HANALL BIOPHARMA CO.,LTD
KOSPI-listed pharma/biotech company co-developing the autoimmune biologics batoclimab and imeropruvate with partner Immunovant.
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Change
Market cap
Business overview
Source: DART corporate disclosureFounded in 1973 and listed on the KOSPI in 1989, HanAll Biopharma is a pharmaceutical company focused on synthetic and biologic drug R&D. It sells the probiotic drug Biotop, the prostate cancer/central precocious puberty treatment Eligard, the non-absorbable antibiotic Normix, and the hair-loss treatment Hairgro, while co-developing the autoimmune-disease biologics batoclimab (HL161BKN) and imeropruvate (HL161ANS) globally with partner Immunovant. It posted 2025 consolidated revenue of KRW 155.2bn (up 12% year-on-year, including KRW 23.5bn from Biotop) but an operating loss of KRW 0.9bn and net loss of KRW 5.6bn; batoclimab demonstrated superior efficacy in a Phase 3 myasthenia gravis trial in March 2025, while imeropruvate obtained a US composition-of-matter patent in March 2024 and IND approvals across six indications.
Products & technology
- BiotopProbiotic drug
- EligardProstate cancer and central precocious puberty treatment
- NormixNon-absorbable antibiotic
- HairgroHair-loss treatment (finasteride 1mg generic)
Regulatory approvals
data.go.kr195 Korean MFDS drug approvals · 1979–2026 / 7 Korean MFDS device approvals · 1999–2006
- MFDS drugRomibe ODT 10/20mg2026-06-30Drug · Prescription · Approval202601879
- MFDS drugRomibe ODT 10/10mg2026-06-30Drug · Prescription · Approval202601880
- MFDS drugRomibe ODT 10/5mg2026-06-30Drug · Prescription · Approval202601881
- MFDS drugBiotop-D Forte Tab.2026-04-23Drug · OTC · Notification202601188
- MFDS drugPrenone ODT 150mg2026-02-24Drug · Prescription · Approval202600530
- MFDS drugPrenone ODT 75mg2026-02-24Drug · Prescription · Approval202600531
- MFDS drugPrenone ODT 50mg2026-02-24Drug · Prescription · Approval202600532
- MFDS drugBiotop I Forte Powder2026-02-24Drug · OTC · Notification202600551
- MFDS drugALFABONE D tab. 1mcg(Alfacalcidol)2026-01-26Drug · OTC · Notification202600218
- MFDS drugNovabutin 150mg Tab2026-01-22Drug · OTC · Notification202600200
- MFDS drugENZALUTA Soft Capsule 40mg(Enzalutamide)2026-01-07Drug · Prescription · Approval202600049
- MFDS drugPAN-GROW solution 5%2025-12-30Drug · OTC · Notification202503412
Show 68 more
- MFDS drugABCITO Tablet 20mg2025-05-20Drug · Prescription · Approval202501242
- MFDS drugHanall Ketamine HCl Injection2024-01-25Drug · Prescription · Approval202400197
- MFDS drugEAGLEDUO SR Tablet 0.3/1000mg(Enavogliflozin, Metformin Hydrochloride)2023-06-29Drug · Prescription · Approval202302006
- MFDS drugBiosol-F Inj.2023-02-08Drug · Prescription · Notification202300488
- MFDS drugGlusitaduo Tablet 50/1000mg2022-12-21Drug · Prescription · Approval202204575
- MFDS drugGlusitaduo Tablet 50/850mg2022-12-21Drug · Prescription · Approval202204576
- MFDS drugGlusitaduo Tablet 50/500mg2022-12-21Drug · Prescription · Approval202204577
- MFDS drugBiotop-Hi ST Powder2022-12-16Drug · OTC · Notification202204511
- MFDS drugEAGLEX Tablet 0.3mg2022-12-05Drug · Prescription · Approval202204355
- MFDS drugABCITO Tablet 10mg2022-08-24Drug · Prescription · Approval202203386
- MFDS drugGlusitaduo XR Tablet 50/500mg2022-05-13Drug · Prescription · Approval202202018
- MFDS drugGlusitaduo XR Tablet 50/1000mg2022-05-13Drug · Prescription · Approval202202019
- MFDS drugGlusitaduo XR Tablet 100/1000mg2022-05-13Drug · Prescription · Approval202202020
- MFDS drugVENORON D 600mg tab.2022-05-03Drug · OTC · Notification202201813
- MFDS drugGludapa Tablet 5mg2022-03-04Drug · Prescription · Approval202200944
- MFDS drugGludapa Tablet 10mg2022-03-04Drug · Prescription · Approval202200945
- MFDS drugGluforvi 10/100mg Tab.2022-01-28Drug · Prescription · Approval202200495
- MFDS drugABCITO Tablet 40mg2022-01-10Drug · Prescription · Approval202200180
- MFDS drugBiotop-I Fine Granule2021-12-22Drug · OTC · Notification202108073
- MFDS drugBiotop-D Dual Fine Granule2021-12-22Drug · OTC · Notification202108074
- MFDS drugBiotop-I Forte PowderRevoked2021-12-22Drug · OTC · Notification202108075
- MFDS drugBiotop-D Forte Fine Granule2021-12-15Drug · OTC · Notification202107978
- MFDS drugBiotop-D Forte Cap.2021-12-07Drug · OTC · Notification202107827
- MFDS drugBiotop-Hi Forte Cap.2021-12-07Drug · OTC · Notification202107828
- MFDS drugHANALL For Mr. Tab. 100mg2021-10-20Drug · Prescription · Approval202107022
- MFDS drugMelaone SR Tablet 2mg2021-10-13Drug · Prescription · Approval202106894
- MFDS drugAlkabon Plus Tab2021-09-06Drug · OTC · Notification202106375
- MFDS drugBiotop-D Dual Cap.2021-09-03Drug · OTC · Notification202106349
- MFDS drugBio Top Hi Dual Cap.2021-09-03Drug · OTC · Notification202106350
- MFDS drugHANTOZET Tablet 10/10mg2021-02-18Drug · Prescription · Approval202101582
- MFDS drugHANTOZET Tablet 10/20mg2021-02-18Drug · Prescription · Approval202101583
- MFDS drugHANTOZET Tablet 10/40mg2021-02-18Drug · Prescription · Approval202101584
- MFDS drugGlusita Tablet 50mg2021-02-16Drug · Prescription · Approval202101303
- MFDS drugGlusita Tablet 25mg2021-02-16Drug · Prescription · Approval202101304
- MFDS drugGlusita Tab. 100mg2021-02-16Drug · Prescription · Approval202101305
- MFDS drugAlkabon Tab.2020-04-10Drug · OTC · Notification202002550
- MFDS drugAdamo Tab.2019-10-25Drug · Prescription · Approval201907460
- MFDS drugTobidasol plus Inj.2019-10-09Drug · Prescription · Notification201907141
- MFDS drugFine mix Inj.2019-10-07Drug · Prescription · Notification201907113
- MFDS drugDEXYTHIOC TAB2019-07-24Drug · Prescription · Approval201905278
- MFDS drugOMAPE TAB2019-07-09Drug · Prescription · Approval201904634
- MFDS drugVesiguard Tab. 5mg2019-07-08Drug · Prescription · Approval201904620
- MFDS drugVesiguard Tab. 10mg2019-07-08Drug · Prescription · Approval201904621
- MFDS drugCimetro Inj.Revoked2019-01-30Drug · Prescription · Notification201900710
- MFDS drugHEPAMON CAP2018-04-10Drug · Prescription · Approval201801543
- MFDS drugAdamo Soft Cap.2017-12-28Drug · Prescription · Approval201708604
- MFDS drugFine Tathione Inj.2017-12-22Drug · Prescription · Notification201708546
- MFDS drugFine Hepain fusion Inj.2017-11-06Drug · Prescription · Notification201707829
- MFDS drugGLUCOFREE XR TAB 1000mg2017-02-23Drug · Prescription · Approval201701004
- MFDS drugCETRISON INJ 2000mg2016-09-28Drug · Prescription · Notification201605693
- MFDS drugFINE ZINC INJRevoked2016-07-18Drug · Prescription · Notification201604404
- MFDS drugFINE SULTIAMINE INJRevoked2016-07-18Drug · Prescription · Notification201604405
- MFDS drugFINE HIMIN INJ2016-07-15Drug · Prescription · Notification201604382
- MFDS drugGLUCODOWN TAB 250mg2016-07-12Drug · Prescription · Approval201604290
- MFDS drugGLUCODOWN TAB 1000mg2016-07-12Drug · Prescription · Approval201604291
- MFDS drugHanomarin 350mg Soft Cap.2016-06-30Drug · OTC · Notification201604109
- MFDS drugBon-eva Inj.2016-05-18Drug · Prescription · Notification201602723
- MFDS drugBEAROBAN OINT 10g2016-03-25Drug · OTC · Notification201601618
- MFDS drugPAN-GROW CAP2015-11-13Drug · OTC · Notification201507722
- MFDS drugWibis D Tab.Revoked2015-10-30Drug · Prescription · Approval201507503
- MFDS drugHi-oct Inj.2015-10-05Drug · Prescription · Notification201507039
- MFDS drugGlubia Combi Tab. 50/500mgRevoked2015-08-20Drug · Prescription · Approval201505858
- MFDS drugGlubia Combi Tab. 50/1000mgRevoked2015-08-20Drug · Prescription · Approval201505859
- MFDS drugGlubia Combi Tab. 50/850mgRevoked2015-08-20Drug · Prescription · Approval201505860
- MFDS drugFine blue Inj.2015-08-13Drug · Prescription · Notification201505707
- MFDS drugFINE VITA D INJ2015-06-24Drug · Prescription · Notification201504130
- MFDS drugThioctabia HR Tab. 600mgRevoked2015-05-18Drug · Prescription · Approval201502976
- MFDS drugGluvia Tab. 100mgRevoked2015-04-20Drug · Prescription · Approval201502380
Showing the 80 most recent of 202 records.
Clinical trials
data.go.kr40 MFDS clinical trial authorisations · 2012–2026 (Bioequivalence 21 · Phase 1 14 · Phase 3 3 · Phase 2 1 · Phase 2/3 1)
- Phase 1HRD-0692026-04-08
2 trial sites
- Phase 1HRD-0692025-12-18
2 trial sites
- BioequivalenceHRD-0762025-06-02
2 trial sites
- BioequivalenceHRD-0702025-01-16
2 trial sites
- BioequivalenceHRD-0762024-10-23
2 trial sites
- Bioequivalence글루코다운오알서방정1000밀리그램(메트포르민염산염)2021-04-05
2 trial sites
- Bioequivalence글루코다운오알서방정1000밀리그램(메트포르민염산염)2021-04-02
2 trial sites
- Bioequivalence노바부틴서방정(트리메부틴말레산염)2020-10-06
2 trial sites
- Bioequivalence노바부틴서방정(트리메부틴말레산염)2020-09-29
2 trial sites
- Bioequivalence덱시티옥정(알티옥트산트로메타민염)2020-05-25
2 trial sites
- Bioequivalence아다모정0.5밀리그램(두타스테리드)2018-12-27
2 trial sites
- Bioequivalence아다모정0.5밀리그램(두타스테리드)2018-05-25
2 trial sites
Show 28 more
- Bioequivalence테프라정40밀리그램(프로프라놀롤염산염)2017-02-23
2 trial sites
- Bioequivalence글루코다운오알서방정1000밀리그램(메트포르민염산염)2017-02-20
2 trial sites
- Phase 1HL068정2016-03-11
1 trial site
- Bioequivalence글루코다운오알서방정1000mg(메트포르민염산염)2016-01-20
2 trial sites
- Bioequivalence글루코다운정1000mg(메트포르민염산염)2015-12-10
2 trial sites
- Phase 1HL068정2015-12-01
1 trial site
- Phase 1HL0362015-11-18
1 trial site
- Phase 1HL174B정2015-06-30
- Phase 1HL174B정2015-06-29
- Phase 1HL156A2015-06-26
- Bioequivalence아토르탄정20/50mg(아토르바스타틴/로사르탄)2014-12-10
2 trial sites
- Phase 3HL068정2014-04-22
22 trial sites
- BioequivalenceHL040정20/50mg(가칭)2014-03-10
2 trial sites
- Bioequivalence한올보센탄정125mg2014-02-05
2 trial sites
- Phase 2HL068정2013-11-21
- Bioequivalence한올에스오메프라졸정40밀리그램(가칭)2013-07-29
2 trial sites
- Phase 3HL063B정2013-07-22
18 trial sites
- Bioequivalence한올리네졸리드정600mg2013-07-09
2 trial sites
- Phase 1HL172정2013-05-30
1 trial site
- Phase 1HL174SR정2013-05-22
1 trial site
- Phase 1HL174SR정2013-05-22
1 trial site
- Phase 2/3HL-009겔2013-03-12
- Bioequivalence위비스정2013-03-11
- Bioequivalence리트몰정300mg2012-12-31
2 trial sites
- Phase 1HL068정2012-10-31
1 trial site
- Phase 1HL092정(가칭)2012-10-24
1 trial site
- Phase 1HL063B정2012-10-05
1 trial site
- Phase 3HL040XC정(무수아토르바스타틴칼슘,로자탄칼륨)2012-01-18
26 trial sites
R&D and key agreements
Source: DART corporate disclosure바토클리맙(HL161BKN) · 중증근무력증 등 자가면역질환 · 임상 3상(중증근무력증 탑라인 확보, CIDP 임상 2b상) · Fully human anti-FcRn monoclonal antibody co-developed with Immunovant; Harbour BioMed develops it in Greater China (resubmitted China marketing application in June 2024)
아이메로프루바트(HL161ANS) · 그레이브스병·난치성 류마티스 관절염·중증근무력증·만성 염증성 다발성 신경병증·쇼그렌증후군·피부 홍반성 루푸스 · 임상 1상 완료, 6개 적응증 IND 승인 후 임상 개시 · Next-generation anti-FcRn antibody; obtained a US composition-of-matter patent with Immunovant in March 2024
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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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