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Glucagon like peptide 1 (GLP-1) can inhibit the elevation of glucagon, inhibit gastric acid secretion, and slow down gastrointestinal peristalsis. However, the plasma half-life of GLP-1 is only a few minutes to a few hours. Frequent and high-dose administration are required to achieve therapeutic effects which will increase the risk of adverse effects. Therefore, long acting is an important research interest for GLP-1 drugs. Fatty acid chain modification is the widely used long-acting strategy for GLP-1 drugs due to its advantages of definite modification sites, low heterogeneity of modified products, low loss of biological activity, and low toxic effects. To provide references for the CMC research and evaluation of fatty acid chain-modified GLP-1 drugs and other fatty acid chain-modified peptide drugs, this article shares the experience accumulated in the evaluation of fatty acid chain-modified drugs and proposes the evaluation considerations for recombinant fatty acid chain-modified GLP-1 drugs from the perspectives of raw materials for production, production processes, quality control, and stability research.

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胰高血糖素样肽1（glucagon-like peptide 1, GLP-1）具有抑制胰高血糖素升高、抑制胃酸分泌、减缓胃肠道蠕动等作用，但分子的血浆半衰期仅有几分钟到几小时，为达到治疗效果需频繁、高剂量给药，增加了不良反应发生的风险。因此，长效化是GLP-1类药物的重要研究方向。在现有的长效化策略中，脂肪酸链修饰具有修饰位点明确、修饰产物异质性低、生物学活性损失小和毒副作用小等优点，在长效GLP-1药物中广泛应用。本文将结合在实际审评中积累的对脂肪酸修饰的GLP-1类药物的审评经验，从生产用原材料、生产工艺、质量控制、稳定性研究等方面，提出对脂肪酸链修饰的重组GLP-1类药物的药学审评考虑，以期为脂肪酸链修饰的GLP-1及其他脂肪酸链修饰类多肽药物的研究和审评提供参考。

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赵靖，女，助理研究员，主要从事治疗类生物制品的药学审评工作。联系电话：(010)80996160，E-mail: zhaoj@cde.org.cn。

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赵靖，女，助理研究员，主要从事治疗类生物制品的药学审评工作。联系电话：(010)80996160，E-mail: zhaoj@cde.org.cn。

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