《生命科学》 2026, 38(2): 326-339
核药创新进展与诊疗一体化展望
摘 要：
在政策与技术的驱动下，放射性药物（核药）在全球及中国市场实现了深刻的创新跨越与技术范式演进，产品应用也从传统成熟肿瘤领域逐步向多类实体瘤及非肿瘤适应证多元化拓展。本文旨在系统梳理2025年全球及中国放射性药物（核药）领域在诊疗一体化深化背景下的关键进展与演进趋势。关键进展主要体现在三个方面：核素供应上，镥-177（177Lu）实现国产化量产突破，而锕-225（225Ac）作为下一代靶向α治疗核心核素虽仍受限于全球供应链瓶颈，已成为跨国药企战略布局焦点；临床转化上，放射性核素偶联药物（RDC）不仅巩固了在传统瘤种中的疗效优势，还针对神经内分泌分化前列腺癌（NEPC）等难治亚型开发出双靶点策略，并在心血管及神经退行性疾病等非肿瘤领域展现出探索潜力。产业生态上，我国初步构建了覆盖同位素生产、药物研发及全球交易合作的全链条布局，市场增速显著，但专业人才短缺等挑战亟待解决。据此，本文基于“突破瓶颈、强化优势、补齐短板”的发展内核，提出建议未来应着力构建稳定核素供应体系、拓展RDC多病种临床应用场景、加强交叉学科人才培养，并通过政策引导与资源整合，加速迈向基于多组学整合的个体化精准分层治疗新阶段。
通讯作者：江洪波 , Email:hbjiang@sinh.ac.cn
Abstract:
Driven by dual impetuses of supportive policies and cutting-edge technological breakthroughs, the global and Chinese radiopharmaceutical (nuclear medicine) sectors have undergone profound innovative leaps and transformative paradigm shifts in recent years. Moving beyond their traditional foothold in well-established oncology indications, radiopharmaceutical products are now expanding their utility into a diverse spectrum of solid tumors and a broad range of non-oncological therapeutic areas. This paper is dedicated to systematically sorting out and analyzing the pivotal advances and evolutionary trends shaping the global and Chinese radiopharmaceutical landscapes in 2025, against the backdrop of the deepening integration of diagnostic and therapeutic functionalities. These critical developments are manifested in three core dimensions. First, in terms of radionuclide supply, China has achieved a landmark breakthrough in the domestic mass production of lutetium-177 (177Lu), a workhorse radionuclide for targeted therapies. In contrast, actinium-225 (225Ac)—the core radionuclide underpinning next-generation targeted alpha-particle therapy—continues to face severe constraints stemming from global supply chain bottlenecks, yet it has already become a strategic focal point for multinational pharmaceutical corporations vying for competitive edges in the field. Second, regarding clinical translation, radiopharmaceutical conjugates (RDCs) have not only solidified their
proven efficacy advantages in conventional tumor types but also pioneered innovative dual-targeting strategies tailored for refractory subtypes such as neuroendocrine differentiated prostate cancer (NEPC). Moreover, RDCs are demonstrating burgeoning exploratory potential in non-oncological domains, including cardiovascular disorders and neurodegenerative diseases. Third, on the industrial ecosystem front, China has initially constructed a comprehensive full-chain layout encompassing isotope production, drug research and development, and global trade cooperation, with its domestic market witnessing exceptionally robust growth rates. Nevertheless, the industry is confronted with
pressing challenges, most notably the acute shortage of highly skilled professional talents, which demands urgent resolution. Grounded in the core development philosophy of “breaking bottlenecks, consolidating strengths, and addressing shortcomings”, this paper puts forward targeted recommendations for future development: efforts should be concentrated on establishing a stable and resilient radionuclide supply system, expanding the clinical application scenarios of RDCs across multiple disease categories, intensifying the cultivation of interdisciplinary talents, and leveraging policy guidance and resource integration to accelerate the transition toward a new era of individualized precision stratified therapy, which is underpinned by the integration of multi-omics technologies.
Communication Author：JIANG Hong-Bo , Email:hbjiang@sinh.ac.cn
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