The Ministry of Food and Drug Safety said on May 28 that it will file criminal charges against Kolon Life Science, along with the cancellation of the item license, saying Kolon Life Science submitted false data to get permission for Invossa.
The ministry conducted its own test examination, a field survey of Kolon Life Science and an on-site inspection in the U.S. to verify the authenticity of the data submitted at the time of approval.
According to the results of the STR test on Master Cell Bank and Working Cell Bank of Invossa 2 liquid, a specific gene (gag.pol) was found only in the 2 liquid, the ministry said.
Kolon Life Science, however, listed the two-liquid cells as cartilage cells in its data submitted at the time of the authorization.
It was also confirmed that Kolon Life Science hid major facts that were further confirmed before the approval and did not submit. Kolon Life Science hid the number and location of the TGF-β1 gene inserted into the two-liquid cell before its authorization, and did not submit related documents to the ministry.
Concerns are growing that Kolon TissueGene will be delisted from the bourse due to the cancellation of its approval for Invossa. Kolon TissueGene was established in the U.S. and its sales do not take place except for Invossa.
The Korea Exchange is considering whether to refer the documents submitted at the time of Kolon TissueGene's listing to the public to the screening committee on the grounds that they were falsely listed. Depending on the results of the screening, Kolon TissueGene is likely to be delisted.
Kolon TissueGene also recorded a deficit in 2017 and 2018 due to the huge cost of investment in the development of Invossa.
Meanwhile, the cancellation of the approval of Invossa is said to be the biggest crisis in Kolon Group. For Kolon Group, Invossa was not just a new drug. It was the group's future food and hope. Chairman Lee Woong-yeol, 63, who resigned late last year, called it the group's "fourth child" and focused the group's capabilities on marketing the Invossa.
