Kolon TissueGene has avoided being delisted from the Korean stock market. The company is planning to receive a review for returning to the stock market after checking the process of resuming Phase 3 clinical trials for one year.
Korea Exchange held a KOSDAQ Market Committee meeting on Oct. 11 to decide whether it would delist Kolon TissueGene. The committee decided to overturn a previous decision of the Corporate Evaluation Committee and grant Kolon TissueGene a one-year improvement period.
The improvement period will end on Oct. 11, 2020. The KOSDAQ Market Committee will review Kolon TissueGene’s qualifications based on its plan to resume Phase 3 clinical trials for Invossa and the results of the clinical trials. Accordingly, the suspension of Kolon TissueGene’s stock trading was postponed until after Oct. 11, 2020.
“We have made the decision after taking into account the possibility of the U.S. Food and Drug Administration (FDA) allowing Kolon TissueGene to resume Phase 3 clinical trials for Invossa. We have also taken into account Kolon Life Science's relationship with Mitsubishi Tanabe Pharma and its litigation with the Korean Ministry of Food and Drug Safety,” a Korea Exchange official said. Earlier Kolon Tissuegene became subject to a listing eligibility review as the main component of the Invossa, a treatment for osteoarthritis, was found to be kidney cells, not previously known chondrocytes.
Kolon TissueGene is 62.13 percent owned by Kolon Group affiliates, executives and owner family members including Kolon Corp. (27.26 percent), Lee Woong-yeol, a former Kolon Group chairman (17.83 percent), Kolon Life Science (12.57 percent) and Kolon Glotech (2.82 percent).
The U.S FDA told Kolon TissueGene on Sept. 19 to supplement data on Phase 3 clinical trials for Invossa. If Kolon TissueGene submits the requested supplementary data, it will take another 30 days for the FDA’s review. TissueGene has not yet handed in the data.