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Pharma & CDMOKOSDAQ 308430Orphan Drug37 approvals5 trials

Cellbion Co., Ltd

Official website

Cellbion develops Lu-177-Pocuvotide, a PSMA-targeted Theranostics drug for prostate cancer diagnosis and treatment.

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Business overview

Source: DART corporate disclosure

Founded in 2010, Cellbion listed on KOSDAQ in 2024 as a radiopharmaceutical company. It supplies Cellbion Green Injection, Cellbion Mebrofenin Injection, and Dopa Tablet, while developing Lu-177-Pocuvotide, a PSMA-targeted Theranostics drug for prostate cancer diagnosis and treatment. Lu-177-Pocuvotide was selected as one of KDDF's top-10 national new drug development projects in 2023, received nonclinical and clinical R&D funding, and was designated an orphan drug in development and the 11th product under MFDS's Global Innovative product Fast Track (GIFT) program, completing domestic Phase 2 trials.

Products & technology

  • 셀비온그린주
  • 셀비온메브로페닌주
  • 도페정

Regulatory approvals

data.go.kr

1 Orphan Drug designations · 2021 / 36 Korean MFDS drug approvals · 2000–2025

  • OrphanPSMA-DGUL2021-12-27
    Orphan Drug designation · in development20210256037
  • MFDS drugEnticsa Tab. 5mg2025-12-15
    Drug · Prescription · Approval202503271
  • MFDS drugEnticsa Tab. 20mg2025-02-17
    Drug · Prescription · Approval202500341
  • MFDS drugCellbiongreen for injection2022-02-04
    Drug · Prescription · Notification202200558
  • MFDS drughumores solution2020-11-05
    Drug · OTC · Notification202007611
  • MFDS drugAreba Tab. 100mg2020-03-10
    Drug · Prescription · Approval202001633
  • MFDS drugN-talope Tab. 10mg2020-01-17
    Drug · Prescription · Approval202000260
  • MFDS drugNT-teride Tab. 5mg2020-01-14
    Drug · Prescription · Approval202000208
  • MFDS drug아세레캡슐200밀리그램(세레콕시브)2019-10-31
    Drug · Prescription · Approval201907649
  • MFDS drugAplon Tab. 4mg2019-10-22
    Drug · Prescription · Approval201907400
  • MFDS drugNT-ome Tab. 20mg2019-10-04
    Drug · Prescription · Approval201907046
  • MFDS drugNT-ome Tab. 40mg2019-10-04
    Drug · Prescription · Approval201907047
Show 25 more
  • MFDS drugEnticsa Tab. 10mg2019-10-04
    Drug · Prescription · Approval201907050
  • MFDS drug아뮤렉정50밀리그램(에페리손염산염)2019-10-02
    Drug · Prescription · Approval201907018
  • MFDS drugNT-cerein Cap. 50mg2019-09-30
    Drug · Prescription · Approval201906906
  • MFDS drug아발린캡슐150밀리그램(프레가발린)2019-09-26
    Drug · Prescription · Approval201906847
  • MFDS drug아발린캡슐75밀리그램(프레가발린)2019-09-26
    Drug · Prescription · Approval201906857
  • MFDS drugLoxopron Tab. 60mg2019-09-20
    Drug · Prescription · Approval201906583
  • MFDS drugOmepran Cap. 20mg2019-09-19
    Drug · Prescription · Approval201906572
  • MFDS drug아포그릴정100밀리그램(사르포그렐레이트염산염)2019-09-11
    Drug · Prescription · Approval201906412
  • MFDS drugFamsyntex Tab. 250mg2019-09-02
    Drug · Prescription · Approval201906212
  • MFDS drugNT-funazol Cap. 50mg2019-08-23
    Drug · Prescription · Approval201905969
  • MFDS drugNT-xicam Cap. 7.5mg2019-08-05
    Drug · Prescription · Approval201905522
  • MFDS drugSyntec Clofenac Tab. 100mg2019-08-01
    Drug · Prescription · Approval201905471
  • MFDS drugAstraset Tab.2019-07-24
    Drug · Prescription · Approval201905261
  • MFDS drugAstraset-semi Tab.2019-07-24
    Drug · Prescription · Approval201905262
  • MFDS drugSyntex Cefaclor Cap.2018-06-26
    Drug · Prescription · Approval201802642
  • MFDS drugCellbion Isotonic Sodium Chloride for Injection2017-12-11
    Drug · Prescription · Notification201708287
  • MFDS drugDope tablet 5mg2017-10-20
    Drug · Prescription · Approval201707537
  • MFDS drugDope tablet 10mg2017-10-20
    Drug · Prescription · Approval201707538
  • MFDS drugSM Gel 5%Revoked2017-05-01
    Drug · OTC · Notification201702266
  • MFDS drugSM Gel 10.56%Revoked2017-04-26
    Drug · OTC · Approval201702115
  • MFDS drugSM Cream 10.56%2015-04-30
    Drug · OTC · Approval201502630
  • MFDS drugSM Cream 9.6%2008-11-10
    Drug · OTC · Notification200810888
  • MFDS drugCellbionMebrofenin for injection2006-11-20
    Drug · Prescription · Approval200611345
  • MFDS drugCellbionSestamibi for injection2001-02-15
    Drug · Prescription · Approval200100177
  • MFDS drugSM Gel 9.6%Revoked2000-12-28
    Drug · OTC · Notification200102064

Clinical trials

data.go.kr

5 MFDS clinical trial authorisations · 2016–2025 (Phase 1 3 · Phase 1/2 1 · Phase 2 1)

  • Phase 1Lu-177-DGUL2025-09-12

    1 trial site

  • Phase 1/2Lu-177-DGUL2020-07-02

    5 trial sites

  • Phase 1Ga-68-NGUL2020-06-19

    1 trial site

  • Phase 199mTc-MSA2018-08-22

    1 trial site

  • Phase 2갈륨-68 노타-엠에스에이2016-08-04

    2 trial sites

R&D and key agreements

Source: DART corporate disclosure

Lu-177-Pocuvotide · 전립선암(PSMA 표적 Theranostics) · 국내 임상 2상 완료 · Selected as KDDF's 2023 top-10 national new drug project; designated orphan drug in development and GIFT program No. 11 by MFDS

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Sources and updates

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

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