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Medical DevicesKOSPI 0120G098 approvals18 trials

Samyang Biopharm Corporation

Official website

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

As of 2026-10-10, Samyang Biopharm Corporation has 54 Korean MFDS device approvals, 44 Korean MFDS drug approvals, 5 PubMed-indexed papers on record (counted by the MAA Company Index from its own matching of public databases).

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Market cap

Business overview

Source: DART corporate disclosure

Founded and listed on KOSPI in 2025, Samyang Biopharm is a medical device, pharmaceutical, and new drug development company. Its medical device division offers biodegradable surgical sutures and absorbable hemostatic agents, its pharmaceutical division offers solid-tumor and blood-cancer anticancer drugs and patches, and its drug development division conducts R&D based on its proprietary gene therapy drug-delivery platform, SENS. For its first period (November 1 to December 31, 2025), revenue totaled KRW 28,594 million (medical devices KRW 17,868 million, pharmaceuticals KRW 10,626 million), with R&D spending of KRW 4,987 million equal to 17.44% of revenue and a total of 68 R&D achievements.

Products & technology

  • Biodegradable surgical sutureSurgical wound closure
  • Absorbable hemostatic agentWound-care hemostasis
  • Solid-tumor anticancer drugSolid tumor treatment
  • Blood-cancer anticancer drugBlood cancer treatment
  • PatchPharmaceutical patch product
  • SENS drug-delivery platformGene therapy drug delivery

Regulatory approvals

data.go.kr

44 Korean MFDS drug approvals · 1997–2024 / 54 Korean MFDS device approvals · 1996–2025

  • MFDSHemostat, internal, absorbable2025-08-08
    Product approval · Class 4제허 25-546 호
  • MFDSHemostat, internal, absorbable2025-05-27
    Product approval · Class 4제허 25-352 호
  • MFDS drugRheumastop Power Plaster(Diclofenac Sodium)2024-07-23
    Drug · OTC · Notification202401785
  • MFDSSuture, polyglecaprone2022-11-04
    Product approval · Class 4제허 22-740 호
  • MFDSPolydioxanone suture2022-11-04
    Product approval · Class 4제허 22-739 호
  • MFDS drugGemcipharm Inj.2022-10-12
    Drug · Prescription · Approval202203819
  • MFDSPolydioxanone suture2022-07-08
    Product approval · Class 4제허 22-439 호
  • MFDSGraft/prosthesis2022-03-14
    Product approval · Class 4제허 22-170 호
  • MFDSGraft/prosthesis2021-11-23
    Product approval · Class 4제허 21-941 호
  • MFDSPolydioxanone suture2021-06-21
    Product approval · Class 4제허 21-496 호
  • MFDS drugBendalid Inj. 100mg(Bendamustine hydrochloride monohydrate)2020-12-22
    Drug · Prescription · Approval202009132
  • MFDS drugBendalid Inj. 25mg(Bendamustine hydrochloride monohydrate)2020-12-22
    Drug · Prescription · Approval202009133
Show 68 more
  • MFDS drugEverose tab. 2.5mg(Everolimus)2020-07-09
    Drug · Prescription · Approval202004977
  • MFDS drugEverose tab. 5mg(Everolimus)2020-07-09
    Drug · Prescription · Approval202004978
  • MFDS drugEverose tab. 10mg(Everolimus)2020-07-09
    Drug · Prescription · Approval202004979
  • MFDSHemostat, temporary, internal, non-absorbable, gauze2020-01-09
    Product approval · Class 3제허 20-19 호
  • MFDSPolydioxanone suture2019-11-28
    Product approval · Class 4제허 19-781 호
  • MFDSPolydioxanone suture2019-11-28
    Product approval · Class 4제허 19-780 호
  • MFDSPolydioxanone suture2019-10-28
    Product approval · Class 4제허 19-682 호
  • MFDSSuture, absorbable2019-04-25
    Product approval · Class 4제허 19-266 호
  • MFDSSuture, absorbable2019-04-25
    Product approval · Class 4제허 19-264 호
  • MFDSPolydioxanone suture2018-11-29
    Product approval · Class 4제허 18-761 호
  • MFDS drugRheumastop S Plaster(Diclofenac sodium)Revoked2018-11-16
    Drug · OTC · Notification201804566
  • MFDS drugAzalid inj. 100mg(Azacitidine)2018-08-17
    Drug · Prescription · Approval201803358
  • MFDS drugDecilid inj. 40mg(Decitabine)2018-07-25
    Drug · Prescription · Approval201803088
  • MFDSPolydioxanone suture2018-06-19
    Product approval · Class 4제허 18-429 호
  • MFDSSuture, polyglecaprone2018-06-18
    Product approval · Class 4제허 18-421 호
  • MFDS drugAzalid inj. 150mg(Azacitidine)2018-05-31
    Drug · Prescription · Approval201802283
  • MFDSPolydioxanone suture2018-05-24
    Product approval · Class 4제허 18-373 호
  • MFDSPolydioxanone suture2018-05-15
    Product approval · Class 4제허 18-357 호
  • MFDSPolydioxanone suture2017-12-06
    Product approval · Class 4제허 17-920 호
  • MFDS drugLenalid tab(Lenalidomide)2017-08-14
    Drug · Prescription · Approval201706587
  • MFDS drugProtezomib inj. 2.5mg(Bortezomib trimer)2017-05-29
    Drug · Prescription · Approval201702641
  • MFDSDressing, topical hemostasis, external2017-04-12
    Product approval · Class 2제인 17-4277 호
  • MFDSDressing, topical hemostasis, external2017-04-12
    Product approval · Class 2제인 17-4276 호
  • MFDS drugPalseron inj(Palonosetron hydrochloride)2017-02-20
    Drug · Prescription · Approval201700895
  • MFDS drugProtezomib inj.(Bortezomib trimer)2015-09-21
    Drug · Prescription · Approval201506668
  • MFDSDressing, secondary treatment, occlusive, hydrogelRevoked2015-08-27
    Product approval · Class 3수허 15-1458 호
  • MFDS drugPemed S inj.(Pemetrexed disodium 2.5 hydrate)2015-05-18
    Drug · Prescription · Approval201502968
  • MFDSDressing, adhesion barrier2014-12-11
    Product approval · Class 3제허 14-2994 호
  • MFDS drugSamyang Holdings Gemcitabine inj(Gemcitabine hydrochloride)(for export)Revoked2014-09-30
    Drug · Prescription · Approval201404514
  • MFDS drugSurgiGuard Gauze(Oxidized regenerated cellulose)(Original, Fabric, Fibrillar, Non-woven)Revoked2014-09-30
    Drug · Prescription · Notification201404491
  • MFDS drugOxaliplatin inj. 5mg/ml(for export)Revoked2014-08-07
    Drug · Prescription · Approval201403662
  • MFDSSuture instrument only, reusable2014-07-04
    Product approval · Class 1서울 수신 14-1899 호
  • MFDSPolyglactin suture2014-04-14
    Product approval · Class 4제허 14-874 호
  • MFDSSuture, polyglecaprone2014-04-09
    Product approval · Class 4제허 14-828 호
  • MFDSSuture kit, absorbable2014-04-03
    Product approval · Class 4제허 14-795 호
  • MFDSSuture kit, absorbable2014-04-03
    Product approval · Class 4제허 14-796 호
  • MFDS drugSamyang Holdings Rivastigmine Patch 10(Rivastigmine)(for export)Revoked2014-02-28
    Drug · Prescription · Approval201400924
  • MFDS drugSamyang Holdings Rivastigmine Patch 5(Rivastigmine)(for export)Revoked2014-02-28
    Drug · Prescription · Approval201400925
  • MFDS drugDemencure Patch 10(Rivastigmine)Revoked2014-02-28
    Drug · Prescription · Approval201400926
  • MFDS drugDemencure Patch 5(Rivastigmine)Revoked2014-02-28
    Drug · Prescription · Approval201400927
  • MFDSMesh, polymeric, biodegradable2014-01-08
    Product approval · Class 4제허 14-77 호
  • MFDSMesh, polymeric, composite2013-11-07
    Product approval · Class 4제허 13-1890 호
  • MFDS drugPemed inj. 100mg(Pemetrexed disodium 2.5 hydrate)(for export)2013-09-03
    Drug · Prescription · Approval201309178
  • MFDSSuture, medicated2013-02-20
    Product approval · Class 4제허 13-414 호
  • MFDS drugGenexel 1 Vial Inj(Docetaxel anhydrous)(for export)2013-02-07
    Drug · Prescription · Approval201304376
  • MFDS drugNanoxel M Inj. 20mg(Docetaxel anhydrous)2012-12-26
    Drug · Prescription · Approval201210747
  • MFDS drugNanoxel M Inj. 80mg(Docetaxel anhydrous)2012-12-26
    Drug · Prescription · Approval201210748
  • MFDS drugZolenic inj. 4mg(Zoledronic acid monohydrate)2012-09-17
    Drug · Prescription · Approval201206824
  • MFDS drugPemed inj. 500mg(Pemetrexed disodium 2.5 hydrate)(for export)2012-06-13
    Drug · Prescription · Approval201205528
  • MFDSMesh, polymeric, composite2012-03-14
    Product approval · Class 4수허 12-398 호
  • MFDSLigature/mesh, incontinence2012-03-14
    Product approval · Class 3수허 12-399 호
  • MFDSDressing, adhesion barrier2011-12-23
    Product approval · Class 3제허 11-1422 호
  • MFDSSuture, medicated2011-03-07
    Product approval · Class 4제허 11-218 호
  • MFDS drugSamyang Tulobuterol Patch 0.5mg(Tulobuterol)(export name:Tulobuterol patch)(for export)Revoked2011-01-31
    Drug · Prescription · Notification201100484
  • MFDS drugSamyang Tulobuterol Patch 1mg(Tulobuterol)(export name:Tulobuterol patch)(for export)Revoked2011-01-31
    Drug · Prescription · Notification201100485
  • MFDS drugSamyang Tulobuterol Patch 2mg(Tulobuterol)(export name:Tulobuterol patch)(for export)Revoked2011-01-31
    Drug · Prescription · Notification201100486
  • MFDS drugSamyang Holdings Paclitaxel inj(for export)Revoked2009-08-07
    Drug · Prescription · Approval200906190
  • MFDS drugSamyang Holdings Gemcitabine inj. 200mg(export name:SYG Gemcitabine for Injection)(for export)Revoked2008-07-04
    Drug · Prescription · Notification200807414
  • MFDSPolyglactin suture2008-02-15
    Product approval · Class 4제허 08-78 호
  • MFDS drugNexatin inj. 5mg/ml(Oxaliplatin)2008-01-10
    Drug · Prescription · Notification200800437
  • MFDSMesh, polymeric, composite2007-07-20
    Product approval · Class 4제허 07-401 호
  • MFDSLigature/mesh, incontinenceRevoked2005-07-02
    Product approval · Class 3수허 05-583 호
  • MFDSTrocarRevoked2004-08-23
    Product approval · Class 1서울 수신 04-1622 호
  • MFDSLigature/mesh, incontinenceRevoked2004-08-21
    Product approval · Class 3수허 04-1156 호
  • MFDSPolydioxanone suture2004-03-10
    Product approval · Class 4제허 04-254 호
  • MFDS drugGenexol PM Inj. 100mg(Paclitaxel)2001-10-06
    Drug · Prescription · Approval200103890
  • MFDS봉합침Revoked2001-07-16
    Product approval · Class 1서울 수신 01-2233 호
  • MFDS봉합침Revoked2001-06-11
    Product approval · Class 1서울 수신 01-1737 호

Showing the 80 most recent of 98 records.

Clinical trials

data.go.kr

18 MFDS clinical trial authorisations · 2012–2025 (Bioequivalence 11 · Phase 1 5 · Phase 3 2)

  • BioequivalenceSYO-22482025-07-28

    1 trial site

  • BioequivalenceSYO-22482025-07-28

    1 trial site

  • Phase 1SYO-21012024-09-12

    2 trial sites

  • BioequivalenceSYO-17672021-04-30

    2 trial sites

  • BioequivalenceSYO-19872021-01-29

    1 trial site

  • Bioequivalence노프레패취10ug/h(부프레노르핀)(가칭)2020-08-20

    2 trial sites

  • Phase 3나녹셀엠주(도세탁셀무수물)2019-12-24

    7 trial sites

  • Bioequivalence노프레패취10ug/h(부프레노르핀)(가칭)2019-08-09

    2 trial sites

  • Bioequivalence노프레패취20μg/h(부프레노르핀)(가칭)2018-06-28

    2 trial sites

  • Phase 1SYO-16442018-05-24

    1 trial site

  • Bioequivalence에베리드정10밀리그램(에베로리무스)(가칭)2018-03-29

    2 trial sites

  • Phase 3나녹셀엠2016-11-07

    3 trial sites

Show 6 more
  • Bioequivalence니코스탑-20패취(니코틴)2016-10-10

    2 trial sites

  • Phase 1SYP-07092016-10-10

    4 trial sites

  • Bioequivalence삼양바이오팜레날리도마이드정25밀리그램(레날리도마이드)2016-07-22

    2 trial sites

  • Bioequivalence삼양엘로티닙정150mg2013-12-10

    2 trial sites

  • Phase 1SYP-07092013-05-09

    4 trial sites

  • Phase 1SYP-1018 (보리코나졸-PNP주)2012-03-26

    1 trial site

Global clinical trials

ClinicalTrials.gov · sponsor-matched
Show 20 more trials

R&D and key agreements

Source: DART corporate disclosure

SENS 약물전달체 플랫폼 · 유전자치료제 · 연구개발 · Proprietary gene therapy drug-delivery platform used to expand into various therapeutic areas

항암 서방성 개량신약 · 고형암/혈액암 · 연구개발 · Developing sustained-release improved anticancer oral and injectable drug technology

고분자 나노입자 기술 · 세포독성항암제 독성저감 · 연구개발 · Developing polymer nanoparticle technology to reduce cytotoxic anticancer drug toxicity

siRNA/mRNA 핵산전달 기술 · 조직선택적 핵산전달 · 연구개발 · Developing tissue-selective nucleic acid delivery technology for siRNA and mRNA

생분해성 소재 의료미용 제품 · 자가 콜라젠 유도 · 연구개발 · Developing autologous collagen-induction aesthetic medical devices using biodegradable materials

Publications

PubMed · affiliation-matched

Patents

KIPRIS · applicant-matched
Show 22 more patents

AI reads

MAA server logs · IP-verified
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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.

METABIOMED.CO.,LTD10 shared

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

HANS BIOMED CORPORATION7 shared

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

DongBang Medical Co., Ltd.6 shared

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

SEJONG MEDICAL Co.Ltd.,4 shared

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

JETEMA Co.,Ltd.4 shared

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

Hanmi Science Co.,Ltd3 shared

KOSPI-listed operating holding company of the Hanmi Pharm group, also running healthcare and pharmaceutical wholesale businesses.

SHINHUNG CO.,LTD3 shared

Founded in 1964 and KOSPI-listed in 1991, Shinhung manufactures and distributes dental equipment and materials.

T&R Biofab Co., Ltd3 shared

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

OSTEONIC Co., Ltd.3 shared

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

CG MedTech Co.,Ltd.2 shared

Founded in 1997 and KOSDAQ-listed in 2015, CG MedTech makes orthopedic medical devices and also operates an electric energy business.

Alpha AI Co.,Ltd.2 shared

Alpha AI, founded in 1995 and KOSDAQ-listed in 2000, manufactures biocompatible metal implants and surgical instruments.

BNC KOREA, Inc.2 shared

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

Sources and updates

Counts on this page are not company-reported figures. MAA matched records from DART, the Korean MFDS, the US FDA, ClinicalTrials.gov, PubMed and KIPRIS to this company itself, by business registration number or registered name, never by name similarity. They may differ from figures the company publishes.

Company basics
Korea Exchange · DART
Business content
Compiled from disclosure filings
Approvals & clinical trials
Korean MFDS (data.go.kr) · US FDA openFDA — updated weekly
Key disclosures
KRX KIND via OpenDART exchange filings — updated daily
Global clinical trials
ClinicalTrials.gov (US NIH) — sponsor-matched, updated weekly
Financials
DART corporate disclosure filings — annual
Publications
PubMed (US National Library of Medicine) — affiliation-matched, updated daily
Patents
KIPRIS (Korea Institute of Patent Information) — applicant-matched, updated monthly
AI reads
Our server logs, IP-verified every 6 hours
AI visibility
Measured 2026-10-01

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