DT&CRO CO., Ltd.
A full-service CRO supporting the entire drug development cycle from non-clinical studies to phase 4 clinical trials and FDA consulting.
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Business overview
Source: DART corporate disclosureFounded in 2017 and listed on KOSDAQ in 2022, DT&CRO is a full-service CRO covering pharmaceuticals, medical devices, health functional foods, cosmetics, and chemicals. It provides end-to-end drug development services from non-clinical studies (efficacy evaluation, animal alternative testing, safety/toxicity testing) through bioequivalence studies, phase 1-4 clinical trials, and U.S. FDA approval consulting, and operates an analysis center offering ADME/DMPK analysis via its PK/PD center. In 2025 revenue was KRW 47.74 billion, up 32.7% year-on-year from KRW 35.97 billion, and its in-house research institute independently developed biosimilar characterization methods for products including human growth hormone, Herceptin, and Avastin, as well as a DAR analysis method for antibody-drug conjugates (ADC).
Products & technology
- Non-clinical trial servicesEfficacy evaluation, animal alternative testing, safety/toxicity testing
- Clinical trial services (Phase 1-4)From verifying human applicability of drug candidates to post-marketing surveillance
- Analysis center services (PK/PD, ADME/DMPK)Clinical/bioequivalence sample analysis, pharmacokinetic and toxicokinetic analysis
Clinical trials
data.go.kr1 MFDS clinical trial authorisations · 2022 (Phase 1/2a 1)
- Phase 1/2aKAT-1012022-03-23
4 trial sites
R&D and key agreements
Source: DART corporate disclosure바이오시밀러 특성분석 · Established mass spectrometry-based characterization methods for originator biologics including human growth hormone, Herceptin, and Avastin
특성분석법 밸리데이션 · Validated characterization methods for specificity, precision, accuracy, and system accuracy
바이오베터 ADC 특성분석 · Established DAR (Drug-Antibody Ratio) analysis method using intact mass analysis
비임상 유효성평가 서비스 확대를 위한 영상기술 확립 · 2022.08~2023.07 · Established imaging technology for non-clinical efficacy evaluation studies for domestic approval
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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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