Page 133 - 202018
P. 133

zumab and durvalumab[J]. Sci Rep,2017,7(1):5532-  [38]  国家药品监督管理局药品评审中心.受理号:CXSS1800-
             5532.                                              008[EB/OL].(2018-04-19)[2019-12-31]. http://www.
        [27]  LIU K,TAN S,CHAI Y,et al. Structural basis of an-  cde.org.cn/news.do?method=changePage&pageName=ser-
             ti-PD-L1 monoclonal antibody avelumab for tumor thera-  vice&frameStr=19/2019/03/CXSS1800008.
             py[J]. Cell Res,2017,27(1):151-153.           [39]  国家药品监督管理局药品评审中心.受理号:CXSS1800-
        [28]  MARKHAM A,DUGGAN S. Cemiplimab:first global ap-   009[EB/OL].(2018-04-23)[2019-12-31]. http://www.
             proval[J]. Drugs,2018,78(17):1841-1846.            cde.org.cn/news.do?method=changePage&pageName=ser-
        [29]  LIU H,GUO L,ZHANG J,et al. Glycosylation-indepen-  vice&frameStr=19/2019/07/CXSS18 00009
             dent binding of monoclonal antibody toripalimab to FG  [40]  FDA. Center for drug evaluation and research:applica-
             loop of PD-1 for tumor immune checkpoint therapy[J].  tion number:761034 ORIG1S000:clinical pharmacology
             MAbs,2019,11(4):681-690.                           and bio-pharmaceutics review(s)[EB/OL].(2016-05-18).
        [30]  HOY SM. Sintilimab:first global approval[J]. Drugs,  [2019-12-31]  https://www.accessdata.fda.gov/drugsatf-
             2019,79(3):341-346.                                da_docs/nda/2016/761034Orig1s000ClinPharmR.pdf.
        [31]  ANTHONY M,SUSAN JK. Camrelizumab:first global  [41]  FDA. Center for drug evaluation and research:applica-
             approval[J]. Drugs,2019,79(12):1355-1361.          tion number:761049 ORIG1S000:clinical pharmacology
        [32]  ZHANG F,QI X,WANG X,et al. Structural basis of the  and bio-pharmaceutics review(s)[EB/OL].(2017-03-
             therapeutic anti-PD-L1 antibody atezolizumab[J]. Onco-  23)[2019-12-31]. https://www.accessdata.fda.gov/drug-
             target,2017,8(52):90215-90224.                     satfda _docs/nda/2017/761049Orig1s000ClinPharmR.pdf.
        [33]  TAN S,LIU K,CHAI Y,et al. Distinct PD-L1 binding  [42]  FDA. Center for drug evaluation and research:applica-
             characteristics of therapeutic monoclonal antibody dur-  tion number:761069 ORIG1S000:clinical pharmacology
             valumab[J]. Protein Cell,2018,9(1):135-139.        and bio-pharmaceutics review(s)[EB/OL].(2017-05-01)
        [34]  FDA. Center for drug evaluation and research:applica-  [2019-12-31]. https://www.accessdata.fda.gov/drugsatf-
             tion number:125554 ORIG1S000:clinical pharmacology  da_docs/nda/2017/761069Orig1s000ClinPharmR.pdf.
             and bio-pharmaceutics review(s)[EB/OL].(2014-12-22)  [43]  岳雅丽,尹骏,高向东,等.双特异性抗体药物在肿瘤治疗
             [2019-12-31]. https://www.accessdata.fda.gov/drugsatf-  领域的研究进展[J].中国药科大学学报,2019,50(3):
             da_docs/nda/2014/125554Orig1s000ClinPharmR.pdf.    289-298.
        [35]  FDA. Center for drug evaluation and research:applica-  [44]  吴梦仪,徐雯,王洪允.固定剂量给药在抗肿瘤单抗药物
             tion number:125514 ORIG1S000:clinical pharmacology  中的选择和应用[J].中国临床药理学杂志,2019,35
             and bio-pharmaceutics review(s)[EB/OL].(2014-09-04)  (19):2471-2474.
             [2019-12-31] . https://www.accessdata.fda.gov/drugsatf-  [45]  SHI S. Biologics:an update and challenge of their pharma-
             da_docs/nda/2014/125514Orig1s000ClinPharmR.pdf.    cokinetics[J]. Curr Drug Metab,2014,15(3):271-290.
        [36]  FDA. Center for drug evaluation and research:applica-  [46]  LIU B,GUO H,XU J,et al. Acid-induced aggregation pro-
             tion number:125514 ORIG1S000:clinical pharmacology  pensity of nivolumab is dependent on the Fc[J]. MAbs,
             and bio-pharmaceutics review(s)[EB/OL].(2018-09-28).  2016,8(6):1107-1117.
             [2019-12-31]. https://www.accessdata.fda.gov/drugsatf-  [47]  LEE JW. ADME of monoclonal antibody biotherapeutics:
             da_docs/nda/2018761097Orig1s000ClinPharmR.pdf.     knowledge gaps and emerging tools[J]. Bioanalysis,2013,
        [37]  国家药品监督管理局药品评审中心.受理号:CXSS1800-                     5(16):2003-2014.
             006[EB/OL].(2018-03-20)[2019-12-31]. http://www.           (收稿日期:2020-02-25   修回日期:2020-08-19)
             cde.org.cn/news.do?method=changePage&pageName=ser-                                 (编辑:孙 冰)
             vice&frameStr=19/2019/03/CXSS18 00006.













        中国药房    2020年第31卷第18期                                            China Pharmacy 2020 Vol. 31 No. 18  ·2299  ·
   128   129   130   131   132   133   134   135   136   137   138