'Resuscitation' Kolon TissueGene... Trading Resumes from Tomorrow

Exchange Market Deliberation Committee Decides to Resume Trading
Inbosa Clinical Trials Restart and Fundraising
Revival Through Implementation of Improvements

[Asia Economy Reporter Lee Chun-hee] The shares of Kolon TissueGene, which had been suspended from trading, will be traded again on the KOSDAQ market.

Kolon TissueGene announced on the 24th that the resumption of stock trading was decided following the meeting of the Korea Exchange's Corporate Evaluation Committee and the KOSDAQ Market Headquarters Market Committee. This marks the end of a suspension period of about 3 years and 5 months since May 2019. Kolon TissueGene's shares will resume trading from the 25th.

In July 2017, Kolon TissueGene rose to stardom when its 'Invossa (TG-C)', the world's first 'cell and gene therapy for osteoarthritis', received approval from the Ministry of Food and Drug Safety (MFDS). Subsequently, after listing on the KOSDAQ market in November and successfully entering Phase 3 clinical trials in the United States, there were expectations that the company would become a global blockbuster-producing enterprise. Especially, the strong interest and direct nurturing by Lee Woong-yeol, Honorary Chairman of the Kolon Group, heightened these expectations.

However, in May 2019, two years later, the MFDS revoked Invossa's approval. This was because Kolon TissueGene had reported the transduced cells in Invossa as 'cartilage-derived cells' at the time of approval, but it was revealed that they were actually 'kidney-derived cells'. Kolon TissueGene argued that the kidney-derived cells were accidentally mixed in and that safety and efficacy had already been proven through clinical trials, but this argument failed to gain credibility. The U.S. Food and Drug Administration (FDA) also decided to suspend the ongoing Phase 3 clinical trials of Invossa in the United States.

Accordingly, the Korea Exchange also suspended trading of Kolon TissueGene's shares and designated the company for a substantive review of listing eligibility. However, the following year, due to a refusal of audit opinion and additional reasons such as embezzlement and breach of trust in July of the same year, the reasons for the substantive review of listing eligibility continued to accumulate. As a result, the improvement period has continued until now, and stock trading has not resumed for over three years.

Kolon TissueGene's 'Invossa' (Photo by Kolon TissueGene)

During the improvement period, the Korea Exchange required Kolon TissueGene to address the following: ▲ lifting the 2019 clinical hold and resuming patient dosing ▲ expanding new pipelines ▲ technology transfer ▲ securing financial soundness.

Regarding clinical matters, Kolon TissueGene obtained the lifting of the clinical hold from the FDA in April 2020 and resumed patient dosing for the Phase 3 clinical trial for knee osteoarthritis in December last year. In the same month, the FDA also approved plans for a Phase 2 clinical trial to expand the indication to hip osteoarthritis.

On the financial side, the company raised about 100 billion KRW through convertible bond (CB) issuance and paid-in capital increase. Notably, during this process, Honorary Chairman Lee personally contributed about 10 billion KRW from his private funds, demonstrating the firm support and commitment of the owner family and the group.

Han Sung-soo, CEO of Kolon TissueGene, said, “We will definitely repay the shareholders who have trusted and waited for the company for a long time,” and added, “We will do our best to succeed in the TG-C Phase 3 clinical trial.”

This content was produced with the assistance of AI translation services.