[Edaily Reporter Shin Ha-yeon] On the 8th, Daol Investment & Securities assessed that Kolon TissueGene is on the verge of announcing the results of the U.S. Phase 3 clinical trial for its osteoarthritis treatment "TG-C," noting that depending on the results, the company has a chance to secure the status of the world's first disease-modifying osteoarthritis drug (DMOAD).

Lee Ji-soo, an analyst at Daol Investment & Securities, stated, “The top-line results of the U.S. Phase 3 clinical trial for TG-C (osteoarthritis) are scheduled to be announced in July.” She added, “Since improvements in pain and function have been consistently confirmed in both the U.S. Phase 2 and domestic Phase 3 trials, if structural improvements are also proven, the company could secure an exclusive market position as the world’s first DMOAD.”

TG-C is a cell- and gene-based therapy designed to restore the structure of cartilage itself with a single injection in patients with knee osteoarthritis. To date, no DMOAD has been approved by the U.S. Food and Drug Administration (FDA), and a key feature of this treatment is that it maintains long-term efficacy with a single administration without the need for surgery.

The analyst noted, “Superior improvements in pain and function compared to the control group were confirmed in the U.S. Phase 2 and Korean Phase 3 trials,” adding, “Given that the potential for structural improvement has also been observed, we believe the likelihood of success in the U.S. Phase 3 trial is high.”

Two U.S. Phase 3 trials (15302 and 12301) are currently underway, with topline results scheduled to be announced in July and October, respectively. The analyst explained, “If structural improvement is proven, the company can secure an exclusive market position as the world’s first DMOAD,” adding, “Even if the results are only partially successful, FDA approval is still expected, though positioning it as a DMOAD may be difficult.”

He further emphasized, “Collaboration with Lonza regarding the Biologics License Application (BLA) and CMC for early commercialization is currently underway, and manufacturing risks have been largely mitigated,” adding, “Following confirmation of clinical results, we aim to submit the FDA BLA in the first quarter of 2027 and commence commercial sales in 2028.”