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Radionuclide selection, conjugation strategies, and CMC considerations for quality control differences in radionuclide drug conjugates
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Yi-fei DAI, Yu-jia XIE, Tao JIANG, Zhi-jun TU, Ming-hong WANG, Feng REN*
Chinese Journal of New Drugs | 2026, 35(11) : 1138 - 1144
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Chinese Journal of New Drugs | 2026, 35(11): 1138-1144
Radionuclide selection, conjugation strategies, and CMC considerations for quality control differences in radionuclide drug conjugates
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Yi-fei DAI, Yu-jia XIE, Tao JIANG, Zhi-jun TU, Ming-hong WANG, Feng REN*
Affiliations
  • Yangtze River Delta Branch Center for Drug Evaluation and Inspection of the National Medical Products Administration, Shanghai 201210, China
Published: 2026-06-15 doi: 10.20251/j.cnki.1003-3734.2026.11.003
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Radionuclide drug conjugates (RDCs) have shown great potential in the field of nuclear medicine due to their precise targeting and radioactive killing capability. This article comprehensively reviews the selection criteria of radionuclides in RDCs and various conjugation strategies between radionuclides and targeting ligands, and provides an in-depth discussion on the differences in quality control for different radionuclides, aiming to provide a reference for the pharmaceutical research and evaluation of RDCs, and help realize their integrated precision diagnosis and treatment in more diseases.

radionuclide drug conjugates  /  conjugation strategy  /  quality control  /  pharmaceutical research
戴逸飞, 谢雨佳, 姜涛, 涂志军, 王明宏, 任峰. 放射性核素偶联药物的核素选择、偶联策略与质控差异的药学考量. 中国新药杂志, 2026 , 35 (11) : 1138 -1144 . DOI: 10.20251/j.cnki.1003-3734.2026.11.003
Yi-fei DAI, Yu-jia XIE, Tao JIANG, Zhi-jun TU, Ming-hong WANG, Feng REN. Radionuclide selection, conjugation strategies, and CMC considerations for quality control differences in radionuclide drug conjugates[J]. Chinese Journal of New Drugs, 2026 , 35 (11) : 1138 -1144 . DOI: 10.20251/j.cnki.1003-3734.2026.11.003
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Year 2026 volume 35 Issue 11
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doi: 10.20251/j.cnki.1003-3734.2026.11.003
  • Online Date：2026-10-26
  • Published：2026-06-15
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  • Accepted：2025-08-26
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    Yangtze River Delta Branch Center for Drug Evaluation and Inspection of the National Medical Products Administration, Shanghai 201210, China
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表12种不同金属材料的力学参数
科
Family		 属数
Number of
genus		 种数
Number of
species		 占总种数比例
Percentage of
total species (%)		 属
Genus		 种数
Number of
species		 占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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