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Research progress and regulatory perspectives in neoantigen immunotherapy
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Qian LI1, Yi-fei DAI2, Wei WEI1
Chinese Journal of New Drugs | 2023, 32(24) : 2483 - 2488
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Chinese Journal of New Drugs | 2023, 32(24): 2483-2488
Research progress and regulatory perspectives in neoantigen immunotherapy
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Qian LI1, Yi-fei DAI2, Wei WEI1
Affiliations
  • 1Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China
  • 2Yangtze River Delta Branch Center for Drug Evaluation and Inspection of The National Medicine Products Administration, Shanghai 201210, China
Published: 2023-12-30
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Neoantigens are a class of specific polypeptides produced by gene mutations in tumor cells, which can be expressed and processed in cells. They are subsequently presented to the cell surface by major histocompatibility complexes and recognized by T cells, thus activating the body's immune system and initiating a series of immune responses. Due to the rapid development of sequencing technology and artificial intelligence prediction methods, neoantigen-based tumor immunotherapy has emerged as a promising approach for future cancer treatment. In the era of precision medicine, neoantigen-based personalized tumor vaccines and adoptive T cell transfer therapy have shown encouraging results in the treatment of malignant melanoma, brain glioma and other tumors. Furthermore, the combination of neoantigens with other immunotherapies shows significant potential for application. However, as a new personalized treatment approach, its development and regulation are facing numerous challenges. In this article, we briefly introduce the research progress and regulatory status of neoantigens in order to provide reference for the research and development and regulation of neoantigens in China.

neoantigen  /  immunotherapy  /  tumor vaccine  /  precision medicine  /  regulatory challenge
Qian LI, Yi-fei DAI, Wei WEI. Research progress and regulatory perspectives in neoantigen immunotherapy[J]. Chinese Journal of New Drugs, 2023 , 32 (24) : 2483 -2488 .
Year 2023 volume 32 Issue 24
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  • Online Date:2026-03-05
  • Published:2023-12-30
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  • Accepted:2023-11-28
Affiliations
    1Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China
    2Yangtze River Delta Branch Center for Drug Evaluation and Inspection of The National Medicine Products Administration, Shanghai 201210, China
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表12种不同金属材料的力学参数

Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
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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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