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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.

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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

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.

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.

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.

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.

IL DONG PHARMACEUTICAL CO., LTD.100

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

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.

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.

Medy-Tox Inc.99

Founded 2000, KOSDAQ-listed 2009, Medy-Tox develops and exports botulinum toxin biopharmaceuticals including Meditoxin and Innotox.

GC Biopharma Corp.97

KOSPI-listed comprehensive pharmaceutical company specializing in blood products and vaccines, with FDA-approved immunoglobulin ALYGLO.

BIO-FD&C CO.,LTD.85

Founded 2005, KOSDAQ-listed 2022, BIO-FD&C develops plant-cell platform-based cosmeceutical materials and biopharma pipelines.

Sources and updates

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

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