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哮喘是当今世界威胁公共健康的最主要的慢性肺部疾病,作为治疗中重度和难治性哮喘的特效药奥马珠单抗治疗费用相对昂贵,生物类似药CMAB007的研制可以降低治疗费用。本研究用质谱分析一种奥马珠单抗生物类似药CMAB007与原研药的一致性,分别从氨基酸分析、肽图、N/C端序列,还原质谱,寡糖含量,N糖分析等层面对CMAB007和奥马珠单抗进行了系统的比对研究,为进一步临床研究打下基础。结果表明CMAB007和奥马珠单抗氨基酸序列一致,赖氨酸剪切也基本一致,带唾液酸修饰糖形和带核心岩藻糖形比例相近,高甘露糖形比例差异不大,CMAB007略低于奥马珠单抗。因此CMAB007满足生物类似药在结构比对上一致性的要求,有望成为国内首先上市的重组抗人Ig E单克隆抗体药物。
Asthma is the most important chronic lung disease that threatens public health in the world today. Olabuzumab, a specific drug used to treat moderate-to-severe and refractory asthma, is relatively expensive to treat. The development of the biosimilar CMAB007 can reduce the cost of treatment. In this study, mass spectrometry was used to analyze the consistency of Omazumab biosimilar drug CMAB007 with the original drug. The amino acid sequence of CMAB007 And omalizumab were systematically compared to lay the foundation for further clinical research. The results showed that the amino acid sequence of CMAB007 was consistent with that of omalizumab, and the cleavage of lysine was basically the same. The ratio of sialic acid-modified glycoform and core fucose was similar to that of high-mannose, and CMAB007 was slightly lower than Omalizumab. Therefore, CMAB007 meets the requirement of biosimilars for consistency in structural alignment and is expected to be the first commercially available recombinant anti-human Ig E monoclonal antibody drug in China.