Bio Solution Co.,Ltd.
KOSDAQ-listed biotech developing cell therapies including Keraheal for burns and CartiLife for cartilage defects, plus human tissue models.
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Business overview
Source: DART corporate disclosureFounded in 2000 and listed on KOSDAQ in 2018, Bio Solution is a cell therapy and human tissue model company. Its pipeline includes the burn treatments Keraheal and Keraheal-Allo, the cartilage defect treatments CartiLife and Cartiroid, and the osteoarthritis candidate SpheroCure, alongside cornea, skin, oral mucosa, and bronchial mucosa human tissue models and bioconvergence materials such as exosomes, PDRN, and collagen. CartiLife received conditional advanced biopharmaceutical approval in 2019, obtained a variation approval removing that condition in July 2021, and completed a Phase 2 trial in the US, while the company signed a domestic exclusive sales agreement with Mundipharma Korea (2020-2022) and a joint patent application agreement with the Korea Institute of Radiological & Medical Sciences (2005-2026, 70:30 equity split), and holds 40 registered and 20 pending patents.
Products & technology
- KerahealBurn treatment (autologous cell therapy)
- Keraheal-AlloBurn treatment (allogeneic cell therapy)
- CartiLifeCartilage defect (osteoarthritis, trauma) treatment
- CartiroidCartilage defect treatment (allogeneic)
- SpheroCureOsteoarthritis (DMOAD) drug candidate
- Human tissue models (cornea, skin, oral mucosa, bronchial mucosa)Tissue models for alternative testing and toxicity evaluation
- Bioconvergence materials (exosome, PDRN, collagen)Cosmetic and functional ingredient materials
Regulatory approvals
data.go.kr3 Korean MFDS drug approvals · 2021 / 2 Korean MFDS device approvals · 2018–2021
- MFDS drugKeraheal-Allo2021-08-25Drug · Prescription · Approval202106170
- MFDS drugKeraheal2021-08-25Drug · Prescription · Approval202106171
- MFDS drugCartiLife2021-07-22Drug · Prescription · Approval202105509
- MFDSDressing, occlusive, hydrogel2021-02-17Product approval · Class 2제인 21-4132 호
- MFDSNasal splint, externalRevoked2018-03-21Product approval · Class 1제신 18-341 호
Clinical trials
data.go.kr5 MFDS clinical trial authorisations · 2012–2026 (Phase 3 2 · Phase 1/2a 1 · Phase 2 1 · Phase 1 1)
- Phase 1/2a스페로큐어2026-07-13
- Phase 3카티라이프(바솔자가연골유래연골세포)2019-09-24
18 trial sites
- Phase 2카티라이프(바솔자가연골유래연골세포)2013-09-09
5 trial sites
- Phase 3케라힐-알로(Keraheal-Allo)2013-04-04
2 trial sites
- Phase 1카티라이프(바솔자가연골유래연골세포)2012-07-13
2 trial sites
R&D and key agreements
Source: DART corporate disclosure항암면역세포치료제(NK, NKT, γδT, 4세대 CAR) · 고형암 · 후보물질 발굴 · Research started in 2019
스페로큐어 · 골관절염(DMOAD) · 임상 1/2a상 준비 · Research started in 2022, Korea
카티로이드 · 연골결손(골관절염, 외상) · 호주 임상 1/2상 · Research started in 2017; IND approved by Australian HREC in Jan 2026
카티라이프 · 연골결손(골관절염, 외상) · 국내 품목허가, 미국 임상 2상 완료 · Research started in 2005; conditional approval Apr 2019; condition removed via variation approval Jul 2021
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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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