????[1] 公開資料顯示,截至2025年5月29日公示獲批為止,澤尼達(dá)妥單抗是國家藥品監(jiān)督管理局唯一批準(zhǔn)用于 HER2陽性膽道癌的抗HER2雙抗。在全球范圍,澤尼達(dá)妥單抗是美國食品藥品監(jiān)督管理局(FDA)目前唯一批準(zhǔn)用于 HER2+ 膽道癌(BTC)的抗HER2雙抗,尚無其他同類產(chǎn)品獲批該適應(yīng)癥: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=補(bǔ)體依賴性細(xì)胞毒性,ACCC=抗體依賴性細(xì)胞介導(dǎo)的細(xì)胞毒作用,ADCP=抗體依賴性細(xì)胞介導(dǎo)的細(xì)胞吞噬作用