JOINN is the institution with the largest volume of drug carcinogenicity studies completed in China. Our carcinogenicity testing system complies with international GLP principles, and study designs are fully aligned with guidance documents from the US FDA, ICH, OECD and China NMPA. JOINN hosts a highly experienced pathology expert team for carcinogenicity studies, with abundant historical background data, profound pathological diagnostic expertise and comprehensive capability for carcinogenicity data interpretation.
Long-term Carcinogenicity Studies
•2-year rat carcinogenicity study
•2-year mouse carcinogenicity study
Short-term Carcinogenicity Study
•6-month Tg.rasH2 transgenic mouse carcinogenicity study
Rat Strains
•SD rat
•Wistar rat
Mouse Strain
•Tg.rasH2 transgenic mouse
•The first institution in China to systematically build up historical background data for 2-year rat carcinogenicity studies.
•Pioneer in China applying the Provantis LIMS system to carcinogenicity studies.
• Comprehensive standard operating procedures for carcinogenicity statistical analysis; capable of NTP- and FDA-compliant survival analysis and Poly-3 tumor analysis.
•One of China's earliest CROs performing 26-week carcinogenicity studies in Tg.rasH2 mice.
•China-leading CRO with the highest number of completed rat and transgenic-mouse carcinogenicity studies; multiple study protocols have passed FDA ECAC review.
Background: The client commissioned JOINN to conduct a 2 year SD rat carcinogenicity study to support global IND filing.
Background: Early-stage carcinogenic risk assessment was required for a biologic candidate.
Solution: A 6-month short-term carcinogenicity study was performed using the Tg.rasH2 transgenic mouse model. Rapid data collection and analysis were completed to evaluate the compound’s carcinogenic potential.
Outcome: Generated scientific evidence for subsequent R&D decision-making. The timeline was shortened by 60 % compared with conventional long-term studies, greatly improving R&D efficiency.
Solution: A customized study protocol was developed based on the generic drug’s metabolic profile, complying with EMA and NMPA guidelines. Robust technical workflows and professional pathological analysis ensured accurate and compliant data.
Outcome: The study successfully passed EMA and NMPA reviews and facilitated product launch.
