SEOUL, Aug. 26 (Korea Bizwire) — The Korea Exchange, South Korea’s bourse operator, said Monday it has tentatively decided to delist Kolon TissueGene Inc., an affiliate of Kolon Life Science, from the local stock market as it submitted a false document when it was listed two years ago.
But the company is allowed to seek further review for the decision, which means that depending on the final outcome of the review, shares of Kolon TissueGene could be delisted or remain on the KOSDAQ market.
Kolon TissueGene, a U.S.-based affiliate of Kolon Life Science, was listed on the secondary market in 2017.
The trading of Kolon TissueGene has been suspended since late May after the government revoked its permit for the gene therapy drug Invossa for mislabeling and false reporting of an ingredient.
In July, the Ministry of Food and Drug Safety made the final decision banning the production and sale of Invossa after it canceled the license for the drug made by Kolon Life Science in late May and ordered the suspension of sales in April.
Kolon Life acknowledged that a substance in the joint pain treatment drug had been mislabeled since 2003, with authorities arguing the company intentionally did not disclose additional data it discovered on the problem before submitting the drug for approval.
State regulators added that the drugmaker failed to provide a scientific cause for the mix-up.
A material used in Invossa, which was approved for sale in 2017, came from a kidney cell instead of from cartilage as stated in the document submitted for approval, according to the drug authorities.
There have been no cases of side effects associated with Invossa, but all people who have received treatment will be closely monitored for upwards of 15 years.
A total of 438 hospitals and clinics have administered 3,707 doses of the drug so far.
Early this month, a Seoul court turned down a request by Kolon Life Science to suspend the government’s decision to prohibit the production and sale of Invossa, saying that Invossa’s safety has not been fully guaranteed.
It ruled that the ministry’s measure is justifiable as the original permit was based on false reporting of a key ingredient.
Its market capitalization stood at 489 billion won in late May when its trading was suspended, with a total of 59,445 retail investors holding 36.3 percent of Kolon TissueGene.