地缘政治风险下中国生物医药耗材供应链韧性的数字化重构机制Digital Reconstruction Mechanisms for Supply Chain Resilience in China's Biopharmaceutical Consumables Sector under Geopolitical Risks

Abstract

Against the backdrop of intensifying geopolitical competition and global biopharmaceutical supply chain restructuring, Chinese biopharmaceutical firms face systematic security challenges in critical production consumables. Key inputs such as single-use bioreactor bags, chromatography resins, filtration assemblies and cell culture media remain highly dependent on Western multinational suppliers. With the BIOSECURE Act incorporated into the U.S. federal legislative framework, together with export controls and friend-shoring policies, supply chain risk has shifted from a commercial efficiency issue to a strategic question of national security and industrial resilience. Drawing on resource dependence theory, normal accident theory and dynamic capabilities theory, this paper develops an integrated analytical framework and examines import dependence, tight coupling, domestic substitution barriers and digital reconstruction mechanisms in China’s biopharmaceutical consumables supply chain. It argues that digital twins, generative AI and agentic AI are evolving from tactical efficiency tools into strategic resilience infrastructure. Digital twins reduce process substitution risks through virtual validation; generative AI mitigates information asymmetry through multi-source intelligence and supply chain knowledge graphs; and agentic AI improves network reconfiguration through autonomous decision-making and compliance orchestration.

在地缘政治博弈加剧、全球生物医药产业链加速重组的背景下，中国生物医药企业正面临关键生产耗材供应安全的系统性挑战。一次性生物反应器袋、层析填料、过滤组件、细胞培养基等核心耗材长期由欧美跨国企业主导，叠加美国《生物安全法案》进入联邦法律体系、出口管制与友岸外包政策强化，供应链风险已从商业效率问题上升为国家安全与产业韧性问题。本文依据资源依赖理论、常态事故理论与动态能力理论构建整合分析框架，按照“外部风险冲击-理论机理-风险现状-数字化重构-企业落地路径”的逻辑，系统分析中国生物医药耗材供应链的进口依赖、紧密耦合与国产替代瓶颈。研究认为，数字孪生、生成式AI与代理型AI正在从战术性效率工具升级为战略性韧性基础设施：数字孪生通过工艺模拟降低替代验证风险，生成式AI通过多源情报解析与供应链知识图谱突破信息不对称，代理型AI通过自主协同决策与合规编排提升网络重组效率。不同类型企业应结合资源禀赋形成差异化路径：CDMO企业侧重全球双源与合规防御，大型药企侧重纵向整合与战略储备，初创Biotech侧重双路备份与轻量化数字运营。