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Peptide drugs are a class of medical products that are important and special. However, compared with common small-molecule chemical drugs, the technical guidelines for peptide chemical drugs from regulatory agencies and international organizations are needing improvement. In this paper, we discuss some specific technical requirements for the quality research of peptide chemical generic drugs by analyzing some case studies. It is suggested that different analytical methods of orthogonal principles should be applied combined with the characteristics of the drug to explain the consistency between generic drugs and reference listed drugs, as well as the rationality of impurities control strategy, which will promote the improvement of the study and the possibility of approval.

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多肽药物是一类重要而特别的药物。但相比普通小分子化学药，目前各国监管机构和国际组织对多肽化学药物的技术要求尚不完善。本文就多肽化学仿制药质量研究的一些特殊技术要求进行探讨，通过一些案例分析提示应采用不同原理的分析方法并结合品种特点全面说明仿制药与参比制剂的一致性及杂质控制策略的合理性，以提高多肽化学仿制药的研究水平和通过率。

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王少戎，男，副研究员，主要从事药品审评工作。E-mail: wangshr@cde.org.cn。

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王少戎，男，副研究员，主要从事药品审评工作。E-mail: wangshr@cde.org.cn。

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