| <P style="TEXT-ALIGN: left; TEXT-INDENT: 24pt; MARGIN: 0cm 0cm 0pt; mso-line-height-alt: 0pt; mso-char-indent-count: 2.0; mso-pagination: widow-orphan" align=left><SPAN style="FONT-FAMILY: 宋体; COLOR: black; FONT-SIZE: 12pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial"><SPAN style="FONT-FAMILY: 宋体; COLOR: black; FONT-SIZE: 12pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial"></SPAN>美国</SPAN><SPAN style="FONT-FAMILY: Arial; COLOR: black; FONT-SIZE: 12pt" lang=EN-US XML:LANG="EN-US">FDA</SPAN><SPAN style="FONT-FAMILY: 宋体; COLOR: black; FONT-SIZE: 12pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">于</SPAN> <SPAN style="FONT-FAMILY: Arial; COLOR: black; FONT-SIZE: 12pt" lang=EN-US XML:LANG="EN-US">9</SPAN><SPAN style="FONT-FAMILY: 宋体; COLOR: black; FONT-SIZE: 12pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">月</SPAN><SPAN style="FONT-FAMILY: Arial; COLOR: black; FONT-SIZE: 12pt" lang=EN-US XML:LANG="EN-US">12</SPAN><SPAN style="FONT-FAMILY: 宋体; COLOR: black; FONT-SIZE: 12pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">日</SPAN><SPAN style="FONT-FAMILY: 宋体; COLOR: black; FONT-SIZE: 12pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">批准</SPAN><SPAN style="FONT-FAMILY: Arial; COLOR: black; FONT-SIZE: 12pt" lang=EN-US XML:LANG="EN-US">C 11</SPAN><SPAN style="FONT-FAMILY: 宋体; COLOR: black; FONT-SIZE: 12pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">（放射性同位素，以下简</SPAN><SPAN style="FONT-FAMILY: Arial; COLOR: black; FONT-SIZE: 12pt" lang=EN-US XML:LANG="EN-US">C 11</SPAN><SPAN style="FONT-FAMILY: 宋体; COLOR: black; FONT-SIZE: 12pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">）胆碱注射液的生产和使用，这是一种用于帮助检测复发的前列腺癌正电子发射断层扫描（</SPAN><SPAN style="FONT-FAMILY: Arial; COLOR: black; FONT-SIZE: 12pt" lang=EN-US XML:LANG="EN-US">PET</SPAN><SPAN style="FONT-FAMILY: 宋体; COLOR: black; FONT-SIZE: 12pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">）显像剂。</SPAN></P>
<P style="TEXT-ALIGN: left; TEXT-INDENT: 24pt; MARGIN: 0cm 0cm 0pt; mso-line-height-alt: 0pt; mso-char-indent-count: 2.0; mso-pagination: widow-orphan" align=left><SPAN style="FONT-FAMILY: 宋体; COLOR: black; FONT-SIZE: 12pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">胆碱</SPAN><SPAN style="FONT-FAMILY: Arial; COLOR: black; FONT-SIZE: 12pt" lang=EN-US XML:LANG="EN-US">C 11</SPAN><SPAN style="FONT-FAMILY: 宋体; COLOR: black; FONT-SIZE: 12pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">注射液通过静脉注射给药，以产生能够图像以帮助确定复发性前列腺癌患者身体的特定部位，随后作组织取样和检验。</SPAN><SPAN style="FONT-FAMILY: Arial; COLOR: black; FONT-SIZE: 12pt" lang=EN-US XML:LANG="EN-US"><BR><SPAN style="mso-spacerun: yes"><FONT face=Arial> <WBR> <WBR> <WBR></FONT></SPAN></SPAN> <SPAN style="FONT-FAMILY: 宋体; COLOR: black; FONT-SIZE: 12pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">前列腺癌早期治疗后血液中前列腺特异性抗原（</SPAN><SPAN style="FONT-FAMILY: Arial; COLOR: black; FONT-SIZE: 12pt" lang=EN-US XML:LANG="EN-US">PSA</SPAN><SPAN style="FONT-FAMILY: 宋体; COLOR: black; FONT-SIZE: 12pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">）水平升高的患者以</SPAN><SPAN style="FONT-FAMILY: Arial; COLOR: black; FONT-SIZE: 12pt" lang=EN-US XML:LANG="EN-US">C 11</SPAN><SPAN style="FONT-FAMILY: 宋体; COLOR: black; FONT-SIZE: 12pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">胆碱注射液作</SPAN><SPAN style="FONT-FAMILY: Arial; COLOR: black; FONT-SIZE: 12pt" lang=EN-US XML:LANG="EN-US">PET</SPAN><SPAN style="FONT-FAMILY: 宋体; COLOR: black; FONT-SIZE: 12pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">成像。</SPAN><SPAN style="FONT-FAMILY: 宋体; COLOR: black; FONT-SIZE: 12pt; mso-bidi-font-family: 宋体">即使传统的影像学检查，如电脑断层扫描（</SPAN><SPAN style="FONT-FAMILY: Arial; COLOR: black; FONT-SIZE: 12pt" lang=EN-US XML:LANG="EN-US">CT</SPAN><SPAN style="FONT-FAMILY: 宋体; COLOR: black; FONT-SIZE: 12pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">）没有显示出任何癌症的迹象，</SPAN><SPAN style="FONT-FAMILY: Arial; COLOR: black; FONT-SIZE: 12pt" lang=EN-US XML:LANG="EN-US">PSA</SPAN><SPAN style="FONT-FAMILY: 宋体; COLOR: black; FONT-SIZE: 12pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">升高提示前列腺癌可能已经复发。不过</SPAN><SPAN style="FONT-FAMILY: Arial; COLOR: black; FONT-SIZE: 12pt" lang=EN-US XML:LANG="EN-US">PET</SPAN><SPAN style="FONT-FAMILY: 宋体; COLOR: black; FONT-SIZE: 12pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">成像不能替代组织取样和检验。</SPAN><SPAN style="FONT-FAMILY: Arial; COLOR: black; FONT-SIZE: 12pt" lang=EN-US XML:LANG="EN-US"><BR><FONT face=Arial><SPAN style="mso-spacerun: yes"> <WBR> <WBR> <WBR></SPAN> C 11</FONT></SPAN><SPAN style="FONT-FAMILY: 宋体; COLOR: black; FONT-SIZE: 12pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">胆碱注射液必须在一个专门的设施生产和生产后短时间内使用。事实上在过去几年</SPAN><SPAN style="FONT-FAMILY: Arial; COLOR: black; FONT-SIZE: 12pt" lang=EN-US XML:LANG="EN-US">C 11</SPAN><SPAN style="FONT-FAMILY: 宋体; COLOR: black; FONT-SIZE: 12pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">胆碱注射液</SPAN><SPAN style="FONT-FAMILY: Arial; COLOR: black; FONT-SIZE: 12pt" lang=EN-US XML:LANG="EN-US">PET</SPAN><SPAN style="FONT-FAMILY: 宋体; COLOR: black; FONT-SIZE: 12pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">成像已被生产和使用，但没有一个生产实施获得过</SPAN><SPAN style="FONT-FAMILY: Arial; COLOR: black; FONT-SIZE: 12pt" lang=EN-US XML:LANG="EN-US">FDA</SPAN><SPAN style="FONT-FAMILY: 宋体; COLOR: black; FONT-SIZE: 12pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">授权。食品和药品现代化法案要求</SPAN><SPAN style="FONT-FAMILY: Arial; COLOR: black; FONT-SIZE: 12pt" lang=EN-US XML:LANG="EN-US">FDA</SPAN><SPAN style="FONT-FAMILY: 宋体; COLOR: black; FONT-SIZE: 12pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">所有在美国销售和使用的</SPAN><SPAN style="FONT-FAMILY: Arial; COLOR: black; FONT-SIZE: 12pt" lang=EN-US XML:LANG="EN-US">PET</SPAN><SPAN style="FONT-FAMILY: 宋体; COLOR: black; FONT-SIZE: 12pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">产品通过相应的审批程序实施生产规范（</SPAN><SPAN style="FONT-FAMILY: Arial; COLOR: black; FONT-SIZE: 12pt" lang=EN-US XML:LANG="EN-US">GMP</SPAN><SPAN style="FONT-FAMILY: 宋体; COLOR: black; FONT-SIZE: 12pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">）。</SPAN><SPAN style="FONT-FAMILY: Arial; COLOR: black; FONT-SIZE: 12pt; mso-font-kerning: 0pt" lang=EN-US XML:LANG="EN-US">Mayo</SPAN><SPAN style="FONT-FAMILY: 宋体; COLOR: black; FONT-SIZE: 12pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">诊所是首个获得</SPAN><SPAN style="FONT-FAMILY: Arial; COLOR: black; FONT-SIZE: 12pt" lang=EN-US XML:LANG="EN-US">FDA</SPAN><SPAN style="FONT-FAMILY: 宋体; COLOR: black; FONT-SIZE: 12pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">批准允许其生产</SPAN><SPAN style="FONT-FAMILY: Arial; COLOR: black; FONT-SIZE: 12pt" lang=EN-US XML:LANG="EN-US">C 11</SPAN><SPAN style="FONT-FAMILY: 宋体; COLOR: black; FONT-SIZE: 12pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">氯化胆碱注射液的机构。</SPAN><SPAN style="FONT-FAMILY: Arial; COLOR: black; FONT-SIZE: 12pt" lang=EN-US XML:LANG="EN-US"><BR></SPAN></P> |
