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拟议的贝瓦西祖马布生物相似BAT1706和参考贝瓦西祖马布之间的物理化学和功能相似性评估

Di Cao¹, Chunping Deng¹, Guangying Wang¹

¹Bio-Thera Solutions, Ltd., Floor 5, Building A6, 11 Kai-Yuan Blvd, Huangpu District, Guangzhou, 510530, Guangdong, China.

|July 21, 2023

概括

建议使用的贝瓦齐祖马布生物类似剂BAT1706显示与欧盟/美国参考贝瓦齐祖马布具有很高的物理化学和功能相似性. 这项综合性评估支持其作为转移性结直肠癌等癌症的可比治疗选择的潜力.

科学领域:

生物化学和分子生物学
药理学和制药科学药理学和制药科学
在瘤学瘤学.

背景情况:

贝瓦西祖马布是一种生物向血管内皮生长因子A (VEGF-A),对于治疗转移性结直肠癌等癌症至关重要.
根据BAT1706的建议,它是一种与贝瓦齐祖马布生物相似的药物,需要进行严格的评估,以确认其与参考产品的相似性.
建立生物相似性涉及全面的物理化学和功能特征.

研究的目的:

与来自美国和欧盟的参考贝瓦西祖马布相比,对BAT1706进行全面的物理化学和功能相似性评估.
评估BAT1706和参考贝瓦西祖马布的关键质量属性.

主要方法:

对广泛的产品属性的表征,包括初级和更高阶结构,翻译后的修改,纯度,稳定性和强度.
利用敏感的,最先进的分析技术进行评估.
分析了多个批次的美国贝瓦西祖马布 (n=18),欧盟贝瓦西祖马布 (n=29) 和BAT1706药物 (n=10).

主要成果:

与欧盟/美国贝瓦西祖马布相比,BAT1706表现出相同的氨基酸序列和无法区分的更高阶结构.
在翻译后的修改,甘氨酸样本和充电变异中观察到相似之处.
实力是可比的,在VEGF-A结合和中和活性方面,已证明统计学上的等价性.

结论:

广泛的比较实践证实,BAT1706在所有评估的物理化学和功能属性方面与欧盟/美国贝瓦西祖马布相匹配.
这些发现支持BAT1706作为与参考贝瓦齐祖马布非常相似的生物类药物.
这些数据为BAT1706.的监管评估提供了坚实的基础.

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