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Pharma & CDMOKOSDAQ 308430Orphan Drug37 approvals6 trials

Cellbion Co., Ltd

Official website

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

As of 2026-10-11, Cellbion Co., Ltd has 36 Korean MFDS drug approvals, 6 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 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

6 MFDS clinical trial authorisations · 2016–2026 (Phase 1 3 · Phase 3 1 · Phase 1/2 1 · Phase 2 1)

  • Phase 3Lu-177-DGUL2026-09-28

    5 trial sites

  • 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

Global clinical trials

ClinicalTrials.gov · sponsor-matched

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

Key disclosures

KRX KIND via OpenDART

Publications

PubMed · affiliation-matched

Patents

KIPRIS · applicant-matched
Show 9 more patents

AI reads

MAA server logs · IP-verified
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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

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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