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Biotech & Drug DiscoveryKOSDAQ 1854903 approvals8 trials

KOSDAQ-listed biotech venture developing mRNA vaccines, AAV gene therapies, and the EG-MCV4 meningococcal vaccine.

As of 2026-10-10, EyeGene,Inc has 3 Korean MFDS device approvals, 17 PubMed-indexed papers on record (counted by the MAA Company Index from its own matching of public databases).

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Business overview

Source: DART corporate disclosure

Founded in 2000 and listed on KOSDAQ in 2015, EyeGene is a biotech venture specializing in gene and cell therapies (GCT) and vaccines. Its pipeline includes an mRNA vaccine (Capless saRNA platform), AAV gene therapies targeting macular degeneration and diabetic retinopathy, the quadrivalent meningococcal conjugate vaccine EG-MCV4, and the recombinant botulinum toxin EG-rBTX100. Its mRNA vaccine, developed since 2020, has completed Phase 1/2a trials domestically and abroad with a co-development consortium of 5 partner companies; EG-MCV4 has completed domestic Phase 2 trials and is preparing for Phase 3, targeting domestic military procurement and entry into Latin America (PAHO) and Southeast Asia from 2028; and EG-rBTX100 is being developed with Korea BMI, with clinical trials planned from 2027.

Regulatory approvals

data.go.kr

3 Korean MFDS device approvals · 2023–2026

  • MFDSGraft/prosthesis, biomaterial2026-02-12
    Product approval · Class 4제허 26-142 호
  • MFDSGraft/prosthesis, biomaterial2025-01-21
    Product approval · Class 4제허 25-45 호
  • MFDSGeneral gene amplificator, nucleic acid, without fluorescence meter2023-11-27
    Product approval · Class 1체외 제신 23-1694 호

Clinical trials

data.go.kr

8 MFDS clinical trial authorisations · 2012–2025 (Phase 2 2 · Phase 1 2 · Phase 2/3 1 · Phase 1/2a 1 · Phase 2a 1)

  • Phase 2/3EG-MCV42025-06-30

    13 trial sites

  • Phase 1/2aEG-COVID2021-08-31

    2 trial sites

  • Phase 2EG-Mirotin2020-03-12

    1 trial site

  • Phase 2EG-Myocin2019-02-19

    9 trial sites

  • Phase 2aEG-Decorin 연고2018-10-30

    1 trial site

  • Phase 1EG-Myocin2017-11-28

    1 trial site

  • Phase 1/2EG-Decorin 연고2013-01-21

    10 trial sites

  • Phase 1EG-HPV2012-09-10

    1 trial site

Global clinical trials

ClinicalTrials.gov · sponsor-matched

R&D and key agreements

Source: DART corporate disclosure

mRNA 백신(Capless saRNA) · 코로나19 등 감염병 · 임상 1/2a상 완료(2020년부터 개발), 차세대 백신 개발중 · Consortium formed with 5 domestic and international partners; uses a new LNP delivery system

AAV 유전자치료제 · 황반변성, 당뇨망막증, 희귀 망막질환 · 연구개발중 · Aims for long-term efficacy from a single administration

EG-MCV4(4가 수막구균 접합백신) · 수막구균 감염 · 국내 임상 2상 완료, 3상 준비중 · Plans domestic military procurement and entry into Latin America (PAHO) and Southeast Asia from 2028; developed with Korea BMI

EG-rBTX100(유전자재조합 보툴리눔톡신) · 보툴리눔톡신 적응증 · 비임상 시험중, 2027년 임상 계획 · Developed with Korea BMI; pursuing licensing-out deals in parallel

Key disclosures

KRX KIND via OpenDART
Show 4 more events

Publications

PubMed · affiliation-matched
Show 7 more publications

Patents

KIPRIS · applicant-matched
Show 119 more patents

AI reads

MAA server logs · IP-verified
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Measured since Aug 27, 2026 · 5 AI engines · last read Oct 9, 2026

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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.

Hanmi Science Co.,Ltd1 shared

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

BioPlus Co., Ltd1 shared

Founded in 2003 and KOSDAQ-listed in 2021, BioPlus develops HA-based bio medical devices and biopharmaceuticals using its proprietary MDM Technology platform.

T&R Biofab Co., Ltd1 shared

Founded in 2013 and KOSDAQ-listed in 2018, T&R Biofab commercializes 3D bioprinting systems, bioinks, and biodegradable scaffolds.

DongBang Medical Co., Ltd.1 shared

KOSDAQ-listed medical device maker producing disposable acupuncture needles, cupping cups, and hyaluronic acid dermal fillers.

BIOBIJOU Co., Ltd.1 shared

KOSDAQ-listed aesthetics exporter behind HA skin booster CANDOLOV SERUM and filler brands COLENA and CANDORLOV.

BIONEERCORPORATION1 shared

Bioneer, founded in 1992 and KOSDAQ-listed in 2005, provides gene analysis equipment, molecular diagnostics, and RNAi drug development.

LabGenomics. Co., Ltd.1 shared

KOSDAQ-listed molecular genetic diagnostics company providing NGS-based non-invasive prenatal testing (NIPT) under the MomGuard brand.

HANDOK Inc.1 shared

KOSPI-listed comprehensive pharma company behind Amaryl diabetes drug and the USD 86.25M HL5101 anticancer out-license deal.

PharmaResearch Co., Ltd.1 shared

KOSDAQ-listed medical device company producing PDRN pharmaceuticals, HA fillers, and Rejuran-branded cosmetics.

SEEGENE, INC.1 shared

Founded in 2000 and KOSDAQ-listed in 2010, Seegene develops syndromic multiplex PCR molecular diagnostic reagents.

OSTEONIC Co., Ltd.1 shared

Established in 2012 and listed on KOSDAQ in 2018, Osteonic manufactures implants for the CMF, Trauma, Sports Medicine, and Spine categories.

CAREGEN CO.,LTD.1 shared

CAREGEN develops peptide-based cosmeceuticals sold in 130 countries and ophthalmic drug candidates CG-P5 and CG-T1.

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

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