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Pharma & CDMOKOSPI 002390Orphan Drug171 approvals48 trials

HANDOK Inc.

Official website

KOSPI-listed comprehensive pharma company behind Amaryl diabetes drug and the USD 86.25M HL5101 anticancer out-license deal.

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Market cap

Business overview

Source: DART corporate disclosure

Founded in 1954 and listed on the KOSPI in 1976, Handok is a comprehensive pharmaceutical and healthcare company. It sells the diabetes drugs Amaryl and Tenelia, the hypertension drugs Aprovasc and Aprovel, the kidney-disease drug Renvela, the digestive aid Festal, and the hangover remedy Readycue, while operating the home diagnostic device brand BaroJan and the health-food brands Nature Set and Theracurmin, alongside a contract manufacturing and real-estate leasing business. In May 2021 it out-licensed the targeted anticancer drug HL5101 (CHC2014) to AUM Biosciences and CMG Pharmaceutical for a total deal value of USD 86.25 million (plus 3.5-5.5% royalties), in-licensed the stem-cell therapy SCM-AD from SCM Lifescience in May 2019 alongside a KRW 4 billion equity investment, and signed multiple additional in-licensing agreements with Rezolute, ABL Bio, Welt, and Spark Biopharma.

Products & technology

  • AmarylDiabetes treatment
  • TeneliaDiabetes treatment
  • AprovascHypertension treatment
  • AprovelHypertension treatment
  • RenvelaKidney-disease treatment
  • FestalDigestive aid
  • ReadycueHangover remedy
  • BaroJanHome diagnostic device brand
  • Nature SetHealth functional food brand
  • TheracurminHealth food

Regulatory approvals

data.go.kr

7 Orphan Drug designations · 2014–2025 / 145 Korean MFDS drug approvals · 1964–2026 / 19 Korean MFDS device approvals · 1999–2026

  • Orphan레티판리맙(주사제)2025-05-07
    Orphan Drug designation20250140257
  • Orphan악사틸리맙(Axatilimab)2025-03-05
    Orphan Drug designation20240165822
  • Orphan에프가티지모드 알파(Efgartigimod alfa)2024-12-27
    Orphan Drug designation · in development20240223076
  • Orphan파크리티닙(pacritinib)2024-08-09
    Orphan Drug designation20240139793
  • OrphanGX-H9(인간 성장호르몬 하이에프씨(hGH-hyFc))2024-03-04
    Orphan Drug designation · in development20230188358
  • Orphan타파시타맙(주사제)2023-10-01
    Orphan Drug designation20250120295
  • OrphanHL2351(hIL-1Ra-hyFc) 100mg/ml 주사제2014-10-30
    Orphan Drug designation · in development20140166123
  • MFDS drugVonjo capsule(Pacritinib citrate)2026-08-13
    Drug · Prescription · Approval202602368
  • MFDSInfusion pump, manually-operated2026-03-09
    Product approval · Class 2수인 26-4163 호
  • MFDS drugClearteen Gel2025-08-18
    Drug · OTC · Notification202502143
  • MFDS drugMODUNAROLL solution2025-05-22
    Drug · OTC · Notification202501262
  • MFDS drugHandok Acetaminophen Syrup2025-03-24
    Drug · OTC · Notification202500675
Show 68 more
  • MFDS drugVyvgart inj. (Efgartigimod alfa)2025-01-20
    Drug · Prescription · Approval202500142
  • MFDS drugMODUSTA Tab. 0.2mg (Dutasteride)2024-07-25
    Drug · Prescription · Approval202401804
  • MFDS drugKETOTOP ACTIVE PLASTER2024-05-30
    Drug · OTC · Notification202401344
  • MFDS drugItchy Rescue Plaster2024-01-04
    Drug · OTC · Notification202400026
  • MFDS drugAprovasc Tab. 150/5mg (Irbesartan, Amlodipine besylate)2023-11-28
    Drug · Prescription · Approval202303233
  • MFDS drugAprovasc Tab. 150/10mg (Irbesartan, Amlodipine besylate)2023-11-28
    Drug · Prescription · Approval202303234
  • MFDS drugAprovasc Tab. 300/5mg (Irbesartan, Amlodipine besylate)2023-11-28
    Drug · Prescription · Approval202303235
  • MFDS drugMinjuvi Inj.2023-06-09
    Drug · Prescription · Approval202301795
  • MFDS drugPemazyre Tablet 13.5mg2023-04-25
    Drug · Prescription · Approval202301337
  • MFDS drugPemazyre Tablet 9mg2023-04-25
    Drug · Prescription · Approval202301338
  • MFDS drugPemazyre Tablet 4.5mg2023-04-25
    Drug · Prescription · Approval202301339
  • MFDS drugVyxeos liposomal inj.2022-11-30
    Drug · Prescription · Approval202204315
  • MFDS drugFestal Superzyme Tab.2021-12-21
    Drug · OTC · Notification202108052
  • MFDSMicrobial identification analyzer2021-09-06
    Product approval · Class 1체외 수신 21-1666 호
  • MFDSMicrobial identification analyzer2021-08-31
    Product approval · Class 1체외 수신 21-1633 호
  • MFDSMicrobial identification analyzer2019-09-03
    Product approval · Class 1체외 수신 19-2236 호
  • MFDS drugOlmediqual HCT Tab. 5/40/12.5mg2018-12-26
    Drug · Prescription · Approval201805279
  • MFDS drugOlmediqual HCT Tab. 10/40/12.5mg2018-12-26
    Drug · Prescription · Approval201805280
  • MFDS drugOlmediqual HCT Tab. 5/20/12.5mg2018-12-26
    Drug · Prescription · Approval201805281
  • MFDS drugGalafold Cap.2017-12-20
    Drug · Prescription · Approval201708429
  • MFDS drugTelmidiqual Tab. 40/5mg2016-09-30
    Drug · Prescription · Approval201605769
  • MFDS drugTelmidiqual Tab. 80/5mg2016-09-30
    Drug · Prescription · Approval201605770
  • MFDS drugTelmidiqual Tab. 40/10mg2016-09-30
    Drug · Prescription · Approval201605771
  • MFDS drugDefitelio Inj. 200mg2016-02-18
    Drug · Prescription · Approval201600952
  • MFDSMicrobial identification analyzer2015-10-15
    Product approval · Class 1체외 수신 15-719 호
  • MFDS drugMegarozet Tab. 10/20mg2015-09-24
    Drug · Prescription · Approval201506791
  • MFDS drugMegarozet Tab. 10/10mg2015-09-24
    Drug · Prescription · Approval201506792
  • MFDS drugMegarozet Tab. 10/5mg2015-09-24
    Drug · Prescription · Approval201506793
  • MFDS drugImojev Injection2015-04-03
    Drug · Prescription · Approval201501821
  • MFDS drugTenelia M SR Tab. 10/750mg2015-03-31
    Drug · Prescription · Approval201501697
  • MFDS drugTenelia M SR Tab. 10/500mg2015-03-31
    Drug · Prescription · Approval201501699
  • MFDS drugTenelia M SR Tab. 20/1000mg2015-03-31
    Drug · Prescription · Approval201501700
  • MFDS drugOlmediqual Tab. 10/40mg2014-12-31
    Drug · Prescription · Approval201406181
  • MFDS drugOlmediqual Tab. 5/40mg2014-12-31
    Drug · Prescription · Approval201406182
  • MFDS drugOlmediqual Tab. 5/20mg2014-12-31
    Drug · Prescription · Approval201406183
  • MFDS drugThytamin Plus Tab.2014-12-29
    Drug · OTC · Notification201406121
  • MFDS drugThytamin Tab.2014-09-15
    Drug · OTC · Notification201404221
  • MFDSEye testing instruments2014-04-29
    Product approval · Class 2수허 14-1792 호
  • MFDS drugTenelia Tab. 20mg2014-04-29
    Drug · Prescription · Approval201402038
  • MFDS drugRosuvastaqual Tab. 5mg2014-04-09
    Drug · Prescription · Approval201401680
  • MFDS drugWannabe Strong Soft Cap.Revoked2014-02-21
    Drug · OTC · Notification201400817
  • MFDS drugWannabe Olive Soft Cap.Revoked2014-02-18
    Drug · OTC · Notification201400732
  • MFDS drugRosuvastaqual Tab. 20mg2014-01-28
    Drug · Prescription · Approval201400388
  • MFDS drugRosuvastaqual Tab. 10mg2014-01-28
    Drug · Prescription · Approval201400389
  • MFDS drugMegaforge Tab. 10/160mgRevoked2013-08-29
    Drug · Prescription · Approval201309058
  • MFDS drugMegaforge Tab. 5/160mgRevoked2013-08-29
    Drug · Prescription · Approval201309059
  • MFDS drugMegaforge Tab. 5/80mgRevoked2013-08-29
    Drug · Prescription · Approval201309060
  • MFDS drugX-pain ER semi Tab.2013-06-27
    Drug · Prescription · Approval201307895
  • MFDS drugAricept Tab. 23mg2013-05-16
    Drug · Prescription · Approval201307375
  • MFDSLancet, automatic, single-useRevoked2013-05-08
    Product approval · Class 2수인 13-813 호
  • MFDS drugClearteen Topical Soln. 2%2013-04-10
    Drug · OTC · Approval201306847
  • MFDSDevice, nerve conduction velocity measurementRevoked2012-12-10
    Product approval · Class 2수허 12-1832 호
  • MFDSElectrode, externalRevoked2012-11-08
    Product approval · Class 1경인 수신 12-326 호
  • MFDS drugX-pain ER Tab.2012-10-31
    Drug · Prescription · Approval201207591
  • MFDS drugCelex Cap. 200mg2011-06-28
    Drug · Prescription · Approval201103995
  • MFDSGeneral gene amplificator, nucleic acid, without fluorescence meterRevoked2011-05-31
    Product approval · Class 1체외 수허 11-600 호
  • MFDS drugInovelon Film coated Tab.400mg2009-07-27
    Drug · Prescription · Approval200905915
  • MFDS drugInovelon Film coated Tab.200mg2009-07-27
    Drug · Prescription · Approval200905916
  • MFDS drugInovelon Film coated Tab.100mg2009-07-27
    Drug · Prescription · Approval200905917
  • MFDS drugFess Natural Nasal Spray2009-07-20
    Drug · OTC · Approval200905706
  • MFDS drugPaxerontin CR Tab. 25mg2008-09-12
    Drug · Prescription · Approval200809458
  • MFDS drugPaxerontin CR Tab. 12.5mg2008-08-18
    Drug · Prescription · Approval200808754
  • MFDS drugCleocin-T Topical soln. 1%2008-06-25
    Drug · Prescription · Notification200807035
  • MFDS drugAmaryl-Mex Sr Tab. 2/500mg2008-05-16
    Drug · Prescription · Approval200805555
  • MFDS drugAricept Evess Tab. 5mg2008-03-19
    Drug · Prescription · Approval200802979
  • MFDS drugAricept Evess Tab. 10mg2008-03-19
    Drug · Prescription · Approval200802980
  • MFDS drugAmaryl M Tab. 1/500mg2007-12-18
    Drug · Prescription · Approval200713518
  • MFDS의료용원심분리기Revoked2007-08-14
    Product approval · Class 1서울 수신 07-1525 호

Showing the 80 most recent of 171 records.

Clinical trials

data.go.kr

48 MFDS clinical trial authorisations · 2012–2025 (Bioequivalence 18 · Phase 1 14 · Phase 3 9 · Phase 2 5 · Phase 1/2 1)

  • Phase 1HD-P0232025-08-04

    2 trial sites

  • Phase 1HD-P0232025-03-04

    2 trial sites

  • Phase 1HD-PC0092024-06-04

    2 trial sites

  • Phase 1HD-P0232024-01-26

    2 trial sites

  • Phase 2HDB001A2023-11-08

    3 trial sites

  • Phase 1아프로바스크정2022-09-23

    1 trial site

  • Phase 1아프로바스크정2022-09-06

    1 trial site

  • Phase 1아프로바스크정2022-09-06

    1 trial site

  • Phase 3테넬리아정(MP-513정)2022-07-12

    11 trial sites

  • Phase 3아프로바스크정2022-06-09

    9 trial sites

  • Phase 3아프로바스크정2022-05-26

    23 trial sites

  • Phase 3테넬리아정(MP-513정)2021-05-24

    9 trial sites

Show 36 more
  • Phase 1테넬리아정(MP-513정)2020-06-24

    1 trial site

  • Phase 1/2HDB001A2020-03-17

    4 trial sites

  • Phase 2아프로바스크정2020-03-04

    20 trial sites

  • Phase 1NOV16012019-05-08

    10 trial sites

  • Phase 3ACT-541468A2019-03-04

    2 trial sites

  • Phase 3ACT-541468A2018-12-14

    7 trial sites

  • Phase 1테넬리아정(MP-513정)2018-12-06

    1 trial site

  • BioequivalenceHL1510RBE2018-11-26

    2 trial sites

  • BioequivalenceHL1513RBE2018-02-23

    2 trial sites

  • Phase 1테넬리아정(MP-513정)2016-10-13

    1 trial site

  • Bioequivalence몬테퀄산4밀리그램(몬테루카스트나트륨)2016-09-09

    2 trial sites

  • Phase 4테넬리아정(MP-513정)2016-08-01

    5 trial sites

  • Bioequivalence수로신디정(탐스로신염산염)2016-07-28

    2 trial sites

  • Bioequivalence한독아자티오프린정2015-11-20

    2 trial sites

  • Bioequivalence한독세레콕시브캡슐 200mg2015-11-04

    2 trial sites

  • Phase 2HL2351주2015-10-27

    1 trial site

  • Bioequivalence한독몬테루카스트츄정 4mg2015-04-21

    2 trial sites

  • Bioequivalence테바프레가발린캡슐 300mg2015-01-26

    2 trial sites

  • Bioequivalence한독에스시탈로프람정20mg2015-01-20

    2 trial sites

  • Phase 3테넬리아정(MP-513정)2015-01-19

    9 trial sites

  • Bioequivalence한독엘로티닙정150mg2014-11-26

    2 trial sites

  • Bioequivalence한독메트포르민정 850mg2014-05-29

    2 trial sites

  • Bioequivalence메가비카정10/40밀리그램2014-05-12

    2 trial sites

  • Phase 1HL1511정2014-03-17

    1 trial site

  • Phase 1HL2351주2014-03-05

    1 trial site

  • Phase 1HL1513정2013-08-20

    1 trial site

  • Bioequivalence한독메트포르민정 1000mg2013-07-30

    2 trial sites

  • Bioequivalence한독올란자핀오디정10밀리그람2013-07-19

    2 trial sites

  • Bioequivalence한독몬테루카스트츄정5밀리그램(몬테루카스트나트륨)2013-07-09

    2 trial sites

  • Bioequivalence한독레트로졸2.5mg정2013-07-09

    2 trial sites

  • Bioequivalence한독올란자핀정10밀리그램(올란자핀)2013-07-03

    2 trial sites

  • Bioequivalence한독몬테루카스트정10밀리그램(몬테루카스트나트륨)2013-05-27

    2 trial sites

  • Phase 2STA-90902012-10-02

    4 trial sites

  • Phase 3테넬리아정(MP-513정)2012-09-19

    5 trial sites

  • Phase 2STA-90902012-07-31

    5 trial sites

  • Phase 3테넬리아정(MP-513정)2012-03-06

    13 trial sites

R&D and key agreements

Source: DART corporate disclosure

HL5101(CHC2014) · Pan-TRK 저해 표적항암신약 · 국내 임상 1상 완료(기술이전 후 AUM Biosciences/CMG제약 진행) · Out-licensed worldwide (excluding Korea) to AUM Biosciences and CMG Pharmaceutical in May 2021 for USD 86.25M in upfront/milestones plus 3.5-5.5% sales royalties

SCM-AD · 중증 아토피 피부염 · 임상 2상 완료 · In-licensed domestic development/sales rights from SCM Lifescience in May 2019, alongside a KRW 4bn equity investment

RZ358 / RZ402 · 국내 개발 및 상업화 단계(라이선스인) · Acquired exclusive Korean development/commercialization rights from Rezolute, Inc. in September 2020

ABL001 / ABL111 · 국내 라이선스 계약 · Obtained a Korea license from ABL Bio in December 2020

Not yet compiled: business overview. Send us materials and we will add them

Companies approved for the same productsPharma & CDMO

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

GC Medical Science Corporation3 shared

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

JW PHARMACEUTICAL3 shared

Founded in 1945, JW Pharmaceutical holds an original drug pipeline including Rivalo and Hemlibra, plus the IV nutrition product Winuf and OTC brand Hwakol.

DONG-A ST CO.,LTD2 shared

Dong-A ST, spun off from Dong-A Socio Holdings in 2013 and KOSPI-listed, makes prescription drugs like Growtropin, Stillen, and Bacchus.

OSANG HEALTHCARE CO.,LTD.2 shared

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

PROTIA INC.2 shared

KOSDAQ-listed in-vitro diagnostics company selling PROTIA Allergy-Q allergy diagnostic products domestically and in 80+ countries.

Sugentech, Inc.2 shared

Founded in 2011 and KOSDAQ-listed in 2019, Sugentech develops multiplex immunoblot, point-of-care, and digital healthcare diagnostics.

ASTA Co., Ltd.1 shared

Founded in 2006 and KOSDAQ-listed in 2017, ASTA develops MALDI-TOF mass spectrometry diagnostic and industrial systems.

CLASSYS Inc.1 shared

CLASSYS Inc., established in 2015 and listed on KOSDAQ, makes aesthetic medical devices using HIFU, MRF, MNRF, and laser technologies.

LabGenomics. Co., Ltd.1 shared

KOSDAQ-listed molecular genetic diagnostics company providing NGS-based non-invasive prenatal testing (NIPT) under the MomGuard brand.

NanoenTek,Inc.1 shared

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

RollingStone Co., Ltd.1 shared

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

WON TECH CO.,Ltd.1 shared

Founded in 2019 and KOSDAQ-listed the same year, WON TECH makes aesthetic laser, RF, and HIFU devices including Oligio and Picocare.

Sources and updates

Company basics
Korea Exchange · DART
Business content
Compiled from disclosure filings
AI visibility
Measured 2026-08-13

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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