l Kolon TissueGene’s CEO presented the TG-C program during the Company Presentation session at BIO 2025, highlighting the unique competitive advantages of TG-C.
l Exploring a Range of Strategic Options, Including Licensing-Out, to Maximize the Value of TG-C
Kolon TissueGene, Inc. (KTG), a clinical-stage biopharmaceutical company developing advanced allogeneic cell and gene therapies for degenerative joint diseases, announced the successful conclusion of its business development activities at BIO 2025, the world’s largest biotechnology convention, held in Boston, USA starting June 16.
BIO 2025 (BIO International Convention) attracted over 20,000 leaders from the biotech and pharmaceutical industries across more than 30 countries. Kolon TissueGene drew intensified global interest for TG-C, reinforcing its position as a key innovator in the osteoarthritis treatment landscape.
As an invited speaker at the Company Presentation session, KTG’s CEO highlighted the significant progress of TG-C, the company’s first-in-class disease-modifying osteoarthritis drug (DMOAD), which is a novel therapeutic candidate designed to modulate immune responses and deliver long-lasting anti-inflammatory and regenerative effects. In a U.S.-based Phase 2 clinical trial, TG-C demonstrated statistically significant improvements in pain and joint function. Additionally, MRI imaging suggested a trend toward structural improvement in cartilage. A 55% reduction in total knee arthroplasty (TKA) incidence compared to historical controls was also observed in long-term follow-up data presented at the 2025 OARSI World Congress on Osteoarthritis.
Beyond the presentation, Kolon TissueGene also held partnering meetings with more than 30 pharma companies attending BIO 2025 to discuss commercialization opportunities. Dr. Jeon noted, “There is a high possibility that we will form strategic partnerships with companies we met at BIO. Although we received meeting requests from over many different companies, we carefully selected 35 companies that are serious potential partners and focused our efforts on engaging with them.”
As TG-C approaches commercialization, Kolon TissueGene is actively exploring a range of strategic options to maximize market value post-launch, including marketing alliances, licensing deals, and distribution partnerships. Key potential partners fall into three categories: global pharmaceutical giants (Big Pharma), specialty pharma companies with expertise in specific therapeutic areas, and marketing-focused firms. Dr. Jeon explained, “We are considering out-licensing with Big Pharma, co-promotion with specialty pharma, and even in-house commercialization as viable options.”
He added, “We are on the verge of completing our pivotal Phase 3 studies by 2026, with a Biologics License Application (BLA) submission expected in 2027. Despite facing unprecedented regulatory and development challenges as the world’s first-in-class innovative cell and gene therapy for osteoarthritis, we have persevered with unwavering determination. Through relentless effort, we’ve successfully advanced TG-C through each stage of development and clinical trials to date. Given the program’s promising outlook, we plan to minimize the time between trial completion and market entry. Once we submit the Biologics License Application (BLA), we will begin preparations to target orthopedic and pain clinics as our primary market. Simultaneously, we will respond proactively to the growing interest from global pharmaceutical companies by advancing collaboration discussions.”
TG-C is a first-in-class cell and gene therapy developed by Kolon TissueGene for the treatment of knee osteoarthritis. The product has completed dosing in its U.S. Phase 3 clinical trial and is currently in the patient follow-up stage. Kolon TissueGene estimates the size of the osteoarthritis market across the top 7 countries (U.S., France, Germany, Italy, Spain, U.K., and Japan) to be approximately KRW 3.8 trillion (USD 2.8 billion) as of 2024.
About Kolon TissueGene, Inc.
Kolon TissueGene is a U.S.-headquartered biopharmaceutical company based in Rockville, Maryland, focused on the development and commercialization of first-in-class allogeneic cell and gene therapies for musculoskeletal disorders. Its lead asset, TG-C, is in advanced clinical development for knee osteoarthritis and has demonstrated strong potential as a disease-modifying therapy in both clinical and imaging outcomes.
About Kolon Group
Kolon TissueGene is a subsidiary of Kolon Group, a leading South Korean industrial conglomerate with a proud legacy of innovation spanning over six decades. Established in 1954 as Korea’s first nylon manufacturer, Kolon played a pivotal role in the country’s early industrialization. Today, the Group operates across a wide range of sectors, including advanced materials, chemicals, construction, fashion, mobility, healthcare, and high-tech industries. Comprising over 40 affiliated companies, Kolon Group continues to drive innovation with a strong focus on biopharmaceuticals, digital transformation, and high-performance composite solutions for mobility, energy, aerospace, and defense applications.