Medical AI Alliance
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Medical DevicesKOSPI 069620376 approvals212 trials

DAEWOONG PHARMA

Official website

Founded in 2002 via spin-off from Daewoong Co. and KOSPI-listed the same year, Daewoong Pharma is known for Nabota, Fexuclue, and Enblo.

Price

Change

Market cap

Business overview

Source: DART corporate disclosure

Daewoong Pharmaceutical was established in October 2002 via spin-off from Daewoong Co., Ltd. and listed on KOSPI in November 2002 as a pharmaceutical manufacturer and distributor. Key products include the new drugs Fexuclue (Korea's 34th new drug) and Enblo (Korea's 36th new drug, an SGLT-2 inhibitor), Woorusa, and the botulinum toxin Nabota, plus digital healthcare products such as the FreeStyle Libre glucose monitor, MobiCare wearable ECG, CartBP blood pressure ring, and the Wiski AI diagnostic-assist solution. In 2025 on a separate basis, the company posted revenue of KRW 1,391.0 billion and operating profit of KRW 203.6 billion, with Nabota contributing KRW 228.9 billion in sales, about 16.5% of revenue, and roughly 84% export share.

Products & technology

  • NabotaBotulinum toxin (aesthetic toxin)
  • FexuclueKorea's 34th locally developed new drug
  • EnbloKorea's 36th new drug, SGLT-2 inhibitor
  • Woorusa
  • thynC™AI-based smart bedside monitoring system
  • FreeStyle LibreContinuous glucose monitor
  • MobiCareWearable ECG device
  • CartBPRing-type continuous blood pressure monitor
  • WiskiAI diagnostic-assist solution for blindness-causing diseases

Regulatory approvals

data.go.kr

374 Korean MFDS drug approvals · 1970–2026 / 2 Korean MFDS device approvals · 2016–2024

  • MFDS drugRuxovi tablet 20mg(Ruxolitinib Hemifumarate)2026-07-24
    Drug · Prescription · Approval202602140
  • MFDS drugRuxovi tablet 10mg(Ruxolitinib Hemifumarate)2026-07-24
    Drug · Prescription · Approval202602141
  • MFDS drugRuxovi tablet 5mg(Ruxolitinib Hemifumarate)2026-07-24
    Drug · Prescription · Approval202602142
  • MFDS drugRuxovi tablet 15mg(Ruxolitinib Hemifumarate)2026-07-24
    Drug · Prescription · Approval202602143
  • MFDS drugPancreno Tab. 250002026-06-22
    Drug · OTC · Approval202601752
  • MFDS drugBaricynaps 4mg (Baricitinib)2026-06-22
    Drug · Prescription · Approval202601753
  • MFDS drugTerbicleone Tab. 250mg2026-05-12
    Drug · Prescription · Approval202601375
  • MFDS drugNoseBalance Nasal Spray2026-04-09
    Drug · OTC · Notification202601009
  • MFDS drugEasyWhiQCream(Hydroquinone)2026-02-25
    Drug · OTC · Notification202600562
  • MFDS drugBAROEZET TAB. 1/10MG2026-01-29
    Drug · Prescription · Approval202600266
  • MFDS drugBrivatop tab.10mg(Brivaracetam)2025-09-11
    Drug · Prescription · Approval202502405
  • MFDS drugBrivatop tab.25mg(Brivaracetam)2025-09-11
    Drug · Prescription · Approval202502406
Show 68 more
  • MFDS drugBrivatop tab.50mg(Brivaracetam)2025-09-11
    Drug · Prescription · Approval202502407
  • MFDS drugBrivatop tab.100mg(Brivaracetam)2025-09-11
    Drug · Prescription · Approval202502408
  • MFDS drugEasyScaroff gel2025-07-23
    Drug · OTC · Notification202501870
  • MFDS drugEasyToningCream(Hydroquinone)2025-07-21
    Drug · OTC · Notification202501833
  • MFDS drugC-Cold Premium Tab.2025-07-10
    Drug · OTC · Notification202501737
  • MFDS drugDaewoong Miglitol Tab.2025-07-07
    Drug · Prescription · Approval202501687
  • MFDS drugXELTOFA Tab. 10mg2025-06-23
    Drug · Prescription · Approval202501539
  • MFDS drugXELTOFA Tab. 5mg2025-06-23
    Drug · Prescription · Approval202501540
  • MFDS drugFexuclue 20mg film-coated tablets2025-05-12
    Drug · Prescription · Approval202501159
  • MFDS drugBarofeno tab.2025-04-30
    Drug · Prescription · Approval202501049
  • MFDS drugCLEANCOL Tablet2025-04-28
    Drug · Prescription · Approval202501006
  • MFDS drugBonica-D Tab.2025-04-24
    Drug · OTC · Notification202500982
  • MFDS drugDaewoong Ca-D Tab.2025-04-10
    Drug · OTC · Notification202500840
  • MFDS drugImabec tablet 100mg(Imatinib mesylate)2025-03-31
    Drug · Prescription · Approval202500743
  • MFDS drugImabec tablet 400mg(Imatinib mesylate)2025-03-31
    Drug · Prescription · Approval202500744
  • MFDS drugDaewoongNicergolineTab.10mg2025-02-03
    Drug · Prescription · Approval202500213
  • MFDS drugOfild tab. 150mg2025-01-16
    Drug · Prescription · Approval202500123
  • MFDS drugOfild tab. 100mg2025-01-16
    Drug · Prescription · Approval202500124
  • MFDS drugDaewoong Ketamine injection2025-01-08
    Drug · Prescription · Approval202500061
  • MFDS drugdaewoong glutathione Tab. 100mg2024-12-31
    Drug · OTC · Notification202403110
  • MFDS drugIrricol2024-12-20
    Drug · Prescription · Approval202403036
  • MFDS drugEasy Panthenol Ointment(D-Panthenol)2024-11-28
    Drug · OTC · Notification202402822
  • MFDS drugAmitapen Injection2024-11-26
    Drug · Prescription · Approval202402794
  • MFDSSterile saline, wound irrigation2024-11-14
    Product approval · Class 2수인 24-614 호
  • MFDS drugEasy End Six Ace Tab.2024-10-18
    Drug · OTC · Notification202402457
  • MFDS drugRENCLIB tablet 75mg(Palbociclib)2024-10-07
    Drug · Prescription · Approval202402381
  • MFDS drugRENCLIB tablet 100mg(Palbociclib)2024-10-07
    Drug · Prescription · Approval202402382
  • MFDS drugRENCLIB tablet 125mg(Palbociclib)2024-10-07
    Drug · Prescription · Approval202402383
  • MFDS drugC-Cold A Tab.2024-09-09
    Drug · OTC · Notification202402181
  • MFDS drugC-Cold Night Tab.2024-09-09
    Drug · OTC · Notification202402182
  • MFDS drugBRIDEX prefiiled syringe inj.2024-08-21
    Drug · Prescription · Approval202402021
  • MFDS drugeasy clear cream2024-08-20
    Drug · OTC · Notification202402013
  • MFDS drugPeramivict Premix Injection2024-08-13
    Drug · Prescription · Approval202401970
  • MFDS drugComekina Spray2024-08-07
    Drug · OTC · Notification202401925
  • MFDS drugMobaren 5% Foam Aerosol2024-08-01
    Drug · OTC · Notification202401866
  • MFDS drugDUTARIMO2024-07-25
    Drug · Prescription · Approval202401802
  • MFDS drugGinkgoShot Focus-On Capsule2024-07-25
    Drug · OTC · Notification202401801
  • MFDS drugGluta-S Tab.2024-07-15
    Drug · OTC · Notification202401743
  • MFDS drugMagon Shot Max Liquid2024-07-02
    Drug · OTC · Notification202401605
  • MFDS drugMagon Shot Liquid2024-07-02
    Drug · OTC · Notification202401606
  • MFDS drugIrricol2024-05-31
    Drug · Prescription · Approval202401365
  • MFDS drugAPSOLA Tab.2024-04-17
    Drug · Prescription · Approval202400867
  • MFDS drugLITORVAZET tablet 10/5mg2024-03-29
    Drug · Prescription · Approval202400700
  • MFDS drugLet Eat Vi Pro One Tab.2024-03-26
    Drug · OTC · Notification202400657
  • MFDS drugRabeguard Tablet 10/600mg2024-03-06
    Drug · Prescription · Approval202400481
  • MFDS drugDaewoongNicergolineTab.30mg2024-02-29
    Drug · Prescription · Approval202400431
  • MFDS drugJuflie Topical Solution2024-02-21
    Drug · Prescription · Approval202400367
  • MFDS drugEasy End Six Eve Tab.2023-10-26
    Drug · OTC · Notification202302993
  • MFDS drugEnvlomet SR Tab. 0.3/1000mg(Enavogliflozin, Metformin Hydrochloride)2023-06-13
    Drug · Prescription · Approval202301819
  • MFDS drugRabeguard Tablet 20/600mg2023-06-08
    Drug · Prescription · Approval202301789
  • MFDS drugMacimit2023-05-26
    Drug · Prescription · Approval202301686
  • MFDS drugSevelmer Tab.2023-05-26
    Drug · Prescription · Approval202301687
  • MFDS drugImpactamin Signature2023-04-18
    Drug · OTC · Notification202301266
  • MFDS drugDaewoong Ginkgoshot Tab. 240mg2023-03-31
    Drug · OTC · Notification202301101
  • MFDS drugCold N Tab.2023-02-23
    Drug · OTC · Notification202300670
  • MFDS drugDW Calmadi Soft Cap.2023-02-13
    Drug · OTC · Notification202300522
  • MFDS drugFORXILOMET XR Tab. 10/1000mg(Dapagliflozin, Metformin)2023-01-27
    Drug · Prescription · Approval202300356
  • MFDS drugFORXILOMET XR Tab. 5/500mg(Dapagliflozin, Metformin)2023-01-18
    Drug · Prescription · Approval202300297
  • MFDS drugFORXILOMET XR Tab. 10/500mg(Dapagliflozin, Metformin)2023-01-18
    Drug · Prescription · Approval202300298
  • MFDS drugTafvir tab2023-01-12
    Drug · Prescription · Approval202300226
  • MFDS drugEnvlo 0.3 mg film-coated tablets2022-11-30
    Drug · Prescription · Approval202204314
  • MFDS drugEzn6 Night Soft capsule2022-11-22
    Drug · OTC · Notification202204213
  • MFDS drugDexahigh Tab. 4mg2022-10-31
    Drug · Prescription · Approval202203949
  • MFDS drugFexuclue 10mg film-coated tablets2022-08-18
    Drug · Prescription · Approval202203319
  • MFDS drugCrezet2022-08-04
    Drug · Prescription · Approval202203187
  • MFDS drugDaewoong Rosuvastatin Tablet 2.5mg2022-07-12
    Drug · Prescription · Approval202202878
  • MFDS drugImpactamin Once TabRevoked2022-07-06
    Drug · OTC · Notification202202797
  • MFDS drugMylanta S Suspension2022-07-05
    Drug · OTC · Notification202202795

Showing the 80 most recent of 376 records.

Clinical trials

data.go.kr

212 MFDS clinical trial authorisations · 2012–2026 (Phase 1 106 · Bioequivalence 57 · Phase 3 37 · Phase 2 7 · Extension 2)

  • BioequivalenceDWJ16402026-07-29

    2 trial sites

  • Phase 3DWP160012026-07-16
  • Phase 3DWP14012정2026-07-10
  • Phase 1DWJ16222026-07-06

    2 trial sites

  • Phase 1DWJ16222026-07-06

    2 trial sites

  • BioequivalenceDWJ17002026-06-24

    2 trial sites

  • Phase 3DWP14012정2026-06-23
  • Phase 1DWJ14542026-04-15

    2 trial sites

  • Phase 1DWJ14532026-04-14

    2 trial sites

  • Phase 1DWJ15252026-03-18

    1 trial site

  • Phase 1DWJ15252026-03-18

    1 trial site

  • Phase 3DWP160012026-03-04

    1 trial site

Show 68 more
  • BioequivalenceDWJ14832026-02-12

    2 trial sites

  • Phase 1DWJ16212026-02-02

    2 trial sites

  • Phase 1DWJ16212026-02-02

    2 trial sites

  • BioequivalenceDWJ16722025-12-16

    2 trial sites

  • Phase 1DWJ16222025-11-06

    2 trial sites

  • Phase 1DWJ16222025-10-31

    2 trial sites

  • BioequivalenceDWJ16832025-10-30

    1 trial site

  • BioequivalenceDWJ16832025-10-30

    1 trial site

  • BioequivalenceDWZ25012025-09-29

    10 trial sites

  • BioequivalenceDWJ14452025-09-22

    1 trial site

  • Phase 1DWRX50032025-09-17

    1 trial site

  • BioequivalenceDWJ16632025-08-22

    2 trial sites

  • Phase 1DWP160012025-07-24
  • BioequivalenceDWJ16402025-07-04

    2 trial sites

  • Phase 1DWJ15112025-05-28

    1 trial site

  • Phase 3DWP7122025-05-26

    3 trial sites

  • Phase 1DWJ15752025-03-04

    1 trial site

  • Phase 1DWJ15752025-03-04

    1 trial site

  • Phase 3DWJ16212024-10-11

    19 trial sites

  • Phase 1DWP160012024-10-09
  • Phase 3DWJ16222024-09-30

    20 trial sites

  • Phase 1DWRX5001GOV2024-09-06

    1 trial site

  • BioequivalenceDWJ15892024-08-20

    2 trial sites

  • Phase 1DWN12088주2024-08-09

    1 trial site

  • Phase 3DWP160012024-06-25

    8 trial sites

  • Phase 1DWP2125252024-06-25

    1 trial site

  • BioequivalenceDWJ16072024-05-13

    2 trial sites

  • Phase 1DWP14012정2024-05-09
  • BioequivalenceDWJ16152024-03-06

    2 trial sites

  • Phase 1DWP7122023-11-08

    1 trial site

  • Phase 1DWJ14312023-11-03

    1 trial site

  • Phase 1DWJ14312023-11-03

    1 trial site

  • Phase 3DWP160012023-10-13

    3 trial sites

  • Phase 3DWP14012정2023-09-26

    7 trial sites

  • Phase 1DWJ16222023-09-18

    1 trial site

  • BioequivalenceDWJ14832023-08-31

    1 trial site

  • BioequivalenceDWJ15682023-07-17

    2 trial sites

  • BioequivalenceDWJ15672023-07-17

    2 trial sites

  • BioequivalenceDWJ15432023-07-05

    2 trial sites

  • BioequivalenceDWJ15432023-07-03

    2 trial sites

  • Phase 1DWJ14542023-06-30

    1 trial site

  • Phase 1DWJ14542023-06-29

    1 trial site

  • BioequivalenceDWJ15732023-05-24

    2 trial sites

  • Phase 3DWJ16092023-05-16

    7 trial sites

  • Phase 1DWJ15752023-05-08

    1 trial site

  • Phase 1DWJ15752023-05-08

    1 trial site

  • BioequivalenceDWJ15412023-04-20

    2 trial sites

  • BioequivalenceDWJ10802023-04-03

    1 trial site

  • Bioequivalence대웅닌테다닙정(DWJ1531정)2023-02-28

    1 trial site

  • Phase 1DWP160012023-02-27
  • Phase 1DWJ16101012022-12-15

    1 trial site

  • Phase 1DWP160012022-12-14
  • Phase 1DWJ15632022-12-09

    1 trial site

  • Phase 3DWJ15752022-11-15

    28 trial sites

  • Phase 3DWP160012022-11-03

    5 trial sites

  • Phase 2DWN12088주2022-09-06

    10 trial sites

  • Phase 1DWP14012정2022-08-19
  • Phase 1DWP160012022-08-10
  • Phase 1DWP160012022-05-10

    1 trial site

  • BioequivalenceDWJ15592022-04-07

    2 trial sites

  • BioequivalenceDWJ15382022-03-02

    2 trial sites

  • Phase 1DWJ14542022-02-21

    1 trial site

  • Phase 1DWJ14542022-02-21

    1 trial site

  • Phase 1DWJ14642022-01-27

    1 trial site

  • BioequivalenceDWJ15402022-01-20

    1 trial site

  • Phase 1DWP14012정2022-01-18
  • Phase 2DWP7082022-01-17

    15 trial sites

  • Phase 1DWJ14732022-01-06

    1 trial site

Showing the 80 most recent of 212 records.

R&D and key agreements

Source: DART corporate disclosure

베르시포로신(DWN12088) · 특발성 폐섬유증 · 글로벌 임상 2상 · Designated as an orphan drug and Fast Track development program by the US FDA

세마글루타이드 마이크로니들 패치 · 비만 · 임상 1상 · Core candidate in the metabolic/obesity portfolio

DWP216 · 항암 · Anticancer candidate selected for the National New Drug Development Project

DWP220 · 중증 간 섬유증 · Oral new drug candidate in development

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Companies approved for the same productsMedical Devices

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

CLASSYS Inc.1 shared

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

JW PHARMACEUTICAL1 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.

WSI Co., Ltd.1 shared

Founded and KOSDAQ-listed in 2018, WSI distributes spine/joint devices and has expanded into medical robots and pharma via subsidiaries.

JETEMA Co.,Ltd.90

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

i-SENS, Inc.90

Founded in 2000 and KOSDAQ-listed in 2013, i-SENS makes blood glucose monitors and point-of-care testing devices.

SEJONG MEDICAL Co.Ltd.,85

Founded in 2010 and KOSDAQ-listed in 2018, Sejong Medical manufactures laparoscopic surgical instruments.

NanoenTek,Inc.85

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

Noul Co., Ltd.85

Founded in 2015 and listed on KOSDAQ in 2022, Noul develops the on-device AI diagnostic platform miLab™ for blood and cancer testing.

DRGEM CORPORATION85

KOSDAQ-listed manufacturer of diagnostic X-ray imaging systems and core components such as generators and tubes.

LabGenomics. Co., Ltd.85

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

Corentec Co., Ltd.85

Founded in 2000 and KOSDAQ-listed in 2013, Corentec makes artificial joints; hip and knee implants exceed 85% of revenue.

OSTEONIC Co., Ltd.85

Established in 2012 and listed on KOSDAQ in 2018, Osteonic manufactures implants for the CMF, Trauma, Sports Medicine, and Spine categories.

Sources and updates

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

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