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Biotech & Drug DiscoveryKOSDAQ 04853025 approvals4 trials

iNtRON Biotechnology, Inc.

Official website

Founded in 1999 and listed on KOSDAQ in 2011, iNtRON Biotechnology develops bacteriophage-based new drugs via its itLysin and IMPA platforms alongside a molecular diagnostics business.

As of 2026-10-10, iNtRON Biotechnology, Inc. has 25 Korean MFDS device approvals, 27 PubMed-indexed papers on record (counted by the MAA Company Index from its own matching of public databases).

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Market cap

Products & technology

  • COVID-19 molecular diagnostic kitCOVID-19 diagnosis
  • Rapid antigen diagnostic kitInfectious disease diagnosis
  • Pneumococcus diagnostic kitPneumococcal infection diagnosis
  • Animal antibiotic alternativeReplacement for veterinary antibiotics

Regulatory approvals

data.go.kr

25 Korean MFDS device approvals · 2013–2023

  • MFDSIVD reagents for extracting nucleic acids2023-09-05
    Product approval · Class 1체외 제신 23-1339 호
  • MFDSIVD reagents for extracting nucleic acids2023-08-30
    Product approval · Class 1체외 제신 23-1300 호
  • MFDSExtractor, nucleic acid2023-08-03
    Product approval · Class 1체외 제신 23-1197 호
  • MFDSIVD reagents for extracting nucleic acids2023-07-14
    Product approval · Class 1체외 제신 23-1098 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), immunological methodRevoked2022-11-17
    Product approval · Class 3체외 제허 22-771 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), immunological methodRevoked2022-02-08
    Product approval · Class 3체외 제허 22-80 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnosticsRevoked2021-12-10
    Product approval · Class 3체외 제허 21-998 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), immunological methodRevoked2021-04-05
    Product approval · Class 3체외 제허 21-252 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), immunological methodRevoked2020-07-03
    Product approval · Class 3체외 제허 20-538 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnosticsRevoked2020-04-28
    Product approval · Class 3체외 제허 20-327 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnosticsRevoked2020-04-06
    Product approval · Class 3체외 제허 20-256 호
  • MFDSIVD reagents for extracting nucleic acids2019-10-08
    Product approval · Class 1체외 제신 19-1315 호
Show 13 more
  • MFDSExtractor, nucleic acid2017-06-08
    Product approval · Class 1체외 제신 17-610 호
  • MFDSIVD reagents for extracting nucleic acids2017-02-20
    Product approval · Class 1체외 제신 17-169 호
  • MFDSOther reagents, classⅠ, for molecular diagnosticsRevoked2014-03-13
    Product approval · Class 1경인 체외 제신 14-211 호
  • MFDSOther reagents, classⅠ, for molecular diagnosticsRevoked2014-03-13
    Product approval · Class 1경인 체외 제신 14-212 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnosticsRevoked2014-02-12
    Product approval · Class 3체외 제허 14-395 호
  • MFDSOther reagents, classⅠ, for molecular diagnosticsRevoked2014-01-09
    Product approval · Class 1경인 체외 제신 14-33 호
  • MFDSOther reagents, classⅠ, for molecular diagnostics2014-01-09
    Product approval · Class 1경인 체외 제신 14-34 호
  • MFDSOther reagents, classⅠ, for molecular diagnostics2014-01-09
    Product approval · Class 1경인 체외 제신 14-35 호
  • MFDSOther reagents, classⅠ, for molecular diagnostics2014-01-09
    Product approval · Class 1경인 체외 제신 14-36 호
  • MFDSOther reagents, classⅠ, for molecular diagnostics2014-01-09
    Product approval · Class 1경인 체외 제신 14-37 호
  • MFDSOther reagents, classⅠ, for molecular diagnostics2014-01-09
    Product approval · Class 1경인 체외 제신 14-38 호
  • MFDSIVD reagents for extracting nucleic acids2013-08-12
    Product approval · Class 1경인 체외 제신 13-344 호
  • MFDSIVD reagents for Infectious disease marker(Drug resistant microorganism)Revoked2013-04-18
    Product approval · Class 3체외 제허 13-721 호

Clinical trials

data.go.kr

4 MFDS clinical trial authorisations · 2013–2026 (Phase 1 2 · Phase 1/2a 1 · Phase 2 1)

  • Phase 1/2aN-Rephasin® SAL2002026-06-08

    2 trial sites

  • Phase 1N-Rephasin® SAL2002017-08-16

    1 trial site

  • Phase 2N-Rephasin® SAL2002016-01-06

    2 trial sites

  • Phase 1N-Rephasin® SAL2002013-01-24

    1 trial site

Global clinical trials

ClinicalTrials.gov · sponsor-matched

R&D and key agreements

Source: DART corporate disclosure

MRSA 대응 API 기반 심내막염 치료제 · 심내막염(Endocarditis) · itLysin platform-based, using MRSA-targeting active pharmaceutical ingredient

황색포도알균 탈집락 제제 · 병원내 감염(황색포도알균) · itLysin platform-based decolonization agent

장내 CRE 탈집락 제제 · 그람음성균 감염(CRE) · itLysin platform-based, using gram-negative-targeting active pharmaceutical ingredient

장내 C. difficile 탈집락 제제 · Clostridioides difficile 감염 · itLysin platform-based decolonization agent

재발성 CDI 치료제 · 재발성 C. difficile 감염(Recurrent CDI) · itLysin platform-based treatment for recurrent CDI

TgC-PhageE · 대장암 면역치료 · First IMPA™ platform candidate, designed via AI analysis to target both pks+ E.coli and its toxin colibactin

비만 치료제 · 비만 · Under development on the IMPA™ platform

퇴행성 뇌질환 치료제 · 퇴행성 뇌질환 · Under development on the IMPA™ platform

Key disclosures

KRX KIND via OpenDART

Publications

PubMed · affiliation-matched
Show 17 more publications

Patents

KIPRIS · applicant-matched
Show 286 more patents

AI reads

MAA server logs · IP-verified
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Times AI engines pulled iNtRON Biotechnology, Inc.'s records

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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.

Boditech Med Inc.5 shared

KOSDAQ-listed point-of-care immunodiagnostics company supplying diagnostic cartridges and the ichroma/AFIAS instrument series.

HLB PANAGENE Co., LTD.5 shared

Founded in 1976 and KOSDAQ-listed in 2000, HLB PANAGENE develops PNA-based molecular diagnostic and diagnostic automation products.

OSANG HEALTHCARE CO.,LTD.4 shared

Founded 1996, listed on KOSDAQ in 2024, OSANG HEALTHCARE develops and sells biochemistry, immunodiagnostic, and molecular IVD products.

RollingStone Co., Ltd.4 shared

KOSDAQ-listed in-vitro diagnostics company developing the LabChip-based VERI-Q molecular diagnostic device series.

BIONEERCORPORATION4 shared

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

Access Bio, Inc.4 shared

Founded in 2002 and KOSDAQ-listed in 2013, Access Bio develops rapid diagnostic tests for malaria, COVID-19, and other infectious diseases.

SEEGENE, INC.4 shared

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

CALTH. Inc4 shared

Holds manufacturing approvals for 42 point-of-care diagnostic reagents and devices in the IVD market.

SD BIOSENSOR INC.4 shared

KOSPI-listed in-vitro diagnostics company known for the STANDARD Q antigen/antibody test kits.

NanoenTek,Inc.3 shared

Founded in 1987 and listed on KOSDAQ in 2000, NanoenTek develops Lab-On-a-Chip in-vitro diagnostic devices and life science instruments.

Gencurix Inc.3 shared

Founded 2011, KOSDAQ-listed 2020, Gencurix develops liquid-biopsy diagnostics: breast cancer prognosis and lung/colorectal companion tests.

GC Medical Science Corporation3 shared

GC Medical Science Corporation, KOSDAQ-listed since 2014, operates diagnostic reagent, blood glucose, and hemodialysis solution businesses.

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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