全球监管新格局！EMA 多肽指南正式生效 助力麦科奥特创新药全球化布局

在技术要求上，指南体现了 “质量源于设计” 的核心理念，并对关键环节提出突破性要求：

1. 杂质研究深度化：强制要求对高分子量杂质（如二聚体、聚集体）进行具体鉴别与定量，摒弃以往笼统的检测报告。

2. 生产工艺灵活化：正式允许生产中的子批次合并与拆分，并将常规的“再纯化”步骤从复杂的“返工”审批中分离，赋予企业更大的合规生产灵活性。

3. 质量标准严密化：要求质量标准必须包含反离子类型及限度，并对特定工艺残留物（如氢氟酸裂解工艺中的氟化物）进行控制。

4. 注册路径澄清：指南特别明确，通过化学合成、但参照生物制品开发的肽类药物（如某些GLP-1类似物），不能通过生物类似药途径简化申报，必须证明与参照药的高度相似性。这一规定将对全球“仿制”生物药的合成肽开发者产生重大影响。

美国、中国此前已相继出台多肽药物相关指南，EMA此次行动完成了全球三大医药市场监管框架的构建。新指南虽然提高了技术门槛，确立明确、统一的规则，将极大减少企业申报过程中的不确定性，长期有助于引领助力中国多肽创新药企业，如麦科奥特这样的多功能肽创新药企业，实现从‘中国创新’到‘全球影响’的更高质量、更高效的方向发展，最终惠及全球患者。

A New Era in Global Regulation: EMA Peptide Guideline Takes Effect, Boosting MICOT’s Global Innovation Strategy

In terms of technical requirements, the guideline embodies the core concept of "Quality by Design" and introduces groundbreaking requirements for key areas:

In-depth Impurity Profiling: Mandatory specific identification and quantification of high-molecular-weight impurities (e.g., dimers, aggregates), moving away from vague detection reports used in the past.

Flexible Manufacturing Processes: Formal allowance for merging and splitting of sub-batches during production, and separation of routine "re-purification" steps from complex "reworking" approval processes, granting companies greater compliance and production flexibility.

Enhanced Quality Standards: Requirements for quality standards to include counterion types and limits, and controls for specific process residues (e.g., fluoride from hydrofluoric acid cleavage processes).

Clarified Regulatory Pathways: The guideline explicitly states that peptide drugs developed as biologics but manufactured via chemical synthesis (e.g., certain GLP-1 analogs) cannot follow the biosimilar pathway for simplified submissions. Instead, they must demonstrate high similarity to the reference drug. This provision will significantly impact developers of synthetic peptides globally that aim to "copy" biologic drugs.

Following earlier guidelines issued by the United States and China on peptide drugs, the EMA’s action completes the construction of regulatory frameworks across the three major global pharmaceutical markets. While the new guideline raises the technical threshold, establishing clear and unified rules will significantly reduce uncertainties in the corporate submission process. In the long term, this will help guide and empower innovative Chinese peptide drug companies, such as multi-functional peptide innovators like Micot, to advance from "Innovation in China" to "Global Impact" with higher quality and greater efficiency, ultimately benefiting patients worldwide.