“As the head of Kolon Life Science and chief medical officer of Kolon TissueGene, I have devoted a lot of time to the successful approval and commercial production of TG-C (formerly Invossa-K).”

Kolon Life Science’s gene therapy Invossa presented another challenge for Kim, who had previously left Hanmi Pharmaceutical after leading a landmark technology transfer for domestic drug development. He took on the difficult task of developing a new drug at a smaller firm. His decision to revive Invossa—which had been stigmatized following its license revocation by the Ministry of Food and Drug Safety—raised questions. Even after Kolon announced it had received a Remove Clinical Hold letter for its phase 3 trial of TG-C, both the industry and market remained skeptical.

Against this backdrop, the company has progressed from resuming patient dosing in its U.S. phase 3 trial to managing clinical sites and data, and now to preparing for commercial production. Following in the footsteps of SK biopharmaceuticals, Kolon has been steadily preparing to enter the global market with its own capabilities. Korea Biomedical Review sat down with Kim Sun-jin, CEO of Kolon Life Science and the driving force behind Kolon Group’s bio business, to learn more about the development of TG-C and the group’s blueprint for its biotech ambitions.

Question: What led you to join Kolon Group, especially at a time when the company’s image was tarnished due to the Invossa controversy?

Answer: Before joining Kolon Group, our initial goal was to get TG-C off the U.S. phase 3 clinical hold. After a thorough scientific review of the FDA’s letter, we concluded that the hold could be lifted.

Sometimes, social judgments aren’t grounded in science. During the Invossa controversy, the public was shocked to learn that 293 cells—transformed human fetal kidney cells—were mistakenly labeled as cancerous. The key task was to present a scientific case to the FDA explaining that 293 cells are not cancer cells, that the tumors observed in experimental animals are not indicative of cancer, and that tumorigenic cells are not the same as cancer cells. My primary role was to build a legal and scientific defense to convey this logic to the FDA.

After completing the task of lifting the FDA’s clinical hold on TG-C, I was preparing to return to Platbio (now Kolon Pharma). But at that point, Kolon asked me to take on the role of Head of Clinical Affairs in the U.S. So, I joined the group as an independent director and Chief Medical Officer of Kolon TissueGene. In that sense, joining the Kolon Group was a natural progression.

Although conducting clinical trials for degenerative diseases during the Covid-19 pandemic was far from easy, we successfully completed phase 3 dosing thanks to the full support and cooperation of the entire Kolon Group. There’s a lot to share about the TG-C phase 3 study—from the Independent Data Monitoring Committee (IDMC) meetings held every three months to clinical site visits and meticulous data management.

Q: Your top priority after taking office was likely the phase 3 study of TG-C. Where does the study currently stand?

A: Kolon TissueGene CEO Noh Moon-jong is in charge of the overall strategy for TG-C, while I oversee clinical development as CMO. Currently, Kolon TissueGene is completing phase 3 dosing and patient follow-up in the U.S. in preparation for marketing authorization and commercialization. For production, Kolon Life Science plans to mass-produce TG-C through its subsidiary, Kolon Biotech.

The company is preparing to launch production facilities and secure FDA due diligence approval—a process that requires significant investment and workforce expansion. At the same time, preparations and administrative procedures are underway to export the technology to China and other international markets.

Q: As the head of TG-C as well as Kolon Life Science, Kolon Pharma, and Kolon Biotech, what have been your top priorities across these roles?

A: Kolon Life Science has undergone organizational changes in research, production, and management, and it was a big challenge to change the research organization. Fortunately, our researchers quickly adapted, and we focused on progressively organizing our existing pipeline and developing new challenges. I have high expectations for the Pharmaceutical Ingredients and Specialty Chemicals Divisions because they develop new materials and processes, as well as explore the right market to target.

With the addition of a new drug development function to the Chemical Division, the Chemical Research Institute has launched an active drug development program. The production expertise we’ve accumulated over time is expected to play a key role in advancing new drug development. Efforts in anticancer drug development within the pharmaceutical division, along with research capabilities using allograft models, have been effectively integrated with the life sciences and biotechnology teams. Recently, with the appointment of a new CFO, the R&D center and the management support center are now working together more cohesively.

Q: How does Kolon’s R&D for new drug development work?

A: The three Kolon Group companies have established a joint R&D council. Kolon Life Science has streamlined its pipeline and research projects and is now focusing on securing new technologies and materials through open innovation, in addition to internal development and new project initiatives. Kolon Pharma’s new drug division is also engaging in both internal and external collaborations through joint R&D programs, alongside its existing projects and pipeline. Some compounds are currently being discussed for potential technology transfer with global pharmaceutical companies.

Q: Kolon Life Science’s drug pipelines include KLS-2031 and KLS-3201. What is the development strategy for these candidates?

A: KLS-2031, which targets neuropathic pain, has shown efficacy in a diabetic foot pain model and is about to be published in a scientific journal. KLS-3201, an anti-cancer cytogenetic pipeline, is being pursued for potential technology transfer based on robust preclinical data using an allograft model. We are also considering independent clinical development in parallel with licensing discussions.

Q: What is the role of Kolon Pharma’s new drug division?

A: The division possesses full-cycle development capabilities from the discovery stage through to preclinical development. We take particular pride in our strong in vivo efficacy testing and histopathology analysis capabilities. We’ve already secured novel targets in pancreatic and ovarian cancers, and we are currently finalizing a lead candidate for pancreatic cancer.

Q: What is the specific direction of Kolon Biotech’s CDMO business?

A: Kolon Biotech’s primary mission is the production and supply of TG-C. This includes both the dedicated manufacturing of TG-C and the broader CDMO business. We are currently focusing our efforts on process development and completing the necessary facilities for commercial-scale production of TG-C. At the same time, we are steadily building a track record in the general CDMO field. By strengthening our team with experienced professionals in R&D and manufacturing, we aim to build a foundation for global competitiveness.

Q: The roles of the three Kolon bio companies seem well defined. What is the Kolon Group’s long-term blueprint for its bio business?

A: The core concept is the “Kolon Bio R&D Chain.” Kolon Life Science has built capabilities in cell and gene therapy with TG-C. Kolon Pharma has secured a cancer drug development platform through M&A. Kolon Biotech has built infrastructure for TG-C commercialization. If these companies can generate synergies across the drug development lifecycle, they will form a vital pillar of Kolon Group’s future growth.

In addition, through an active open innovation program, we plan to expand our pipeline by partnering with domestic and global drug developers—particularly in areas such as autoimmune diseases.