Abstract：
Anti-CD52 monoclonal antibody had been employed in the treatment of chronic lymphoblastic leukemia and multiple sclerosis. Previously we developed a perfusion process to produce the biosimilar mAb named Mab-TH. A series of quality assessments were conducted in the fields of structural identification, purity analysis and activity measurement. After these quality researches, this report laid emphasis on preclinical pharmacology and toxicology evaluation. The Mab-TH was characterized in biological, pharmacological and toxicological properties in comparison with the original drug, Alemtuzumab. Binding activity and immune dependent toxicity as in vitro activity were evaluated. Severer immune deficient mice transplanted with human leukemia cell line were also used as in vivo pharmacological model and a four-week repeated dosing study in cynomolgus monkeys was conducted to evaluate the safety differences. Our results demonstrated that Mab-TH, the anti-CD52 antibody generated by perfusion process, had high similarity in in vitro and in vivo activities compared to Alemtuzumab in relevant preclinical models. The results supported it as a biosimilar candidate for clinical evaluation.
摘要：
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