[1] 公开资料显示,截至2025年5月29日公示获批为止,泽尼达妥单抗是国家药品监督管理局唯一批准用于 HER2阳性胆道癌的抗HER2双抗。在全球范围,泽尼达妥单抗是美国食品药品监督管理局(FDA)目前唯一批准用于 HER2+ 胆道癌(BTC)的抗HER2双抗,尚无其他同类产品获批该适应症:https://investor.jazzpharma.com/news-releases/news-release-details/jazz-pharmaceuticals-announces-us-fda-approval-ziiherar
[2] Bingfeng Han, Rongshou Zheng, Hongmei Zeng, et al. Cancer incidence and mortality in China, 2022. JNatl Cancer Cent. 2024 Feb 2;4(1):47-53.
[3] Banales JM, Marin JJG, Lamarca A, et al. Cholangiocarcinoma 2020: the next horizon in mechanisms and management. Nat Rev Gastroenterol Hepatol. 2020 Sep;17(9):557-588
[4] Valle J, Wasan H, Palmer DH, et al. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med. 2010; 362: 1273–81.
[5] CDC=补体依赖性细胞毒性,ACCC=抗体依赖性细胞介导的细胞毒作用,ADCP=抗体依赖性细胞介导的细胞吞噬作用