生物医药“工业—临床”一体化平台构建研究

Research on the Construction of an “Industrial-Clinical” Integrated Platform in Biopharmaceuticals

摘要

生物医药产业是国家战略性新兴产业，其技术成果转化的效率与效能直接关系到产业竞争力和新质生产力的培育。当前，我国生物医药领域面临“实验室-中试-临床-产业”链条断裂、主体协同不畅、要素流通受阻等系统性瓶颈，大量创新成果难以跨越“死亡之谷”。本文基于创新生态与产业协同理论，系统提出构建“工业-临床”一体化平台的核心路径。研究认为，该平台应以“需求牵引、全链协同、数据驱动”为核心理念，通过机制创新整合“政产学研医金服”多元主体与全要素资源，打通从临床需求挖掘到规模化商业化的闭环。文章构建了平台的“一核三链五支撑”理论框架，剖析了“核心-网络”化运行、技术经理人驱动、数据共享等核心机制，并结合国内典型案例提出分阶段实施路径与系统性政策建议，以期为我国生物医药产业高质量发展提供管理范式与实践参考。

Abstract

The biopharmaceutical industry is a national strategic emerging industry, and the efficiency and effectiveness of its technological transformation directly impact industrial competitiveness and the cultivation of new high-quality productivity. Currently, China’s biopharmaceutical sector faces systemic bottlenecks such as fragmented “lab-scale to pilot-scale to clinical to industrial” chains, poor interorganizational collaboration, and restricted factor circulation, making it difficult for numerous innovative achievements to cross the “valley of death.” Based on the theory of innovation ecology and industrial synergy, this study systematically proposes a core pathway for building an “industrial-clinical” integrated platform. The research argues that this platform should adopt the core principles of “demand-driven, end-to-end collaboration, and data-driven innovation,” integrating diverse stakeholders (government, industry, academia, research, medicine, finance, and service) and all-factor resources through institutional innovation to establish a closed-loop system from clinical need identification to large-scale commercialization. The paper constructs a theoretical framework of “one core, three chains, and five supports” for the platform, analyzes key mechanisms such as “core-network” operation, technology manager-driven approaches, and data sharing, and proposes phased implementation strategies and systemic policy recommendations based on domestic case studies. These findings aim to provide a management paradigm and practical reference for the high-quality development of China’s biopharmaceutical industry.

关键词

生物医药 / 成果转化 / 一体化平台 / 工业-临床协同 / 创新生态

Key words

biopharmaceuticals / technology transfer / integrated platform / industry-clinical collaboration / innovation ecosystem

参考文献

[1] 中国生物工程学会. 2025年中国生物医药科技成果转化研究报告[R]. 2025.

[2] 蔡东晨. 打通科技成果转化“最后一公里”助力生物医药产业高质量发展[N/OL]. 工信部网站, 2025-06-24.

[3] 张,李. 生物医药成果转化“中试瓶颈”突破路径研究[J]. 中国科技论坛, 2024(6):89-96.

[4] 陈,王. 医工融合视角下临床-工业一体化转化平台构建[J]. 中华医学科研管理杂志, 2024, 37(2):121-125.

[5] 国家发展改革委. 全面创新改革试验百佳案例之二十六--促进医药科技成果转移转化的“华西模式”[EB/OL]. 2026-04-10.

[6] 国药中生生物技术研究院. 八个技术支撑平台全面开放,打造生物医药创新全链条赋能体系[EB/OL]. 2025-06-05.

[7] 苏州工业园区管理委员会. 从“单兵作战”到“生态协作”园区加速组建生物医药概念验证联合体[EB/OL]. 2025-12-10.

[8] 苏州工业园区管委会. 持续释放创新协同效应[EB/OL]. 2025-09-19.

[9] 北京市科学技术委员会. 诺赛基因打造CGT概念验证平台助力基因治疗创新突破[EB/OL]. 2025-10-30.

[10] 复旦大学上海医学院. 这个沙龙铺路架桥,打造临床转化“快车道”[EB/OL]. 2026-01-21.