Kolon Life Science Secures Canadian Patent for TG-C ‘Cell Therapy Efficacy Evaluation Method’

▷ Patent for TG-C efficacy evaluation method - securing objective criteria for cell therapy treatment effects 

▷ Registered in 7 countries including Canada - expected to strengthen competitiveness and achieve successful international market entry 

Kolon Life Science (CEO Kim Sun-jin) announced on the 11th that a patent for 'Cell Therapy Efficacy Evaluation Method’ for TG-C (formerly Inbosa)—an osteoarthritis cell and gene therapy being developed by affiliate Kolon TissueGene—had been granted in Canada. 

The Canadian patent, jointly filed by Kolon Life Science and Kolon TissueGene, follows registrations in the US, Japan, China, Australia, Hong Kong, and Singapore. This further strengthens the technological credibility and market exclusivity foundation necessary for TG-C's global commercialization. 

TG-C is a cell and gene therapy product composed of two components: Solution 1, which contains allogeneic cartilage-derived chondrocytes, and Solution 2, which contains genetically modified cells expressing radiation-irradiated ‘TGF-β1’ (a gene that suppresses inflammation and promotes the production of cartilage components). It is administered by injecting a mixture of Solution 1 and Solution 2 in a 3:1 ratio into the knee joint cavity. This helps alleviate pain by suppressing joint inflammation and improves joint function and structure. 

The core of the patent lies in establishing criteria for quantitatively evaluating the efficacy and quality of TG-C. The expression levels of TGF-β1 secreted by the transformed cells in Solution 2 and ‘TSP-1’ produced by the chondrocytes in Solution 1 were adopted as key efficacy evaluation indicators. TSP-1 is a multifunctional protein involved in maintaining immune homeostasis. When these components are expressed above a certain threshold, it can be confirmed that the therapeutic effect of the produced treatment remains uniformly consistent. 

This technological foundation is expected to serve as a key driver in TG-C's future global expansion. Cell therapies are living cell-based medicines that react sensitively to even minute changes in raw materials, culture environments, and process conditions. Ensuring consistent quality is a core challenge throughout the entire process, from development to commercialization. Consequently, regulatory authorities and partner companies place significant importance on establishing clear evaluation criteria that can demonstrate the scientific efficacy and quality reproducibility of the therapeutic. 

This patent also holds significant regional importance. Canada is recognized as one of the technologically advanced nations with stringent regulatory standards, alongside major markets such as the United States and Europe. It is particularly regarded as a high-growth emerging market in the cell therapy sector. According to global market research firm Spherical Insights, the Canadian cell therapy market is projected to grow at a CAGR of 24.29% from 2023 to 2033, reaching approximately USD 1.0605 billion by 2033.

Kim Sun-jin, CEO of Kolon Life Science, stated, “The Canadian patent registration further strengthens the foundation for objectively evaluating TG-C's efficacy in treating osteoarthritis,” adding, “This is a significant achievement in enhancing scientific credibility for global market entry.”