administrative Court (Jun Soon-wook, vice-president) dismissed Kolon Life Science's application for suspension from the Ministry of Food and Drug Safety.
Inbosa is an osteoarthritis gene therapy injection consisting of 1 fluid containing human chondrocytes and 2 fluids containing transformed cells with chondrocyte growth factor (TGF-β1).
In 2017, it was approved by the Korea Food and Drug Administration as the first gene therapy drug in Korea.
However, the two-transformed cells were found to be kidney cells that are likely to cause tumors, not chondrocytes, so the KFDA canceled the product permit.
Kolon Life also filed an administrative lawsuit against the disposition of the Food and Drug Administration and also applied for an administrative suspension to suspend the disposition.
Court denies application for suspension of Kolon Life's 'Inbosa' permission
2019-08-13T12:46:09.318Z
Kolon Life Science asked to temporarily suspend the disposition of an item for the osteoarthritis gene therapy Inbosakei, but it was not accepted by the court. The 12 administrative divisions of the Seoul Administrative Court dismissed Kolon Life Science's application for suspension from the Ministry of Food and Drug Safety.
Source: sbskr