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Anti-tumor drug supervision in China from 2010 to 2024: the evolution and prospect of drug review standards.

作者信息

Tang Ling, Song Yuanyuan, Zhang Hong, Hao Ruimin, Tong Xin, Ai Xing, Ma Jun, Yang Zhimin

机构信息

Office of Clinical Trial Management, Center for Drug Evaluation, National Medical Products Administration, Beijing, P. R. China.

Office of Clinical Evaluation 1, Center for Drug Evaluation, National Medical Products Administration, Beijing, P. R. China.

出版信息

Cancer Commun (Lond). 2025 Jan;45(1):63-67. doi: 10.1002/cac2.12630. Epub 2024 Nov 20.

DOI:10.1002/cac2.12630
PMID:39563620
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11758239/
Abstract
摘要
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6b24/11758239/9d9c99258100/CAC2-45-63-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6b24/11758239/9d9c99258100/CAC2-45-63-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6b24/11758239/9d9c99258100/CAC2-45-63-g001.jpg

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本文引用的文献

1
Criteria and regulatory considerations for the conditional approval of innovative antitumor drugs in China: from the perspective of clinical reviewers.中国创新抗肿瘤药物附条件批准的标准及监管考量：临床审评视角
Cancer Commun (Lond). 2023 Feb;43(2):171-176. doi: 10.1002/cac2.12400. Epub 2023 Jan 22.
2
[Rethinking the marketing strategy of anti-tumor drugs by single-arm trials supported].[单臂试验支持下的抗肿瘤药物营销策略再思考]
Zhonghua Zhong Liu Za Zhi. 2022 Jun 23;44(6):587-592. doi: 10.3760/cma.j.cn112152-20210513-00376.
3
Moving pan-cancer studies from basic research toward the clinic.
将泛癌研究从基础研究推向临床。
Nat Cancer. 2021 Sep;2(9):879-890. doi: 10.1038/s43018-021-00250-4. Epub 2021 Sep 16.
4
Milestone Analyses of Immune Checkpoint Inhibitors, Targeted Therapy, and Conventional Therapy in Metastatic Non-Small Cell Lung Cancer Trials: A Meta-analysis.免疫检查点抑制剂、靶向治疗和常规治疗在转移性非小细胞肺癌试验中的里程碑分析：一项荟萃分析。
JAMA Oncol. 2017 Aug 10;3(8):e171029. doi: 10.1001/jamaoncol.2017.1029.
5
Chidamide (CS055/HBI-8000): a new histone deacetylase inhibitor of the benzamide class with antitumor activity and the ability to enhance immune cell-mediated tumor cell cytotoxicity.西达本胺（CS055/HBI-8000）：一种新型苯酰胺类组蛋白去乙酰化酶抑制剂，具有抗肿瘤活性，并能增强免疫细胞介导的肿瘤细胞细胞毒性。
Cancer Chemother Pharmacol. 2012 Apr;69(4):901-9. doi: 10.1007/s00280-011-1766-x. Epub 2011 Nov 12.