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Pharma & CDMOKOSPI 0631608 approvals4 trials

CKD Bio Corp.

Official website

Spun off from Chong Kun Dang in 2001, CKD Bio is a fermentation and biotech company spanning APIs, probiotics, microbiome, and botulinum toxin.

As of 2026-10-08, CKD Bio Corp. has 2 Korean MFDS device approvals, 6 Korean MFDS drug approvals, 10 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

Spun off from Chong Kun Dang as its API business division in November 2001 and listed the same year, CKD Bio is a fermentation and biotech company and a core affiliate of the Chong Kun Dang Group. It produces active pharmaceutical ingredients including antibiotics (Rifampicin, cephalosporins), the beta-lactamase inhibitor Potassium Clavulanate, the diabetes drug Acarbose, and the immunosuppressants Cyclosporin A and Tacrolimus, along with probiotics and the botulinum toxin product Timevers (100- and 200-unit, approved by Korea's MFDS in 2025), and it operates the CYMRC microbiome research center with Yonsei University Health System. Operating three production sites in Ansan, Osong, and Yesan, it supplies products to about 40 countries worldwide, with product-group revenue shares of 59.2% for antibiotics, 12.1% for immunosuppressants, 11.1% for probiotics, and 4.3% for cardiovascular agents.

Products & technology

  • Potassium ClavulanateBeta-lactamase inhibitor (enhances penicillin antibiotic efficacy)
  • DMCTRaw material for the tetracycline antibiotic minocycline
  • Rifamycin OIntermediate for rifaximin, used for IBS, hepatic encephalopathy, and traveler's diarrhea
  • TeicoplaninAntibiotic
  • AcarboseType 2 diabetes treatment
  • ProbioticsHealth functional food ingredients and finished products
  • Timevers Inj. 100/200 unitsBotulinum toxin product (glabellar line indication)

Regulatory approvals

data.go.kr

6 Korean MFDS drug approvals · 2022–2026 / 2 Korean MFDS device approvals · 2014

  • MFDS drugLabi Cap Capsule2026-02-11
    Drug · OTC · Notification202600393
  • MFDS drugTYEMVERS for Injection 200 Units(Clostridium Botulinum Toxin Type A)2025-09-16
    Drug · Prescription · Approval202502453
  • MFDS drugTYEMVERS for Injection 100 Units(Clostridium Botulinum Toxin Type A)2025-03-31
    Drug · Prescription · Approval202500753
  • MFDS drugTYEMVERS L for Injection (Clostridium botulinum Toxin Type A) (For Export)Revoked2023-03-24
    Drug · Prescription · Approval202301026
  • MFDS drugPRUVYBO for Injection 200 Units(Clostridium botulinum Toxin Type A)(for export only)2023-02-09
    Drug · Prescription · Approval202300501
  • MFDS drugPRUVYBO for Injection 100 Units(Clostridium botulinum Toxin Type A)(for export only)2022-02-09
    Drug · Prescription · Approval202200626
  • MFDSIVD reagents for Infectious disease marker(Detection of low infectivity pathogen), immunological method2014-12-19
    Product approval · Class 2체외 제인 14-3197 호
  • MFDSIVD reagents for Infectious disease marker(Detection of low infectivity pathogen), immunological method2014-12-19
    Product approval · Class 2체외 제인 14-3198 호

Clinical trials

data.go.kr

4 MFDS clinical trial authorisations · 2022–2023 (Phase 1 3 · Phase 3 1)

  • Phase 3CKDB-501A2023-03-27

    3 trial sites

  • Phase 1CKDB-501B2022-06-14

    1 trial site

  • Phase 1CKDB-501A2022-04-08

    2 trial sites

  • Phase 1CKDB-501A2022-01-18

    1 trial site

Global clinical trials

ClinicalTrials.gov · sponsor-matched

R&D and key agreements

Source: DART corporate disclosure

마이크로바이옴 신약 파이프라인 · 알츠하이머 치매, MASH(대사이상 관련 간질환) · Strengthening its pipeline through the CYMRC microbiome research center, established jointly with Yonsei University Health System.

보툴리눔톡신 균주 상용화 · 2019년 라이선스 도입, 2024년 중국 NMPA 임상3상 IND승인, 2025년 식약처 품목허가 · Licensed in a botulinum strain for commercialization from a European research institute in 2019, completed a dedicated Osong production plant (about KRW 45.7 billion invested) in 2021, and obtained export-only 100-unit product approval in 2022.

Key disclosures

KRX KIND via OpenDART

Publications

PubMed · affiliation-matched

Patents

KIPRIS · applicant-matched
Show 124 more patents

AI reads

MAA server logs · IP-verified
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Times AI engines pulled CKD Bio Corp.'s records

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Last 30 days
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All time
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  • OpenAIOAI-SearchBot31
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  • AnthropicClaudeBot2
  • GoogleGoogleOther1

Measured since Aug 27, 2026 · 4 AI engines · last read Oct 7, 2026

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Companies approved for the same productsPharma & CDMO

Ranked by how many MFDS product categories overlap. Not a ranking — a pointer to where to look.

Access Bio, Inc.1 shared

Founded in 2002 and KOSDAQ-listed in 2013, Access Bio develops rapid diagnostic tests for malaria, COVID-19, and other infectious diseases.

AHN-GOOK PHARMACEUTICAL Co., Ltd.1 shared

Ahn-Gook Pharmaceutical sells the cough/expectorant drug Sinecuran and the eye-health supplement Tobicom.

Boditech Med Inc.1 shared

KOSDAQ-listed point-of-care immunodiagnostics company supplying diagnostic cartridges and the ichroma/AFIAS instrument series.

CALTH. Inc1 shared

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

DONG-A ST CO.,LTD1 shared

Dong-A ST, spun off from Dong-A Socio Holdings in 2013 and KOSPI-listed, makes prescription drugs like Growtropin, Stillen, and Bacchus.

GC Medical Science Corporation1 shared

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

HUMASIS CO., LTD.1 shared

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

NanoenTek,Inc.1 shared

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

SD BIOSENSOR INC.1 shared

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

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.

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.

IL DONG PHARMACEUTICAL CO., LTD.100

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

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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