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Regulator delays decision on delisting Kolon TissueGene
  • By Jeong Sae-im
  • Published 2019.09.18 14:27
  • Updated 2019.09.18 14:27
  • comments 0

The Korea Exchange said it has delayed its decision whether to delist Kolon TissueGene.

The KRX’ Kosdaq Market Committee said it would extend the deadline of its review on Kolon TissueGene by 15 more business days from Sept. 18, under Paragraphs 2 and 10 of the Article 33 of the Kosdaq Listing Regulations.

The delay pushed the deadline to Oct. 11.

The KRX reportedly decided to delay the decision to see whether the U.S. regulator will approve the resumption of phase-3 trials on Invossa-K, the suspended gene therapy developed by Kolon TissueGene, and how the prosecution’s investigation into the mislabeled drug unfolds.

Kolon TissueGene has submitted additional data to the U.S. Food and Drug Administration to resume the phase-3 study on the suspended osteoarthritis treatment. The FDA is likely to announce the review result in late September at the earliest.

The KRX's Corporate Review Committee decided to delist Kolon TissueGene on Aug. 26.

The corporate review board ruled that the company did not mention the mislabeling in the document submitted to the KRX even though it received a notice from a contract manufacturer in March 2017, before listing, that the second fluid of Invossa contained kidney-derived (GP2-293) cells, not cartilage-derived cells as labeled.

The Ministry of Food and Drug Safety revoked the license of Invossa due to a false document submitted to the ministry.

The company requested a court to suspend the government’s decision to nullify the Invossa license, but the court turned down the request.

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