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Pharma & CDMOKOSPI 009420202 approvals40 trials

HANALL BIOPHARMA CO.,LTD

Official website

KOSPI-listed pharma/biotech company co-developing the autoimmune biologics batoclimab and imeropruvate with partner Immunovant.

As of 2026-10-10, HANALL BIOPHARMA CO.,LTD has 7 Korean MFDS device approvals, 195 Korean MFDS drug approvals, 11 PubMed-indexed papers on record (counted by the MAA Company Index from its own matching of public databases).

Price

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Market cap

Business overview

Source: DART corporate disclosure

Founded 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.kr

195 Korean MFDS drug approvals · 1979–2026 / 7 Korean MFDS device approvals · 1999–2006

  • MFDS drugRomibe ODT 10/20mg2026-06-30
    Drug · Prescription · Approval202601879
  • MFDS drugRomibe ODT 10/10mg2026-06-30
    Drug · Prescription · Approval202601880
  • MFDS drugRomibe ODT 10/5mg2026-06-30
    Drug · Prescription · Approval202601881
  • MFDS drugBiotop-D Forte Tab.2026-04-23
    Drug · OTC · Notification202601188
  • MFDS drugPrenone ODT 150mg2026-02-24
    Drug · Prescription · Approval202600530
  • MFDS drugPrenone ODT 75mg2026-02-24
    Drug · Prescription · Approval202600531
  • MFDS drugPrenone ODT 50mg2026-02-24
    Drug · Prescription · Approval202600532
  • MFDS drugBiotop I Forte Powder2026-02-24
    Drug · OTC · Notification202600551
  • MFDS drugALFABONE D tab. 1mcg(Alfacalcidol)2026-01-26
    Drug · OTC · Notification202600218
  • MFDS drugNovabutin 150mg Tab2026-01-22
    Drug · OTC · Notification202600200
  • MFDS drugENZALUTA Soft Capsule 40mg(Enzalutamide)2026-01-07
    Drug · Prescription · Approval202600049
  • MFDS drugPAN-GROW solution 5%2025-12-30
    Drug · OTC · Notification202503412
Show 68 more
  • MFDS drugABCITO Tablet 20mg2025-05-20
    Drug · Prescription · Approval202501242
  • MFDS drugHanall Ketamine HCl Injection2024-01-25
    Drug · Prescription · Approval202400197
  • MFDS drugEAGLEDUO SR Tablet 0.3/1000mg(Enavogliflozin, Metformin Hydrochloride)2023-06-29
    Drug · Prescription · Approval202302006
  • MFDS drugBiosol-F Inj.2023-02-08
    Drug · Prescription · Notification202300488
  • MFDS drugGlusitaduo Tablet 50/1000mg2022-12-21
    Drug · Prescription · Approval202204575
  • MFDS drugGlusitaduo Tablet 50/850mg2022-12-21
    Drug · Prescription · Approval202204576
  • MFDS drugGlusitaduo Tablet 50/500mg2022-12-21
    Drug · Prescription · Approval202204577
  • MFDS drugBiotop-Hi ST Powder2022-12-16
    Drug · OTC · Notification202204511
  • MFDS drugEAGLEX Tablet 0.3mg2022-12-05
    Drug · Prescription · Approval202204355
  • MFDS drugABCITO Tablet 10mg2022-08-24
    Drug · Prescription · Approval202203386
  • MFDS drugGlusitaduo XR Tablet 50/500mg2022-05-13
    Drug · Prescription · Approval202202018
  • MFDS drugGlusitaduo XR Tablet 50/1000mg2022-05-13
    Drug · Prescription · Approval202202019
  • MFDS drugGlusitaduo XR Tablet 100/1000mg2022-05-13
    Drug · Prescription · Approval202202020
  • MFDS drugVENORON D 600mg tab.2022-05-03
    Drug · OTC · Notification202201813
  • MFDS drugGludapa Tablet 5mg2022-03-04
    Drug · Prescription · Approval202200944
  • MFDS drugGludapa Tablet 10mg2022-03-04
    Drug · Prescription · Approval202200945
  • MFDS drugGluforvi 10/100mg Tab.2022-01-28
    Drug · Prescription · Approval202200495
  • MFDS drugABCITO Tablet 40mg2022-01-10
    Drug · Prescription · Approval202200180
  • MFDS drugBiotop-I Fine Granule2021-12-22
    Drug · OTC · Notification202108073
  • MFDS drugBiotop-D Dual Fine Granule2021-12-22
    Drug · OTC · Notification202108074
  • MFDS drugBiotop-I Forte PowderRevoked2021-12-22
    Drug · OTC · Notification202108075
  • MFDS drugBiotop-D Forte Fine Granule2021-12-15
    Drug · OTC · Notification202107978
  • MFDS drugBiotop-D Forte Cap.2021-12-07
    Drug · OTC · Notification202107827
  • MFDS drugBiotop-Hi Forte Cap.2021-12-07
    Drug · OTC · Notification202107828
  • MFDS drugHANALL For Mr. Tab. 100mg2021-10-20
    Drug · Prescription · Approval202107022
  • MFDS drugMelaone SR Tablet 2mg2021-10-13
    Drug · Prescription · Approval202106894
  • MFDS drugAlkabon Plus Tab2021-09-06
    Drug · OTC · Notification202106375
  • MFDS drugBiotop-D Dual Cap.2021-09-03
    Drug · OTC · Notification202106349
  • MFDS drugBio Top Hi Dual Cap.2021-09-03
    Drug · OTC · Notification202106350
  • MFDS drugHANTOZET Tablet 10/10mg2021-02-18
    Drug · Prescription · Approval202101582
  • MFDS drugHANTOZET Tablet 10/20mg2021-02-18
    Drug · Prescription · Approval202101583
  • MFDS drugHANTOZET Tablet 10/40mg2021-02-18
    Drug · Prescription · Approval202101584
  • MFDS drugGlusita Tablet 50mg2021-02-16
    Drug · Prescription · Approval202101303
  • MFDS drugGlusita Tablet 25mg2021-02-16
    Drug · Prescription · Approval202101304
  • MFDS drugGlusita Tab. 100mg2021-02-16
    Drug · Prescription · Approval202101305
  • MFDS drugAlkabon Tab.2020-04-10
    Drug · OTC · Notification202002550
  • MFDS drugAdamo Tab.2019-10-25
    Drug · Prescription · Approval201907460
  • MFDS drugTobidasol plus Inj.2019-10-09
    Drug · Prescription · Notification201907141
  • MFDS drugFine mix Inj.2019-10-07
    Drug · Prescription · Notification201907113
  • MFDS drugDEXYTHIOC TAB2019-07-24
    Drug · Prescription · Approval201905278
  • MFDS drugOMAPE TAB2019-07-09
    Drug · Prescription · Approval201904634
  • MFDS drugVesiguard Tab. 5mg2019-07-08
    Drug · Prescription · Approval201904620
  • MFDS drugVesiguard Tab. 10mg2019-07-08
    Drug · Prescription · Approval201904621
  • MFDS drugCimetro Inj.Revoked2019-01-30
    Drug · Prescription · Notification201900710
  • MFDS drugHEPAMON CAP2018-04-10
    Drug · Prescription · Approval201801543
  • MFDS drugAdamo Soft Cap.2017-12-28
    Drug · Prescription · Approval201708604
  • MFDS drugFine Tathione Inj.2017-12-22
    Drug · Prescription · Notification201708546
  • MFDS drugFine Hepain fusion Inj.2017-11-06
    Drug · Prescription · Notification201707829
  • MFDS drugGLUCOFREE XR TAB 1000mg2017-02-23
    Drug · Prescription · Approval201701004
  • MFDS drugCETRISON INJ 2000mgRevoked2016-09-28
    Drug · Prescription · Notification201605693
  • MFDS drugFINE ZINC INJRevoked2016-07-18
    Drug · Prescription · Notification201604404
  • MFDS drugFINE SULTIAMINE INJRevoked2016-07-18
    Drug · Prescription · Notification201604405
  • MFDS drugFINE HIMIN INJ2016-07-15
    Drug · Prescription · Notification201604382
  • MFDS drugGLUCODOWN TAB 250mg2016-07-12
    Drug · Prescription · Approval201604290
  • MFDS drugGLUCODOWN TAB 1000mg2016-07-12
    Drug · Prescription · Approval201604291
  • MFDS drugHanomarin 350mg Soft Cap.2016-06-30
    Drug · OTC · Notification201604109
  • MFDS drugBon-eva Inj.2016-05-18
    Drug · Prescription · Notification201602723
  • MFDS drugBEAROBAN OINT 10g2016-03-25
    Drug · OTC · Notification201601618
  • MFDS drugPAN-GROW CAP2015-11-13
    Drug · OTC · Notification201507722
  • MFDS drugWibis D Tab.Revoked2015-10-30
    Drug · Prescription · Approval201507503
  • MFDS drugHi-oct Inj.2015-10-05
    Drug · Prescription · Notification201507039
  • MFDS drugGlubia Combi Tab. 50/500mgRevoked2015-08-20
    Drug · Prescription · Approval201505858
  • MFDS drugGlubia Combi Tab. 50/1000mgRevoked2015-08-20
    Drug · Prescription · Approval201505859
  • MFDS drugGlubia Combi Tab. 50/850mgRevoked2015-08-20
    Drug · Prescription · Approval201505860
  • MFDS drugFine blue Inj.2015-08-13
    Drug · Prescription · Notification201505707
  • MFDS drugFINE VITA D INJ2015-06-24
    Drug · Prescription · Notification201504130
  • MFDS drugThioctabia HR Tab. 600mgRevoked2015-05-18
    Drug · Prescription · Approval201502976
  • MFDS drugGluvia Tab. 100mgRevoked2015-04-20
    Drug · Prescription · Approval201502380

Showing the 80 most recent of 202 records.

Clinical trials

data.go.kr

40 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

Global clinical trials

ClinicalTrials.gov · sponsor-matched
Show 6 more trials

R&D and key agreements

Source: DART corporate disclosure

바토클리맙(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

Key disclosures

KRX KIND via OpenDART

Publications

PubMed · affiliation-matched
Show 1 more publications

Patents

KIPRIS · applicant-matched
Show 243 more patents

AI reads

MAA server logs · IP-verified
87
Times AI engines pulled HANALL BIOPHARMA CO.,LTD's records

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Queries from users who connected this index to their own AI.

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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 productsPharma & CDMO

Ranked by how many MFDS product categories overlap. Not a ranking — a pointer to where to look.

DongBang Medical Co., Ltd.2 shared

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

SEWOONMEDICAL CO,. LTD.2 shared

Founded in 1982 and KOSDAQ-listed in 2008, Sewoon Medical manufactures medical aspirators and catheters/tubes.

Hanmi Pharm. Co., Ltd.1 shared

KOSPI-listed pharmaceutical company behind the combination drugs Amosartan (hypertension) and Rosuzet (dyslipidemia).

L&C BIO Co., Ltd1 shared

L&C BIO manufactures human tissue grafts across 11 tissue types, including the acellular dermal matrix MegaDerm, plus tissue-based medical devices.

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.

Hugel, Inc.1 shared

Hugel is a KOSDAQ-listed pharmaceutical/CDMO company making a botulinum toxin injectable and the hyaluronic acid filler The Chaeum.

HUONS CO., LTD.1 shared

KOSDAQ-listed pharmaceutical and healthcare company producing lidocaine anesthetics and the Kynix hyaluronic-acid eye-drop line.

YUNGJIN PHARM. CO., LTD1 shared

Founded in 1962 and listed on the KOSPI in 1973, Yungjin Pharm is a KT&G Group pharmaceutical affiliate exporting antibiotic injectables and APIs and operating a CMO business.

GC Medical Science Corporation1 shared

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

JETEMA Co.,Ltd.1 shared

Founded 2009, listed on KOSDAQ in 2019, JETEMA develops hyaluronic acid fillers, botulinum toxin biopharmaceuticals, and lifting threads.

PharmaResearch Co., Ltd.1 shared

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

YUHAN CORPORATION1 shared

Founded in 1926 and listed on the KOSPI in 1962, Yuhan Corporation is a comprehensive pharmaceutical company known for its innovative drug Leclaza.

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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