ISU Abxis Co., Ltd.
KOSDAQ-listed pharma company selling Abcertin, Fabagal, and Clotinab antibody/enzyme therapies while co-developing a hemophilia drug with Catalyst Biosciences.
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Business overview
Source: DART corporate disclosureFounded 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.kr5 Korean MFDS drug approvals · 2006–2015
- MFDS drugPheburane Granule2015-08-21Drug · Prescription · Approval201505868
- MFDS drugAbcertin Injection 400IU2015-05-08Drug · Prescription · Approval201502789
- MFDS drugFabagal Injection2014-01-07Drug · Prescription · Approval201400051
- MFDS drugAbcertin Injection 200IU2012-10-09Drug · Prescription · Approval201207109
- MFDS drugClotinab Injection2006-12-28Drug · Prescription · Approval200611394
Clinical trials
data.go.kr9 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
R&D and key agreements
Source: DART corporate disclosure혈우병 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)
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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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