Detection of recombinant erythropoietin biosimilar Jimaixin™ after administration in healthy subjects,Drug Testing and Analysis

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Detection of recombinant erythropoietin biosimilar Jimaixin™ after administration in healthy subjects
Drug Testing and Analysis ( IF 2.6 ) Pub Date : 2021-08-14 , DOI: 10.1002/dta.3143
Laurent Martin ₁ , Rafik Kafi ₁ , Xinmiao Zhou ₂ , Lisi Zhang ₂ , Magnus Ericsson ₁ , Alexandre Marchand ₁

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Jimaixin™ (Jintan Ltd, China) is a biosimilar of recombinant erythropoietin (rEPO) now authorized for therapeutic application in China. With a risk of abuse by athletes, a clear evaluation of its detection using the electrophoretic methods in use in antidoping laboratories was necessary. In a previous work, we showed that Jimaixin™ electrophoretic profile presented slight changes compared with the original drug (first generation rEPO) and that a spike of Jimaixin™ in urine and serum was well identified by SDS-PAGE but with less performance by IEF-PAGE unless a neuraminidase treatment was applied first. The aims of this research were to perform an intravenous administration of Jimaixin™ on three healthy subjects (one microdose [10 IU/kg] and three therapeutic doses [50 IU/kg]) and to evaluate the detection in urine and blood up to 7 days post administration. Analysis of the samples showed that Jimaixin™ detection was complicated by IEF-PAGE due to the loss of the most distinctive basic isoforms. In addition, a neuraminidase treatment did not improve detection (contrary to the observations from spike experiments). On the contrary, Jimaixin™ was very efficiently detected in blood and urine by SDS-PAGE: up to 40 h after a microdose and up to 7 days after the therapeutic doses. The effect of Jimaixin™ on hematological parameters was limited to a clear but transitory increase of the reticulocytes. These data give new elements to better survey a potential misuse of Jimaixin™ by athletes.

更新日期：2021-08-14

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