[Bio USA] Kolon Life Science to Focus on 'TG-C' Rather Than Aggressive CDMO Expansion

"It Takes Time in the Early Stages of the CDMO Business"

Kolon Life Science has announced its intention to focus on the success of its knee osteoarthritis treatment, TG-C, rather than aggressively expanding its CDMO (Contract Development and Manufacturing Organization) business.

Seonjin Kim, CEO of Kolon Life Science, held a meeting on the 18th (local time) at the 2025 BIO International Convention (BIO USA) held in Boston, USA, to announce future plans. Photo by BIO USA Joint Press Team

Seonjin Kim, CEO of Kolon Life Science, held a meeting on the 18th (local time) at the 2025 BIO International Convention (BIO USA) in Boston, USA, where he stated, "We are currently manufacturing products such as stem cells and exosomes as part of our CDMO business," but emphasized, "Our top priority and the area receiving the largest investment is the production of TG-C, so we will focus on that."

However, he made it clear that the company is not abandoning the CDMO business. He added, "We plan to steadily expand our contract manufacturing business by increasing our production lines," and explained, "Since a track record is the most important factor in the CDMO business, it may take some time in the early stages."

TG-C is currently undergoing Phase 3 clinical trials in the United States, conducted by its subsidiary Kolon TissueGene. The company plans to submit a Biologics License Application (BLA) to the FDA as soon as follow-up monitoring of U.S. Phase 3 clinical trial patients is completed in the second half of next year.

The pipeline the company is most looking forward to after the success of TG-C is a gastrointestinal metabolic anticancer drug. Kim stated, "Although I cannot disclose specific details, we have begun work on a gastrointestinal metabolic anticancer drug through industry-academia collaboration."

He further explained, "There is a tendency to think that products will fall behind unless they utilize innovative technologies such as artificial intelligence (AI), but what truly matters are the indications and methods of administration," adding, "In this respect, we expect metabolic anticancer drugs to play a significant role in the next-generation cancer treatment market."

Previously, in 2000, Kolon Life Science secured the Asian rights to TG-C, the world's first cell and gene therapy for knee osteoarthritis, from its subsidiary Kolon TissueGene. TG-C was later approved in Korea in 2017 under the name Invossa, but in 2019, the approval was revoked after it was discovered that the clinical product contained cells with carcinogenic potential that differed from the approved specifications. However, after about a year of investigation, the FDA allowed the resumption of U.S. Phase 3 clinical trials for TG-C in 2020, accepting Kolon TissueGene's claim that the manufacturing process, including radiation treatment, eliminates carcinogenic risks.