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Clinical pharmacological research considerations for antisense oligonucleotide drugs
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Rui-rui HE1, 2, Jing WANG1, 2, Shu-jie LIU1, 2, Mei-xia LIU1, 2, Shao-dan LIU1, 2, Chun-min WEI1, 2, Min Li1, 2
Chinese Journal of Clinical Pharmacology | 2026, 42(7) : 1030 - 1034
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Chinese Journal of Clinical Pharmacology | 2026, 42(7): 1030-1034
• Drug Evaluation and Administration •
Clinical pharmacological research considerations for antisense oligonucleotide drugs
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Rui-rui HE1, 2, Jing WANG1, 2, Shu-jie LIU1, 2, Mei-xia LIU1, 2, Shao-dan LIU1, 2, Chun-min WEI1, 2, Min Li1, 2
Affiliations
  • 1.Center for Drug Evaluation, National Medical Products Administration, Beijing 100163, China
  • 2.State Key Laboratory of Drug Regulatory Science, Beijing 100163, China
Published: 2026-04-17 doi: 10.13699/j.cnki.1001-6821.2026.00.021
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As the third-generation therapeutics following small-molecule drugs and biologics, small nucleic acid drugs have become a hotspot in innovative drug research and development due to their strong targeting, unique mechanism of action, and great potential for expanded indications. They have demonstrated significant clinical value in rare diseases, cardiovascular diseases and other therapeutic areas. Antisense oligonucleotide (ASO) drugs, as a major category of small nucleic acid drugs, are driving the overall development of nucleic acid therapeutics. Clinical pharmacology research is a critical step in drug research and translational development, which directly determines the rationality of dosage, safety, and clinical efficacy of drugs. Based on the structural characteristics, mechanism of action, and research and development features of ASO drugs, this paper systematically reviews the key issues in their clinical pharmacology research, providing a reference for improving the efficiency of clinical research and development of ASO drugs in China.

antisense oligonucleotide drugs  /  clinical pharmacological research  /  dose exploration  /  pharmacokinetics  /  quantitative pharmacology
Rui-rui HE, Jing WANG, Shu-jie LIU, Mei-xia LIU, Shao-dan LIU, Chun-min WEI, Min Li. Clinical pharmacological research considerations for antisense oligonucleotide drugs[J]. Chinese Journal of Clinical Pharmacology, 2026 , 42 (7) : 1030 -1034 . DOI: 10.13699/j.cnki.1001-6821.2026.00.021
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doi: 10.13699/j.cnki.1001-6821.2026.00.021
  • Receive Date：2026-02-26
  • Online Date：2026-08-06
  • Published：2026-04-17
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History
  • Received：2026-02-26
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Affiliations
    1.Center for Drug Evaluation, National Medical Products Administration, Beijing 100163, China
    2.State Key Laboratory of Drug Regulatory Science, Beijing 100163, 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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