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Biotech & Drug DiscoveryKOSDAQ 0868205 approvals5 trials

Bio Solution Co.,Ltd.

Official website

KOSDAQ-listed biotech developing cell therapies including Keraheal for burns and CartiLife for cartilage defects, plus human tissue models.

As of 2026-10-10, Bio Solution Co.,Ltd. has 2 Korean MFDS device approvals, 3 Korean MFDS drug approvals, 8 PubMed-indexed papers on record (counted by the MAA Company Index from its own matching of public databases).

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Market cap

Business overview

Source: DART corporate disclosure

Founded 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.kr

3 Korean MFDS drug approvals · 2021 / 2 Korean MFDS device approvals · 2018–2021

  • MFDS drugKeraheal-Allo2021-08-25
    Drug · Prescription · Approval202106170
  • MFDS drugKeraheal2021-08-25
    Drug · Prescription · Approval202106171
  • MFDS drugCartiLife2021-07-22
    Drug · Prescription · Approval202105509
  • MFDSDressing, occlusive, hydrogel2021-02-17
    Product approval · Class 2제인 21-4132 호
  • MFDSNasal splint, externalRevoked2018-03-21
    Product approval · Class 1제신 18-341 호

Clinical trials

data.go.kr

5 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 disclosure

항암면역세포치료제(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

Key disclosures

KRX KIND via OpenDART
Show 2 more events

Publications

PubMed · affiliation-matched

Patents

KIPRIS · applicant-matched
Show 72 more patents

AI reads

MAA server logs · IP-verified
86
Times AI engines pulled Bio Solution Co.,Ltd.'s records

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9
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Times an AI needed something not yet in its index and fetched this page fresh while answering. Citations served from the index leave no trace here.

77
Index crawls

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0
Direct AI-tool queries (MCP)

Queries from users who connected this index to their own AI.

16
live 4
Last 7 days
64
live 5
Last 30 days
86
live 9
All time
  • OpenAIChatGPT-Userlive9
  • OpenAIOAI-SearchBot69
  • PerplexityPerplexityBot3
  • GoogleGoogleOther3
  • AnthropicClaudeBot2

Measured since Aug 27, 2026 · 4 AI engines · last read Oct 8, 2026

User-agent strings can be forged, so we do not count them at face value. We count only requests matched against vendor-published IP ranges, or confirmed by forward-verified reverse DNS. MCP queries are actual calls to this index's tool endpoint.

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Companies approved for the same productsBiotech & Drug Discovery

Ranked by how many MFDS product categories overlap. Not a ranking — a pointer to where to look.

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CAREGEN CO.,LTD.1 shared

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Hanmi Science Co.,Ltd1 shared

KOSPI-listed operating holding company of the Hanmi Pharm group, also running healthcare and pharmaceutical wholesale businesses.

HANS BIOMED CORPORATION1 shared

KOSDAQ-listed medical device company producing human tissue implants Bella Cell HD and SureFuse.

Humedix Co., Ltd.1 shared

KOSDAQ-listed aesthetics and CMO company behind the Elravie/Revolax hyaluronic-acid fillers and Leedstox botulinum toxin.

HUONS CO., LTD.1 shared

KOSDAQ-listed pharmaceutical and healthcare company producing lidocaine anesthetics and the Kynix hyaluronic-acid eye-drop line.

JW PHARMACEUTICAL1 shared

Founded in 1945, JW Pharmaceutical holds an original drug pipeline including Rivalo and Hemlibra, plus the IV nutrition product Winuf and OTC brand Hwakol.

SEWOONMEDICAL CO,. LTD.1 shared

Founded in 1982 and KOSDAQ-listed in 2008, Sewoon Medical manufactures medical aspirators and catheters/tubes.

Wonbiogen Co.,Ltd.1 shared

Wonbiogen Co.,Ltd., established September 2018, listed on KOSDAQ in December 2018, manufactures wound dressings and moist wound dressings.

AHNLAB,INC.100

KOSDAQ-listed integrated security company behind the V3 antivirus and AhnLab TrusGuard and XDR solutions.

Inventage Lab Inc.100

Drug delivery system company behind the long-acting injectable platform IVL-DrugFluidic and the LNP delivery platform IVL-GeneFluidic.

ORGANOIDSCIENCES LTD.100

Organoid-based biotech founded 2018, KOSDAQ-listed 2025, developing the ATORM-C regenerative therapeutic and ODISEI evaluation solution.

Sources and updates

Counts on this page are not company-reported figures. MAA matched records from DART, the Korean MFDS, the US FDA, ClinicalTrials.gov, PubMed and KIPRIS to this company itself, by business registration number or registered name, never by name similarity. They may differ from figures the company publishes.

Company basics
Korea Exchange · DART
Business content
Compiled from disclosure filings
Approvals & clinical trials
Korean MFDS (data.go.kr) · US FDA openFDA — updated weekly
Key disclosures
KRX KIND via OpenDART exchange filings — updated daily
Global clinical trials
ClinicalTrials.gov (US NIH) — sponsor-matched, updated weekly
Financials
DART corporate disclosure filings — annual
Publications
PubMed (US National Library of Medicine) — affiliation-matched, updated daily
Patents
KIPRIS (Korea Institute of Patent Information) — applicant-matched, updated monthly
AI reads
Our server logs, IP-verified every 6 hours
AI visibility
Measured 2026-10-01

This page is compiled from public sources without the company's involvement. If anything is inaccurate or incomplete, please let us know. Materials provided by the company are labelled as such.

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