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In order to enhance patient compliance, subcutaneous injection (SI) is one of the important directions for differentiated development of therapeutic recombinant protein drugs (TRPDs). This has resulted in a significant rise in clinical trial applications and license applications of biologics in recent years. As for SI products, there are some special considerations in the development of formulation, excipient quality control, product quality control and stability studies compared with those of intravenous administration dosage forms, which are due to the inherent properties of TRPDs and the potential impact of high concentration formulation on product quality and stability, as well as the application of special excipients, represented by hyaluronidase. This manuscript presents a summary of the application of TRPDs in SI dosage form since 2020, discusses the special considerations in the review of chemical manufacturing and control (CMC), and the possible challenges that arise in the R&D and manufacturing process of this type of products. The objective is to offer patients new TRPD products that are safe, effective, quality-controlled, and user-friendly through the collaborative efforts of sponsors and the regulatory authority by strengthening technical communication.

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为了提高患者依从性，皮下注射剂型是治疗用重组蛋白类药物差异化开发的重要方向之一。近年来，其临床试验申请和上市申请数量显著增加。而皮下注射剂型产品因治疗用重组蛋白类药物本身的固有属性、高浓度制剂对产品质量和稳定性的潜在影响、以透明质酸酶为代表的特殊辅料的应用等因素，在制剂处方开发、辅料质量控制、制剂质量控制和稳定性研究等方面与静脉给药剂型的药学研究相比存在一些特殊考量。本文汇总了2020年以来皮下注射剂型治疗用重组蛋白类药物申报情况，对药学专业审评中的特殊考量展开讨论，并提出该类药物研发与生产过程中可能存在的挑战，以期通过研发生产机构和监管机构共同努力，强化技术交流，为患者提供安全有效、质量可控、使用便捷的新型治疗用重组蛋白类药物。

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赛文博，男，副主任药师，主要从事生物制品药学审评工作。联系电话：(010)80996158，E-mail: saiwb@cde.org.cn。

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赛文博，男，副主任药师，主要从事生物制品药学审评工作。联系电话：(010)80996158，E-mail: saiwb@cde.org.cn。

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