
Recently, the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China announced that Lepu Biopharma’s Class 1 new drug MRG007 has been approved for clinical trials,aiming to develop treatments for locally advanced or metastatic solid tumors.
Public information indicates that this is aCDH17-targeted antibody-drug conjugate (ADC),formed by conjugating a novel humanized IgG1 antibody with the cytotoxic agent Exatecan, featuring a balanced drug-to-antibody ratio. This differentiated design is expected to enhance anti-tumor efficacy and broaden the therapeutic window.
According to preclinical study results released by researchers, MRG007 demonstratedsignificant and dose-dependent tumor growth inhibition in various gastrointestinal tumor models and colorectal cancer models expressing CDH17. Exploratory toxicology studies showed that MRG007 exhibitedgood pharmacokinetic properties and safety tolerance.
Operations | Li Muzi

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