Kolon Life Science said it has decided to appeal to the Supreme Court against the revocation of the manufacturing and sales license for its knee osteoarthritis cell and gene therapy, Invossa-K Inj.
This move comes after the company faced defeats in both the district and appellate courts.
Most recently, the Seoul High Court upheld the lower court's decision rejecting Kolon Life Science's appeal to suspend the Ministry of Food and Drug Safety's order canceling the approval for Invossa-K, a gene therapy for osteoarthritis, on Feb. 7.
In a statement released upon filing the appeal, Kolon Life Science expressed respect for the judiciary's decision but voiced concerns over what it perceives as misunderstandings of legal principles and misjudgments regarding the safety of Invossa by the appellate court.
The company stressed it aims to rectify these issues, striving to restore the scientific achievements and value of Invossa.
The legal battle stemmed from the Ministry of Food and Drug Safety's revoking Invossa's license in 2019.
The revocation was based on discrepancies regarding the origins of the product's key ingredients.
Invossa comprises 75 percent of human chondrocytes (HC) and 25 percent of transformed cells (TC). In 2004, the company thought TCs were derived from cartilage. However, it was later found that TCs were HEK 293 cells derived from the kidneys.
Despite the origin issues, the company stressed that all pre-approval non-clinical and clinical trials were conducted with consistency, and Invossa had been validated for safety and efficacy by the MFDS.
Kolon Life Science also emphasized that the ongoing litigation is independent of its subsidiary Kolon TissueGene's Phase 3 clinical trial in the U.S. for TG-C, formerly known as Invossa. The trial is proceeding smoothly, with patient enrollment nearing completion for a study involving 1,020 participants.
TG-C is not only being tested for knee osteoarthritis but has also entered phase 2 trials for hip osteoarthritis. In December 2023, the U.S. FDA approved the expansion of TG-C's indications to include degenerative disc disease.