Kolon TissueGene shares to resume trading on Kosdaq from Oct.25
The Korea Exchange (KRX) held a corporate review committee on Monday and decided to maintain the listing of Kolon TissueGene on the tech-heavy Kosdaq market.
Kolon TissueGene's shares will resume trading on Tuesday, ending the 41-month trading suspension.
The KRX had suspended the trading of Kolon TissueGene's shares after the Ministry of Food and Drug Safety requested Kolon Life Science to discontinue the manufacturing and sales of Invossa-K in March 2020.
The request came after a short tandem repeat (STR) analysis of Kolon TissueGene had revealed the osteoarthritis treatment had a cell line different from the one permitted by the regulatory agency.
Invossa is comprised of human chondrocytes (HC, 75 percent) and transformed cells (TC, 25 percent). In 2004, the company thought TCs were derived from cartilage. However, it was later found that TCs were HEK 293 cells derived from the kidneys.
While Kolon TissueGene held a news conference and apologized for "mislabeling" one of its key compositions for Invossa-K, the MFDS eventually revoked the product license of Invossa in May 2020.
The company has since been fighting an uphill battle to prevent the company from delisting.
Adding on to the company's woes, Kolon TissueGene faced further delisting woes after the KRX designated TissueGene as a subject for listing eligibility review in July 2020 due to the company's receiving an adverse audit opinion for the fiscal year of 2019 and the first half of 2020.
The KRX decided to give Kolon TissueGene a one-year grace period to improve its management after holding a review committee meeting on Sept. 1, 2021.
The KRX had demanded that Kolon TissueGene lift the U.S. Food and Drug Administration's clinical hold on Invossa and resume trials, expand new pipelines, license out its treatment candidate, and secure financial soundness during the improvement period.
Accordingly, Kolon TissueGene resolved the clinical hold set by the FDA and resumed patient administration of Invossa for its phase 3 clinical trials on Dec. 21 of last year, and received additional FDA approval to conduct a phase 2 clinical trial for Invossa in treating hip osteoarthritis.
Also, the company signed a technology export contract for Invossa with Juniper Biologics, a Singapore-based biopharmaceutical firm, in April.
Under the accord, Kolon Life Science will receive a down payment of 15 billion won ($12.18 million) and an additional 723.4 billion won depending on the development and commercialization progress of Invossa.
The company has also improved its financial structure after receiving additional funds through a capital increase to be participated in by the Kolon Group and its Chairman Lee Woong-yeol.
"We will do our best to repay the shareholders who have trusted and waited for the company to resume trading for a long time," Kolon TissueGene CEO Han Sung-soo said. "We will do our best to complete Invossa's phase 3 clinical trial."
The resumption of trading for Kolon TissueGene's shares comes as a relief for retail investors holding a large percentage of shares.
Kolon TissueGene has about 65,000 minority shareholders, holding a combined 34.48 percent stake in the company.