Kolon Life Science Secures Singapore Patent for TG-C Therapeutic Composition

▶ Additional patent secured for composition and manufacturing method, including technology for obtaining cells of uniform size

▶ Expanding patent portfolio across major Asian markets… Accelerating commercialization and production readiness

 Kolon Life Science (CEO Han-gook Lee) announced on the 17th that a patent for a "pharmaceutical composition for preventing or treating osteoarthritis" related to TG-C, an osteoarthritis cell and gene therapy being developed by its affiliate Kolon TissueGene, has been approved for registration in Singapore.

With this patent approval, Kolon Life Science has strengthened its quality control foundation by stably securing cells of a specific size required for the manufacturing of TG-C. This patent has previously been registered in the United States, South Korea, Japan, and Australia, and is currently pending in other countries, including China and Canada.

TG-C is an osteoarthritis cell and gene therapy administered via injection into the intra-articular space of the knee. It is administered by mixing Part 1, consisting of allogeneic cartilage-derived chondrocytes, and Part 2, consisting of irradiated transformed cells transduced with the TGF-β1 gene, at a 3:1 ratio.

The patent relates to a composition and a manufacturing method for preventing or treating osteoarthritis, which includes cells of a specific size as an active ingredient. It encompasses technology to stably secure cells of a uniform size using a cell filtration mesh with a specific pore size during the process of removing aggregates formed during cell culture or isolating cells into a single-cell state.

Through this patent, Kolon Life Science has acquired the rights within Singapore for the composition and manufacturing method that secures the two types of cells used in TG-C within a specific size range and utilizes them as an intra-articular injection. This strengthens the foundation for maintaining consistent cell size during the manufacturing process and ensuring stable product quality.

Kolon Life Science expects that this Singapore patent registration will serve as a core foundation supporting its future overseas business expansion. As Singapore is one of the major hubs for the bio and healthcare industry in Asia, securing these rights is anticipated to have a positive impact on the global commercialization of TG-C.

Kolon Life Science, which is in charge of the development and commercialization of TG-C in the Asian region, has been expanding its patent rights related to TG-C in major Asian countries recently. Based on these achievements, the company plans to further accelerate its preparations for commercialization.

In addition, the company is speeding up the establishment of a mass-production infrastructure in preparation for the commercialization of TG-C. Through its subsidiary, Kolon Biotech, the company is building advanced processing facilities that meet cGMP standards, while continuously upgrading automated processes to secure stable mass-production capabilities for cell and gene therapies.

Han-gook Lee, CEO of Kolon Life Science, stated, "This patent registration demonstrates that our core technological competitiveness in stably securing cells within a specific size range during the TG-C manufacturing process and maintaining product uniformity continues to be recognized internationally. We will remain committed to driving the global commercialization of TG-C and strengthening our technological competitiveness."

Meanwhile, Kolon TissueGene, the original developer of TG-C, is scheduled to announce the topline results of the U.S. Phase 3 clinical trials for TG-C this coming July. Following the announcement, the company plans to officially commence preparations for the Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA), aiming to submit the application in the first quarter of next year.