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Biotech & Drug DiscoveryKOSDAQ 0868905 approvals9 trials

ISU Abxis Co., Ltd.

Official website

KOSDAQ-listed pharma company selling Abcertin, Fabagal, and Clotinab antibody/enzyme therapies while co-developing a hemophilia drug with Catalyst Biosciences.

As of 2026-10-10, ISU Abxis Co., Ltd. has 5 Korean MFDS drug approvals, 10 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 2001 and listed on KOSDAQ in 2009, ISU Abxis is a pharmaceutical company specializing in antibody and enzyme replacement therapies. It sells Abcertin, Fabagal, and Clotinab as its main products, and its 2025 revenue was KRW 56.7 billion, down about 6% year-on-year, comprising KRW 53.3 billion in product sales (94.0%), KRW 2.4 billion in merchandise sales (4.3%), and KRW 1.0 billion in other sales (1.7%). In September 2013 it signed an agreement with Catalyst Biosciences of the US, worth USD 1.75 million, to co-develop a subcutaneous hemophilia drug (through 2035, with worldwide rights excluding Korea), and since July 2019 it has been co-researching the Alzheimer's candidate ISU203 with Kyungpook National University.

Products & technology

  • AbcertinEnzyme replacement therapy
  • FabagalEnzyme replacement therapy
  • ClotinabAntibody therapy

Regulatory approvals

data.go.kr

5 Korean MFDS drug approvals · 2006–2015

  • MFDS drugPheburane Granule2015-08-21
    Drug · Prescription · Approval201505868
  • MFDS drugAbcertin Injection 400IU2015-05-08
    Drug · Prescription · Approval201502789
  • MFDS drugFabagal Injection2014-01-07
    Drug · Prescription · Approval201400051
  • MFDS drugAbcertin Injection 200IU2012-10-09
    Drug · Prescription · Approval201207109
  • MFDS drugClotinab Injection2006-12-28
    Drug · Prescription · Approval200611394

Clinical trials

data.go.kr

9 MFDS clinical trial authorisations · 2012–2025 (Phase 3 4 · Phase 2 3 · Phase 1 2)

  • Phase 3애브서틴주(이미글루세라제)2025-04-17
  • Phase 3클로티냅주(압식시맙)2019-07-18

    10 trial sites

  • Phase 1ISU1042017-08-17

    5 trial sites

  • Phase 1ISU3042017-03-27

    3 trial sites

  • Phase 3파바갈주(ISU303)2016-12-26

    9 trial sites

  • Phase 2클로티냅주(압식시맙)2013-03-29

    8 trial sites

  • Phase 2파바갈주(ISU303)2012-09-21

    4 trial sites

  • Phase 3애브서틴주(이미글루세라제)2012-05-23
  • Phase 2파바갈주(ISU303)2012-02-10

    5 trial sites

Global clinical trials

ClinicalTrials.gov · sponsor-matched

R&D and key agreements

Source: DART corporate disclosure

혈우병 신약(피하주사) · 혈우병(B형) · 임상2상 완료(남아프리카공화국), 한국 임상1상 완료(2013~2018) · Only subcutaneous hemophilia therapy in development, unlike existing IV treatments

ISU203 · 알츠하이머 · in vivo 효능검증 예비시험 공동연구중 · ASM inhibitor mechanism targeting amyloid-beta accumulation

ISU104 · 재발성/전이성 두경부암(대장암·유방암 적응증 확장 예정)

Key disclosures

KRX KIND via OpenDART

Publications

PubMed · affiliation-matched

Patents

KIPRIS · applicant-matched
Show 34 more patents

AI reads

MAA server logs · IP-verified
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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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