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Kolon TissueGene Shares to Resume Trading on KOSDAQ

KOLONTISSUEGENE

2022.11.07

▷ Corporate Review Committee and KOSDAQ Market Committee decide to keep Kolon TissueGene listed

 Tasks for improvement imposed by KRX, faithfully completed

▷ With recovering market trust, funding will become easier

 Best efforts to be made to succeed in phase 3 clinical trial for US FDA

 

 The shares of Kolon TissueGene (Co-CEOs Moon Jong Noh, Sung Han) will resume trading on KOSDAQ in 3 years and 5 months. Kolon TissueGene announced on October 24 that the company will remain listed after deliberation by the KRX Corporate Review Committee and KOSDAQ Market Committee. Based on this decision, the shares of Kolon TissueGene will resume trading on October 25, and funding is expected to get easier as the company regains trust of the market.

 

After voluntarily suspending the clinical trial in 2019 due to "mislabeling" of cell origination, US Food and Drug Administration (FDA) announced the clinical hold and Korea Ministry of Food and Drug Safety (MFDS) revoked the product license of Invossa-K produced by Kolon Life Science Inc. And the trading of the company's shares on KOSDAQ was suspended in May 2019. During the 3-times' grace period granted by KRX to make improvements, Kolon TissueGene faithfully completed the action plans, and the trade resumption decision was made after the final deliberation of individual and comprehensive requirements.

 

 During the grace periods, KRX requested Kolon TissueGene to: get FDA's clinical hold of 2019 lifted and resume administration to patients; expand new pipelines; enter into out-licensing deals; and improve its financial soundness.

 

 Kolon TissueGene resumed phase 3 clinical trial in December 2021 after the FDA lifted the clinical hold in April 2020, following which the FDA approved phase 2 clinical trial to extend TG-C administration to treating hip osteoarthritis. Kolon TissueGene completed all the tasks imposed by KRX by successfully licensing out its osteoarthritis cell gene treatment TG-C to Juniper Biologics based in Singapore through its Asian licensee, Kolon Life Science, and securing the funding for clinical trials with proactive support of the majority shareholder.

 

 Sung Han, CEO of Kolon TissueGene, emphasized that "we will make it up to our shareholders who trusted us and waited for us for a long time. We will do our very best to succeed in the phase 3 TG-C clinical trial."

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