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Pharma & CDMOKOSPI 006280Orphan Drug283 approvals67 trials

GC Biopharma Corp.

Official website

KOSPI-listed comprehensive pharmaceutical company specializing in blood products and vaccines, with FDA-approved immunoglobulin ALYGLO.

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Market cap

Business overview

Source: DART corporate disclosure

Founded in 1969 and listed on KOSPI in 1989, GC Biopharma is a comprehensive pharmaceutical company centered on blood products and vaccines. Its immunoglobulin ALYGLO (10% IVIG) received U.S. FDA approval in December 2023 and launched in the U.S. market in August 2024, alongside Hunterase, the world's first intracerebroventricular (ICV) treatment for Hunter syndrome, and Green Gene F, a hemophilia treatment approved by China's NMPA in 2021. 2025 consolidated revenue was KRW 1,991.3 billion (up 18.54% year-over-year), with blood products accounting for 39.7% of sales, general pharmaceuticals 24.1%, vaccines 15.1%, OTC products 5.5%, and diagnostics/analysis 9.1%.

Products & technology

  • ALYGLO (10% IVIG)Intravenous immunoglobulin therapy
  • Varicella Vaccine (2nd generation)Varicella (chickenpox) vaccine
  • HunteraseTreatment for Hunter syndrome (ICV formulation)
  • Green Gene FHemophilia treatment

Regulatory approvals

data.go.kr

1 Orphan Drug designations · 2025 / 278 Korean MFDS drug approvals · 1974–2026 / 4 Korean MFDS device approvals · 2004–2011

  • Orphan성분명: 재조합 인간 헤파란-N-설파테이즈2025-09-04
    Orphan Drug designation · in development20250147205
  • MFDS drugCold-Lock Max total Soft capsule2026-08-04
    Drug · OTC · Notification202602255
  • MFDS drugAzelaheal Cream2026-07-29
    Drug · OTC · Notification202602196
  • MFDS drugCold-Lock Max Cough Soft capsule2026-07-29
    Drug · OTC · Notification202602197
  • MFDS drugGreennose strong Cap.2026-07-28
    Drug · OTC · Notification202602184
  • MFDS drugCold-Lock Max Nose Soft capsule2026-07-21
    Drug · OTC · Notification202602098
  • MFDS drugDaviduo ODT2026-06-30
    Drug · Prescription · Approval202601882
  • MFDS drugDaviduo ODT 10/10mg2026-06-30
    Drug · Prescription · Approval202601883
  • MFDS drugDaviduo ODT 10/5mg2026-06-30
    Drug · Prescription · Approval202601884
  • MFDS drugZenol Cool Plaster2026-05-26
    Drug · OTC · Notification202601501
  • MFDS drugTelmiSolo Tab. 20mg2026-05-20
    Drug · Prescription · Approval202601475
  • MFDS drugRozepine Tablet 5/5/10mg(amlodipine, rosuvastatin, ezetimibe)2026-04-27
    Drug · Prescription · Approval202601246
Show 68 more
  • MFDS drugRozepine Tablet 5/20/10mg(amlodipine, rosuvastatin, ezetimibe)2026-04-27
    Drug · Prescription · Approval202601247
  • MFDS drugRozepine Tablet 5/10/10mg(amlodipine, rosuvastatin, ezetimibe)2026-04-27
    Drug · Prescription · Approval202601248
  • MFDS drugRozepine Tablet 10/5/10mg(amlodipine, rosuvastatin, ezetimibe)2026-04-27
    Drug · Prescription · Approval202601249
  • MFDS drugRozepine Tablet 10/20/10mg(amlodipine, rosuvastatin, ezetimibe)2026-04-27
    Drug · Prescription · Approval202601250
  • MFDS drugRozepine Tablet 10/10/10mg(amlodipine, rosuvastatin, ezetimibe)2026-04-27
    Drug · Prescription · Approval202601251
  • MFDS drugNeovono Tab 20mg2026-02-26
    Drug · Prescription · Approval202600581
  • MFDS drugNeovono Tab 10mg2026-02-26
    Drug · Prescription · Approval202600582
  • MFDS drugTelmiDouble Tablet 20/2.5mg (telmisartan, amlodipine besylate)2026-02-26
    Drug · Prescription · Approval202600593
  • MFDS drugGoing-Long Sol.2026-02-13
    Drug · OTC · Notification202600435
  • MFDS drugCooldreamlong Tab. (Doxylamine Succinate)2026-01-30
    Drug · OTC · Notification202600284
  • MFDS drugTelmitriple Tab.80/5/25mg(telmisartan,Amlodipine,Chlorthalidone)2026-01-30
    Drug · Prescription · Approval202600285
  • MFDS drugTelmitriple Tab.80/5/12.5mg(telmisartan,Amlodipine,Chlorthalidone)2026-01-30
    Drug · Prescription · Approval202600286
  • MFDS drugTelmitriple Tab.40/5/12.5mg(telmisartan,Amlodipine,Chlorthalidone)2026-01-30
    Drug · Prescription · Approval202600287
  • MFDS drugNEOCALCIDOL Soft Cap. 0.5mcg2025-12-29
    Drug · OTC · Notification202503409
  • MFDS drugNEOCALCIDOL Soft Cap. 1mcg2025-12-29
    Drug · OTC · Notification202503410
  • MFDS drugPantheheal Ointment(D-Panthenol)2025-12-22
    Drug · OTC · Notification202503345
  • MFDS drugNeotego Tab. 50mg2025-11-20
    Drug · Prescription · Approval202503031
  • MFDS drugNeotego Tab. 25mg2025-11-20
    Drug · Prescription · Approval202503032
  • MFDS drugNeofexo Tab.180mg2025-11-12
    Drug · Prescription · Approval202502922
  • MFDS drugIbu Cough Soft Cap.2025-09-10
    Drug · OTC · Notification202502392
  • MFDS drugIbu Cold Soft Cap.2025-09-09
    Drug · OTC · Notification202502386
  • MFDS drugIbu Nose Soft Cap.2025-09-09
    Drug · OTC · Notification202502387
  • MFDS drugNeofexo Tab.120mg2025-07-29
    Drug · OTC · Notification202501961
  • MFDS drugForminempa XR tab. 12.5/1000mg(empagliflozin, metformin)2025-07-09
    Drug · Prescription · Approval202501713
  • MFDS drugForminempa XR tab. 5/1000mg(empagliflozin, metformin)2025-07-09
    Drug · Prescription · Approval202501714
  • MFDS drugForminempa XR tab. 25/1000mg(empagliflozin, metformin)2025-07-09
    Drug · Prescription · Approval202501715
  • MFDS drugForminempa XR tab. 10/1000mg(empagliflozin, metformin)2025-07-09
    Drug · Prescription · Approval202501716
  • MFDS drugForminlina SR Tab.2.5/750mg2025-04-14
    Drug · Prescription · Approval202500884
  • MFDS drugBARYTHRAX Injection2025-04-08
    Drug · Prescription · Approval202500820
  • MFDS drugNeo Cande Tab. 4mg2025-03-17
    Drug · Prescription · Approval202500590
  • MFDS drugZenol Coin Mild Plaster2025-02-07
    Drug · OTC · Notification202500259
  • MFDS drugNeofeno Tablet 48mg(Fenofibrate)2025-02-06
    Drug · Prescription · Approval202500240
  • MFDS drugNeo Cande Tab. 32mg2024-12-19
    Drug · Prescription · Approval202403022
  • MFDS drugCold-lock kids ibufen syrup2024-11-26
    Drug · OTC · Notification202402790
  • MFDS drugNeopran Tab. 50mg2024-11-06
    Drug · Prescription · Approval202402623
  • MFDS drugLinaEmpa Tab. 25/5mg2024-09-23
    Drug · Prescription · Approval202402281
  • MFDS drugLinaempa Tab. 10/5mg2024-09-23
    Drug · Prescription · Approval202402282
  • MFDS drugZenol Loxo Power Gel2024-09-09
    Drug · OTC · Notification202402194
  • MFDS drugSitadapam 5/50/1000mg SR tab.2024-07-24
    Drug · Prescription · Approval202401791
  • MFDS drugSitadapam SR tab.2024-07-24
    Drug · Prescription · Approval202401792
  • MFDS drugZenol Dampuro Tab.2024-07-23
    Drug · OTC · Notification202401775
  • MFDS druggreennose plus soft cap.2024-07-17
    Drug · OTC · Notification202401758
  • MFDS drugServer Cool S Solution2024-05-28
    Drug · OTC · Notification202401301
  • MFDS drugLinadapag2024-04-22
    Drug · Prescription · Approval202400935
  • MFDS drugcold-lock kidspen syrup2024-04-03
    Drug · OTC · Notification202400752
  • MFDS drugForminlina SR Tab.5/1000mg2024-03-29
    Drug · Prescription · Approval202400694
  • MFDS drugForminlina SR Tab.2.5/1000mg2024-03-29
    Drug · Prescription · Approval202400695
  • MFDS drugB-max Ever Premium Tab.2024-03-28
    Drug · OTC · Notification202400679
  • MFDS drugColds-Lock Nasal Spray2024-03-27
    Drug · OTC · Notification202400673
  • MFDS drugAllerjet Soft Cap2023-09-18
    Drug · OTC · Notification202302768
  • MFDS drugCol Lock Cold Syrup2023-08-11
    Drug · OTC · Notification202302414
  • MFDS drugGCbiopharma KyungOkGo2023-07-06
    Drug · OTC · Notification202302062
  • MFDS drugzenol power gel2023-05-30
    Drug · OTC · Notification202301700
  • MFDS drugTaksen acetaminophen 500mg Tablet2023-04-21
    Drug · OTC · Notification202301311
  • MFDS drugDaviduo Tab. 10/2.5mg2023-03-07
    Drug · Prescription · Approval202300774
  • MFDS drugServer Cool Gel2023-02-28
    Drug · OTC · Notification202300708
  • MFDS drugLivmarli Solution(Maralixibat Chloride)2023-02-28
    Drug · Prescription · Approval202300725
  • MFDS drugB-max Z Tab.2023-02-02
    Drug · OTC · Notification202300436
  • MFDS drugFormindapa SR Tab.10/500mg2023-01-12
    Drug · Prescription · Approval202300238
  • MFDS drugFormindapa SR Tab.10/1000mg2023-01-12
    Drug · Prescription · Approval202300239
  • MFDS drugServer Cool Easy GelRevoked2022-12-19
    Drug · OTC · Notification202204538
  • MFDS drugNeodapa Tab. 5mg2022-12-05
    Drug · Prescription · Approval202204364
  • MFDS drugCold-Lock total Soft capsule2022-08-02
    Drug · OTC · Notification202203176
  • MFDS drugCold-Lock cough Soft capsule2022-08-02
    Drug · OTC · Notification202203177
  • MFDS drugCold-Lock Nose Soft capsule2022-06-10
    Drug · OTC · Notification202202409
  • MFDS drugNeodapa Tab. 10mg2022-05-31
    Drug · Prescription · Approval202202299
  • MFDS drugRozetelpine Tab. 40/5/10/5mg2022-05-23
    Drug · Prescription · Approval202202188
  • MFDS drugRozetelpine Tab. 40/10/10/5mg2022-05-23
    Drug · Prescription · Approval202202189

Showing the 80 most recent of 283 records.

Clinical trials

data.go.kr

67 MFDS clinical trial authorisations · 2012–2026 (Phase 1 19 · Bioequivalence 14 · Phase 3 13 · Phase 2 7 · Phase 3b 3)

  • BioequivalenceGC2144A2026-07-01

    1 trial site

  • Phase 3MG11112026-07-01

    8 trial sites

  • Phase 1GC4006A2025-12-18

    3 trial sites

  • BioequivalenceGC2144A2025-12-12

    1 trial site

  • Phase 1/2GC3111B2025-03-12

    4 trial sites

  • Phase 1/2HM15421(GC1134A)2025-01-09

    2 trial sites

  • BioequivalenceGC2139A2024-11-13

    1 trial site

  • Phase 1GC1130A2024-07-10

    2 trial sites

  • Phase 1GC2133A2024-01-26

    2 trial sites

  • BioequivalenceGC2132A2023-12-28

    1 trial site

  • BioequivalenceGC2124B2023-08-02

    1 trial site

  • Phase 1GC2133A2023-07-27

    1 trial site

Show 55 more
  • BioequivalenceGC2125A2023-03-21

    1 trial site

  • Phase 1GC2129A2022-12-02

    1 trial site

  • Phase 1GC2129A2022-11-16

    1 trial site

  • Phase 3b정주용 헤파빅주(정맥주사용 B형 간염 사람면역글로불린)2022-07-20

    8 trial sites

  • Phase 1bMG11132022-04-29

    4 trial sites

  • Phase 1GC11232022-04-07

    3 trial sites

  • Phase 2MG11112021-11-09

    16 trial sites

  • BioequivalenceGC2125A2021-10-27

    1 trial site

  • BioequivalenceGC2123A2021-10-25

    2 trial sites

  • BioequivalenceGC2124A2021-10-05

    1 trial site

  • Phase 1GC21212021-06-08

    1 trial site

  • BioequivalenceGC7002 20mg2020-09-09

    1 trial site

  • Phase 2aGC51312020-08-20

    15 trial sites

  • Phase 1GC70092020-08-03

    1 trial site

  • BioequivalenceGC70012020-07-24

    1 trial site

  • BioequivalenceGC70012019-11-27

    1 trial site

  • BioequivalenceGC7002 2.5mg2019-11-26

    1 trial site

  • BioequivalenceGC7002 20mg2019-11-26

    1 trial site

  • Phase 2GC31112019-07-05

    8 trial sites

  • Phase 2a아이비-글로불린에스엔주 10%2019-05-21

    1 trial site

  • Phase 3GC31072019-02-20

    10 trial sites

  • Phase 1MG11132018-12-14

    2 trial sites

  • Phase 2aGC1102(헤파빅-진)2018-09-27

    5 trial sites

  • Phase 2GC31142018-07-25

    4 trial sites

  • Phase 3GC1111(헌터라제(이두설파제-베타))2018-02-19

    1 trial site

  • Phase 2/3GC1102(헤파빅-진)2018-01-10

    9 trial sites

  • Phase 1/2aGC11182017-12-26

    6 trial sites

  • Phase 1GC31142017-10-13

    1 trial site

  • Phase 1GC31072017-08-10

    1 trial site

  • Phase 3GC3110A2017-06-07

    13 trial sites

  • Phase 2그린진에프주2000단위(베록토코그알파)(혈액응고인자VIII,유전자재조합)2016-11-29

    2 trial sites

  • Phase 3GC1111(헌터라제(이두설파제-베타))2016-11-18

    1 trial site

  • Phase 1GC31132016-10-28
  • Phase 2MG11112016-07-14

    10 trial sites

  • Phase 3GC3110A2016-07-01

    10 trial sites

  • Phase 3b정주용헤파빅주(정맥주사용B형간염사람면역글로불린)2016-06-07
  • Phase 1GC31112016-03-25

    5 trial sites

  • Phase 3GC31062015-11-13

    9 trial sites

  • Phase 3한타박스(신증후출혈열백신)2015-07-17

    6 trial sites

  • Phase 1GC1102(헤파빅-진)2015-07-07

    1 trial site

  • Phase 3GC3110A2015-06-25

    12 trial sites

  • Phase 1MG11112014-12-18

    1 trial site

  • Phase 1GC11182014-10-28

    2 trial sites

  • Phase 3GC3110A2014-09-29

    9 trial sites

  • Phase 1/2aGC31062014-08-28

    1 trial site

  • Phase 2GC1102(헤파빅-진)2014-08-25

    1 trial site

  • Phase 2GC6101A정2014-05-13

    14 trial sites

  • Phase 1/2aGC3110A2014-03-26

    1 trial site

  • Phase 3GC11072014-03-14

    8 trial sites

  • Phase 3아이비-글로불린에스엔주 10%2014-01-14

    20 trial sites

  • Phase 3MG11092013-05-20

    4 trial sites

  • Phase 3bGC1111(헌터라제(이두설파제-베타))2012-06-07

    1 trial site

  • Phase 2bJX-5942012-04-13

    9 trial sites

  • Phase 1GC11192012-03-21

    3 trial sites

  • Phase 1GC1102(헤파빅-진)2012-02-07

    1 trial site

R&D and key agreements

Source: DART corporate disclosure

차세대 프리미엄 대상포진백신 · 대상포진 · 확장 임상 2상 진행중 · Developed through U.S. subsidiary Curevo Inc., established 2017

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.

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.

BNC KOREA, Inc.1 shared

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

DongKookPharmaceuticalCo.,Ltd.1 shared

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

DONGWHA PHARM.CO.,LTD1 shared

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

JETEMA Co.,Ltd.1 shared

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

Medy-Tox Inc.1 shared

Founded 2000, KOSDAQ-listed 2009, Medy-Tox develops and exports botulinum toxin biopharmaceuticals including Meditoxin and Innotox.

METABIOMED.CO.,LTD1 shared

KOSDAQ-listed medical device company manufacturing synthetic bioresorbable suture yarn and dental root canal filling materials.

Samyang Biopharm Corporation1 shared

Founded and KOSPI-listed in 2025, Samyang Biopharm develops medical devices, pharmaceuticals, and new drug candidates.

T&R Biofab Co., Ltd1 shared

Founded in 2013 and KOSDAQ-listed in 2018, T&R Biofab commercializes 3D bioprinting systems, bioinks, and biodegradable scaffolds.

IL DONG PHARMACEUTICAL CO., LTD.100

Founded and listed on the KOSPI in 2016, Il Dong Pharmaceutical manufactures products including the Aronamin vitamin line.

Yuyu Pharma, Inc.100

Founded in 1941 and listed on the KOSPI in 1975, Yuyu Pharma is a pharmaceutical company with a co-promotion agreement with Dong-A ST for Tanamin.

ILDONG HOLDINGS CO.,LTD100

Founded in 1941 and listed on the KOSPI in 1975, Ildong Holdings is the holding company of the Ildong Pharmaceutical Group, overseeing pharmaceutical, aesthetic medical device, and drug development affiliates.

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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