Kolon Life Science will move to strengthen its bio business by replacing its CEO. The timing comes ahead of the announcement of U.S. phase 3 clinical trial results for the gene therapy for osteoarthritis, "TG-C." Observers say the personnel move prepares for future overseas expansion and technology transfer of the company's own pipeline.
Kolon Life Science on the 26th held its 26th annual general meeting of shareholders at Kolon One & Only Tower in Gangseo District, Seoul, and approved an agenda item to appoint Lee Hanguk, former CEO of Gunil Pharmaceutical, as an inside director. The company plans to appoint Lee as CEO following a board resolution in the afternoon. Incumbent CEO Kim Seonjin will remain as an adviser.
Lee, born in 1973, graduated from the Department of Chemistry at Yonsei University. At Daewoong Bio Co. and Daewoong Pharmaceutical, Lee handled active pharmaceutical ingredient synthesis and overseas regulatory affairs (RA) and business development (BD), working in synthetic research, formulation research, and the U.S. branch. Lee joined Gunil Pharmaceutical in 2018 and served as head of the medical division and head of research and development. Lee led European approval and overseas business development for Gunil Pharmaceutical's dyslipidemia treatment "Rosumega."
The personnel change comes about a year after Jeon Seungho joined Kolon TissueGene as CEO. The two worked together for about 15 years at Daewoong Pharmaceutical in the past, and the group is expected to strengthen collaboration in the bio business. Jeon, who took office in Mar. 2025, completed a one-year term, and a proposal to reappoint Jeon for a three-year term passed at the shareholders meeting held on the day.
Kolon Life Science is set to announce phase 3 results for TG-C this year. TG-C is a gene therapy for osteoarthritis developed by Kolon TissueGene. It was previously approved in Korea as "Invossa-K Inj.," but the approval was revoked in 2019 due to an ingredient mislabeling issue. After correcting the component information, the U.S. phase 3 resumed, and results are scheduled for sequential disclosure in July and Oct.
After TG-C commercialization, Kolon Life Science will handle technology transfer and distribution strategies focused on its licensed territories. The company holds TG-C rights in a total of 40 countries, including Rights Territory A, which comprises 15 countries such as Japan and India, and Rights Territory B, which comprises 25 countries such as Australia and the Middle East and Africa. If clinical results are secured, potential revenue generation through technology transfer contracts is being discussed.
A company official said, "We are currently working with regulators in China and Japan to prepare for entry into regional clinical trials."
At present, Kolon Life Science's sales structure is overwhelmingly weighted toward the chemicals business. As of the cumulative third quarter last year on a consolidation basis, more than 98% of 164.3 billion won in sales came from chemicals. Sales in the bio segment, centered on contract development and manufacturing (CDMO), remained around 2.9 billion won.
On an annual basis, last year's consolidated sales were 209 billion won, with operating profit of 17.6 billion won. Sales rose about 30% from a year earlier, and operating profit swung to a surplus. Net profit also improved from a 93.1 billion won loss the previous year to a 24.8 billion won surplus. Expanded supply of precision chemical products for electronic materials to affiliate Kolon Industries drove the earnings improvement.
To expand sales in the bio business, technology transfer results from its in-house pipeline are essential. Kolon Life Science is developing "KLS-2031," a treatment for lumbosacral radiculopathy, and "KLS-3021," a treatment for solid tumors. KLS-2031 has entered U.S. phase 1/2a, while KLS-3021 is in preclinical research.
Kolon Life Science also expects to grow bio sales through its CDMO subsidiary Kolon Biotech. Kolon TissueGene earlier said it would collaborate with Swiss company Lonza for initial TG-C production and then establish an in-house manufacturing system through Kolon Biotech.
A company official said, "Along with responding to TG-C production, we are also working to expand new CDMO orders," adding, "We plan to continue growing the chemicals business alongside the bio business based on our existing competitiveness."