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Pharma & CDMOKOSPI 003060453 approvals37 trials

Aprogen Biologics Inc.

Official website

Aprogen Biologics develops Remicade, Rituxan, and Herceptin biosimilars and operates a world top-5 scale antibody production facility.

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Market cap

Business overview

Source: DART corporate disclosure

Founded in 1960, Aprogen Biologics listed on the KOSPI in 1984 as a synthetic and biopharmaceutical manufacturer. Its KGMP-certified plant in Hwaseong, Gyeonggi produces generic drugs across circulatory, central nervous system, digestive, and metabolic categories (KRW 57,186 million in sales), while its Osong plant in Cheongju, Chungbuk operates a world top-5 scale antibody facility capable of over 2.8 million liters of culture and 3,000kg of antibody API annually, producing biopharmaceuticals (KRW 5,575 million in sales). It holds domestic license-in agreements from Aprogen Inc. worth KRW 1.6 billion each for the Remicade biosimilar GS071 (global Phase 3 completed), the Rituxan biosimilar AP056 (preclinical completed), and the Herceptin biosimilar AP063 (global Phase 1 completed), with total sales of KRW 73,226 million and an operating loss of KRW 60,380 million.

Products & technology

  • 제네릭 의약품(순환계용약·중추신경계용약·소화기관용약·대사성의약품)
  • 바이오의약품 생산 용역

Regulatory approvals

data.go.kr

451 Korean MFDS drug approvals · 1971–2026 / 2 Korean MFDS device approvals · 2014

  • MFDS drugASECA Cream2026-08-18
    Drug · OTC · Notification202602397
  • MFDS drugMIGNEX Tablet2026-08-13
    Drug · Prescription · Approval202602375
  • MFDS drugNANICA Cream2026-08-03
    Drug · OTC · Notification202602236
  • MFDS drugLAVECA Cream2026-07-23
    Drug · Prescription · Notification202602122
  • MFDS drugActi_V Tab.2026-07-14
    Drug · OTC · Notification202602032
  • MFDS drugCituran Tab. 50mg2026-06-29
    Drug · Prescription · Approval202601843
  • MFDS drugOmecol S Tab.2026-05-18
    Drug · OTC · Notification202601433
  • MFDS drugMolbaren Cap.2026-04-21
    Drug · OTC · Notification202601156
  • MFDS drugCo-free Tab.2025-10-30
    Drug · OTC · Notification202502804
  • MFDS drugFETAVA Tab.2025-08-28
    Drug · Prescription · Approval202502259
  • MFDS drugALUANTINE Tablet2025-05-14
    Drug · OTC · Notification202501197
  • MFDS drugEmpacombi XR Tab. 10/1000mg(Empagliflozin,Metformin)2025-05-09
    Drug · Prescription · Approval202501135
Show 68 more
  • MFDS drugEmpacombi XR Tab. 25/1000mg(Empagliflozin,Metformin)2025-04-01
    Drug · Prescription · Approval202500764
  • MFDS drugBigforce SOL2025-03-04
    Drug · OTC · Notification202500471
  • MFDS drugEmpavia Tab. 25/5mg(Empagliflozin, Linagliptin)2025-02-26
    Drug · Prescription · Approval202500417
  • MFDS drugEmpavia Tab. 10/5mg(Empagliflozin, Linagliptin)2025-02-26
    Drug · Prescription · Approval202500418
  • MFDS drugLopestop Cap.2024-12-02
    Drug · OTC · Notification202402832
  • MFDS drugHaengmac Tab. 240mg2024-10-18
    Drug · OTC · Notification202402456
  • MFDS drugENDRIN capsule2024-06-25
    Drug · OTC · Notification202401529
  • MFDS drugBigchonmax-800 Tab.2024-05-24
    Drug · OTC · Notification202401284
  • MFDS drugAmantine tablet 20mg(Memantine Hydrochloride)2024-04-30
    Drug · Prescription · Approval202401047
  • MFDS drugEmpeace F Tab.2024-04-15
    Drug · OTC · Notification202400847
  • MFDS drugLinacombi XR Tab. 2.5/1000mg(Linagliptin,Metformin)2024-03-19
    Drug · Prescription · Approval202400573
  • MFDS drugLinacombi XR Tab. 5/1000mg(Linagliptin,Metformin)2024-03-19
    Drug · Prescription · Approval202400574
  • MFDS drugMZ Empeace Tab.2024-02-26
    Drug · OTC · Notification202400402
  • MFDS drugNicero Tab. 30mg(Nicergoline)2024-02-22
    Drug · Prescription · Approval202400379
  • MFDS drugLinahana Tab.2023-12-22
    Drug · Prescription · Approval202303418
  • MFDS drugOmecoF Tab.2023-12-15
    Drug · OTC · Notification202303351
  • MFDS drugIncleanS Tab.2023-11-10
    Drug · OTC · Notification202303114
  • MFDS drugDapa M duo SR Tab. 5/500mg2023-09-06
    Drug · Prescription · Approval202302655
  • MFDS drugDapa M duo SR Tab. 10/500mg2023-09-06
    Drug · Prescription · Approval202302656
  • MFDS drugEmpacombi Tab. 12.5/1000mg2023-09-06
    Drug · Prescription · Approval202302659
  • MFDS drugEmpacombi Tab. 12.5/500mg2023-09-06
    Drug · Prescription · Approval202302660
  • MFDS drugEmpacombi Tab. 12.5/850mg2023-09-06
    Drug · Prescription · Approval202302661
  • MFDS drugBigchon-800 Tab.2023-08-28
    Drug · OTC · Notification202302543
  • MFDS drugBigchon-F 600 Tab.2023-08-10
    Drug · OTC · Notification202302381
  • MFDS drugRorashot Soft Cap. (Loratadine)2023-08-09
    Drug · OTC · Notification202302370
  • MFDS drugBul-keeper Cream2023-07-26
    Drug · OTC · Notification202302258
  • MFDS drugBetaselmin Soft Cap.2023-05-09
    Drug · OTC · Notification202301486
  • MFDS drugSaengco A Soft Cap.2023-05-09
    Drug · OTC · Notification202301489
  • MFDS drugSaeng cough A Soft Cap.2023-05-09
    Drug · OTC · Notification202301490
  • MFDS drugSaengcol A Soft Cap.2023-05-09
    Drug · OTC · Notification202301491
  • MFDS drugKobico Nasal Solution2023-03-29
    Drug · OTC · Notification202301041
  • MFDS drugSockcol A Soft Cap.2023-03-22
    Drug · OTC · Notification202301007
  • MFDS drugSSock cough A Soft Cap.2023-03-21
    Drug · OTC · Notification202300976
  • MFDS drugSockco A soft cap.2023-01-31
    Drug · OTC · Notification202300393
  • MFDS drugDukafin Tab. 30/2.5mg2023-01-06
    Drug · Prescription · Approval202300085
  • MFDS drugDukafin Tab. 60/5mg2023-01-06
    Drug · Prescription · Approval202300098
  • MFDS drugDukafin Tab. 60/2.5mg2023-01-06
    Drug · Prescription · Approval202300113
  • MFDS drugApulofen Tab.2022-10-13
    Drug · OTC · Notification202203823
  • MFDS drugLCMelanin Tab2022-07-06
    Drug · OTC · Notification202202803
  • MFDS drugPamopos Tab.2022-04-21
    Drug · OTC · Notification202201650
  • MFDS drugMicasil Topical Solution2022-04-08
    Drug · OTC · Notification202201492
  • MFDS drugEmpacombi Tab. 5/500mg2022-04-04
    Drug · Prescription · Approval202201333
  • MFDS drugEmpacombi Tab. 5/850mg2022-04-04
    Drug · Prescription · Approval202201334
  • MFDS drugEmpacombi Tab. 5/1000mg2022-04-04
    Drug · Prescription · Approval202201335
  • MFDS drugDapahana Tab. 5mg2022-02-23
    Drug · Prescription · Approval202200836
  • MFDS drugBodran Cream2022-01-27
    Drug · OTC · Notification202200464
  • MFDS drugDapahana Tab. 10mg2022-01-13
    Drug · Prescription · Approval202200237
  • MFDS drugSitava-M tablet 50/850mg2022-01-12
    Drug · Prescription · Approval202200225
  • MFDS drugSitava-M tablet 50/500mg2022-01-12
    Drug · Prescription · Approval202200226
  • MFDS drugSitava-M50/1000mg2022-01-12
    Drug · Prescription · Approval202200227
  • MFDS drugDapavia Tab. 10/100mg2022-01-04
    Drug · Prescription · Approval202200054
  • MFDS drugAprogen Thymosin2021-11-29
    Drug · Prescription · Approval202107679
  • MFDS drugDapa M Tab. 10/1000mg2021-10-12
    Drug · Prescription · Approval202106874
  • MFDS drugDapa M Tab. 5/1000mg2021-10-12
    Drug · Prescription · Approval202106875
  • MFDS drugSpizyme S Tap.2021-08-10
    Drug · OTC · Notification202105844
  • MFDS drugSaengco S Soft Cap.2021-06-29
    Drug · OTC · Notification202104921
  • MFDS drugSaeng Cough S Soft Cap.2021-06-28
    Drug · OTC · Notification202104905
  • MFDS drugSaengcol S Soft Cap.2021-06-24
    Drug · OTC · Notification202104856
  • MFDS drugBicscomin F tab.2021-05-18
    Drug · OTC · Notification202103983
  • MFDS drugSock cough F Soft Cap.2021-03-29
    Drug · OTC · Notification202102731
  • MFDS drugBenfostar Tab.Revoked2021-03-26
    Drug · OTC · Notification202102684
  • MFDS drugSockcol F Soft Cap.Revoked2021-03-25
    Drug · OTC · Notification202102604
  • MFDS drugEmpahana Tab. 10mg2021-03-16
    Drug · Prescription · Approval202102373
  • MFDS drugEmpahana Tab. 25mg2021-03-16
    Drug · Prescription · Approval202102374
  • MFDS drugSockco F Soft Cap.2021-03-11
    Drug · OTC · Notification202102248
  • MFDS drugAzetam Tablet 10/40mg2021-02-18
    Drug · Prescription · Approval202101390
  • MFDS drugAzetam Tablet 10/20mg2021-02-18
    Drug · Prescription · Approval202101391
  • MFDS drugAzetam Tablet 10/10mg2021-02-18
    Drug · Prescription · Approval202101392

Showing the 80 most recent of 453 records.

Clinical trials

data.go.kr

37 MFDS clinical trial authorisations · 2012–2026 (Bioequivalence 29 · Phase 1 8)

  • Phase 1AP-26012026-04-21

    2 trial sites

  • Bioequivalence피젯탐정4/10밀리그램(피타바스타틴칼슘,에제티미브)2025-04-30

    2 trial sites

  • Bioequivalence두타탐스캡슐2025-04-14

    2 trial sites

  • Bioequivalence보노엔정20밀리그램(보노프라잔푸마르산염)2025-01-09

    2 trial sites

  • Phase 1페타바정(피타바스타틴,페노피브레이트)2024-08-09

    2 trial sites

  • Phase 1엠파콤비서방정10/1000밀리그램(엠파글리플로진,메트포르민)2024-06-10

    2 trial sites

  • Phase 1엠파콤비서방정10/1000밀리그램(엠파글리플로진,메트포르민)2024-06-05

    2 trial sites

  • Phase 1(가칭)엠파메트서방정25/1000밀리그램(엠파글리플로진,메트포르민)2024-02-08

    2 trial sites

  • Phase 1(가칭)엠파메트서방정25/1000밀리그램(엠파글리플로진,메트포르민)2024-02-06

    2 trial sites

  • Bioequivalence엠파비아정25/5밀리그램2023-12-20

    2 trial sites

  • Bioequivalence틴틴정(펜터민염산염)2023-04-17

    2 trial sites

  • Bioequivalence펜디펜정(645203630)2023-03-24

    2 trial sites

Show 25 more
  • Bioequivalence레보브론정2023-03-09

    2 trial sites

  • Phase 1리나듀오서방정5/1000밀리그램(가칭)2023-01-20

    2 trial sites

  • Phase 1리나듀오서방정5/1000밀리그램(가칭)2023-01-19

    2 trial sites

  • Bioequivalence리나하나정(리나글립틴)2022-09-01

    2 trial sites

  • Bioequivalence로젯탐정10/20밀리그램2022-04-15

    2 trial sites

  • Bioequivalence그로모정5밀리그램(피나스테리드)2022-03-07

    2 trial sites

  • BioequivalenceDSAT2022-01-27

    2 trial sites

  • BioequivalenceDSAT2022-01-25

    2 trial sites

  • Bioequivalence에이프로젠클로피도그렐정(클로피도그렐황산염)2021-09-29

    2 trial sites

  • Bioequivalence에소메라정40밀리그램(에스오메프라졸마그네슘삼수화물)2021-07-13

    2 trial sites

  • Bioequivalence로젯탐정10/10밀리그램2021-03-15

    2 trial sites

  • Bioequivalence엑사디핀정10/160밀리그램2020-09-16

    1 trial site

  • Bioequivalence라토바정20밀리그램(아토르바스타틴칼슘수화물)2020-08-31

    1 trial site

  • Bioequivalence로젯탐정10/20밀리그램2019-10-15

    2 trial sites

  • Bioequivalence아젯탐정10/40mg2019-10-14

    2 trial sites

  • Bioequivalence에이프로젠로수바스타틴칼슘정10밀리그램2019-02-11

    2 trial sites

  • Bioequivalence라토바정20밀리그램(아토르바스타틴칼슘수화물)2018-05-03

    2 trial sites

  • Bioequivalence기네스타정2017-02-08

    2 trial sites

  • Bioequivalence슈넬클래리트로마이신정500mg2016-03-31

    2 trial sites

  • Bioequivalence라토바정20밀리그램(아토르바스타틴칼슘수화물)2016-03-31

    2 trial sites

  • Bioequivalence쎄레코캡슐200mg(세레콕시브)2016-03-18

    2 trial sites

  • Bioequivalence모사프린정(모사프리드시트르산염수화물)2015-06-30

    2 trial sites

  • Bioequivalence록소프렌정(록소프로펜나트륨수화물)2015-06-10

    2 trial sites

  • Bioequivalence슈넬플루코나졸캡슐50밀리그램2015-01-15

    2 trial sites

  • Bioequivalence슈넬멜록시캄캡슐2012-01-19

    2 trial sites

R&D and key agreements

Source: DART corporate disclosure

GS071(레미케이드바이오시밀러) · 류마티스 관절염, 크론병 등 자가면역질환 · 글로벌 임상3상 완료, 일본·중남미 판매허가, 터키 품목허가 진행중 · Licensed in-country from Aprogen Inc. on 2009-08-27, total contract value KRW 1.6bn (KRW 1.1bn paid); 5% royalty on net sales

AP056(리툭산바이오시밀러) · 비임상 완료, 글로벌 임상1상 준비중 · Licensed in-country from Aprogen Inc. on 2010-01-11, total contract value KRW 1.6bn (KRW 100mn paid)

AP063(허셉틴바이오시밀러) · 글로벌 임상1상 완료, 유럽 등 품목허가 준비중 · Licensed in-country from Aprogen Inc. on 2011-08-03, total contract value KRW 1.6bn

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.

OSANG HEALTHCARE CO.,LTD.2 shared

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

NanoenTek,Inc.2 shared

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

HUMASIS CO., LTD.2 shared

KOSDAQ-listed IVD company producing COVID-19 and HIV point-of-care diagnostic reagents alongside rubber products and entertainment businesses.

Sugentech, Inc.2 shared

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

GC Medical Science Corporation2 shared

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

KWANGDONG PHARMACEUTICAL CO.,LTD2 shared

Kwangdong Pharmaceutical, founded in 1963 and KOSPI-listed in 1989, manufactures prescription drugs and beverages.

SD BIOSENSOR INC.2 shared

KOSPI-listed in-vitro diagnostics company known for the STANDARD Q antigen/antibody test kits.

Hanmi Pharm. Co., Ltd.1 shared

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

SINSIN PHARMACEUTICAL Co., LTD.1 shared

Sinsin Pharmaceutical sells medicated patches and OTC medicines through direct deals with over 13,000 pharmacies nationwide.

Precision Biosensor Inc.1 shared

KOSDAQ-listed IVD company producing time-resolved fluorescence immunodiagnostic products under the Exdia TRF brand.

CALTH. Inc1 shared

Holds manufacturing approvals for 42 point-of-care diagnostic reagents and devices in the IVD market.

VIVOZON PHARMACEUTICAL CO., LTD.1 shared

Vivozon Pharmaceutical, founded in 2002 and KOSDAQ-listed in 2005, makes ETC/OTC drugs and runs CMO/OEM businesses across about 190 items.

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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