The one-year grace period granted to Kolon TissueGene has ended. The securities authorities suspended the company’s stock transaction over the past year due to controversy over unwarranted ingredient change in Invossa, the world’s first osteoarthritis cell genetic treatment.

In a public notice on Wednesday, the Korea Exchange said the one-year “improvement period” for Kolon TissueGene had ended.

Kolon TissueGene must submit documents detailing how it implemented its improvement plans and experts’ confirmation of such implementation results within 15 business days from the end of the improvement period. The deadline for submission, according to this rule, is Sept. 23.

KRX will hold a corporate screening committee meeting within 20 business days of receiving the documents from Kolon TissueGene, deliberate them, and decide whether to delist the company.

Accordingly, the result of the deliberation falls under delisting, the securities authorities will hold the Kosdaq Market Committee meeting within 20 business days of the screening meeting and finalize whether to delist the company.

After the Ministry of Food and Drug Safety revealed that Kolon TissueGene used kidney cells instead of cartilage cells as permitted in its osteoarthritis treatment in March 2020, the stock exchange judged that the documents submitted for listing review were falsely stated or omitted.

Besides, Kolon TissueGene is undergoing two substantive reviews of eligibility for listing on two accounts – alleged breach of trust and embezzlement by a former director and continuous business loss (continuous business loss occurred to deduct corporate tax expenses above 50 percent of equity capital in two of the last three business years).

Last December, Kolon TissueGene resumed phase 3 clinical trials in the U.S. on knee osteoarthritis patients for Invossa or TG-C in American name. The company plans to recruit 1,020 patients from about 80 U.S. clinical institutions and administer Invossa to them to complete the trials next year.

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