| <P style="BACKGROUND: whitesmoke; MARGIN: 0cm 0cm 0pt; VERTICAL-ALIGN: top; TEXT-INDENT: 24pt; TEXT-ALIGN: left; mso-pagination: widow-orphan; mso-line-height-alt: 0pt; mso-char-indent-count: 2.0" align=left><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-font-kerning: 0pt; mso-ansi-language: en; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial"><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-font-kerning: 0pt; mso-ansi-language: en; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial"></SPAN>意大利</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">制药公司</SPAN><SPAN lang=EN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt; mso-ansi-language: en" XML:LANG="EN">Sigma-Tau</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">在</SPAN> <SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">10</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">月</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">4</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">日</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">宣布，其与美国国立健康研究院研究院合作开发的外用眼科治疗药</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">Cystaran0.44</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">％（</SPAN><SPAN lang=EN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt; mso-ansi-language: en" XML:LANG="EN"><SPAN lang=EN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt; mso-ansi-language: en" XML:LANG="EN"><SPAN lang=EN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt; mso-ansi-language: en" XML:LANG="EN"><SPAN lang=EN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt; mso-ansi-language: en" XML:LANG="EN"></SPAN></SPAN><SPAN lang=EN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt; mso-ansi-language: en" XML:LANG="EN"><SPAN lang=EN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt; mso-ansi-language: en" XML:LANG="EN"><SPAN lang=EN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt; mso-ansi-language: en" XML:LANG="EN"><SPAN lang=EN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt; mso-ansi-language: en" XML:LANG="EN"><SPAN lang=EN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt; mso-ansi-language: en" XML:LANG="EN"><SPAN lang=EN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt; mso-ansi-language: en" XML:LANG="EN"><SPAN lang=EN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt; mso-ansi-language: en" XML:LANG="EN"><SPAN lang=EN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt; mso-ansi-language: en" XML:LANG="EN"><SPAN lang=EN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt; mso-ansi-language: en" XML:LANG="EN"><SPAN lang=EN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt; mso-ansi-language: en" XML:LANG="EN"><SPAN lang=EN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt; mso-ansi-language: en" XML:LANG="EN"><SPAN lang=EN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt; mso-ansi-language: en" XML:LANG="EN"><SPAN lang=EN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt; mso-ansi-language: en" XML:LANG="EN"><SPAN lang=EN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt; mso-ansi-language: en" XML:LANG="EN">cysteamine</SPAN></SPAN></SPAN></SPAN></SPAN></SPAN></SPAN></SPAN></SPAN></SPAN></SPAN></SPAN></SPAN></SPAN></SPAN></SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-font-kerning: 0pt; mso-ansi-language: en; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">，</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">半胱胺滴眼液）已获得美国</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">FDA</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">批准，用于治疗</SPAN><SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #222222; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">胱氨酸病所致</SPAN></SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">角膜胱氨酸结晶积聚。</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">Cystaran</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">被作为罕用药，在美国获得</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">7</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">年的市场独占权。</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US"><BR><SPAN style="mso-spacerun: yes"><FONT face=Arial><FONT color=#333333> <WBR> <WBR> <WBR></FONT></FONT></SPAN></SPAN> <SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">半胱胺是一种的胱氨酸剥夺剂，它能降低胱氨酸病患者细胞的胱氨酸含量。然而，在口服给药时半胱胺不达到角膜，因此对胱氨酸病患者无法奏效。</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">Cystaran</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">为局部滴眼用，为</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">FDA</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">批准用于</SPAN><SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #222222; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">胱氨酸病所致</SPAN></SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">角膜胱氨酸结晶积聚患者唯一眼科治疗药。</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US"><BR><SPAN style="mso-spacerun: yes"><FONT face=Arial><FONT color=#333333> <WBR> <WBR> <WBR></FONT></FONT></SPAN></SPAN> <SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">许多角膜胱氨酸结晶积聚患者为儿童，这种慢性和折磨人的疾病使他们的生活受到严重影响。</SPAN><SPAN lang=EN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt; mso-ansi-language: en" XML:LANG="EN">Cystaran</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-font-kerning: 0pt; mso-ansi-language: en; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">的获准可使他们减少病痛。</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US"><BR><SPAN style="mso-spacerun: yes"><FONT face=Arial><FONT color=#333333> <WBR> <WBR> <WBR></FONT></FONT></SPAN></SPAN> <SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">美国国家健康研究院人类基因组研究所临床主任</SPAN><SPAN lang=EN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt; mso-ansi-language: en" XML:LANG="EN">William A. Gahl</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-font-kerning: 0pt; mso-ansi-language: en; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">指出：本品的获准是</SPAN><SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #222222; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">胱氨酸病</SPAN></SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">儿童和成人患者的福音。</SPAN></P>
<P style="BACKGROUND: whitesmoke; MARGIN: 0cm 0cm 0pt; VERTICAL-ALIGN: top; TEXT-INDENT: 24pt; TEXT-ALIGN: left; mso-pagination: widow-orphan; mso-line-height-alt: 0pt; mso-char-indent-count: 2.0" align=left><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">Cystaran</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">项目获得</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">FDA</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">罕用药基金的部分支持。</SPAN></P>
<P style="BACKGROUND: white; MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 24pt; TEXT-ALIGN: left; mso-pagination: widow-orphan; mso-line-height-alt: 0pt; mso-char-indent-count: 2.0" align=left><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">由美国国家健康研究院开展的一系列对照临床试验中对</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">Cystaran</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">安全性和疗效作了评价。约有</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">300</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">名患者参与试验，研究结果支持半胱胺滴眼液可作为角膜胱氨酸结晶积聚的有效治疗手段。报告的最常见的不良反应（发生率≥</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">10</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">％）为对光敏感、发红、眼痛</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">/</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-font-kerning: 0pt; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">刺激、头痛和视野缺损。</SPAN></P> |
