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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.

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新生抗原是由肿瘤细胞基因突变而产生的一类特异性多肽，可在细胞内表达和加工，随后被主要组织相容性复合物呈现至细胞表面，并被T细胞识别，从而激活机体的免疫系统，引起一系列免疫应答反应。随着测序技术和人工智能预测方法的快速发展，新生抗原疗法已成为未来肿瘤治疗的重要发展方向。在精准医疗的时代背景下，基于新生抗原的个体化肿瘤疫苗和过继性Ｔ细胞转移疗法在恶性黑色素瘤、脑胶质瘤等肿瘤治疗领域显示出鼓舞人心的结果，并且新生抗原联合其他免疫治疗的方案也展现出广阔的应用前景。然而，这种新兴的个体化治疗方法在充满医学前景的同时也伴随着复杂的研发、监管等挑战。本文将简要介绍新生抗原的研究进展和监管现状，以期为我国新生抗原的研发、监管等提供参考。

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李倩，女，主审审评员，主要从事生物制品药学研究。联系电话：(010)80996186，E-mail: liqian@cde.org.cn。

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李倩，女，主审审评员，主要从事生物制品药学研究。联系电话：(010)80996186，E-mail: liqian@cde.org.cn。

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