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Pharma & CDMOKOSDAQ 950160

Kolon TissueGene, Inc.

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Founded in 1999 and listed on KOSDAQ in 2017, Kolon TissueGene is developing the osteoarthritis cell and gene therapy TG-C, now in US Phase 3 trials.

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Market cap

Products & technology

  • TG-CCell and gene therapy for osteoarthritis

R&D and key agreements

Source: DART corporate disclosure

TG-C 무릎골관절염(Knee OA) · 무릎골관절염 · 미국 FDA 임상3상(2개 Pivotal study, 2024년 7월 1,066명 환자등록 완료, 추적관찰중) · Dosing began in 2018 but was voluntarily paused in 2019 over a possible cell-origin error, leading to an FDA Clinical Hold; the company received a Remove Clinical Hold Letter in 2020 and resumed dosing in December 2021. It plans to file for FDA approval (BLA) after the follow-up period ends.

TG-C 고관절골관절염(Hip OA) · 고관절골관절염 · FDA 임상2상 승인 · Received FDA approval for a Phase 2 trial, though the company plans to prioritize the more advanced knee osteoarthritis program.

TG-C 퇴행성척추디스크질환(DDD) · 퇴행성 척추 디스크질환 · 전임상 완료, FDA IND 승인(2023년 12월) · Preclinical animal studies showed a significant reduction in pain from damaged discs after TG-C injection; based on this data, the company submitted an IND to the FDA and received approval in December 2023.

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Sources and updates

Company basics
Korea Exchange · DART
Business content
Compiled from disclosure filings
AI visibility
Measured 2026-08-13

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