| <P class=MsoNormal style="MARGIN: 2.5pt 1.25pt 2.5pt 0cm; TEXT-INDENT: 21pt; LINE-HEIGHT: 20pt; TEXT-ALIGN: left; mso-line-height-rule: exactly; mso-pagination: widow-orphan; mso-char-indent-count: 2.0; mso-para-margin-top: 2.5pt; mso-para-margin-right: .12gd; mso-para-margin-bottom: 2.5pt; mso-para-margin-left: 0cm" align=left><FONT size=3><SPAN style="FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-bidi-font-weight: bold; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">欧洲批准</SPAN><SPAN lang=EN-US style="mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-bidi-font-weight: bold"><FONT face="Times New Roman">IDM Pharma</FONT></SPAN><SPAN style="FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-bidi-font-weight: bold; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">公司的米伐木肽注射剂（</SPAN><SPAN lang=EN-US style="mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-bidi-font-weight: bold"><FONT face="Times New Roman">mifamurtide</FONT></SPAN><SPAN style="FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-bidi-font-weight: bold; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">，</SPAN><SPAN lang=EN-US style="mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt"><FONT face="Times New Roman">L-MTP-PE</FONT></SPAN><SPAN style="FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-bidi-font-weight: bold; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">，</SPAN><SPAN lang=EN-US style="mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-bidi-font-weight: bold"><FONT face="Times New Roman">:Mepact</FONT></SPAN><SPAN style="FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-bidi-font-weight: bold; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">）上市，用于治疗非转移性可切除的骨肉瘤（少见但主要造成儿童和青年死亡的骨瘤）。本品是</SPAN><SPAN lang=EN-US style="mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-bidi-font-weight: bold"><FONT face="Times New Roman">20</FONT></SPAN><SPAN style="FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-bidi-font-weight: bold; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">余年来首个获准上市治疗骨肉瘤的新药。本品可在欧盟</SPAN><SPAN lang=EN-US style="mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-bidi-font-weight: bold"><FONT face="Times New Roman">27</FONT></SPAN><SPAN style="FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-bidi-font-weight: bold; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">个成员国以及冰岛、列支敦士登和挪威销售。</SPAN><FONT face="Times New Roman"><SPAN style="mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-bidi-font-weight: bold"> </SPAN><SPAN lang=EN-US style="mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt"><?xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /><o:p></o:p></SPAN></FONT></FONT></P><BR>
<P class=MsoNormal style="MARGIN: 2.5pt 1.25pt 2.5pt 0cm; TEXT-INDENT: 21pt; LINE-HEIGHT: 20pt; TEXT-ALIGN: left; mso-line-height-rule: exactly; mso-pagination: widow-orphan; mso-char-indent-count: 2.0; mso-para-margin-top: 2.5pt; mso-para-margin-right: .12gd; mso-para-margin-bottom: 2.5pt; mso-para-margin-left: 0cm" align=left><FONT size=3><SPAN style="FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-bidi-font-weight: bold; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">米伐木肽是</SPAN><SPAN lang=EN-US style="mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-bidi-font-weight: bold"><FONT face="Times New Roman">20</FONT></SPAN><SPAN style="FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-bidi-font-weight: bold; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">余年来首个改善骨肉瘤患者长期存活的药品。患者术前化疗，随后手术切除骨瘤，而后再化疗。当患者接受术后化疗的同时也静脉注射注射本品免疫治疗（一周</SPAN><SPAN lang=EN-US style="mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-bidi-font-weight: bold"><FONT face="Times New Roman">2</FONT></SPAN><SPAN style="FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-bidi-font-weight: bold; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">次，</SPAN><SPAN lang=EN-US style="mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-bidi-font-weight: bold"><FONT face="Times New Roman">3</FONT></SPAN><SPAN style="FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-bidi-font-weight: bold; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">个月，随后一周</SPAN><SPAN lang=EN-US style="mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-bidi-font-weight: bold"><FONT face="Times New Roman">1</FONT></SPAN><SPAN style="FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-bidi-font-weight: bold; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">次，</SPAN><SPAN lang=EN-US style="mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-bidi-font-weight: bold"><FONT face="Times New Roman">6</FONT></SPAN><SPAN style="FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-bidi-font-weight: bold; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">个月）。化疗如同炸弹摧毁肿瘤，而米伐木肽如同魔铲可彻底清除疾病显微战壕内的残留物。</SPAN><FONT face="Times New Roman"><SPAN style="mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-bidi-font-weight: bold"> </SPAN><SPAN lang=EN-US style="mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt"><o:p></o:p></SPAN></FONT></FONT></P><BR>
<P class=MsoNormal style="MARGIN: 2.5pt 0cm; TEXT-INDENT: 21pt; LINE-HEIGHT: 20pt; TEXT-ALIGN: left; mso-line-height-rule: exactly; mso-pagination: widow-orphan; mso-char-indent-count: 2.0" align=left><FONT size=3><SPAN style="FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-bidi-font-weight: bold; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">米伐木肽通过刺激诸如巨噬细胞等某些白细胞来杀灭肿瘤细胞。本品制成球形脂质体，囊泡内是胞壁酰三肽（</SPAN><SPAN lang=EN-US style="mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-bidi-font-weight: bold"><FONT face="Times New Roman">MTP</FONT></SPAN><SPAN style="FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-bidi-font-weight: bold; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">）。此脂质触发巨噬细胞去消耗米伐木肽。一旦消耗完，</SPAN><SPAN lang=EN-US style="mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-bidi-font-weight: bold"><FONT face="Times New Roman">MTP</FONT></SPAN><SPAN style="FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-bidi-font-weight: bold; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">刺激尤其是在肝、脾和肺内的巨噬细胞去寻找肿瘤并杀灭之。</SPAN><SPAN style="mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt"><FONT face="Times New Roman"> <SPAN lang=EN-US><o:p></o:p></SPAN></FONT></SPAN></FONT></P><BR>
<P class=MsoNormal style="MARGIN: 2.5pt 0cm; TEXT-INDENT: 21pt; LINE-HEIGHT: 20pt; TEXT-ALIGN: left; mso-line-height-rule: exactly; mso-pagination: widow-orphan; mso-char-indent-count: 2.0" align=left><FONT size=3><SPAN style="FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-bidi-font-weight: bold; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">米伐木肽注射剂</SPAN><SPAN style="FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">获准上市基于</SPAN><SPAN lang=EN-US style="FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-bidi-font-weight: bold; mso-ascii-font-family: ’Times New Roman’">Ⅲ</SPAN><SPAN style="FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-bidi-font-weight: bold; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">期临床研究结果。国立癌症研究所（</SPAN><SPAN lang=EN-US style="mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt"><FONT face="Times New Roman">NCI</FONT></SPAN><SPAN style="FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">）建立的协作组，由儿童肿瘤组（</SPAN><SPAN lang=EN-US style="mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt"><FONT face="Times New Roman">COG</FONT></SPAN><SPAN style="FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">）进行研究，完成本品治疗骨肉瘤最大研究课题在册的患者约</SPAN><SPAN lang=EN-US style="mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt"><FONT face="Times New Roman">800</FONT></SPAN><SPAN style="FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">例。研究评价了<SPAN style="mso-bidi-font-weight: bold"><FONT face=宋体>米伐木肽</FONT></SPAN>与</SPAN><SPAN lang=EN-US style="mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt"><FONT face="Times New Roman">3</FONT></SPAN><SPAN style="FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">～</SPAN><SPAN lang=EN-US style="mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt"><FONT face="Times New Roman">4</FONT></SPAN><SPAN style="FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">种辅助化疗药（顺铂、多柔比星、甲氨蝶呤、有或无异环磷酰胺）联合用药的结果。研究显示，<SPAN style="mso-bidi-font-weight: bold"><FONT face=宋体>米伐木肽与化学药物联合使用可使死亡率降低约</FONT></SPAN></SPAN><SPAN lang=EN-US style="mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-bidi-font-weight: bold"><FONT face="Times New Roman">30%</FONT></SPAN><SPAN style="FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-bidi-font-weight: bold; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">，</SPAN><SPAN lang=EN-US style="mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-bidi-font-weight: bold"><FONT face="Times New Roman">78&</FONT></SPAN><SPAN style="FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-bidi-font-weight: bold; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">经治疗的患者存活长达</SPAN><SPAN lang=EN-US style="mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-bidi-font-weight: bold"><FONT face="Times New Roman">6</FONT></SPAN><SPAN style="FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-bidi-font-weight: bold; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">年以上。</SPAN></FONT></P>
<P class=MsoNormal style="MARGIN: 2.5pt 0cm; TEXT-INDENT: 21pt; LINE-HEIGHT: 20pt; TEXT-ALIGN: left; mso-line-height-rule: exactly; mso-pagination: widow-orphan; mso-char-indent-count: 2.0" align=left><FONT size=3><SPAN style="FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-bidi-font-weight: bold; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">（数据<FONT size=3><SPAN style="FONT-FAMILY: 宋体; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">来源：中国医药数字图书馆网站</SPAN><SPAN lang=EN-US><FONT face="Times New Roman"> ）</FONT></SPAN></FONT></SPAN></FONT></P> |
