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Pharma & CDMOKOSDAQ 200670110 approvals2 trials

Humedix Co., Ltd.

Official website

KOSDAQ-listed aesthetics and CMO company behind the Elravie/Revolax hyaluronic-acid fillers and Leedstox botulinum toxin.

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Market cap

Business overview

Source: DART corporate disclosure

Founded in 2003 and listed on KOSDAQ in 2014, Humedix is a hyaluronic-acid-based aesthetics and CMO company. Its aesthetics division supplies the Elravie Premier and Revolax fillers, Leedstox botulinum toxin, Elravie Cosmetic skincare, and the Dermashine/Dermacne medical devices, while its CMO division manufactures arthritis treatments such as Hyhial Once, Hyhial Plus, and Hyhial injections, Prosan eye drops, and HA/PDRN/sodium-heparin raw pharmaceutical ingredients. It develops new products by combining previously approved active pharmaceutical ingredients (APIs) with biocompatible-polymer drug delivery technologies based on hyaluronic acid, PDRN, and PEG, and operates under approval standards including China's NMPA, Brazil's Anvisa, Europe's EMA, and the US FDA.

Products & technology

  • Elravie Premier (filler)Aesthetic dermal filler
  • Revolax (filler)Aesthetic dermal filler
  • Leedstox (botulinum toxin)Aesthetic botulinum toxin
  • Hyhial Once/Plus/injectionArthritis treatment
  • Prosan eye dropsOphthalmic eye-drop treatment

Regulatory approvals

data.go.kr

79 Korean MFDS drug approvals · 1996–2026 / 31 Korean MFDS device approvals · 2011–2026

  • MFDSGraft/prosthesis, biomaterial2026-04-24
    Product approval · Class 4제허 26-314 호
  • MFDSGraft/prosthesis, biomaterial2026-04-24
    Product approval · Class 4제허 26-313 호
  • MFDSGraft/prosthesis, biomaterial2026-04-22
    Product approval · Class 4제허 26-307 호
  • MFDS drugHufresh Eye drops 0.5%(Carboxymethylcellulose Sodium)(Single-dose)2026-04-02
    Drug · OTC · Notification202600945
  • MFDS drugHUAREN Eye Drops(Polydeoxyribonucelotide sodium)(Single-dose)2025-12-02
    Drug · OTC · Notification202503143
  • MFDSGraft/prosthesis, biomaterial2025-09-09
    Product approval · Class 4제허 25-618 호
  • MFDS drugCGcough Tab.2025-05-09
    Drug · Prescription · Approval202501136
  • MFDS drugGado-Q prefilled Inj.2025-03-26
    Drug · Prescription · Approval202500703
  • MFDS drugOlifit Inj.2024-12-11
    Drug · Prescription · Approval202402922
  • MFDS drughuga inj2024-07-12
    Drug · Prescription · Approval202401724
  • MFDSDressing, fluid-impermeable film2024-06-04
    Product approval · Class 2제인 24-554 호
  • MFDS drugHufresh Eye drops 1%(Carboxymethylcellulose Sodium)(Single-dose)2023-04-20
    Drug · OTC · Notification202301298
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  • MFDSGraft/prosthesis, biomaterial2022-07-06
    Product approval · Class 4제허 22-434 호
  • MFDS drugHuequa-S Eye Drops (single use)2022-06-20
    Drug · Prescription · Approval202202568
  • MFDSGraft/prosthesis, biomaterial2022-01-19
    Product approval · Class 4제허 22-37 호
  • MFDSGraft/prosthesis, biomaterial2021-11-02
    Product approval · Class 4제허 21-878 호
  • MFDSGraft/prosthesis, biomaterial2021-09-16
    Product approval · Class 4제허 21-776 호
  • MFDSDressing, fluid-impermeable film2021-04-28
    Product approval · Class 2제인 21-4359 호
  • MFDSDressing, fluid-impermeable film2021-04-27
    Product approval · Class 2제인 21-4354 호
  • MFDS drugHudaxin Inj.(Thymosin alpha-1)2021-04-19
    Drug · Prescription · Approval202103184
  • MFDS drugVivitoxin Inj. 100unit(Clostridium Botulinum Toxin Type A)2021-03-11
    Drug · Prescription · Approval202102247
  • MFDS drugHumetov Film coated Tab. 10/10mgRevoked2021-02-18
    Drug · Prescription · Approval202101576
  • MFDS drugHumetov Film coated Tab. 10/20mgRevoked2021-02-18
    Drug · Prescription · Approval202101577
  • MFDS drugHumetov Film coated Tab. 10/40mgRevoked2021-02-18
    Drug · Prescription · Approval202101578
  • MFDSGraft/prosthesis, biomaterial2020-10-08
    Product approval · Class 4제허 20-867 호
  • MFDSDressing, fluid-impermeable film2020-08-19
    Product approval · Class 2제인 20-4768 호
  • MFDS drugHumedix Sterilized Water for Injection2020-05-28
    Drug · Prescription · Notification202004005
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), immunological methodRevoked2020-05-18
    Product approval · Class 3체외 제허 20-368 호
  • MFDSGraft/prosthesis, biomaterial2020-03-23
    Product approval · Class 4제허 20-206 호
  • MFDS drugHubandron Inj.(Ibandronate Sodium Monohydrate)2020-01-29
    Drug · Prescription · Notification202000457
  • MFDSGraft/prosthesis, biomaterial2020-01-03
    Product approval · Class 4제허 20-9 호
  • MFDS drugHutadine Eye Drops 0.1%(Olopatadine Hydrochloride)2019-11-07
    Drug · Prescription · Approval201907808
  • MFDS drugHupixaban Tab. 2.5mg(Apixaban)2019-10-15
    Drug · Prescription · Approval201907267
  • MFDS drugHupixaban Tab. 5mg(Apixaban)2019-10-15
    Drug · Prescription · Approval201907268
  • MFDS drugIbufen Inj.(Ibuprofen)2019-07-18
    Drug · Prescription · Notification201904810
  • MFDS drugPiosin Tab. 15mg2019-03-19
    Drug · Prescription · Approval201901673
  • MFDS drugHumia Inj.(BDDE bridged Sodium Hyaluronate Gel)2019-03-08
    Drug · Prescription · Approval201901449
  • MFDS drugDonerin Tab. 10mg (donepezil HCl)2019-02-14
    Drug · Prescription · Approval201900918
  • MFDS drugDonerin Tab. 5mg (donepezil HCl)2019-02-14
    Drug · Prescription · Approval201900923
  • MFDS drugHulecin Eye Drops(Levofloxacin)2019-01-31
    Drug · Prescription · Notification201900775
  • MFDS drugHuclo Eye Drops(Diclofenac Sodium)2019-01-30
    Drug · Prescription · Notification201900709
  • MFDS drugHutomycin Eye Drops(Tobramycin)2019-01-30
    Drug · Prescription · Notification201900726
  • MFDS drugHuflox Eye Drops(Ofloxacin)2019-01-14
    Drug · Prescription · Notification201900158
  • MFDSGraft/prosthesis, biomaterial2019-01-08
    Product approval · Class 4제허 19-21 호
  • MFDS drugHumetholone-T Eye Drops2018-12-21
    Drug · Prescription · Notification201805225
  • MFDS drugHemetholone Eye Drops(Fluorometholone)2018-12-20
    Drug · Prescription · Notification201805186
  • MFDS drugHutofen Eye Drops(Ketotifen Fumarate)2018-12-10
    Drug · OTC · Notification201804962
  • MFDSGel for medical use, non-sterilized2018-07-30
    Product approval · Class 1제신 18-964 호
  • MFDS drugRevitalex Inj.(Polydeoxyribonucleotide Sodium)2018-04-11
    Drug · Prescription · Notification201801563
  • MFDS drugRevitalex Pre-filled Inj.(Polydeoxyribonucleotide Sodium)2018-04-11
    Drug · Prescription · Notification201801564
  • MFDS drugProsn 0.3% Eye Drops(Sodium Hyaluronate)(Single-dose)2018-01-09
    Drug · Prescription · Notification201800137
  • MFDSGraft/prosthesis, biomaterial2017-12-13
    Product approval · Class 4제허 17-941 호
  • MFDSGraft/prosthesis, biomaterial2017-12-13
    Product approval · Class 4제허 17-940 호
  • MFDS drugEivasta Tab. 10/160mg2017-07-26
    Drug · Prescription · Approval201706190
  • MFDS drugEivasta Tab. 5/80mg2017-07-24
    Drug · Prescription · Approval201706139
  • MFDS drugEivasta Tab. 5/160mg2017-07-14
    Drug · Prescription · Approval201705678
  • MFDS drugMontestal tab. 10mg (monteleukast)2017-04-24
    Drug · Prescription · Approval201702073
  • MFDS drugEitista Tab. 80/5mg2017-02-06
    Drug · Prescription · Approval201700616
  • MFDS drugEitista Tab. 40/5mg2017-02-06
    Drug · Prescription · Approval201700618
  • MFDSGraft/prosthesis, biomaterial2017-01-24
    Product approval · Class 4제허 17-73 호
  • MFDS drugHumedix Glutathione Inj. 600mg(Glutathione(Reduced))(for export)2016-12-30
    Drug · Prescription · Notification201607404
  • MFDS drugHumedix Glutathione Inj. 1200mg(Glutathione(Reduced))(for export)2016-12-28
    Drug · Prescription · Notification201607343
  • MFDS drugHusop-S Eye Drops(single use)(for export)2016-11-18
    Drug · Prescription · Notification201606673
  • MFDS drugHuniz Tiropramide HCI Tablet2015-05-27
    Drug · Prescription · Approval201503193
  • MFDS drugHuniz Aceclofenac Tablet2015-05-14
    Drug · Prescription · Approval201502927
  • MFDS drugHuniz Nizatidine Capsule 150mg2015-04-28
    Drug · Prescription · Approval201502541
  • MFDS drugHuniz Clopidogrel Bisulfate Tablet2015-04-23
    Drug · Prescription · Approval201502401
  • MFDSGraft/prosthesis, biomaterial2015-03-16
    Product approval · Class 4제허 15-362 호
  • MFDS drugSerocob cap. 200mg (celecoxib)2014-12-23
    Drug · Prescription · Approval201406030
  • MFDS drugProsan 0.15% Eye Drops(Sodium Hyaluronate)(Single-dose)2014-12-04
    Drug · Prescription · Notification201405740
  • MFDS drugHigh Hyal Plus Inj.2%(Sodium Hyaluronate)2014-07-07
    Drug · Prescription · Approval201402999
  • MFDSGraft/prosthesis, biomaterial2014-04-09
    Product approval · Class 4제허 14-830 호
  • MFDS drugKerocid Tab. (loxoprofen Na)2013-07-23
    Drug · Prescription · Approval201308352
  • MFDS drugFlucan Capsule 50mg(Fluconazole)2013-03-20
    Drug · Prescription · Approval201306321
  • MFDS drugRabena Tab. 10mg (rabeprazole)2012-11-15
    Drug · Prescription · Approval201208286
  • MFDS drugFreestar Tab. 5mg(Finasteride)2012-10-31
    Drug · Prescription · Approval201207578
  • MFDSGraft/prosthesis, biomaterial2012-09-10
    Product approval · Class 4제허 12-1158 호
  • MFDS drugHuclor cap.(Cefaclor Hydrate)2012-08-27
    Drug · Prescription · Approval201206594
  • MFDSNasal splint, external2012-07-13
    Product approval · Class 1대전 제신 12-46 호
  • MFDSGraft/prosthesis, biomaterial2012-01-25
    Product approval · Class 4제허 12-108 호

Showing the 80 most recent of 110 records.

Clinical trials

data.go.kr

2 MFDS clinical trial authorisations · 2021–2024 (Phase 3 1 · Bioequivalence 1)

  • Phase 3프로산0.3%점안액(히알루론산나트륨)(1회용)2024-05-20

    1 trial site

  • Bioequivalence휴클러캡슐(HMC3-077)2021-10-20

    2 trial sites

R&D and key agreements

Source: DART corporate disclosure

API-생체적합성 고분자(HA·PDRN·PEG) 융복합 DDS 개발전략 · Combines previously approved APIs with drug delivery technology to improve durability, reduce side effects, and develop new indications, under a Low-Cost-High-Effectiveness strategy

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.

DongKookPharmaceuticalCo.,Ltd.5 shared

KOSDAQ-listed comprehensive healthcare and pharmaceutical company behind the gum treatment Insadol and the wound-care ointment Madecassol.

PharmaResearch Co., Ltd.4 shared

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

BNC KOREA, Inc.3 shared

Founded and listed on the KOSDAQ in 2016, BNC Korea is a biohealthcare company specializing in HA fillers, botulinum toxin, and dermo-cosmetics.

CAREGEN CO.,LTD.3 shared

CAREGEN develops peptide-based cosmeceuticals sold in 130 countries and ophthalmic drug candidates CG-P5 and CG-T1.

DongBang Medical Co., Ltd.3 shared

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

HANS BIOMED CORPORATION3 shared

KOSDAQ-listed medical device company producing human tissue implants Bella Cell HD and SureFuse.

JETEMA Co.,Ltd.3 shared

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

BioPlus Co., Ltd2 shared

Founded in 2003 and KOSDAQ-listed in 2021, BioPlus develops HA-based bio medical devices and biopharmaceuticals using its proprietary MDM Technology platform.

DONGWHA PHARM.CO.,LTD2 shared

Dongwha Pharm, founded in 1897 and KOSPI-listed in 1976, is a diversified company centered on pharmaceuticals.

GC Medical Science Corporation2 shared

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

HUONS CO., LTD.2 shared

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

L&C BIO Co., Ltd2 shared

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

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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