¥xÆW¥¼¤W¥«ªÑ²¼ °]¸gºô 

¥¼¤W¥«  

¥¼¤W¥«ªÑ²¼¦æ±¡,¿³ÂdªÑ²¼¶R½æ,¥¼¤W¥«ÂdªÑ²¼¬d¸ß,§Ö³t´x´¤¥¼¤W¥«ªÑ²¼¶R½æ¯ß°Ê

Åwªï¨Ó¨ì¥²´Iºô ¤â¾÷ª© ¥[¤J·|­û µn¤J ­º­¶
¥¼¤W¥«ÂdªÑ²¼¦æ±¡¬d¸ß,¥¼¤W¥«ªÑ²¼¶R½æ¹L¤á,¿³ÂdªÑ²¼¦æ±¡¬d¸ß¡ã§K¥I¶O±M½u¡G0800-035-178
°Q½×°Ï>ÃĵØÂåÃÄ
ªø´Á«ù¦³¥Ø¼Ð»ù500¤¸¥H¤W     µoªí·s¸ÜÃD ¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¥ý¶i10000164  µoªí®É¶¡:2014/7/22 ¤W¤È 09:05:58
ÃÒ¥æ©Ò­«¤j°T®§¤½§i

(6446)ÃĵØÃĤ½§i¥»¤½¥q¦V¬ü°êFDA¥Ó½ÐP1101¥Î©óªvÀø¯u©Ê¬õ¦å²y¼W¥Í¯g(Polycythemia Vera)¤§²Ä¤T´ÁÁ{§É¸ÕÅç¡A¤wÀòFDA®Ö­ã¡C

1.¨Æ¹êµo¥Í¤é:103/07/21

2.¤½¥q¦WºÙ:ÃĵØÂåÃĪѥ÷¦³­­¤½¥q

3.»P¤½¥qÃö«Y(½Ð¿é¤J¥»¤½¥q©ÎÁpÄݤ½¥q):¥»¤½¥q

4.¬Û¤¬«ùªÑ¤ñ¨Ò(­Y«e¶µ¬°¥»¤½¥q¡A½Ð¶ñ¤£¾A¥Î):¤£¾A¥Î

5.µo¥Í½t¥Ñ:¥»¤½¥q¦V¬ü°êFDA¥Ó½ÐP1101¥Î©óªvÀø¯u©Ê¬õ¦å²y¼W¥Í¯g(Polycythemia Vera)¤§²Ä¤T´ÁÁ{§É¸ÕÅç(IND½s¸¹119047)¡A¤wÀòFDA¥¿¦¡³qª¾¥i«ö­pµe¶i¦æ(¥ç§Y¬ü°êFDA®Ö­ã±µ¨ü¦b¼Ú¬w¶i¦æ¤§²Ä¤T´ÁÁ{§É¸ÕÅç­pµe)¡C

6. ¦]À³±¹¬I:¶i¦æ¤½§i¡C

7.¨ä¥LÀ³±Ô©ú¨Æ¶µ:

(1)¥»¤½¥q«e©ó102¦~9¤ë26¤é»P¬ü°êFDA¶i¦æPre-IND meeting¡A·|¤¤FDA©x­û«Øij¥»¤½¥q¥i¿ï¾Ü¶È¥H¦b¼Ú¬w¶i¦æ¤§PROUD-PV trail(§YP1101¥Î©óªvÀø¯u©Ê¬õ¦å²y¼W¥Í¯g²Ä¤T´ÁÁ{§É¸ÕÅç)¼Æ¾Úµ²ªG¡A³w°e¬ü°êFDA¥Ó½ÐÃÄÃÒ¡C

(2)PROUD-PV trail«Y¥»¤½¥q±ÂÅv(Out-Licensing)¹Ù¦ñAOP¤½¥q¦b¼Ú¬w¶i¦æ¤§²Ä¤T´ÁÁ{§É¸ÕÅç¡F¸g»PAOP¤½¥q¨ó°Ó«áij©w¡A¥Ñ¥»¤½¥q©e°UAOP¤½¥q¾á¥ôCROÅU°Ý¡A¨ó§U¬ü°êIND¥Ó½Ð°e¥ó¨Æ©y¡C



¶}ª©·|­û¡u¥ý¶i¡v½Ðºô¤Íµo¨¥µÛ­«©ó²z©Ê°Q½×·sÃĶi«×¡AµL¿×¤£²z©Êªº¥´À£¡A½Ð¦Ü¨ä¥Lª©°Ï¡A¤À¬y¬O¬°¤F¦³§Q§ë¸ê¤H·j´M

·|­û¡Gl0164310146473  µoªí®É¶¡:2019/5/17 ¤W¤È 11:33:32²Ä 6869 ½g¦^À³
6446±q¨Ó´N¬O¤é¦¨¥æ¶q«D±`¤p§NªùªÑ,¥B©xªÑ¬Oªø´Á§ë¸ê¤£¥i¯àµu½u¶i¥X,¸³¨Æ¤Î¸gÀç·F³¡¤j³¡¤À¬O¬ì¾Ç®a¨S¦³Å@½L¯à¤O,©Ò¥H¥»¨Ó´N«Ü®e©ö¨ü¦³¤ß¤H¤h¾Þ±±¾É­PªÑ»ù¼Éº¦¼É¶^,¦pªG§ë¸êªÌ»{¦P6446¥¼¨Ó¥|¦~«áeps¦³¾÷·|¹F¨ì20¤¸¥H¤W,¨º¥H²{¦bªºªÑ»ù100¤¸¥XÀY,§Úı±o«Ü«K©y(¥»¤H¤£¬O»¡­·²D¸Ü,§Ú¨ì¥Ø«e±b­±·l¥¢¤w°ª¹F¥x¥_¥«°Ï¤@¶¡®M©Ð¤F)¦Ü©óÃö¤£Ãöª©­Ó¤H¤£»{¬°¦³¨º»ò¤jªºÃö«Y
¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GAT10147586  µoªí®É¶¡:2019/5/17 ¤W¤È 11:32:17²Ä 6868 ½g¦^À³
¤p³Ê§L¤@¤H¤@«H....

Dear Sir

½Ð°Ý³o¼ËªºG´CÅéªø´Á­t­±©ó¶Q¤½¥qªº¤½¶}¨¥½×, ¥ª¥k¥«³õªÑ»ù, ¤½¥q¦p¦ó¦]À³? www.genetinfo.com/investment/featured/item/26571.html

¬°¦ó¤½¥q¤£ª½±µ©M¥L­Ì·¾³q¼á²M¥ô¥Ñ¥«³õÄÆ·n?

½ò¬õ½u¤F¶Ü? ´£³øÃÒºÞ·|½Õ¬d?

°w¹ï²Î¤@¨é°Ó¤@¦Û¥h¦~12¤ë¨Ó¤@ª½§Q¥Î¤½¥q§Q¦h»P¼W¸ê½pÀq´Á¤j½æªÑ²¼, ¤½¥q¦bªk»¡·|®ÉÅ¥°_¨Ó°ò¥»­±¨Ã¤£ÅÜ, ¦ý¬OªÑ»ù´X¥G¸y±Ù? ¤½¥qªº«HÅA»P´Á±æ? ¤½¥q¦p¦ó¦]À³?

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡Gmtalps200110147181  µoªí®É¶¡:2019/5/17 ¤W¤È 11:25:46²Ä 6867 ½g¦^À³
¤½¥qµL­·µL«B¡A°ò¥»­±¤]¨S¦³ÅܤơC¥u¬O¤@­Ó¤½§i¡AÅýªÑ»ù¶^¤F§Ö35%¡C¥ô¦ó¤H³£©Ó¨ü¤£¦í§a¡CÃöª©¥u¬OÅý¤j®a¥ý¤ñ¸û¦n¹L¨Ç¡C¥i¬O¹ï©ó¹ê»Ú­±©ó¨ÆµL¸É¡C

³o¸Ì´NºâÃö¤F¡C¦³¤ß¤H¤hÁÙ¬O¥i¥H¦b§Oªº½×¾Â¶}ª©¡A´²¤á¤]´N¦ÛµM¤S·|¸s»E¨ì­þ¸Ì¡C

²{¦b«Ü¦h¤½Ãö¤½¥q¡A²{¦b°£¤F¦³¤H¾nª©¥~¡C¤w¸g¶i¨B¨ì¶R½æÃöÁä¦r¡A¬Æ¦Ü¼g»jµïµ{¦¡ª¦¤å¡C

¥H«e¬O¤j¼Æ¾Ú¤ÀªR¡A²{¦b¤w¸gºt¤Æ¨ìAI¤ÀªR¤F¡C´²¤á®Ú¥»¨Sªk©è§Ü¡C

·Q·Q¡G

¥¼¨ÓÁÙ¦³1¡ã2­Ó¤ëªº¨úÃҨ쪺¶}©l¾P°â¶¡ªÅµ¡´Á¡A

ªÅµ¡´Á«á¶}©l¶}½æªºº¯³z²vªº¦¨ªøª¬ªp¤]¬O¥¼ª¾¼Æ¡C©Ò¥HÁÙ¬O¦³¤@¬q«Üªøªº¸ô­n¨«¡C

¥¼¨ÓÁÙ¦³¦³«Ü¦hªÅ¶¡¥i¥HÅý¤H¨ä¤â¡C´NºâÃöª©¡A¦b¦³¤ß¤H¤h¦h¾Þ§@¤U§Ú­Ì¸ú¤]¸ú¤£¹L¡C

½Ä°Ê¤U¡A§Ú¥»¨Ó¬OÃÙ¦¨Ãöª©ªº¡A¦ý¬O§Ú·Q¤F¤@¤U¡A§Ú²{¦bı±o¤@¤Á´N¶¶¨ä¦ÛµM§a¡C

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¦V¤õ¸ª10144359  µoªí®É¶¡:2019/5/17 ¤W¤È 11:24:50²Ä 6866 ½g¦^À³
¤½¥qÁÙ¤Û·Q160¡ã200ªº¼W¸ê»ù¶Ü¡H

·à¤l¤j¶}¤f¡A­n¤@°ï¿ú¨ÓÄ~Äò¿N¡H

»~§P±¡¶Õ¡A¦Û§Ú·Pı¨}¦n¡IÃøÃã¨ä©S....

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡Gvito10147056  µoªí®É¶¡:2019/5/17 ¤W¤È 11:23:13²Ä 6865 ½g¦^À³
³o®a¤½¥qÀ³¸Ó­n¤Þ¶i±M·~¸g²z¤H

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡Gjacky10140691  µoªí®É¶¡:2019/5/17 ¤W¤È 11:22:00²Ä 6864 ½g¦^À³
¦¨¥æ¶q¤w©ñ¤j¤F,¤]ºâ¦n¨Æ,§Æ±æ¤µ¤ÑÃz¥X¤Ñ¶q,¶T©ö¾Ô¦A¥[¤W¥xªÑ¿n®z¤£®¶,¤S¶}°ª¨«§C,¬Û®t¤S¶W¹L¦ÊÂI

­Y¯à¦AÃz¥X¤Ñ¶q,´N¥i¯à¬O±j¯Pªº´«¤â¶q!

§Æ±æÃz¥X¤Ñ¶q!

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GÂŤÑ10143709  µoªí®É¶¡:2019/5/17 ¤W¤È 11:19:10²Ä 6863 ½g¦^À³
Ãö±¼³oª©ªÑ»ùÀ³¸Ó·|§óºG ¦]¬°¨S¦³¥ô¦ó°Ñ¦Ò¸ê°T ªÑ»ùÁÙ°ª¹F100¤¸¡C
¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G·R°êªÌ10141267  µoªí®É¶¡:2019/5/17 ¤W¤È 11:18:51²Ä 6862 ½g¦^À³
¶R¹LÃĵØÃĦh¦¸´Á«Ý£¸­¸¨R¤Ñ

²¦³º£¸½u­«½SÃÄ

ÁöµM¤£¬Oªø»·©¾¹ê¤á

¦ý¹ï©ó¤½¥q¸ê°T¤£³z©ú¤£¹ïµ¥

¤½吿ªø¤[¤£²M¤£·¡

¯uªº¬°¤j®a·P¨ì®ð¼«

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GDreamtiger10145627  µoªí®É¶¡:2019/5/17 ¤W¤È 11:10:59²Ä 6861 ½g¦^À³
«Ü¥i±¤¡A¤£¹L´²¤á§Ú

¤]¬O¦]¬°³oª©Åý§Úª¾¹DÃĵتº«e´º

¥i¬O¡A¤]Åý§Ú²æÂ÷§Þ³N­±¦Ó¤£°ÊªÑ²¼

¸ê²£´X¥G¸y±Ù

ı±oÁÙ¬O¦³¥i¬°¡A¦pªG¨S¨º»ò¦h¤j¤jªºÂà¸ü¸ê°T¡A©Î³\¦­´N±óªÑ¤F¡A¥u¬O¦³¤H¦b¾Þ§@³oÀÉ«Ü©úÅã...­ü

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GAT10147586  µoªí®É¶¡:2019/5/17 ¤W¤È 11:02:57²Ä 6860 ½g¦^À³
¥ý¶i¤j¬Oª©¥D, §A·í¦~ªº¦n·N, ¬Û«H«Ü¦h¤j¤jµL¨pªº°^ÄmÅý¤j®a¤]¤@°_¾Ç²ß«Ü¦h±M·~»â°ì, °ÝÃD¬O¤½¶}ªº¶°«ä¼s¯q¦ü¥G¦ü¥G§ó®e©öÅý¦³¤ß¤H¾Þ§@§@¬°¤Ï«ü¼Ð, ¦¨¬°§PÂ_ À¿µ£¾c²z½×ªº«ü¼Ð»P¤è¦V.

+1ªÌµLªk¡¦¡¦¥Á¥D¡¦¡¦²Î­p»P§ë²¼.

¥ý¶i¤j: It¡¦s up to your decision now....

¥t¥~, ÃÒ¥æ©Ò¨S¤H¬d Gºô³o¼Ëªº¨¥½×¬O§_¤w¨è·N¼vÅT¥«³õªÑ»ù ©Î³o¥»¬O¥«³õ¦­¤w¦s¦b ÂDZM·~´CÅ餧¦W¦Ó¦æ¥¦¹ê?

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¦V¿ú¨«10137837  µoªí®É¶¡:2019/5/17 ¤W¤È 11:02:47²Ä 6859 ½g¦^À³
+1

¦U¦ì«e½ú«á·|¦³´Á~

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¶³²H­·»´10146472  µoªí®É¶¡:2019/5/17 ¤W¤È 10:56:18²Ä 6858 ½g¦^À³
Ãöª©«e¨Ó¤ä«ù¤@¤U!!!

¤J¤â´X±i~~~

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GSunfive10145942  µoªí®É¶¡:2019/5/17 ¤W¤È 10:50:36²Ä 6857 ½g¦^À³
©_©Ç! ¦pªG¤½¥q¯u·|ÁÈ¿ú, ¤S¦ó¥²­nÃö±¼¦¹ª©©O!? ¿úÁȱo¦h, ªÑ»ù¦ÛµM°ª!! §Ú·Q, ¥u­n±N¼ÐÃD¸Ìªº500®³±¼§Y¥i!!
¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GAnderson10143089  µoªí®É¶¡:2019/5/17 ¤W¤È 10:41:40²Ä 6856 ½g¦^À³
+1000
¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GROGER588910148151  µoªí®É¶¡:2019/5/17 ¤W¤È 10:37:42²Ä 6855 ½g¦^À³
Ãöª©+1

³Ì¦­¶K¥XAOPºM¦^°T®§,¦ý¬O¯«¸g¤j±ø±Ó¾U«×¤£°÷,¤ñ§O¤H¦­ª¾°T®§¤]¨S¥Î,Orz.

±j¯P·Pıgºô¨º½g[²Î¤@]¤j½×·½¦Û³oÃä.

­±¾À«ä¹L¥b¦~¤£¦A¶K¤å.

[·|­û¡G¤pªL10142678 µoªí®É¶¡:2019/5/15 ¤W¤È 10:17:39²Ä 6802 ½g¦^À³

....«Ü©êºp¡A§Ú²{¦b¾¨¶q¤£ª½±µ´£¨Ñµª®×¡A¦]¬°¦b³o°Q½×°Ï¸Ì¡A­A¼L¥Ö¤lÁÙ¬O¤ñ¸û»´ÃP¡A

¦Ó¥B¦³¤£¤Ö¤H¨Ó³o¸Ì«õªF¦è¡C]

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡Gªü¤¯10134641  µoªí®É¶¡:2019/5/17 ¤W¤È 10:37:20²Ä 6854 ½g¦^À³
+1
¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡Gmtalps200110147181  µoªí®É¶¡:2019/5/17 ¤W¤È 10:37:12²Ä 6853 ½g¦^À³
+1
¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GAT10147586  µoªí®É¶¡:2019/5/17 ¤W¤È 10:32:45²Ä 6852 ½g¦^À³
¤Ï¥¿, ¤w¸gP1101¤w¤W¥«. ·Q­n¬ã¨s¤À¨ÉªÌ¤]¤£»Ý¦b¦¹ ¡¦¡¦ÄmÄ_¡¦¡¦©Î¡¦¡¦Æg´­¡¦¡¦ ®{¼W§ë¾÷ªÌ/¤j¤á (®£Às­Ì) ¿s¦ø,

·Q­n¥´ªÅªÌ, ¤]¤£»Ý­nÂǦ¹¹F¨ì¸¨¤«¤U¥Û¥Øªº.

­Y·Q­n¤À¨É, ¨º´N¨p¤U¤T¤­¦n¤Í§a.

²¦³º§ë¸êÁÙ¬O¦Û¤vªº¥\½Ò.

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¥ý¶i10000164  µoªí®É¶¡:2019/5/17 ¤W¤È 10:31:29²Ä 6851 ½g¦^À³
¦U¦ìı±oÃöÂI¦¹¼ÐÃDª©­±¡A¹ïªÑ»ù¦³©ÒÀ°§U¡A½Ð+1§ë²¼......
¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¤pÃC10147871  µoªí®É¶¡:2019/5/17 ¤W¤È 10:29:58²Ä 6850 ½g¦^À³
«D±`Æg¦PÃö±¼¦¹ª©+1¡C¤w¸g¥¢¥h¸ê°T¥æ¬yªº¥Î·N¡C
¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G±i±M­û10145380  µoªí®É¶¡:2019/5/17 ¤W¤È 10:27:24²Ä 6849 ½g¦^À³
«D±`Æg¦PÃö±¼³oª© +1
¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GAT10147586  µoªí®É¶¡:2019/5/17 ¤W¤È 10:26:52²Ä 6848 ½g¦^À³
«D±`¦P·N avandia ¤jªº«Øij! §ë¸êªÌ³£ª¾À¿¥Ö¾c²z½×, ¦¹ª©¥u¬OÅý§ó¦h§ë¾÷ªÌ/¤j¤á ¬ã§P¬O§_¨C­ÓÀ¿¥Ö¾cªÌ³£¦b(¼ÖÆ[©Î¬O´dÆ[)½Í½×¥L­Ìªº¼Ðªº......; ¥u¯à»¡®£Às¦³¤Ó¦h©å¦HªºµÛ²ª!!!
¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡Gavandia10146474  µoªí®É¶¡:2019/5/17 ¤W¤È 10:21:47²Ä 6847 ½g¦^À³
±j¯P«ØijÃö±¼³o­Óª©§a

¥u¦³Åý°Q½×®ø¥¢(¤£½×¦hªÅ) ÅýÄw½X¨I¾ýÃĵØÃĤ~¦³¾÷·|­«¥Í

²{¶¥¬q¤w¸g¶i¤J¤£²z©Ê±þ½L¶¥¬q ¦­´Á§C¦¨¥»¤jªÑªF ¬Æ¦Ü³s«e°}¤l©¾¤ß¤O®¼ªº°ê²¼¤j¤áÄw½X³£ÃP°Ê¤F

²{¦b¤j®a³£«Ü²M·¡ ªÑ»ù·|ºtÅܦܤµ°£¤F¤½¥q¦Û¤vªº°ÝÃD¥~ ´N¬OÄw½X

¦b³o¸Ì¸ê°T¤Ó¦h ´²¤áªº·Qªk§¹¥þ³Q¥D¤O´x´¤³z¹ý

¥u­ngoogle ¡iÃĵØÃÄ¡j°¨¤W´N¥X²{ 500¤¸¼ÐÃD

¨S¬Ý¹L¥ô¦óötªÑ·|¦bºô¸ô¤W§ä¨ì¥ô¦ó¹ï«e´º¦p¦¹³z©úªº¸ê°T

¨C¤@­Ó¦bºô¸ô¤W¹L«×§j±·ªº¤½¥q ªÑ»ù´X¥G³£¨S¦³¦n¤U³õ¬O¨Æ¹ê

º¡º¡ªº§j±·Åý¤½¥q¥¼¨Ó©Ê¤w¸g²@µL·Q¹³ªÅ¶¡

ªÑ»ù¤ÏÀ³¥²µM¬O¦b¤@¤ù¼Ò½kªÅ¶¡¤¤ ¸g¹LÄw½X¨}©Ê´«¤â¤§¤U¤£Â_«e¶i

²{¶¥¬q´²¤á¤@ª½§â¶R½L¥á¦b§C»ù¦ì°Ï Åý¦³Äw½Xªº¤j¤á¤@ª½§ä¾÷·|¥Î¤j¶qáè±þ

Äw½X´c©Ê´«¤â §C±µªº´²¤á©¹©¹·í¤Ñ©Î¬O¹j¤Ñ´N®M¨c µM«áÄ~Äò¦h±þ¦h´«¥t¤@§å®M¨c´²¤á

ÁöµM«Ü¤£±Ë ¦ý¬°¤F¦U¦ìªÑªFªº§ë¸êÅv¯q «Øij¥ý¶i¤j §â³o­Óª©Ãö¤F§a

¥¼¨Ó¤j®a´N³z¹L¤½¥q¤½§i©Î¬O·s»D¸ê°T¥hÅv¿Å¦Û¤v§ë¸ê¤è¦V©Î³\¤ñ¸û¦n

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¦p±`10145350  µoªí®É¶¡:2019/5/17 ¤W¤È 10:12:39²Ä 6846 ½g¦^À³
°²¦p¤@¦Ê¤¸¶^¯}«á´«90¤¸¦³¼µ..¦A¨Ó80¦³¼µ...¦A¨Ó70¦³¼µ..¦A¨Ó....
¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GÂŤÑ10143709  µoªí®É¶¡:2019/5/17 ¤W¤È 09:47:52²Ä 6845 ½g¦^À³
100¤¸¤W¤U¦³¤ä¼µ¡C
¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GAnderson10143089  µoªí®É¶¡:2019/5/17 ¤W¤È 09:44:08²Ä 6844 ½g¦^À³
¨C¤Ñ¶}½L´N¬O¶^¡A«¢«¢«¢¡A¯ºÂ½¤F¡A²Î¤@½æ¥ú¤F¶^¶Õ¦³°±¶Ü? §ó¦h¤HÄ~Äò½æ¦Ó¤w¡C

¥X³f§¹¦¨¡A¨B¤J¤£­p¥N»ù­Ë³f¤F¡C

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¤ý¸I¥J10148138  µoªí®É¶¡:2019/5/16 ¤U¤È 09:50:52²Ä 6843 ½g¦^À³
¬K©M´º©ú ¤j¤j

§A»¡ªº¤]¬O¦³¹D²z ²{¦b³o­ÓÂIÁ¿³o­Ó¤]¬O³Q¬ÝªÅªº¥´Áy

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡Gl0164310146473  µoªí®É¶¡:2019/5/16 ¤U¤È 09:11:17²Ä 6842 ½g¦^À³
¬Ý¦hªº´N¶R¶i,¬ÝªÅªº´N½æ¥X,¬ÕÁ«¥»¦Û­t,´L­«·PÁ¨C¦ì§ë¸ê¥ý¶i¤§¸ê°T¤À¨É,¬Û«HªÌµ¹­Ó´xÁn,¤£¬Û«HªÌ°¨¦ÕªF­·,§Æ±æ´î¤Ö¤£¥²­nªº¥ß³õª§Ä³
¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¬K©M´º©ú10141799  µoªí®É¶¡:2019/5/16 ¤U¤È 08:58:25²Ä 6841 ½g¦^À³
¤ý¸I¥J¤j¡A¨C­Ó¤H³£¦³¦Û¤vªº¦ô­È§a¡A

Á¿¤F¤S­n³Q§å¬O¦h¤è¥´¤â¤F¡A

©Ò¥H¤£½Í³o­Ó¡C

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¤ý¸I¥J10148138  µoªí®É¶¡:2019/5/16 ¤U¤È 08:48:35²Ä 6840 ½g¦^À³
¥i¥H¶^¦¨³o¼Ë³æ³æ´N©t¨àÃÄÃÒ¨ú¾P¦Ó¤w¶Ü¡H

ªk¤H³¡¦ì³£¨SÅÜ°ÊÕÙ ¯u©_©Ç¤F ÁÙ¬O¥L­Ì¦³¥t¥~ºÞ¹DÁ×ÀI

ÁÙ­n­±¹ï¼W¸ê §Ú¬Ý¯}¦Ê¾÷·|«Ü¤j ³o¦¸¯uªº®â¤F

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¤pÃC10147871  µoªí®É¶¡:2019/5/16 ¤U¤È 06:47:20²Ä 6839 ½g¦^À³
³o¦¸§ë¸ê¤HÀ³¸Ó³QÀ~¯}Áx¤F¡A¸õ²î¸õ¤ôªº³£µo¥Í¤F¡A°ß¦³¦Û¤vª¾¹D¦b§ë¸ê¤°»òªº¤H¨S¨«¡A¤f³U°÷²`ªº¨S¨«¡A¤jªÑªF¨S¨«¡A¥~¸ê¨S¨«¡C§Ú¥Ø«e¦bÃĵاë¸êªº±b¤W¸ê²£¤jÁY¤ô¡A¦ý§Úª¾¹D¬°¤°»ò¦Ó§ë¸ê¥¦¡A§@­Ó½ñ¹ê§Ö¼Öªº§ë¸ê¤H ¡C
¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡Gªü¤¤10143502  µoªí®É¶¡:2019/5/16 ¤U¤È 06:30:14²Ä 6838 ½g¦^À³
¬Ý¨º¼Ë¦h¤ÀªR

¹ï¥Ø«e§ë¸ê¤H¨Ó»¡¤w¸g¨S·N¸q

³Ì²×ÁÙ¬O­n¬ÝAOP¾P°â¦¨ÁZ

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡Gªü¤¤10143502  µoªí®É¶¡:2019/5/16 ¤U¤È 06:16:08²Ä 6837 ½g¦^À³
®}¥É§g¢¬¥ý±´2039´Á¡j

³ÌªñÃĵØÃĤ@«h¡u¦X§@¹Ù¦ñ¢Ï¢Ý¢ÞºM¦^¥HBesremi(P1101°Ó«~¦W)ªvÀø¯u©Ê¬õ¦å²y¼W¥Í¯g(¢Þ¢ä)©t¨àÃÄ»{ÃÒ¡vªº¤½§i¦A«×¦¨¬°¥«³õÃöª`ªºµJÂI¡A³o­Ó¤½§iÅý¤½¥qªÑ»ù¶^°±½ö¥­¡A¦A¸g¼á²MªÑ»ù¶^´TÁͽw¡A¦ý¬O«o¤]³y¦¨¤½¥q¨C¨C¤½§i´N¨S¦n¨Æªº¦L¶H¡A¤@­Ó¬ãµo¤Q¾l¦~ªºªø®Ä«¬¤zÂZ¯À¡A¦bÀò±o¼Ú·ù°ß¤@®Ö­ãªvÀø¢Þ¢äªº¤@½u¥ÎÃÄ«á¡A«o¸¨±oªÑ»ù¯}©³ªº¨«ªk¡A§ë¸ê¤H±¡¦ó¥H³ô¡H¦]¦¹¡A¤£ºÞ¬O¤½¥qÁÙ¬O¥DºÞ¾÷Ãö¡A¤½§i¤º®eÀ³¸Ó·V­«¦A·V­«¡I

§¹¾ã±Ô­z¦^À³§ë¸ê¤H

¨ä¹ê¡A³z¹L¥Í§Þ¤½¥qªº¤½§i¡A§ë¸ê¤H¤]¤£Â_¦b¾Ç²ß¡B¶i¨B¡A³o¬O¦n¨Æ¡A¥xÆWªº¥Í§Þ¤½¥q³£ÁÙ¦b¾Ç²ß¶¥¬q¡A¥B°ê¤º¥DºÞ¾÷Ãöªº¸T§Ò«Ü¦h¡A¦A»¡©ú¶µ¥Ø¤¤¤£¯à¦³¹w´ú©Êªºµû¦ô¡B¤£¯à¦³¼Ò½k¦a±a¡B§ó¤£¥i¦³°²³]©Êªº»¡ªk¡A¦]¦¹¡A·í¡u²Ä¤@­Ó¡v¦ÛµM­n©Ó¨ü³Ì±jªº²Ä¤@ªi½ÄÀ»¡A§Y«K¤½§i¤£¥i¦³¥DºÞ¾÷Ãöªº¸T§Ò¤º®e¡A¦ý¬O¦Ü¤Ö¦b¦^À³§ë¸ê¤Hªº²Ä¤@®É¶¡¡A­n¯à§¹¾ãªº±Ô­z«e¦]«áªG¡A¥H¤Î¤½¥q«áÄòªº¦]À³¹ïµ¦¡C

´N®³ÃĵØÃĪº¤½§i¨Ó»¡¡A¡u¢Ï¢Ý¢ÞºM¦^ªº­ì¦]¬O¦]¬°¢Ï¢Ý¢Þ¦b¦³ÃöÅãµÛ®Ä¯q¦p¦w¥þ©Ê¤Î¦³®Ä©ÊªºÄ³ÃD¤W¤£Ä@·N´£¥X§ó¦h½×­z¡C¡v³o¥y¸Üªº³Ìª½±µ¸ÑŪ´N¬OµLªk´£¥X¡C¦ÓµLªk´£¥Xªº­ì¦]¡A¬O¤£¬OBesremi¯uªº¥u¤ñ¢Ö¢ã(hydroxyurea)¦n¤@¨Ç¡H¨ä¹ê¡A¹L¥h¥H¨Ó¤@ª½¨S¦³¯u¥¿ªvÀø¢Þ¢äªº¤@½uÃĪ«¡A¤~·|±Ä¥Î¤w¸g¦³¤T¤Q¾l¦~¾ú¥vªº¢Ö¢ã¡AÁöµM¦³Âø­µÅã¥Ü¡A¨Ï¥Î¢Ö¢ã³Ì²×¥i¯à­PÀù¡F¤£¹L¡A¢Þ¢ä¦bÂå¾Ç¤ÀÃþ¤W¡A¬O³QÂkÃþ¦b°©Åè¼W¥Í©Ê¸~½F(myeloproliferative neoplasms)¸Ìªº¡A·N«ä¬O»¡¡A¢Þ¢äªº¯fµ{¶i®i¦b¼Æ¦~«á¥i¯àÂàÅܦ¨¦åÀù¡F´«¥y¸Ü»¡¡A¥u­nµLªk¦³®Ä±±¨î¡A³Ì²×ÁÙ¬O·|ºtÅܦ¨¦åÀù¡A¤]¦]¦¹¢Ö¢ãÃĪ«ªvÀùªº»¡ªk¡A«Ü¦³¥i¯à¬OµLªkªø´Á¦³®Ä±±¨î¡A¥H¦Ü©ó³Ì²×ÁÙ¬O¨«¤W¯fµ{¶i®iªº²×ºÝ©Ò­P¡C

¦ÓBesremi¬Oªñ¦~¨Ó²Ä¤@­Ó³Q®Ö­ã¥Î©óªvÀø¢Þ¢äªº¤@½u¥ÎÃÄ¡A¦b¦¹¤§«e¡A¤w¦³¿ÕµØªº¢Þ¢ä¤G½u¥ÎÃÄJakafi®Ö­ã¤W¥«¡A¥B¾P°âÃB¤@¦~¤ñ¤@¦~°ª¡F¤]´N¬O»¡¡A¨Ï¥Î¢Ö¢ã©Î©ñ¦åªvÀøµL®Äªº¢Þ¢ä¯f±w±Ä¥Î¤G½uªº¨Ï¥Î²v«ùÄòÃk¤É¡AµM®Ú¾ÚJakafiÁ{§É¨Ï¥Î¸gÅ窺Âå¥Íµo²{¡AÁöµMJakafi¯à½w¸Ñ¯e¯f¤¤µÊŦ¸~¤jªº¤£¾A¯gª¬¡A¦ý¬O¤@¥¹°±ÃÄ«á´¶¹M¹w«á¤£¨Î¡F¦Óªø´Á¨Ï¥ÎJakafiªº¯f±w¡A©¹©¹¯e¯f©ó¼Æ¦~«á´_µo(relapse)¡A¦Ó¤@¥¹¯e¯f´_µo±N­±Á{µLÃÄ¥i¥Îªº±¡§Î¡C¥B®Ú¾Ú¬ü°ê¼w¦{¤j¾Ç¦w¼w¥ÍÂå¾Ç¤¤¤ß¦å²G¬ì±Ð±ÂSrdan Verstovsek³Ì·sÁ{§É¬ã¨sµo²{¡A¸gJakafiªvÀø¡B°±ÃÄ«á´_µoªº°©ÅèÅÖºû¤Æ¯g±wªÌ¤¤¡A¤T¤­¢H¯f¤Hªº¦åÀù²Ó­M¥X²{·sªº°ò¦]¬ðÅÜ¡A¨ä¤¤¥]§t·¥´c©ÊªºASXL1°ò¦]¬ðÅÜ¡A³o±N¤j´TÁYµu¯f¤Hªº¦s¬¡²v¡A¥Ñ¥­§¡¤Q¤»­Ó¤ë­°¬°¤»­Ó¤ë¡C¦ÓJakafi¦­©ó¤@¤­¦~¤T¤ëÀò±o¼Ú·ùÃÄÃÒ«á¡A¤]©ó¦P¦~¥|¤ë¤½§iºM¦^¸ÓÃĪº©t¨àÃÄ»{ÃÒ¡A¦ý«o¤£¼vÅT¨ä¾P°â·~ÁZ¡C

³t¼fÃĵØÃĢТڢϥӽÐ

¦]¦¹¡AµLªk´£¥X§ó¦h¼Æ¾Ú½×­zªº­ì¦]¡A¬O¢Ï¢Ý¢Þ¦³¨S¦³¥²­nªá¶O§ó¦hªº®É¶¡»P¶O¥Î¥h»s§@§ó¦hªº¼Æ¾Ú¨Óºûô©t¨àÃĪº¸ê®æ¡H·íªì¢Ï¢Ý¢Þ¥Ó½Ð©t¨àÃĸê®æ»{©w¡A¥Øªº¬O¬°¤F¥[³t·sÃĪº¼f®Ö»P¤W¥«¡A¦p¤µ¤w¸g¾Ö¦³ÃÄÃÒ¡A¤S¬O¤@½u¥ÎÃÄ¡A¢Ï¢Ý¢Þ±N¿úªá¦b¾P°âªº¤M¤f¤W¨ÃµL¤£§´¡A¥B¿ÕµØªºJakafiºM¦^©t¨àÃÄ»{ÃÒ«á¡A¾P°â¤@¼Ë±j±jºu¡F©Ò¥H¡A²{¦b´Nµ¥¢Ï¢Ý¢Þ¥æ¥X¾P°â¼Æ¾Ú¨ÓÃÒ©ú§Y¥i¡C

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G±i±M­û10145380  µoªí®É¶¡:2019/5/16 ¤U¤È 03:53:46²Ä 6836 ½g¦^À³
¦n¤@¬q®É¶¡¨S¨Ó³o³}³} ¨£¨ìÃĵض^¯}«eªi§CÂI136ª½¦V100¾aÃl ±þÁn¶©¶© ¥O§ÚÅ宪¤£¤w ¤ß¦³±­±­²j

§Ú©ê¤F§Ö3¦~ ¦n¤£®e©ö¼õ¨ì®³¨ìÃÄÃÒ¤§¤é«o¤S¬O¶^¶Õªº¶}©l 160¥þ¬Ý¯}½æ¥ú 20±i¿é¤F20´X¸U ¤ß²z­±·t¦ÛûTÁn¤£Â_ ¿ù¬Ý¼ÐªºªÑ ¦Û§Ú³¬ªù«ä¹L®³¦^³Ñ¾l¸êª÷¥d¹ê¦b ·íªì¬°¦ó·|¤@ÀY®â¤JÃÄµØ ¶V¶R¶V¦h ¨º¥i±o­n¸Ü»¡·í®ÉIPO©â¤¤

2±i µM«á¶}©l¥h±Mª`³o¤äªÑ²¼ ¤×¨ä¬O[ªø´Á«ù¦³¥Ø¼Ð»ù500¤¸¥H¤W] ³o¼ÐÃD¤ÓÁq°Ê¤F ¦b¥[¤W¤@°ï

¬Ý¦hªº¨¥½×»P¸ê°T ´N¹³¤¤¸Îª©ªº¤Ñ©R¤j ¤\¹Ø³á ¤£¾å¥h­þ¨à§äªº¸ê®Æ»P¼Æ¾Ú §â´²¤á«¡±o¯í¿é¿é ¤°»ò

¥Ø¼Ð»ù¤W¤d¤¸ «ü¤é¥i«Ý ³s§Ú³£§Ô¤£¦í¤p¶R3±i ³Ì«á¤j¿é¥X³õ §Ú­n±j½Õªº¬O³o°Q½×°Ï¦³«Ü¦h°µ¦hªº¥´¤â

¨ä¤¤¥]§t³oÁq°Êªº¼ÐÃD¥»¨­´N¬O³Ì¤jªº¥]µÛ¿}¦çªºÁÀ¨¥ ±M·~¯À¾i¤£¨¬ªº´²¤á¥u¯àºCºC¤@¨B¨B±¼¤J³´¨À¦ÓµLªk¦Û©Þ

¥H¤µ¤Ñªº¦¬»ù ¨S°±·lªºÀ³¸Ó³£²`³´®M©Ð ¦ó®É¯à¸Ñ®M ­«¨£¥ú©ú ªü¨a¡H

¨ä¹êÃĵؤ]¤£¬O¥þ¨S§Æ±æ ¼Ú¬wÃÄÃÒ³£®³¨ì¤Fº¥º¥¦³¦¬¤J... §Y¨ÏºM¾P©t¨àÃĸê®æ ´Nºâ¦³¬Y¨Ç¼vÅT ¤]¤ÏÀ³¦bªÑ»ù¤W

°²¥H®É¤é ©ú¦~©³¬ü°êÃÄÃÒ¦pªG¨ì¤â ¨ºÀ禬À³¸Ó´N¦pªê²KÁl ¤j¦³¥i¬° ªÑ»ù±þ¨ì³o¼Ë¤F §Ú¤âÄo¤FÀH®É³£·Q¶R¦^.....

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡Gmtalps200110147181  µoªí®É¶¡:2019/5/16 ¤U¤È 12:44:33²Ä 6835 ½g¦^À³
ÁÂÁÂAT¤jªº»¡©ú¸ÑÄÀ¡I

²{¦bªºªÑ»ù¡A§Ú¬å¤]¬å¤£¤U¥h¡A¥Ø«e¤]¥u¯à¬ÝÀ¸¤F¡C

§Æ±æ¦~©³¯à¦³¦n®ø®§¡C

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GAT10147586  µoªí®É¶¡:2019/5/16 ¤W¤È 11:59:24²Ä 6834 ½g¦^À³
¥Ó½ÐÂ÷¶}©t¨àÃĸê®æªº­ì¤å³ø§i

www.ema.europa.eu/en/documents/orphan-maintenance-report/besremi-epar-withdrawal-assessment-report-orphan-maintenance_en.pdf

¬°¦ó§Ú»¡³o¬O¤@¥÷§tº±³Jªº¤½§i?

­º¥ý, ¤½¥q¥i¥H±N­è­èPO¦b©xºô·|¤Þ°_§ë¸ê¤H»~¸Ñªº¬ÛÃö¸ÑÄÀ ¦b¤½§i«e´N±j½Õ, Besremi¤T´ÁÁ{§É¤w§¹¦¨, ±N³o¨Ç¨Æ«áªº¸ÑÄÀ¦b¤½§i«eºK­n±j½Õ¥H«OÅ@§ë¸ê¤H, ÁקK§ë¸ê¤H»~¸Ñ (²¦³º, §ë¸ê¤H¤£¬O·sÃĤ½¥q­û¤u»PCHMP/COMP¾¤u)

¦A¬Ý¤@¤U (¤Ó¯ó²vªº) ¤½§i:

6.¦]À³±¹¬I:

AOP ¤½¥qªººM¦^«Y¦] AOP ¤½¥q¦b¦³ÃöÅãµÛ®Ä¯q¦p¦w¥þ©Ê¤Î¦³®Ä©ÊªºÄ³ÃD

¤W¤£Ä@·N´£¥X§ó¦h½×­z¡C(º±³J§t¤F¤Ó¤jÁû¤F§a!!)

©t¨àÃÄ©e­û·|COMP ¤£¬O³Ì«áÃÄÃÒ¼f®Ö¾÷Ãö, ¬O©t¨àÃĸê®æµû¼f¾÷Ãö. ©Ò¥H·í³o­Ó¾÷Ãöµû½×»Ý­n§ó¦hªº¸ê®Æ, ¨ä¹ê¬O°ò©ó»PHUªº¤ñ¸û©Ê°ò¦¦Ó«DBesremiÃĪ«¥»¨­ªºÁ{§Éµ²ªG/¦w¥þ©Ê»P¦³®Ä©Ê³Q¥þ½L§_»{ (§_«hÃÄÃҳ̫á«ç»ò·|³Q®Öµo?- EMAµ¹¤©ÃÄÃÒ¹LÃö»P§_¬Oµû¦ô¾ã­ÓÁ{§É¼Æ¾Ú¬O§_Benefit > Risk).

ÃÄÃҥӽФè­Õ­Y¤£·QÄ~Äò¯Ó®É¶¡¥Î©t¨àÃĸê®æ¥h¥Ó½ÐÃÄÃÒ, ¨Ì³W©w, ´N¥²¶·¦b¥¿¦¡®ÖµoÃÄÃÒ«e´N¿ì²zÂ÷¶}³o­Ó¸ê®æ (·íµM, ¥Ó½Ð¤èÁÙ¬O¥i¥H¥Ó½ÐÃÄÃÒ, ¹ï«áÄòªº¦æ¾P¿W½æÅv¤]¥¿¦p¤½¥qªº¸ÑÄÀ, ¨S¦³¼vÅT)¡C

¦p¤W¤½§i, §ë¸ê¤H¤£¥h¬Ý­^¤å­ì¤åµ´¹ï·|¥H¬°¬OBesremiÃĪ«¦³¦w¥þ©Ê»P¦³®Ä©ÊºÃ¼{!

½Ð°Ñ¦Ò¥Ó½ÐÂ÷¶}orphan³ø§iªºÂ²³æºK­n:

©t¨àÃÄ©e­û·|µû½×­«ÂI¬O¦b´Á±æBesremi/P1101¦³

A) ¼sªx°w¹ï¦w¥þ©Ê & ¦³®Ä©Ê»PHUªº¤ñ¸ûÄÄ­z (²¦³º, ©e­û·|»PÂå¬É¥Ø«eªº½T¤]¤£«Ü²M·¡¬O¤°»ò¾÷¨î¹ï©ó¦P¼Ë¬O¤zÂZ¯À, interferon alpha2b ¬Ý°_¨Ó¤S¤ñalphas 2aÀu),

B) «D¦H©ÊÀø®Ä«ü¼Ð»¡©ú»PÄÄ­z

C) P1101/BesremiÅãµÛ©Ê¦n³B, »Pnon-inferior»¡©ú!

³ü: Significant benefit ÅãµÛªº¦n³B

¥Ó½Ð¤HAOP¥D±i: °ò©ó§ï¶iªºÀø®Ä©M§ïµ½¦w¥þ©Ê¶D¨D¤W, ¥D±iP1101/Besremi¬Û¹ï©óßm°ò脲(HU)¦bÁ{§É¤W¤wÃÒ©ú¤FÀu¶Õ! ¤ä«ùªÌ¥t¥~ÁÙ¥D±i¦¹ÃÄ¥i¥H´£¤É¦w¥þ©Ê¡C±©, ¡K¡K.

COMP©t¨àÃÄ©e­û·|»{¬°§Y¨ÏÁ{§É¼Æ¾Ú¦p¤ªºØºØ¡K³o¨Ç©|¥¼¦b«Ø¥ß©ó§ó¼sªxªº¦w¥þ¬[ºc¤U³Q¶q¤Æ©ÎÀËÅç¡C (µù: ¦ó¿×§ó¼sªxªº¦w¥þ¬[ºc³Q¶q¤Æ»PÀËÅç¥u¦³COMP/ÃÄ°Ó¡K¥L­Ì³o¨Ç±M·~¤H¤h¤~·d±oÀ´!!! §ë¸ê¤H¥ýºJ¶}³o­Ó)

ƒÜ ¦³¤H»{¬°¡A¾ãÅé¦w¥þ©Ê»P¨Ï¥Îªº¨ä¥L¤zÂZ¯À¡]¤zÂZ¯À£\-2a©M2b¡^ªºÃþ§O®ÄÀ³¤@­P¡A¨Ã¥B¦bAOPÁ{§É¶}µo´Á¶¡¡A¦bropegIFN alfa-2bªvÀøªº±wªÌ¤¤¥¼Æ[¹î¨ì¥Õ¦å¯fµo¥ÍÂà¤Æ¡A¦Ó¨âºØ«æ©Ê ¦b¹ï·Ó²Õ¡]§YHUªvÀøªº±wªÌ¡^¤¤Æ[¹î¨ì¥Õ¦å¯f¡C µM¦Ó, ¡K..

ƒÜ COMP©t¨àÃÄ©e­û·|½T»{¬°¡A»PHU¬Û¤ñ, P1101¦p¦ó§ïµ½¦w¥þªº¥D±i©|»Ý¶i¤@¨BÄÄ©ú¡C¦¹¥~, ¤W­z¨ä¥L¶µ¥D±i¥²¶·¹ï«Ø¥ß«D¦H©Ê¤p¤ß¦a¸ÑÄÀ¡A²¦³º«D¦H©Ê¬O¦b­ìÁ{§É¥D­n«ü¼Ð¤Wªº¨Æ«á­×¥¿¡C °w¹ï«D¦H©Ê¥»¨­ªºµ²½×, ¥i¯à¤£¬O«Ü¥R¨¬¥hÃÒ©ú (P1101/Besremi) ©Ò¿×ªº ¡¦¡¦ÅãµÛªº¦n³B significant benefit¡¦¡¦

(¦]¦¹¡K)

¶L: ©t¨àÃÄ©e­û·|¦V¥Ó½Ð¤H¶i¤@¨B´£¥X¤F¤U¦C°ÝÃD¡C

Significant benefit

ÅãµÛªº¦n³B

°ò©ó»Pßm°ò脲HU¬Û¤ñ¸û§ïµ½ªº¥\®Ä©M¦w¥þ©Ê¡A½Ðsponsor¶i¤@¨B¸Ô²ÓÄÄ­z¡A¨Ã¦Ò¼{¥H¤U´XÂI¡G

1. ´£¨Ñ»P©Ò¦³±ÂÅv¹ï¤èªº°Q½×¡A¨Ã»PCHMP°Q½×ªº§ó·s«ü¥Ü¶i¦æ»¡©ú;

2. ¶i¤@¨BÄÄ­z»Pßm°ò脲HU¬Û¤ñ, ¦b·íªì«Ø¥ß«D¦H®Ä©Ê«ü¼Ð®É¡A¥D­nÀø®Ä«ü¼Ð©M«D¦H®Ä©Ê¶¡ªº®t²§¬O¦]¤°»ò¦Ò¶q¦Ó¾É¤J¤F¨Æ«áªº(Àø®Ä«ü¼Ð)­×§ï¥HÀò±oÀø®Ä§ïµ½?

3. ½ÐÄÄ­z (P1101/ Besremi) ¦p¦ó¥i¥H´£¤É¦w¥þ©Ê, ¥ç§Y¥Î¤@­Ó§ó¼sªx¦w¥þ½ü¹ø¤U¡A´£¨ÑP1101/Besremi ©M¨ä¥L¹ï·ÓÃĪ« (·N«ü HU and/or other interferon¨ä¥L¤zÂZ¯Àµ¥..) ¦w¥þ©Êªº¤ñ¸û

¬Ý­¾§r, ¬O§_ı±o©t¨àÃÄ©e­û·|«ÜÁcº¾©O? ¬O§_¥i¥H²z¸Ñ¸Û¦pAOP»P«Ü¦h¨ä¥L­ì¥ý©t¨àÃĦbÃÄÃÒ®Öµo«e©Î¦æ¾P¤@¬q®É¶¡«á¤]¥Ó½Ð¸ê®æ°h¥X©O? (¦]¬°¾Ö¦³³o­Óorphan¸ê®æ»Ý­n«Ü¦h,«Ü¦h,«Ü¦hªº©w´Á³ø§i/¸ê®Æ¦^õX¡K..©Ò¥H, °£«D¸ÓÃįuªºÁÙ¦³«áÄò²`¤J¶}µo»P¬ã¨s§ë¤J®É¤]»Ý­n©e­û·|ªº¬ÛÃö«ü¾É»P¸ê·½, §_«h½Ö¦³¤Ó¦h¸ê·½¥h·d³o¨Ç?)

¬Ý§¹¤FºM°h©t¨àÃĸê®æªº³ø§i­ì¤å»P¤¤¤åºK­n, §Ú¥i¥H±µ¨üAOP/Ãĵج°¤F·m®É¶¡¤W¥«¾P°â¦Ó¥Ó½ÐºM¾Porphan¸ê®æ. Áö¦p¦¹, §A·|ı±o5/13¤½§i«Ü¸Ô¹ê©P¥þ? ¦³«OÅ@§ë¸ê¤H?

¤W­z½Ķ¤§­ì¤åÁÙ­ìºK¿ý:

The sponsor also includes an argument of improved safety, but this is not quantified nor examined in the context of the broader safety profile. It is argued that the overall safety profile was consistent with class effects of other interferons used (interferon alfa-2a and 2b), and that during AOP¡¦s clinical development, no leukaemogenic transformations have been observed in ropegIFN alfa-2b treated patients, whereas two acute leukaemia were observed in the control arm (i.e. HU-treated patients). The Committee considered that an improved safety argument would require further elaboration.

Withdrawal Assessment Report ¡V Orphan Maintenance EMA/47444/2019 Page 7/7

Moreover, the other arguments discussed above have to be interpreted with caution taking into consideration that to establish non-inferiority, post-hoc modifications were introduced in the primary endpoint and non-inferiority margin. It was also pointed out that a non-inferiority conclusion by itself would not suffice to justify significant benefit.

A list of issues was raised to the applicant. 4. COMP list of issues

Significant benefit

Significant benefit is argued on the basis of improved efficacy and safety versus hydroxyurea. The sponsor is requested to further elaborate on the issue taking into consideration the following points:

• Provide a discussion versus all authorised counterparts, indicated for the updated indication as discussed with the CHMP;

• Further elaborate on the issue of improved efficacy versus hydroxyurea, taking into consideration that to establish non-inferiority, post-hoc modifications were introduced in the primary endpoint and non-inferiority margin;

• Further elaborate on the argument of improved safety, in the context of the broader safety profile of the proposed product and the comparator(s);

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡Gªü¤¤10143502  µoªí®É¶¡:2019/5/16 ¤W¤È 11:57:48²Ä 6833 ½g¦^À³
¤£¦n·N«ä¨S¦³½èºÃALAN¤j°ÝÃD

¥u¬Oı±o«Ü¦h°ÝÃD¤½¥q­n¥D°Ê»¡©ú,«Dµ¥§ë¸ê¤H°Ý

³o­Ó»ù¦ì·|¤£·|¤î¶^¨S¤Hª¾

²{¦b¥u¦³¤jªÑªF©Mªk¤H¦³¸ê®æ¥h´ú©³

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡Gmtalps200110147181  µoªí®É¶¡:2019/5/16 ¤W¤È 11:52:05²Ä 6832 ½g¦^À³
±qÆ[¹î°Ñ»PªÌ¡]¥D¨ÆªÌ¡^§ë¤Jªºµ{«×¡A´N¥i¥H·§²¤ª¾¹D­I«áªº¬ÛÃö§Q¯qªº¤j¤p¡I

´N¥Ø«eªº¸ê°T¨Ó¬Ý¡G¤½¥q¦b§ë¤J³o»ò¦hªº®É¶¡¦¨¥»+¸ê·½¦¨¥»+«HÅA¦¨¥».¤£ÁÈ­Ó2¡ã3­¿¹ê¦b»¡¤£¹L¥h¡C

­Y¨ä¥Øªº¥u¬O·QÅý¯S©w¤H¤h¤W¨®¡A¨º¤j®a¤]¥i¥H²³æ±Àºâ¤@¤U¡A¤½¥q¬£ªº©³»ù¦b­þ¸Ì¡C

²{¦b°£¤F­ì©lªÑªF¡A´X¥G©Ò¦³¤H³£¬O®M¨cªº¡I

³oºØ±¡ªp¤U¡A¥u·|Ä~Äò¶^¡Aª½¨ì¤½¥qªº¥Øªº¹F¨ì¤F¡C

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡Gwoodsalan10148205  µoªí®É¶¡:2019/5/16 ¤W¤È 10:33:40²Ä 6831 ½g¦^À³
¨º­Ó¬O¤½¥q¦Û¤v¾ã²zªº§a? ²Ä¤@¦¸¬Ýªk»¡·|³£¦b¸ÑÄÀ³o¨ÇÃÄÃÒ°ÝÃD ¤£¬O½s´¥¼¨Ó»·´º ³o¤@¤Á³£­n©Ç¤½¥q¤½Ãö³¡¤£´£¦­¸ÑÄÀ©t¨àÃÄÃÒ°ÝÃD Ãø©Ç¤µ¤Ñ¦A«G¤@¦¸ºñ¿O ¬Ýqa¥i°Ñ¦Ògºô

www.genetinfo.com/investment/featured/item/26625.html ³Ì«á¨º­Ó°ÝÃD¦^±o¥O¤H¤ß´H ªÑ»ùÅܦ¨³o¼Ë ­n¸ò´²¤á¦h·¾³q ¦n¹³´²¤á¶R±o«Ü§C¤@¼Ë

ÁÂÁª©¥D´£¿ô ¤@¤Á³£­n²z©Ê¬Ý«Ý

¤ß±¡¿E°Ê¤§¾l½Ðª`·Nµo¤å¤º®e¬O§_IJ¥Çªk«ßµ¥°ÝÃD¡A¤W¤@½g§R¤å¬O¥X©óµ½·N´£¿ô¡CBY¥²´Iºôª©¥D

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GAnderson10143089  µoªí®É¶¡:2019/5/16 ¤W¤È 10:25:09²Ä 6830 ½g¦^À³
¤½¥q°µ¿ù¤]¤£¯à½|¡AÁÙ¤@¤ß³RÅ@µÛ¤½¥q¡A¥O¤H¤£±o¤£ÃhºÃ³o­Óª©¼çÂó\¦h¦³¤ß¤H¤£Â_µo¥¬§Q¦h±»Å@¡A¦nÅý¯S©w¤H¤h¥X³f¡C

³Ìªñªº¼W¸ê©M¤½§i³B²z¡A´Nª¾¹D6446¨ì©³¬O«ç¼Ëªº¤@¶¡¤½¥q¡C

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GAnderson10143089  µoªí®É¶¡:2019/5/16 ¤W¤È 10:19:53²Ä 6829 ½g¦^À³
§Ú¯uªº¬Ý¤£À´¤@°ï¤H¬O¦b§j±·¤°»ò¡A¯uªº³o»ò¼F®`ªÑ»ù·|¬O³o¼Ë?

­n§O¤H§O°Û°I¤§«e¡A¥ý¬Ý¬Ý¦Û¤vªºª¼¥Ø§j±·¯uªº¦³¤ñ¸û¼F®`?

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GSunfive10145942  µoªí®É¶¡:2019/5/16 ¤W¤È 10:19:17²Ä 6828 ½g¦^À³
¤½¥q¦A«ç»ò¸ÑÄÀ¤]¬O¨S¥Î¤F! ¤@­Ó¤½¥qªº¸Û«H¬O«D±`­«­nªº! AOP·íªìºM¦^©t¨àÃĪº®É­Ô¤½¥qÀ³¸Ó¬Oª¾¹Dªº. ·í®É«KÀ³¸Ó­«°T§i¶D¤j®a! ¦Ó¤£¬O¦b¤½¥q¶^¦¨³o¼Ëªº®É­Ô¤~§V¤Oªº¸ÑÄÀ!! ¤@­Ó¬O¥D°Ê§iª¾­t³d¥ôªº¸gÀçªÌ, ¤@­Ó¬O§V¤O°{Á×, ·Q¿ìªk°ª»ùÄF¤H¼W¸ê(160¤¸)ªº§ë¾÷ªÌ!!! ·íªì­Y¼W¸ê¦¨¥\, °Z¤£¬O¤S®`ºG¤j®a!!! §Q¥Î³oºØ®ø®§¤£¹ïµ¥ªº§ë¾÷¤âªk, ¯u¬O¤£¥i¨ú!!! ­ü! ¤½¥q«ç»ò¯à¤£°O¨ú±Ð°V!! »â¾É¤H¦³¸Û«H, »¡ªº¸Ü¤j®a¦ÛµM·|«H(¦p ±i©¾¿Ñ, ¤ý¥Ã¼y, ...), ­YµL¸Û«H, ´Nºâ¦ÞÀ齬ªá, ¨ìÀY¨Ó¤]·|¾D¤H³è±ó§r!!!
¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡Gwoodsalan10148205  µoªí®É¶¡:2019/5/16 ¤W¤È 10:16:58²Ä 6827 ½g¦^À³
½Ðª`·Nµo¤å¤§¥Î¦r»ºµü¡AÁÂÁ¡IBY¥²´Iºôª©¥D
¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GAT10147586  µoªí®É¶¡:2019/5/16 ¤W¤È 10:16:45²Ä 6826 ½g¦^À³
¥D¤O´N¬O¬Ý¦b¥»ª©«Ü¦h¤Hªø´Á¬Ý¦n, Incyte¨ú±oÃľã¤]¨S¦³³o¼Ë±þ½L, ¤Ï¦Ó§ß·nª½¤W. ²LºÐ«¬¥«³õ¥u¦n»{¦³®£Às®_³Î. ¥u¯à»¡·Q§C»ù¤W¨®ªº­I´º¹ê¤O¶¯«p¥B¤¿¬½, °t¦X©¹¤Uµ¹Äw½X©ÎÃä½æÃä¶RªÌ§ó¬½....Äê§tº±³J¦¡ªº¤½§i¤£­t³d¥ô, ¤W¥«°s·|·|»¡¦n·t¥Üµ´¹ï¦³¡¦¡¦¤£¯àÁ¿ªº(Good things)¡¦¡¦, Ãø¹D¬O¯u¹³¬Oµ´¹ï¦³¤£¯àÁ¿ªº¡¦¡¦±O±þ¡¦¡¦???

.....®£Às, we know what you are doing....

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡Gªü¤¤10143502  µoªí®É¶¡:2019/5/16 ¤W¤È 10:15:53²Ä 6825 ½g¦^À³
½Ð°ÝAlan¤j³o½g­þ¸Ì¨Óªº

¬°¦ó¤£¦b¤½¶}¸ê°T¯¸»¡©ú

ÁÂÁÂ

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GAT10147586  µoªí®É¶¡:2019/5/16 ¤W¤È 10:02:22²Ä 6824 ½g¦^À³
¦­ª¾¦p¦¹¦ó¥²·íªì, ­Y¨S¬Û·íÄw½X¥i¥H«ùÄòÄÀ©ñÄw½X½æ¥b¦~? ·í§ë¸ê¤H¬O¥Õè? ­Y«D¶§¿Ñ....
¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GAlan Liu10136094  µoªí®É¶¡:2019/5/16 ¤W¤È 09:47:05²Ä 6823 ½g¦^À³
(6446) ÃĵØÃĤ½¥q°w¹ïAOPºM¦^¼Ú·ù©t¨àÃĸê®æ»{ÃÒ¤§°Ý»Pµª

www.pharmaessentia.com/uploads/images/20190515_AOP_ODD_withdraw.pdf

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GAnderson10143089  µoªí®É¶¡:2019/5/16 ¤W¤È 09:21:30²Ä 6822 ½g¦^À³
¤Ñ¤Ñ³£«K©y¡A¼H¼H¡A¥i¥H¶R«K©yªº¡A¬°¤°»ò§A­n¶R¶Qªº¡C
¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¤ý¸I¥J10148138  µoªí®É¶¡:2019/5/16 ¤W¤È 01:35:43²Ä 6821 ½g¦^À³
¬K©M´º©ú¤j¤jªº¤ÀªR¦n³zº« ¥i¤ñÃÒ¨÷°Óªº¤ÀªR¤F«Ü¸Ô²Ó

¥H¤W¬O¦³¾÷·|µo¥Íªº ¥²³º¤G½uÃĨ«¹Lªº¸ô §Ú­Ì¥u¬O´`µÛ¨B½Õ¨«¦Ó¤w

§Ú¤ñ¸û¦n©_ªº¬O °²³]§Aªº§PÂ_³£¥¿½T µM¦Ó¤T¦~«á Ãĵأ¸¦~¯àÁȦh¤Ö¿ú §A¦³¹w¦ô¹L¶Ü¡H

¡]§Ú«üªº¬O«O¦u¦ô­p ·|Ĺ¹L¥Ø«e¥Í§ÞªÑ¤ý¤j¦¿§a¡H¡^

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¥ý¶i10000164  µoªí®É¶¡:2019/5/16 ¤W¤È 12:28:31²Ä 6820 ½g¦^À³
·PÁ¬K©M´º©ú¤j~±M·~¦³²`«×ªº¤ÀªR¡A¥»¤H¤]ªø´Á¬Ý¦n«ù¦³¦ÜFDAÃÄÃÒ¨ì¤âÀ禬µo»Ã

¥»¤H¥Ø«e«ù¦³Ãĵؤw¬ÕÂàÁ«¡A§C»ù¤´¤Ö¼Æ©Ó±µ¡A´N·í¦sªÑ¡A¥Ø¼Ð¤£ÅÜ.....¡C

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡Gmtalps200110147181  µoªí®É¶¡:2019/5/15 ¤U¤È 09:25:57²Ä 6819 ½g¦^À³
¬Ý°_¨Ó126¬O¦u¤£¦í¤F¡C

±µ¤U¨Ó´N¬O¬Ý100¥i¤£¥i¥H¦u¦í¤F¡C

¤£ª¾¤½¥q¬£¥D°Ê¥´À£ªÑ»ùªº­pµe¬O¬°¤F¤°»ò¥Øªº¡H

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¦p±`10145350  µoªí®É¶¡:2019/5/15 ¤U¤È 08:20:20²Ä 6818 ½g¦^À³
·|³l¨ì¶W¥G§A­Ì·Q¹³¤~¨£©³
¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¤ý¸I¥J10148138  µoªí®É¶¡:2019/5/15 ¤U¤È 06:59:25²Ä 6817 ½g¦^À³
¥«³õ¤w§ë¤£«H¥ô²¼

·Q¥[½X©ÎªÌÅu¥­ªºÁÙ¬Oµ¥¼W¸ê®×«á¦A¬Ý¬Ý¤ñ¸û¦n

¥t¥~³oÀÉ­nÀò§Q¤§«e¤£¬O¦³ºô¤Í»¡¼W¸ê®×»¡©ú®Ñ¤W¼g¤]­n2¡ã3¦~

³£­n¶}½æ¤F ¶^¦¨³o¼Ë¯uªº¬O¤j®a¨S®Æ·Q¨ìªº ©¯¦n§Ú¨SÀ£¨­®a

­ì¥»ÁÈ¿úÁÙ¤£¨«·Q­nÀò§Q§ó¦h «o±µ¤F£¸©Û¦^°¨ºj­Ë¦a

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GSunfive10145942  µoªí®É¶¡:2019/5/15 ¤U¤È 05:09:23²Ä 6816 ½g¦^À³
´NÅý§Ú­Ì¬Ý¬Ý³à¥¢©t¨àÃĸê®æ«áªº¼Ú¬w­n»ù¤Î«OÀI²z½ß»P§_¦A»¡§a!!
¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GAnderson10143089  µoªí®É¶¡:2019/5/15 ¤U¤È 04:56:33²Ä 6815 ½g¦^À³
§A­Ì¼ÖÆ[¬Ý¦nªº²z¥Ñ±q¥b¦~«e¨ì²{¦b³£¤@¼Ë¨SÅÜ¡A¦ý¬OªÑ»ù«o¤@ª½¦bÅÜ¡A©¹§A­Ì´Á«Ýªº¤Ï¤è¦VÅÜ¡A¨£°­¤F¡A¤½¥q³Ìªñªí²{¸Û¤£¸Û¹ê¡A¤j®a¤ß¤¤³£¦³¤@§â¤Ø¡C
¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡Gl0164310146473  µoªí®É¶¡:2019/5/15 ¤U¤È 04:56:06²Ä 6814 ½g¦^À³
ªL°õ¦æªø¥u¦³´£¨ì¬Y¼Ú¨t¥~¸ê´¿ªí¹F§ë¸ê¤½¥q¤§·NÄ@¦p¦¹¦Ó¤w¡A¦ý¨Ã¥¼¶i¤@¨B¦³¹L¥ô¦ó¬¢½Íªº°Ê§@¡C

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GUPGO99910144849  µoªí®É¶¡:2019/5/15 ¤U¤È 04:38:35²Ä 6813 ½g¦^À³
«Ü¥X¦â ........©Ò¥H1Q. EPS -1.27
¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡Gªü¤¤10143502  µoªí®É¶¡:2019/5/15 ¤U¤È 04:13:10²Ä 6812 ½g¦^À³
¤¤¸Î¤ò§Q²v16.8%

¤ò§Q21¦Ê¸U

6446¤ò§Q²v101%

¤ò§Q36¦Ê¸U

¤~¶}½æ²Ä¤@©u¤ñ¤¤¸Î¥X¦â¦h¤F

6446¤£Â_¯}©³,¥«³õ¥Ã»·¬O¹ïªº,Åu¥­³{©³¶R³o­Ó¥æµ¹ªk¤H¤Î¤jªÑªF

¤@¯ë´²¤á¥i¯à¤£¾A¦X

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡Gªü¤¤10143502  µoªí®É¶¡:2019/5/15 ¤U¤È 03:49:07²Ä 6811 ½g¦^À³
6446ªº¤ò§Q101%

¤j·§¬O¤W¥«¤WÂd¤½¥q³Ì°ªªº

¤ñª¿´¼°]3529µ¥100%¤ò§QÁÙ°ª

¯u¬O¤£¸Ñ

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GAnderson10143089  µoªí®É¶¡:2019/5/15 ¤U¤È 02:27:34²Ä 6810 ½g¦^À³
¯ºÂ½¤F¡AªÑ»ù±q200¨ì²{¦b§Ö¸y±Ù¡AÁͶմNº¦¤Ö¶^¦h°Õ¡A­n¸ò¶r²¼¹L¤£¥h¡A¨SÃö«Y´NºÆ¨gª¼¥Ø®¼¤U¥h¡A¶R¦n¶Rº¡¡C
¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡Gavandia10146474  µoªí®É¶¡:2019/5/15 ¤U¤È 02:09:34²Ä 6809 ½g¦^À³
ªk»¡·|´£¨ì ²{¼W¤µ¦~ÁÙ¬O¦³¥i¯àÁ|¿ì

¦ý¥H¥Ø«eÃĵØÃĪºªÑ»ù¸ò±Y¼ìªº¤H®ð

¦A¨Ó¤@¦¸²{¼W¥i¯à´N­nª½±µªÑ»ù©¹¨â¦ì¼Æ±´©³¤F

¦ý¤½¥q¿N¿ú³t«×¤Ó§Ö ¤S¦³ET¤T´Á­n·Ç³Æ¶i¦æ

ÁÙ¬O¥²¶·­n¦³Äw¸êºÞ¹D

³Ì¦nªº¤è¦¡´N¬O³z¹L¨p¶Òªº¤è¦¡ ¤Þ¶i°ê¥~¤jªÑªF í©wÄw½X

¥t¥~¼Ú¬wQ2¶}½æ°_©lÂл\¤H¤f ¼w¶ø¥u¦³7000¸U¤H ¬ù ¾ã­Ó¼Ú·ù10%¤H¤f

¼ç¦bPV¯f±w¤j·§¤]¤Q¤À¤§¤@ ¬ù 15000 ¤H

¥Îº¯³z²v10% ­pºâ¤j·§ 1500 ¤H ¨C¦~ÃÄ»ù50000¬üª÷­pºâªº¸Ü

¤@­Ó¤ë¬ù 600¸U¬üª÷ * 15% ¤À¼í»PÃÄ«~¦¨¥»»ù

ºâ¨Óºâ¥h2019¤j·§¥­§¡¤ëÀ禬³»¦h 3000¸U ¥ª¥kªº¤ô·Ç

¶ZÂ÷Àò§Q¯uªºÁÙ¦³«Üªøªº¸ô­n¨«...

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¤pªL10142678  µoªí®É¶¡:2019/5/15 ¤U¤È 12:57:29²Ä 6808 ½g¦^À³
¨S¿ù¡Aoff-label¥u¯àÂå®v¡u¦Û¥D¡vµû¦ô¯f¤H«á¶}¥ß³B¤è(³Ì¦n¦³guideline)¡AÃļt¤£±o¡u¦æ¾P¡v¥¼®Ö¥iªº¾AÀ³¯g¡C

©Ò¥HRoche(Genentech)±q¨Ó¥¼¦æ¾PPegasys¦bPV,ET¾AÀ³¯g¡C

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GROGER588910148151  µoªí®É¶¡:2019/5/15 ¤U¤È 12:31:09²Ä 6807 ½g¦^À³
2012¦~¡GAmgen¦]Off label use¡]¦æ¾PFDA¥¼­ã³\ªº¾AÀ³¯g¡^³Q»@1.5»õ¬üª÷ª½±µ¸o¦æ¤Î6.12»õ¬ÛÃö»@«h¡C

¦bFDA®Ö­ãPVÃÄÃÒ«á,ÁÙ¨S®³¨ìETÃÄÃÒ«e,off label useÁÙ¬O­n¤p¤ßÂÔ·V,§O¶V¹L¬õ½u³Q»@.

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡Gªü¤¤10143502  µoªí®É¶¡:2019/5/15 ¤W¤È 11:47:57²Ä 6806 ½g¦^À³
·Q·Q¬Ý

²{¼W2.5»õ

©âÅÒ¦³2500±i

©â¨ìªº¤HÀH«K½æÀH«KÁÈ

¨C¤Ñ¶q250±i

¹ê¦b¤£´±·Q·|¶^¨ì­þ

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡Gªü¤¤10143502  µoªí®É¶¡:2019/5/15 ¤W¤È 11:40:16²Ä 6805 ½g¦^À³
²{¼W¹ï¥Ø«e¨Ó»¡³Ì¦n¬O¨p¶Ò

¦pªG¬O­ìªÑªF²{¼W¥Ø«e»ù¦ì¤j·§­q105

¥Ø«e¦¨¥æ¶q²{¼W®É¶^¨ì105¾÷²v«Ü¤j

¤§«e°O±oÑÔ¼wªÑ»ù44¥ª¥k

¨p¶Ò47-48¤¸,«á¨Ó¨ºªiªÑ»ùº¦¨ì140¥ª¥k

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¤pÃC10147871  µoªí®É¶¡:2019/5/15 ¤W¤È 11:06:04²Ä 6804 ½g¦^À³
²Î¤@¤j¤á¬O¦]§ë¸ê¤Ó¤[¡AÃĵإæ©ö¤£¼öµ¸(¦³®É¶¡®Ä¯qªº¦Ò¶q)¡A¤ß´H¦]¬O­nªí­z¤ß²Dªº·N«ä(Á`¸g²z¦Ñ¹ê¤H)¡A¦³¼Ú¨t¤j¥~¸ê±µÄ² §Æ±æ¯à¦b¦¹¼W¸ê¾÷·|¥[¤JÃĵءA¤jªÑªF°êµo¤]ªí¹F参»P¡A´N¬Ý¸gÀç¼h«ç¦w±Æ¤F¡C
¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¤pÃC10147871  µoªí®É¶¡:2019/5/15 ¤W¤È 10:43:01²Ä 6803 ½g¦^À³
ÁÂÁ¤pªL¤jµ¥¤H´£¨Ñªºªº¸ê®Æ ²´¨£¬°¾Ì¡A¼Æ¾Ú¸ê®Æ(°ê¥~Âå¬É¯f±w¹ÎÅ骺»{¦P©M²´«eÁÙµLÄvª§ÃĪ«¥X²{)¡A¦n¤½¥q Àu¨q¸gÀç¹Î¶¤(¥ô¦ó§Q¦h¨S¤ÏÀ³¤½¥qÀ³¦³ªº»ù­È,©Ò¦³°ÝÃD¥u¦]Äw½X ¡A·Q·f¶¶­·¨®ªº¤£­@Â÷¶})°ÝÃD´N¯à¸Ñ¨M¡C´N¬Ý§ë¸êªºÄݩʤF¡C
¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G§õªü½÷10147886  µoªí®É¶¡:2019/5/15 ¤W¤È 10:26:38²Ä 6802 ½g¦^À³
¤½¥q³ÌªñªºªÑ»ù½T¹ê¬OÅý§ë¸ê¤H¥¢±æ

¥[¤W³o¦¸©t¨àÃĺM¦^¨Æ¥ó

¤£ºÞ»¡¤°»ò¤j·§³£·|³Q¤j®a½èºÃ

³Ì¦nªº¤èªk´N¬OÀ禬»°§Ö¶i¨Ó

¼Ú¬wÀ禬¶i¨Ó¤§«á

¤]¯à±À¦ô¬ü°ê¥«³õ±¡§Î

¦Ü¤Ö¦b¤G½uÃĨâªÌªº¥«³õ¬O®t¤£¦hªº

¤Ï¥¿²{¦bÁ¿¦A¦h³£¨S¥Î

´NÅý¯uª÷¥Õ»È¥X¨Ó»¡¸Ü

¥t¥~¬Q¤Ñ¦³¨ä¥L¤j¤j´£¨ì

¦³Å¥¨ìªL°õ¦æªøÁ¿¨ì­n¤Þ¶iªk¤H¼W¸ê¡H

¬O¥Nªí­n¨«¨p¶Ò¼W¸êªº·N«ä¶Ü

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¤pªL10142678  µoªí®É¶¡:2019/5/15 ¤W¤È 10:17:39²Ä 6801 ½g¦^À³
Sirius¤j¡A

¦³¨S¦³´£¦­¨Ï¥Î©óETªº¥i¯à©Ê?

¥i¥H¥h¬ÝIncyteªº2018Q3²³ø¡A¾ú¦~¨Ï¥ÎJakafiªºMF»PPV¯f¤H¼Æ¡A

¦A¹ï·ÓMF©MPVÃÄÃÒ¨ú±o®É¶¡ÂI¡A§A´N¥i¥H±oª¾µª®×¤F¡C

«Ü©êºp¡A§Ú²{¦b¾¨¶q¤£ª½±µ´£¨Ñµª®×¡A

¦]¬°¦b³o°Q½×°Ï¸Ì¡A­A¼L¥Ö¤lÁÙ¬O¤ñ¸û»´ÃP¡A

¦Ó¥B¦³¤£¤Ö¤H¨Ó³o¸Ì«õªF¦è¡C

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¦V¿ú¨«10137837  µoªí®É¶¡:2019/5/15 ¤W¤È 09:53:42²Ä 6800 ½g¦^À³
ªk»¡·|¤]¶}§¹¤F,¤µ¤ÑªÑ»ù¦³¤@­¸¨R¤Ñ¶Ü?½Ö¬ÝªºÀ´?½ÖÅ¥ªºÀ´?½Ö«H?

ªÑ²¼¥«³õ¤£´N¬O¦Û¥Ñªº¶}©ñªº¥B¦³¥DºÞ¾÷Ãö¦bºÊ·þ,¦³­þ­Ó§ë¸ê¤H³Q­­¨î¥u¯à¶R©Î¥u¯à½æ,¦pªGÃĵئ³¥ô¦ó¹Hªk¶Ã¬öªº¨Æ¹ê½Ðª½±µ¦V¥DºÞ¾÷ºÞÁ|³ø!µL»Ýµo¨¥½ò¦b¨¥½×¦Û¥Ñ¥|¦r¤W¥u·|¥ÎºÃ°Ý¥y¼Q¾¥¥Ä.....

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GSirius10142542  µoªí®É¶¡:2019/5/15 ¤W¤È 08:39:34²Ä 6799 ½g¦^À³
¤½¥q²³ø¦³´£¨ì¤@¥ó¨Æ¡A§Ú¤§«e¤]¦b·Q¡A´N¬O²³ø22­¶¡A¤½¥q»¡¦bET¥«³õ¤W¥««e¦³¥i¯à³Q´£¦­¥Î©óET¡C

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¤p¥øÃZ10142872  µoªí®É¶¡:2019/5/15 ¤W¤È 08:27:08²Ä 6798 ½g¦^À³
¦w¼w´Ë¤j¤j

§Ú¤§«e¦³»¡¹L¤F

´N³æ¯Â¬O»È¦æªº§Q®§¤ñ¸û§C¤§ÃþªºÀu´f

¨S¦³¥²­n¸¨¤«¤U¥Û

¸â«C¬h

5/2 ½è©ã 520 °ê®õ¥@µØ

5/6 ¸Ñ½è 600 ³Í°ò

ªL°êÄÁ

4/8 ½è©ã 710 °ê®õ¥@µØ

5/3 ¸Ñ½è 244 ³Í°ò

3/29 ½è©ã 710 °ê®õ¥@µØ

3/29 ¸Ñ½è 702 ÀôµØÃÒ¨é

Äw½Xªº³¡¤À§Ú¤]¦C¥X¨Ó¤F

½Ð¬Ý10142872 ½g

²³æ¨Ó»¡´N¬O12/17¨ì¤W©P¤­

¤d±i¤jªÑªFÁöµM¤Ö¤@¤H

¦ý¤d±i¤jªÑªF«ùªÑ¤ñ­««o·L¼W

¥Nªí´N¬O¤jªÑªF¦Û¤v¶R¦^

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GAnderson10143089  µoªí®É¶¡:2019/5/15 ¤W¤È 08:05:19²Ä 6797 ½g¦^À³
§Úı±oÃĵتº¸³ºÊ¨Æ«Ü¯«­C¡A¤@¸Ñ½è§¹¨S¦h¤[ªÑ»ù´N¤j¶^¤FËç¡A§Ï©»¦³¹wª¾¥¼¨Óªº¯à¤O©O!
¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GAT10147586  µoªí®É¶¡:2019/5/14 ¤U¤È 09:27:12²Ä 6796 ½g¦^À³
ªk»¡·|Àɮפw¤W¶Ç¤½¶}¸ê°TÆ[´ú¯¸. FYI...

mops.twse.com.tw/mops/web/t100sb07_1

mops.twse.com.tw/nas/STR/644620190514M001.pdf

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡Gªü¤¤10143502  µoªí®É¶¡:2019/5/14 ¤U¤È 09:13:07²Ä 6795 ½g¦^À³
·íªì¦ô¤@­Ó¤H3-5¸U¬ü¤¸¤@¦~

¤ñ¹w´Á¦n5¸U¬ü¤¸

¼Ú¬w

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GµLµß®ñ10021927  µoªí®É¶¡:2019/5/14 ¤U¤È 09:09:48²Ä 6794 ½g¦^À³
·|­û¡Gªü¤¤10143502 µoªí®É¶¡:2019/5/14 ¤U¤È 07:56:30²Ä 6794 ½g¦^À³

³Í°ò³ø§i

¼Ú¬w²Ä¤G©u¤W¥«,¨C¦~±N¹F5¸U¬ü¤¸

=====================================

³æ¦ì¬O¸U¶Ü?5¸U¬ü¤¸=150¸U¥x¹ô¦Ó¤w,¨C¦~¥u¦³¤Q´X­Ó¤H¨Ï¥Î?

¤Ó¸Ø±i¤F§a!

³æ¦ì:¸U¬ü¤¸?ÁÙ¬O§Ú²´ªá¤F......?

¥t¥~,G©¹¨è·N©¿µø36­Ó¤ë¸ÕÅ窺µ²ªG,¨è·N®³12­Ó¤ëªºµ²ªG¨ÓPK?

¤³¦³³o»ò²`?

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡Gªü¤¤10143502  µoªí®É¶¡:2019/5/14 ¤U¤È 07:56:30²Ä 6793 ½g¦^À³
³Í°ò³ø§i

¼Ú¬w²Ä¤G©u¤W¥«,¨C¦~±N¹F5¸U¬ü¤¸

¬ü°ê³Ì§Ö2021¦~¨úÃÒ

pre bla ¹w­p²Ä¤T©u®i¶}

­YµLÃB¥~Á{§É±N©ó4Q19-1Q20¥Ó½Ðbla

¬yµ{1¦~

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¤p¥øÃZ10142872  µoªí®É¶¡:2019/5/14 ¤U¤È 06:00:12²Ä 6792 ½g¦^À³
Gºô³o½g¤å³¹,¯S§O·Q­n½ò¬õ½u

§â¨é°Ó¶i¥Xªí¦C¥X

´N¬O»¤¾É§ë¸ê¤H

¤½¥q¥i¯à¦³¤º½u¥æ©öªº°ÝÃD

¦]¬°¦C¥X«á¤£°µ¥ô¦ó¸ÑÄÀ

´N¬O·Q­n¹C¨«ªk«ßÃä½t

ÅýŪªÌ¦Û¦æ¸ÑŪ,¦Û¥Ñ¤ßÃÒ

¦pªG¤½¥qÁÙ¨S¦³¥ô¦ó§@¬°,

¨º§Úı±o¤½¥q¤Ó³n®z¤F

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¤p¥øÃZ10142872  µoªí®É¶¡:2019/5/14 ¤U¤È 05:54:44²Ä 6791 ½g¦^À³
§Ú¤£ª¾¹DGºôªº¤H¬°¦ó¤£¥hªk»¡·|

¥u·|¸ú¦b«á­±©ñ¬¶

www.genetinfo.com/investment/featured/item/26571.html

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡Gmtalps200110147181  µoªí®É¶¡:2019/5/14 ¤U¤È 05:40:35²Ä 6790 ½g¦^À³
²³æ»¡©ú¤@¤U¤µ¤ÑÅ¥¨ìªº¡]¥D­n¬O§Ú¦b·Nªº³¡¤À¡^¡A­Y¦³¿ù»~¡A½Ð¨ä¥L¥ý¶i¨ó§U¸É¥R¡C

1.²Î¤@¬O¦]¬°µ¥¤Ó¤[¡A¤ß´H¤F©Ò¥H¹çÄ@¦b¥«³õ²æ°â

2. ¨ú®ø©t¨àÃÄ»{ÃÒ¡AÃÄ»ùªÑ»ù¦ô­p¬O¦³¼vÅT¡]¦]¬°°õ¦æªø§t½k±a¹L¡^¡C¦ý¬O´£«e¤W¥«ªº®Ä¯q»·¤j©óºû«ùÃÄ»ù¡C©Ò¥HÅ¥°_¨Ó¾ãÅé®Ä¯q¬O¥¿­±¡C

3. °õ¦æªø»{¬°ªk¤H¤£¶i³õªº­ì¦]¬O¶q¹L¤Ö¡Aªi°Ê¤£¨¬¡C

4. ¤§«eªº¼W¸ê­pµe¡A¦]Âd¶R¤¤¤ß¼f®Ö¤è¦¡§ïÅÜ¡A­n¨D¸É¥ó¡C¥´¶Ã¸`«µ¡C©Ò¥H¤~¼È°±¡C¹w­p¤µ¦~¤ºÁÙ¬O·|¶i¦æ¡C

5. ¼W¸ê®×¥Ø«e¦³ªk¤H¦b±µ¬¢¤¤¡C¡]¦ý¬O°õ¦æªø»y²j¤£¸Ô¡C¡^

6. Marketing¡Asales force¡Amanufacturingªº³¡¤À¤@ª½¦³«ùÄò¶i¦æ¤Î§ï¶i¡CÅ¥°_¨Ó°ÝÃD¤£¤j¡C¡]ÁÙ¨S½æÃÄ¡A¤j®a³£¤£¾å±oÁÙ·|¦³¤°»ò°ÝÃD¡^

7. ¹w­p¨C¦~·|¦³2-3­Ó°ê®a¶i¦æ¬d¼t¡C©Ò¥H¥x¤¤³æ¦ì¥Ø«e«ùÄò½m§L¡C

8. Forecast¨S¤Ó¦h·sªº¸ê®Æ¡A¦³°w¹ï¼W¸ê­pµe®Ñ¤ºªºÀ禬¹w¦ô¶i¦æ»¡©ú¡G¸Ó¹w¦ô¼Æ¦r¬O¶È¥]§t³oµ§¼W¸ê·|±a¨ÓªºÀ禬¡A¦Ó«D¬O¹w¦ô¤½¥q¾ã¦~·í¦~¾ãÅéÀ禬¡C

9. ­«°T¤º¤åªí¹F¤è¦¡¡A°õ¦æªø©Ó¿Õ§ïµ½¡C

10. Pipelineªº³¡¤À¡A¨ÅÀùÃĶi¤JÃĬF¥Ó½Ð·Ç³Æ¡C PV pre bla ¸ê®ÆÁÙ¦b¾ã²z¤¤¡C

11. ¬ü°êPV ÃĬFªº®Ö­ã¾Þ§@¤è¦¡¡AÅ¥°_¨Ó¤ñ¸û¹³¬Oªìª©­«°Tªº¼f®Ö¤è¦¡¡C¦ý¬O¦æ¬F¬yµ{ÁÙ¬O­nFDA ®Ö­ã¡C¡]­×¥¿«áªº­«°T¡^

12. ¬ü°êÃĬFÀ³¸Ó¦³¾÷·|©ú¦~¤U¥b¦~®³¨ì¡]°õ¦æªø¥´¤Ó·¥¡A¨S¥¿­±¦^ÂСC¤£¹L¦³´£¨ì¡A­«ÂI¦b©ópre bla ªº·Ç³Æµ{«×¡A·Ç³Æ¶V§¹µ½¡AFDA®Ä²v¶V¦n¡^

­Ó¤H¤pµ²¡G °õ¦æªø¦n¹³§ó¦~ÁÚ¤F¡C¤£ª¾¹D¤½¥qªº±µ¯Z¤H­pµe¦³¨S¦³¶}©l°Ê¤F¡C

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¤p¥øÃZ10142872  µoªí®É¶¡:2019/5/14 ¤U¤È 04:59:23²Ä 6789 ½g¦^À³
¤pªL¤j

¨ä¹ê¥xÆW´CÅé±`±`¥¼¼f¥ý§P

³ÌµL¶dªºÀ³¸Ó´N¬O¯Î±Ò´f¤F

¬F©²¤]¼Ö±o¤£ºÞ

¦]¬°´CÅé±`±`­I«á¬O¬F©²¦b¾Þ§@ªº

©Ò¥H³oºØ¤p¨Æ

´Nºâ´CÅé½ò¬õ½u

¤]¨S¥Îªº

»¡¤£©w³o¼Ë¤j®a§ó·Q¥h¬Ý³o®a´CÅé

´CÅé°¨¤W±o¨ì§K¶Oªº«Å¶Ç

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GEric10147757  µoªí®É¶¡:2019/5/14 ¤U¤È 01:58:40²Ä 6788 ½g¦^À³
­þ¦ì¤j¤j¥i°µ½u¤Wªk»¡ª½¼½ªü
¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¤pªL10142678  µoªí®É¶¡:2019/5/14 ¤U¤È 01:38:05²Ä 6787 ½g¦^À³
¦³¶¡«Ü¡uÃö·Ó¡vÃĵتººô¸ô´CÅé¡A¬Q¤Ñ¶}½L«e²Ä¤@®É¶¡´NÂà¸üÃĵتº¤½§i¡A

§â¤½§iªº¼ÐÃD­×§ï¥[¤W¡u¦³°ÝÃD?¡v¡A¤º¤å¶}ÀY¦A¤Uµ§¡u¼Ú·ù¤U¤â­«¤£­«?¡v¡A

ÁöµMµû½×¤£§Ñ¥[¤W°Ý¸¹¡A¦ý³o¦¸¤w®£¦³½ò¬õ½u¤§¸·¡C

¤µ¤Ñ³o´CÅé¤S«ùÄò¸õ°w¡AÁÙ§è¥X¤Ñ®t¦a»·ªº¬ü®É¾Ç¦WÃĬD¾Ô­ì¼t±M§Q¡C

»¡¹ê¦bªº¡A¨C¦¸¬Ý¨ì³o®a´CÅé¹ï¬ü®Éªº³ø¾É³£Ä±±o«Ü¦n¯º¡C

¤@¦~«e¡A¦b¬ü®É¶}©l°_º¦®É¡A¤j¤OÆg¹|¬ü®Élaunch at risk¬O¦]¬°¦³¥ø¹Ï¤ß¡F

¤@¦~«á¡A¦b¬ü®Éº¦¤F¤@­¿®É¡A¤~¨Ó´£¿ôŪªÌlaunch at riskªºªk«ß½ßÀv­·ÀI¡C

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¤p¥øÃZ10142872  µoªí®É¶¡:2019/5/14 ¤U¤È 12:29:25²Ä 6786 ½g¦^À³
­É¥Î°e³ø¤jªº¸ê®Æ,¦^´_¤ý¸I¥J¤jªººÃ°Ý

kknews.cc/zh-tw/science/8m3g89e.html

´N§Ú©Òª¾, ©t¨àÃÄ©M¤@¯Z¥ÎÃÄ,³Ì¤jªº®t²§´N¬OÃÄ»ù©M±M½æ´Á¡A

¥B©t¨àÃĦ]¬°¤H¼Æ¥»¨Ó´N«Ü¤Ö

©Ò¥H¦¬®×³W¼Ò¤p«Ü¦h, ¤]´N¬O¤ñ¸û®e©ö¹F¦¨¤T´ÁÁ{§É¹êÅ窺¼Æ¾Ú

©Ò¥H«Ü¦hÃļt·|³ßÅw¬ãµo¥Î©t¨àÃÄ

¥H¤W´X­Ó®t²§,¥H¥Ø«e¨Ó»¡ªº½T¤£¼vÅTÃĵØ

¤U¤Èªk»¡·|, §Æ±æ¤j®a¯à¥h´N¥h

1.¥l¶}ªk¤H»¡©ú·|¤§¤é´Á¡G108/05/14

2.¥l¶}ªk¤H»¡©ú·|¤§®É¶¡¡G14 ®É 00 ¤À

3.¥l¶}ªk¤H»¡©ú·|¤§¦aÂI¡G°ê®õª÷¿Ä·|ijÆU (¥x¥_¥««H¸q°ÏªQ¤¯¸ô9¸¹¤@¼ÓGÆU)

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¤ý¸I¥J10148138  µoªí®É¶¡:2019/5/14 ¤W¤È 10:08:08²Ä 6785 ½g¦^À³
¨S©t¨àÃÄ»{ÃÒ «OÀI³¡¤À¤£·|¼vÅT½Æ»\²v¶Ü¡H§Ú¬Ý³o¬OÁô¼~§a ¥²³º³o­ÓÃĦ۶O¤£¤Ó¥i¯à

¥Ø«e¥«³õ¹ï³o»¡ªk¤£¶R³æ §Ú¬Ý¤]¥u¯àµ¥¶}½æÀ禬¤F

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GROGER588910148151  µoªí®É¶¡:2019/5/14 ¤W¤È 09:15:20²Ä 6784 ½g¦^À³
®µµÛ[°ß¤@]»P[²Ä¤@]ªºÀu¶Õ,¬ü°ê¥«³õÁÙ¬O¦³©t¨àÃĸê®æ,³o¤äÃĪ«µ´¹ï¦³¬ÝÀY.

¼Ú¬wÁö¨S¤F©t¨àÃĸê®æ,¦ý²´¤U¬OÃĮĻP¦w¥þ©Ê³ÌÀu¦a,ªp¥B«áµL¨ÓªÌ,¨º»ò¦æ¾Pµ¦²¤»P·~°È¦h¥[§â«l,­Ó¤H»{¬°¼vÅT¬Æ·L.

¥t¥~,AT¤j,¨º­ÓEMAµû¦ô³ø§i¬Ý§¹²`«ä¤@¤U¤U,¸Û¦p¤pªL¤j»¡¦aÃĵتº¤½§i¡A¡u«Ü©¾¹êªº¡vÂà¿ýEMAµû¦ô³ø§iªº­«ÂI¡C

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡Gavandia10146474  µoªí®É¶¡:2019/5/14 ¤W¤È 09:14:43²Ä 6783 ½g¦^À³
¬ÝÄw½X¶i¥X´Nª¾¹D ³£¬O¤@¨Ç·Q§Û©³ªº´²¤á½}¤F §O·Q¤Ó¦h

®Ú¥»¨S¦³¥D¤O¤j¤á ªk¤H¦b³{§C©Ó±µ

µu½u¥u¯àºÉ¤O¿v©³ ·Q©¹¤W¼u¤É ®£©È¦³ÂI§xÃø

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GAlan10136952  µoªí®É¶¡:2019/5/14 ¤W¤È 08:57:24²Ä 6782 ½g¦^À³
¦¹ª©¤w³QªÅ¤èÀ~¯}Áx«£¡I¬Q¶q1500¦h±i¦h¥b¬O´²¤á³Q«ðÀ~¥X¨Óªº§a¡I

¦ý¬Oªk¤H¨S±µ¡A­Ë©³¬O½Ö±µ¨«ªº¡A½Ö¦³³o¯ëÁxÃÑ»P¹ê¤O¡H¾ÌÂǵۤS¬O¤°¡H

³o³£¬O­È±o´²¤á»{¯u«ä¦Òªº¡C

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GROGER588910148151  µoªí®É¶¡:2019/5/14 ¤W¤È 08:38:10²Ä 6781 ½g¦^À³
¼~«¥©µ«á¶K;³ß¤@¦­´N¶K,§Ú¤£¬OÃį«§ó¤£¬O¤º¯«,¦ý«æÅå­·¹JµÛºC­¦¤¤¤F,ÃĵؤߺA»P®Ä²v¹ê¦b¬O­ê¦i©Ò«ä.

5/9(¥|)¤j¬ù6ÂI¥bª¾¹D°T®§,·í¤U¬O³ø³ß¤£³ø¼~¤ßºA,¤Ï¥¿¹L¤@·|¨à¤½¥qÀ³¸Ó¦³¤½§i©ÎªÌª©¤W·|¶K¥X,

¥ªµ¥¥kµ¥ÁÙ¬O¨S¦³¥bÂI­·Án?¥u¦n·h°_¥ÛÀY¯{¦Û¤v¦a¸},¯u¨S·Q¨ì³o¦ìºC­¦¤¤ª½¨ì5/13(¤@)¦­¤W¤~¨ì¦Ó¤¤¤È¤~¿ô®©!

¼~:[·|­û¡GROGER588910148151µoªí®É¶¡:2019/5/9 ¤W¤È10:52:47²Ä6631½g¦^À³¤½¥q¬Û·í¤£¸Û¹ê,³oµ¥¤j¨Æ¤£»Ý¤½

§i? ]

³ß:[·|­û¡GROGER588910144700 µoªí®É¶¡:2019/2/17 ¤W¤È 07:35:57²Ä 5940 ½g¦^À³

ec.europa.eu/transparency/regdoc/?]

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡Gªü¤¤10143502  µoªí®É¶¡:2019/5/14 ¤W¤È 06:32:42²Ä 6780 ½g¦^À³
ÃĵØÃÄ¡]6446¡^13¤é¦]¼Ú·ù¦X§@¹Ù¦ñAOPºM¦^©t¨àÃĸê®æ¡AªÑ»ù¤@«×áè±þ¦Ü¶^°±¡A°õ¦æªøªL°êÄÁªí¥Ü¡AAOPºM¦^©t¨àÃĸê®æ¨Ã¤£¼vÅTBesremiRÃÄÃÒ¡A¸Ó·sÃıN¦p´Á©ó²Ä¤G©u¼Ú·ù¤W¥«¶}½æ¡F¥Ø«e¦b¨ä¥¦°ê®aÃÄÃҥӽЫùÄò¥[§Ö¶i«×¡A¥xÆW³W¹º²Ä¤T©u¡A¬ü°ê³ÌºC©ú¦~1¤ë¥Ó½Ð¡A¦Ó¤j³°¡B¤é¥»¹w­p§¹¦¨¤@´ÁÁ{§É«á¡A¤]±N¥H¼Ú·ù¼Æ¾Ú¥Ó½Ð¡C

ªL°êÄÁªí¥Ü¡A¬Ý¦nªvÀø¯u©Ê¬õ¦å²y¼W¥Í¡]PV¡^¾AÀ³ÃÒ¥«³õ¡AÃĵذ£¤F¥x¤¤¼t§ë¤Jªº°w¾¯²£½u¡A³W¹º²Ä¤T©u¦V¥xÆWTFDA¥Ó½ÐÃÄÃÒ¥~¡A¹w´Á¤T¦~¤ºÀHµÛ¨ä¥¦¾AÀ³¯gªº·sÃĶ}µo¡A¥Ø«e¤]±N¦b¦Ë¥_¶é°ÏÂX«Ø·s¼t¡A¹w­p©ú¦~°Ê¤u¡C

¾¨ºÞ·sÃĶ}µo¤õ¤O¥þ¶}¡AÃĵØ13¤é«o¦]AOPºM¦^©t¨àÃĸê®æ¡AªÑ»ù¤@«×áè±þ¿Ä¶^°±¡A²×³õ¥H130¤¸§@¦¬¡A¶^´T8.45¢H¡A¦¨¥æ¶q¯à¤]©ñ¤j¦Ü1,585±i¡A¥«­ÈÁY¤ô¦Ü285»õ¤¸¡A¶^¯}300»õ¤jÃö¡C

Ãĵظ³¨Æªø¸â«C¬hªí¥Ü¡A©t¨àÃÄ»{ÃÒÁö½T«O²£«~¤W¥««á¾Ö¦³10¦~¥«³õ±M½æÅv¡A¦ý¥Ø«e¶}µoªvÀøPV·sÃĤ¤¡A¨Ã¥¼¦³¥H¤zÂZ¯À¾÷Âà³]­pªº·sÃÄ¡A¦]¦¹ºM¦^©t¨àÃĸê®æ¨Ã¤£¼vÅTBesremiRªº¾P°â¡F¥B¸Ó²£«~¬ÛÃö±M§QÅv¦Ü2034¦~¡AÃĵؤ]«ùÄò§ë¤J¸Ó²£«~¬ãµo¡B¥Ó½Ð±M§Q¥H©µªø«OÅ@¡A¦]¦¹¹ïÀç¹B½ÄÀ»¦³­­¡C

¹ê»Ú¤W¡A°£¤FBesremiR±N¦p´Á©ó²Ä¤G©u¦b¼w°ê¡B¶ø¦a§Q¤W¥«¾P°â¥~¡A³Ì¨üÃöª`ªº¬ü°êÃÄÃÒ¡A¦b¤£¥Î¶i¦æÁ{§É¹êÅç¤U¡AÃĵØ5¤ë±N¦VFDA´£¥XPre-BLA¡]·sÃĬdÅçµn°O°e¥ó«e¿Ô¸ß·|ij¡^¡A·|ij®É¶¡¹w¦ô¬ù60∼75¤Ñ«á¡A¦Ó·|ijµ²§ô«á¡A¥b¦~¤ºÃĵػݴ£¥XÃÄÃҥӽСA¥ç§Y³ÌºC©ú¦~1¤ë´N­n´£¥X¥Ó½Ð¡A¥H¨u¯fÃļf¬d¬ù»Ý¤»¦Ü¤E­Ó¤ë¨Ó¬Ý¡Aªk¤H»{¬°¸Ó·sÃĦ³¾÷·|¦b©ú¦~¤U¥b¦~¤W¥«¡C

ªL°êÄÁ»¡¡A°£¤F¬ü¼Ú¥~¡AÃĵزĤT©u¤]±N¦V¥xÆWTFDA¥Ó½ÐÃÄÃÒ¡F¦Ó¤w¦b¤j³°©M¤é¥»¥Ó½Ðªº¤@´ÁÁ{§É¡A¹w´Á¦b¤HÅéÃĪ«°Ê¤O¾Ç¸ÕÅç¡]PK¡^¡A§¹¦¨¼Æ¾Ú¤ÀªRÅã¥ÜºØ±Ú¬Û¦ü©Ê«á¡A±N¥i±æ¥H¼Ú¬w¸ÕÅç¼Æ¾Ú¦V¦U°ê¥DºÞ¾÷Ãö¥Ó½ÐÃÄÃÒ¡C

ªL°êÄÁªí¥Ü¡AÃĵإثe¤]¿n·¥§ë¤J¥]¬AB¨xµ¥¨ä¥¦¾AÀ³¯gªº¶}µo¡A°ò©ó¥¼¨ÓªºÀç¹B»Ý¨D¡A¤]³W¹º¶i¤@¨BÂX¥R²£¯à¡A¹w­p±N¦Ë¥_¥ÍÂå¶é°ÏÂX«Ø·s¼t¡A¹w­p©ú¦~°Ê¤u¿³«Ø¡C

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GµLµß®ñ10021927  µoªí®É¶¡:2019/5/13 ¤U¤È 11:24:32²Ä 6779 ½g¦^À³
¡u§Y±N¤W¥«ªº°ê®a´N¦³¼w°ê©M¶ø¦a§Q¡A¦Ó¥BAOP¤w³qª¾ÃĵØÃıN°w¹ï·ç¤h¤Î¥_¼Ú4°ê´£¥X¾P°â¥Ó½Ð¡C¡v

­ì¤åºô§}: www.ettoday.net/news/20190513/1443485.htm#ixzz5noiaHEYc

======================================================================

¤H¤f:

¼Ú¬w:7.4»õ

¬ü°ê:3.2»õ

¼w°ê:0.82»õ,¶ø¦a§Q:0.09»õ,¦X­p,0.9»õ

®¿«Â+·ç¨å+·ç¤h+¤¦³Á+ªâÄõ=0.3»õ

³£¥[°_¨Ó¶È¼Ú¬wªº1/7¦Ó¤w¡C

¦Ó¥B,5¤ë¤w¹L¤@¥b¤F,¦pªG²{¦b¶}½æ,³o­Ó¤ë¶È½æ¥b­Ó¤ë¦Ó¤w¡C

°²¦p¯à©â15%,¥Bªì´ÁÂл\²v¤£¤@©w¦h°ª,¥B¤£¤@©w·í¤ë´N¯à¤J±b¡C

ÁÙ¬Oµ¥¬ü°ê¤ñ¸û¦n§a!¤ò§Q¦n´X­¿,¥B¤@°ê´N3.2»õ¤H¤f¡C

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GAT10147586  µoªí®É¶¡:2019/5/13 ¤U¤È 11:04:25²Ä 6778 ½g¦^À³
·s»Dµo¥¬³£¥i¥H¨Ô¨Ô¦Ó½Í, ²M´·ªí¹F, ¦ý¬O¤½§i©O?

6.¦]À³±¹¬I:

AOP ¤½¥qªººM¦^«Y¦] AOP ¤½¥q¦b¦³ÃöÅãµÛ®Ä¯q¦p¦w¥þ©Ê¤Î¦³®Ä©ÊªºÄ³ÃD

¤W¤£Ä@·N´£¥X§ó¦h½×­z

¤§«eµ§ªÌÁÙPO¥X­ì¤åµ¹¤j®a°Ñ¦Ò¦³Ãö©t¨àÃÄ¥²¶·ºM¦^ªº´X­Óª¬ªp....¦]¬°¤w¸g¨ú±oÃÄÃÒ¥BÁ{§É¤]ªñ§ÀÁn¤F, ¦b¥h¦~©M±M®a­Ì¤fÀY·|ij¤§«á, AOP/ÃĵبM©wºM¥X¥Î©t¨àÃÄ¥Ó½ÐÃÄÃÒªº¤è¦¡, ¦ô­pÀ³¸Ó¬OÁקK¼W¥[µ{§Ç½ÆÂø»P°Ó·~¤Æ®É¶¡/»P¬ÛÃö¶O¥Î»P§ó¦h¤H¤Oª«¤O§ë¤J, ¦b¤£¼vÅT¨ä(©t¨àÃÄ2011¦~§Y»{¥i)°Ó·~§Q¯q»P±M§Q¤U, ¤@­ÓÁ{§É¤wªñ§ÀÁnÁٻݭn¥Î©t¨àÃĸê®æÄ~Äò¥hÅÍ©M°ÑÁɨú±o±M®a·N¨£¶Ü? ²¦³º±q¥Ó½Ð©t¨àÃĤ@¶}©l, ¨º¬O¤@¾ã®M«ÜÁcº¾ªº¸ê®Æ­n¨D/³ø§i»P³W½d, ·sÃĪº applicant (AOP) / holder (ÃĵØ)µ´¹ï«Ü²M·¡¦b¥h¦~12¤ë§Y±N¨ú±oÃÄÃÒ®É, «ç»ò¹ï¦Û¤v¦³§Q¥[³t°Ó·~¤Æ.

¥u¤£¹L³o¨Ç¦Ò¶q¥i¥H«Ü²³æ²M·¡ªí¹F(¦p¤È¶¡ªº·s»D½Z),«o·d­Ó¤W­z¦]À³±¹¬Iªºªí¹F ¤°»ò¦w¥þ©Ê/®Ä¯q©Ê.....

ÃÒºÞ·|¬O§_»Ý­n¬d¤@¬d­ì­^¤åª©¥» AOP/ÃĵجO§_¯u¦p¤½§iªº²z¥ÑºM¥X, ©Î¬O§_¦³»~¾É§ë¸ê¤H¤§¶û???

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡Gªü¤¤10143502  µoªí®É¶¡:2019/5/13 ¤U¤È 10:50:58²Ä 6777 ½g¦^À³
§Ú¦Û¤v»{¬°

ªk¤H¦³¨S¦³¶i³õ¤ñ¤jªÑªF¨S½æ§ó­«­n

¥h¦~¤W¥b¦~ÁÙ¦³«ùÄò¶R

¤µ¦~´X¥G¨S°Ê§@

¤@­Ó¨S¦³À禬Àò§Qªº¤½¥q,³Ì­«­n¶}ªk»¡Åý¤j®a¤F¸Ñ»ù­È

¥«³õ¥Ã»·¬O¹ïªº

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¥ý¶i10000164  µoªí®É¶¡:2019/5/13 ¤U¤È 10:38:35²Ä 6776 ½g¦^À³
www.ettoday.net/news/20190513/1443485.htm

¤½¥q¬£¥¼¦b²Ä¤@®É¶¡µo§G¡A³o¬O¼vÅTªÑ»ù¤Î§ë¸ê¤H¹ïÃĵØÃÄ«ùªÑ«H¤ß¡C

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GAT10147586  µoªí®É¶¡:2019/5/13 ¤U¤È 10:22:10²Ä 6775 ½g¦^À³
¥J²Ó¤ñ¹ï2016²{¼W³ø§i®Éªº¸³ºÊ¨Æ«ùªÑ vs. ¤½¶}¸ê°Tºô¸³ºÊ¨Æ«ùªÑ¾lÃB, ¨ä¾l¤H´X¥GÅܲ§¤£¤j, °£¤F¤U­±¥D­n¤T­Ó¸³ºÊ¨Æ, ¨ä¤¤¤S¥H¶£®õ§ë¸ê (¥Ø«e¤w«D¸³ºÊ¨Æ)³o³¡¤À°ª«ùªÑ, ¬G´¢´ú¥i¯à¬O³Ì¤j°ª«ùªÑÄw½X½æÀ£¨Ó·½§a???, ¤£ª¾²{ªp¦p¦ó!!!???

¦æ¬F°|°ê®aµo®i°òª÷·|: ´î¤Ö762±i

2016-05¼W¸ê»¡©ú®Ñ®Éªº«ùªÑ: 22,828,296ªÑ

2019-04¸³ºÊ¨Æ¾lÃB©ú²Óªí: 22,066,296ªÑ

Ä£µØ¬Á¼þ: ´î¤Ö334±i

2016-05¼W¸ê»¡©ú®Ñ®Éªº«ùªÑ10,000,000ªÑ

2019-04¸³ºÊ¨Æ¾lÃB©ú²Óªí: 9,666,000ªÑ

¶£®õ§ë¸êªÑ¥÷¦³­­¤½¥q (¥Nªí¤H ³¯´Â©M)-¦]¬°¥Ø«e«D¸³ºÊ¨Æ, ©Ò¥H¬d¤£¨ì¥Ø«e³Ñ¾lªÑ¼Æ!

2016-05¼W¸ê»¡©ú®Ñ®Éªº«ùªÑ10,127,879ªÑ

¥Ø«e¤w«D¸³¨Æ, ©Ò¥H¬dµL¥Ø«e«ùªÑ¾lÃB

³¯´Â©M­Ó¤H

2016-05¼W¸ê»¡©ú®Ñ®Éªº«ù3,077,196ªÑ (¤l¤k758,670)

2019-04¸³ºÊ¨Æ¾lÃB©ú²Óªí: 3,077,196ªÑ(¤l¤k758,670)

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GLibad10145748  µoªí®É¶¡:2019/5/13 ¤U¤È 09:50:57²Ä 6774 ½g¦^À³
Ãĵؤµ¤Ñ¤½§iÂô¤Fº×

500ªº

¤@·|¨à¤ÀªR ¤@·|¨à°ÛÀ¸

ª½¥Õªº»¡

Ãĵئn´Î´Î

¶^°±¸òÃĵصLÃö

¥u¬OªÑ¥Á¤ñ¸û°I

¤£¯à©ÇÃĵأ«

Ãĵدuªº¦n´Î´Î

³o­Ó½×¾Â¯uªº¨S¦³ºÊ·þÃĵتº¤O¶q?

¦Ü¤Ö§Ú¤£«H

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GROGER588910148151  µoªí®É¶¡:2019/5/13 ¤U¤È 09:03:47²Ä 6773 ½g¦^À³
«¥´N®ð¨ì®t¨º¤@ÂIÂI´N­n¥þ³¡°±·l¥X³õ!

[·|­û¡G¤p¥øÃZ10142872 µoªí®É¶¡:2019/5/13 ¤U¤È 07:46:37²Ä 6769 ½g¦^À³

¤µ¤ÑÄw½Xªº½T«Ü¦hªi¬q¾Þ§@ªº°±·l¥X³õ¤£¹L©ú¤Ñ¤U¤Èªºªk»¡·|¯uªº¬O­«ÂI §Ú¬Û«H³oÃä¤@©w·|¦³¤H¥X®uªk»¡·|

¦Ó¤]¦³«Ü¦h§ë¸ê¤HµLªk¥X®uªk»¡·| ]

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GROGER588910148151  µoªí®É¶¡:2019/5/13 ¤U¤È 08:35:51²Ä 6772 ½g¦^À³
¤µ¤Ñ¬O¯u®ð¨ì©üÀYÂà¦V¦Ó·Q¥hªk»¡·|¥áÂû³J.

¤£¦n·N«ä·|¿ù·N,¬OFDAÁÙ¨S®Ö­ã¬°©t¨àÃÄ[ÃÄÃÒ]¤W¥«,¤£¬O§_¨M©t¨àÃÄ[»{ÃÒ].

[·|­û¡G¤pªL10142678 µoªí®É¶¡:2019/5/13 ¤U¤È 06:29:56²Ä 6766 ½g¦^À³

¬Ý¨Ó§ÚÀ°¦£¬d¸ß¬O¦h¾lªº¡A­ì¨Ó³s³oµn¿ý¸ê°T³£¬Ý¤£À´¡Cwww.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=424414 ]

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¤p¥øÃZ10142872  µoªí®É¶¡:2019/5/13 ¤U¤È 08:17:41²Ä 6771 ½g¦^À³
³Ì«á§Ú­Ì¨Ó½Í¤@¤UAOP

©Ò¦³·sÃĤ½¥q

³Ì«áªº¨â­Ó¨½µ{¸O¬O³Ì­«­nªº

1.¤T´ÁÁ{§É¹LÃö

2.®³¨ìÃÄÃÒ

¤j®a·|ı±o§Ú»¡ªº¬O¼o¸Ü¤¤ªº¼o¸Ü

¦ý¦U¦ì¥J²Ó¥h¬Ý

2017 ¦b¦å²G¦~·|¤¤, P1101 ¤T´ÁÁ{§ÉÁöµM¹LÃö

¦ý«o±qÀu¶V©Ê§ï¦¨¤£¦H©ó

¤j®a½|Án¤£Â_

ı±o¤½¥q¦bÄF¤H

¦ý¨Æ¹êÃÒ©ú¨âÂI

1.¤zÂZ¯Àªº®ÄªG¦b²Ä¤T¦~ªº½T¹F¨ìÀu¶V©Ê,³o©M¤G´ÁÁ{§Éªºµ²ªG¹p¦P(·Pı¤ñ¸û¨S¦³°Æ§@¥ÎªºÃÄ¡A³£»Ý­n¤ñ¸û¤[ªº®É¶¡¤~¯àµo´§ÃÄ®Ä)

2.AOP¯uªº¬O«D±`Àu¨qªº¤½¥q, ¬°¦ó³o¼Ë»¡AOP, ¦pªG·í®É¤£§ó§ï¤T´ÁÁ{§Éµ²ªGªº¹F¼ÐªùÂe¡A¨º¦³¥i¯àµLªk¹LÃö,¤]´N¬O¥i¯àÃÄ­«§@¤T´Á

¦AªÌ¥h¦~¦~©³

AOP¬°¤F·Q­n¥i¥H¥[³t®³¨ìÃÄÃÒ, ©ñ±ó¤F©t¨àÃĪº¤å¥ó¸É¥R½×­z¤§Ãþªº

¬°¤F´N¬O§ÖÂI®³¨ìÃÄÃÒ¡A§ÖÂI½æÃÄ

²¦³º¤T´ÁÁ{§É·d¤F¤T¦~,³o¨Ç¦¨¥»­n»°§Ö®³¦^¨Ó

¦U¦ì¤ß¥­®ð©M¦a¤ÀªR¥H¤W¨âÂI

AOP ªº½T¬O«ÜÀu¨qªº¤½¥q

³oºØª¬ªp¦pªGµo¥Í¦b¥xÆWªº·sÃĤ½¥q

§Ú²q³£·|GG

©Ò¥H¦pªG¥i¥H¥´¤À¼Æ

§Úµ¹AOP 95¤À, µ¹ÃÄµØ 59¤À

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¤p¥øÃZ10142872  µoªí®É¶¡:2019/5/13 ¤U¤È 08:04:56²Ä 6770 ½g¦^À³
§Ú­Ì¨Ó²z©Ê«ÈÆ[ªº¬Ý¤@­Ó¼Æ¦r

ªÑÅv¤À´²ªí

norway.twsthr.info/StockHolders.aspx?stock=6446

¤j®a³£«Ü¾á¤ß²Î¤@³o­Ó¨é°Ó¡A±q¥h¦~12/17¤§«á¤@ª½½æªÑ²¼

½æ¤F3000¦h±i

¬O¤£¬O¤½¥q¤º³¡¤H

©Î¬O¤jªÑªF

©Î¬OÃö«Y¤H

¦ý¦U¦ì¥i¥H¬Ý¤@¤U¼Æ¦r·|»¡¸Ü

·í®É¤d±i¤jªÑªFªºªÑÅv¦³ 37¤H, Á`¦@¦û¤F 50.39%

¤W©P¤­¦¬½L²Î­p«h¦³ 36¤H, Á`¦@¦û¤F 50.7%

ÄY®æ»¡°_¨Ó,¤d±i¤jªÑªFªº«ùªÑ¨Ã¥¼´î¤Ö

¥u¬OªÑªF¤Ö¤@¦ì(À³¸Ó´N¬O¨º¦ì²Î¤@¤j¤á)

¤£½×¥L¦³¥ô¦ó²z¥Ñ½æ¥XªÑ²¼

¦ýÁÙ¬O³£³Q¤d±i¤jªÑªF¦¬¦^¥h

¦Ó¤£¬O¬y¦V´²¤á

§Ú·Q³o¯uªº¬O¤£¥Î¤Ó­V³d

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡Gªü¤¤10143502  µoªí®É¶¡:2019/5/13 ¤U¤È 08:03:51²Ä 6769 ½g¦^À³
¦pªG¦³¤j¤j¥h

¥i§_°Ý¤@¤U²{¼W°ÝÃD

³oºØ¦¨¥æ¶q¿ì²{¼W¥²¤j¶^

¤§«e¦³°Ý¹Lªk»¡·|3­Ó¤ë«á,­n¿ì¼W¸ê

¨p¶Ò¤Î¥iÂà¶Å¥i¦æ¶Ü

ÁÂÁÂ

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¤p¥øÃZ10142872  µoªí®É¶¡:2019/5/13 ¤U¤È 07:46:37²Ä 6768 ½g¦^À³
¤µ¤ÑÄw½Xªº½T«Ü¦hªi¬q¾Þ§@ªº°±·l¥X³õ

¤£¹L©ú¤Ñ¤U¤Èªºªk»¡·|¯uªº¬O­«ÂI

§Ú¬Û«H³oÃä¤@©w·|¦³¤H¥X®uªk»¡·|

¦Ó¤]¦³«Ü¦h§ë¸ê¤HµLªk¥X®uªk»¡·|

§Ú·Q¤j®a¥ý§NÀR¤@¤U

¤£¯à¥hªk»¡·|«o·Q°Ý°ÝÃDªº

¥i§_¦bª©¤W¯d¨¥

¦Ó¯à¥hªk»¡·|ªº¡A¬Ý¬Ý¬O§_¯àÀ°¦£°Ý°Ý

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¤pÃC10147871  µoªí®É¶¡:2019/5/13 ¤U¤È 07:18:11²Ä 6767 ½g¦^À³
Aop©MÃĵس£¨Ó¸gÀç¥ø·~ÁÈ¿úªº¡A¨S¨Æ·|§@¹ï¦Û¤v¤£§Qªº¨M©w¶Ü¡HÃĪºÁ{§É ÃÄÃҥӽРÃĪº¦æ¾P¦³¥L­Ì±M·~¤º¦æ¶Ü¡H¦n¤£®e©ö¤@ÁûÃĨ«¨ì¤µ¤Ñ¨úÃÄÃÒ ­è¦nªÑ»ù¤]¶^¡C¬Ý¤£¥X¸gÀç¼h ¤jªÑªF¦³¦ó²z¥Ñ¦b¦¹½æªÑ²¼¡C¦ó¤£·Q·Q¬O¥t¤@¦³¤ß¤H ¦³¯S§O¥Øªº¡C
¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GDreamtiger10145627  µoªí®É¶¡:2019/5/13 ¤U¤È 06:46:50²Ä 6766 ½g¦^À³
¨ä¹ê¬Ý¨ÓÀ³¸Ó¬O·Ç³ÆÀ£§C¶i³f¤F...

6446§Q¦h³£¬O¥X³f

¨º§QªÅ©O??

¦óªp¦³³\¦h¤j¤jÄÀºÃ¹L

©Î³\ºM¾P·|§ó¦n¡A«oÅܦ¨¥«³õªº¤j§QªÅ

À³¸Ó¦³¤H±µªº«Ü¶}¤ßªº

§Ú¨S¿ú¡A¤£µM¤]­n¦A¶R¨â±iªº

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¤pªL10142678  µoªí®É¶¡:2019/5/13 ¤U¤È 06:29:56²Ä 6765 ½g¦^À³
¬Ý¨Ó§ÚÀ°¦£¬d¸ß¬O¦h¾lªº¡A­ì¨Ó³s³oµn¿ý¸ê°T³£¬Ý¤£À´¡C

www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=424414

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GROGER588910148151  µoªí®É¶¡:2019/5/13 ¤U¤È 05:40:56²Ä 6764 ½g¦^À³
.....ªL°êÄÁ«h»¡¡A§¹¥þ¤£·|¦³©Ò¼vÅT¡A[¬ü°ê©t¨àÃÄ»{ÃÒ]¥Ø«e¤w¨ú±o¡C

¡m¥ÍÂåªÑ¡n¼Ú·ù©t¨àÃÄ»{ÃÒ¾DºM¡AÃĵØÃÄ¡G¤£¼vÅT¾P°â¤Î¥L°ê»{ÃÒ

2019/05/13 16:12 ®É³ø¸ê°T

ªL¸³³Ì¦n¯à®³¥X¬ü°ê©t¨àÃÄ»{ÃÒ¤å¥óÃÒ©ú,¤£µM©t¨à¤jÀ¸®£Ãø¦¬³õ!

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GAT10147586  µoªí®É¶¡:2019/5/13 ¤U¤È 05:28:14²Ä 6763 ½g¦^À³
©ú¤Ñ¬Oªk¤H»¡©ú·|, ³o¬q®É¶¡»s³y¾÷·|µ¹¡¦¡¦¯u°²ªk¤H¥Î¬Û¹ï§C·Gªº¦¨¥»¡¦¡¦¤W¨® ¡¦¡¦ ªk¤H­Ì ©Î¿Ñ²¤¦p¤t¥ý¥Í­Ì¡¦¡¦À³¸Ó«Ü¶Â¥Ö....·|¥hÅw¼yªº!
¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GROGER588910148151  µoªí®É¶¡:2019/5/13 ¤U¤È 05:19:24²Ä 6762 ½g¦^À³
¤µ¤Ñ©t¨àÃĸê®æºÃ¼{,¤wªí©ú³o®a¤½¥q¸Û«H¿ºµMµL¦s,©ú¤Ñ¤j·§·|³Q¥áÂû³J!

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GAT10147586  µoªí®É¶¡:2019/5/13 ¤U¤È 05:14:31²Ä 6761 ½g¦^À³
½ÐGoogle ÃĵØ, ¬ðµM¦b¤È«á³o´X¤ÀÄÁ/¤p®É¤º , Yahoo, ¹d¦ë, ¤¤®É, Áp¦X,....µ¥³£¦³Á¿±o¤ñ¸û²M·¡ªº»¡©ú°T®§! Why???

Question:

1. ¸Ü¬O¥i¥HÁ¿²M·¡ªº®É­Ô¦ó¥²§tº±³J?

2. ´CÅé°T®§¤@©w¨Ó¦Û¤½¥q, ­n¤£«ç·|³o¼Ë²M·¡? ©Ò¥Hªí¹F¬O¥i¥H«Ü²M·¡ªº°Õ! ­n¤£­n¦Ó¤w!???

3. ®£Às­n¶}©lÅܦâ¤F¶Ü? ®£Às³g°ý°÷¤F¦ÛµM·|Åܦâ!!!???

4. ¯u¯u°²°², °²°²¯u¯u, ©ú©ú¬O¯u,ÁÙ­n¬G§Ë¥ÈµêÅý¤H¥H¬°¬O°²....¤£­n§Ñ¤F ÀH®Éª`·N ®£Às®É¥N ¨º°¦¸gÀپǺ١¦¡¦¬Ý¤£¨£ªº¤â¡¦¡¦ ªº¯u°²¼v¤l»P¥Í¦s­õ¾Ç!

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GLibad10145748  µoªí®É¶¡:2019/5/13 ¤U¤È 05:11:15²Ä 6760 ½g¦^À³
BesremiºM¦^©t¨àÃÄ»{ÃÒ,µ¥©ó«Å¥¬¶}©l½æBesremi¡C

¬O§Q¦h¨S¿ù ¥ý½æ¥ýĹ

AOP ¦pªG¤£ºM¦^Besremi©t¨àÃÄ»{ÃÒ,

¥i¥Hºò§Ö¤W¥« ? ,¥i¥H¶}©l½æBesremi ?

¤£¯à¹À!

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¤pªL10142678  µoªí®É¶¡:2019/5/13 ¤U¤È 04:43:26²Ä 6759 ½g¦^À³
´£¿ô¤@¤U¡A

§Ú©Ò»¡ªº³o¥y¸Ü¡iAOP¬O¸Óªá®É¶¡Ä~Äò¥h¸òCOMP½×­z?ÁÙ¬OºM¦^©t¨àÃĸê®æÅýBesremi¾¨§Ö¤W¥«?¡j¡A

¥u¬OÃÄÃҥӽФè¦b·í¤U¡A¦]Åv¿Å©Ò»Ý°µªº¨Mµ¦¡A½Ð¤Å§@¬°§Q¦hªº¸ÑŪ¡C

¥t¥~­Ó¤H»{¬°¤µ¤Ñ¦­¤WÃĵتº¤½§i¡A¡u«Ü©¾¹êªº¡vÂà¿ýEMAµû¦ô³ø§iªº­«ÂI¡C

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GROGER588910148151  µoªí®É¶¡:2019/5/13 ¤U¤È 04:43:09²Ä 6758 ½g¦^À³
Ãĵؤ£¥H±`¥ÎªºP1101/Besremi/Ropeg/AOP2014,¥Î³o»òÁ}Àßpegylated proline-interferon¦r²´¥Ó½Ð·d¯«¯µ°Ú?

¦ý¬OFDA Orphan Approval Status: Not FDA Approved for Orphan Indication ???

ÁÂÁ°Õ.

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¤pªL10142678  µoªí®É¶¡:2019/5/13 ¤U¤È 04:33:48²Ä 6757 ½g¦^À³
Roger¤j¡A

www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=367012

¦A¥[°e2µ§

www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=424514

www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=424414

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GROGER588910148151  µoªí®É¶¡:2019/5/13 ¤U¤È 04:26:47²Ä 6756 ½g¦^À³
Ãĵغô­¶»¡2012¦~4¤ëP1101Àò±o¬ü°êFDA®Ö­ã¬°©t¨àÃÄ»{ÃÒ!www.pharmaessentia.com/tw/achievements/2014

¨º«ç·|±q³o¸Ì www.accessdata.fda.gov/scripts/opdlisting/oopd/index.cfm

---¬d¥XNo records found!

¦Ó³o¸Ìwww1.magellanrx.com/documents/2019/04/mrx-pipeline_april-2019.pdf/

---¬OÅã¥ÜBLA;Orphan Drug

½Ð°Ý¤pªL¤j¯à§_½T»{ÃĵØ2012¦~®ÉªºFDA©t¨àÃĸê®æ?ÁÂÁÂ~

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡Gmtalps200110147181  µoªí®É¶¡:2019/5/13 ¤U¤È 04:23:30²Ä 6755 ½g¦^À³
AT¤j¡A±z¥i¥H¦A¼W¥[´X­Ó°Ñ¼Æ¡A¨Ò¦pÄw½X¤ÀÂI¡AªÑ»ù¶q...etc¡C

¥t¥~¦³¤@¥ó¨Æ±¡§x´b§Ú«Ü¤[¡A¤£ª¾ªO¤W¬O§_¦³¤H¦³µª®×¡H

¦pªG¡]¥u¬O¦pªG³á¡^, ¥òµô®×¥u¬Oºt¤@³õÀ¸¡H¨º½Ö·|¨ü¯q¡H

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GLibad10145748  µoªí®É¶¡:2019/5/13 ¤U¤È 04:21:30²Ä 6754 ½g¦^À³
BesremiºM¦^©t¨àÃÄ»{ÃÒ,µ¥©ó«Å¥¬¶}©l½æBesremi¡C

¬O§Q¦h¨S¿ù ¤T·³¤p«Ä³£ª¾¹D

¦ýÃĵط|¤£ª¾¹D¶Ü ?

«ê¦nÃĵرo¤½§i§â¥¦»~¾É¦Ü¦w¥þ©Ê¦³®Ä©Ê°ÝÃD

Åý§ë¸êªÑ¥Á»~»{ºM®ø©t¨àÃÄ

´N¬OºM®ø¼Ú¬wÃÄÃÒ

Åý¤µ¤ÑªÑ»ù¦¬½L´X¥G¶^°±

­W«ä¤£±o¨ä¸Ñ

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡Gvito10147056  µoªí®É¶¡:2019/5/13 ¤U¤È 04:14:49²Ä 6753 ½g¦^À³
³o®a¤½¥qªºµo¨¥¤H §¹¥þ¨S¦b»¡©ú

¾ã­Ó¸ê°T´N¬O«Ü«Ê³¬

¤£³z©ú

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GDDD10148021  µoªí®É¶¡:2019/5/13 ¤U¤È 04:10:57²Ä 6752 ½g¦^À³
­Ó¤H»{¬°¤µ¤éªº½æÀ£°£¤F4¤ëªºÀ禬¤£¨Î¥~¡A§ó¦hªº¬O§ë¸ê¤H¹ï©ó¤½¥q«H¤ßªº³à¥¢¡A

¦L¶H¤¤¤§«e¤½¥q¤j¤j¤p¤pªº¸ê°T³£·|¤½§i¡Aª½¦Ü¤µ¦~«oµo¥Í«Ü¦h¸ê°T³£ªHµL­µ°Tªº±¡ªp¡A

Åý§ë¸ê¤H¥u¯à¸Õ¹Ï±q¦U¤jºô¯¸¥h·j´M¸ê®Æ¡A§ä¥X¤@µ·®ø®§¡A¬Æ¦ÜÁÙ·|µo¿ù­«°T³Q¶}»@(?)¡A

°O±o¼W¸ê®×®É¦³¤H¥h°Ý¤½¥q®³¨ìÃÄÃÒ«ç³£¨S¶}ªk»¡·|»¡©ú¡A

¤½¥q·í®ÉµªÂСA¦]¬°¬O³B¦b¼W¸êªº½pÀq´Á¡A¦b¼W¸ê«á´N·|°¨¤W¹ï¥~»¡©ú¡C

½Öª¾¦b¼W¸ê¨ú®ø«á¡A©ú©ú´N¯à°¨¤W¶}·|»¡©ú¡A«o¿ï¾ÜÅý²³§ë¸êªÌ­W­W¦aµ¥¡A¥u¯à¨ü´e´Ò°×¤Ú¦Y¶À½¬¡A

³oÂI¤½¥q¯uªº­n§ï¡Aµo­Ó·s»D½ZÁ`¦æ§a?¡A¤£µMÃĦA«ç»ò¦n¡A¤½¥qªº¸Û«H¨ü¨ì½èºÃ¡A­þ­Óªk¤H­þ­Ó§ë¸ê¤H·|¶R³æ?

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GµLµß®ñ10021927  µoªí®É¶¡:2019/5/13 ¤U¤È 03:54:40²Ä 6751 ½g¦^À³
¹ï·Ó¡uÃþ¦ü±¡§Î¦p¥«­±¤W PV ²Ä¤G½u¥ÎÃÄ Jakavi ©ó 2015¦~ 3 ¤ë

Àò±o¼Ú·ùÃÄÃÒ¡AEMA¥ç¦b 2015 ¦~ 4 ¤ë¤½¥¬¿ÕµØ¤½¥qºM¦^©t¨àÃÄ»{ÃÒ¡C¡v,

BesremiºM¦^©t¨àÃÄ»{ÃÒµ¥©ó«Å¥¬¶}©l½æBesremi¡C

¬O§Q¦h³Q·í§QªÅ¸ÑŪ¡C

¤­¤ë,¤»¤ëÀ禬¨£¯u³¹¡C

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GµLµß®ñ10021927  µoªí®É¶¡:2019/5/13 ¤U¤È 03:23:45²Ä 6750 ½g¦^À³
§Ú¤]¨Óµ^·æ©M»ï¤@¤U,

¡uAOP¬O¸Óªá®É¶¡Ä~Äò¥h¸òCOMP½×­z?ÁÙ¬OºM¦^©t¨àÃĸê®æÅýBesremi¾¨§Ö¤W¥«?¡v

³o¥y¸ÜÂI¥X­«ÂI¤F,­ì¨Ó¦p¦¹!

¦A¨Ó´N¬Ý¬Ý©ú¤Ñªk»¡¬O¼y¯¬·|ÁÙ¬Oªk·|¤F....

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GLibad10145748  µoªí®É¶¡:2019/5/13 ¤U¤È 03:06:20²Ä 6749 ½g¦^À³
µ^·æ¦X»ï

¤¬¬Û°Û©M

¤£¿ù

´xÁn¹ªÀy

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¤pªL10142678  µoªí®É¶¡:2019/5/13 ¤U¤È 02:41:17²Ä 6748 ½g¦^À³
·Æ½ü¤j¡A

(ºM¦^¼Ú·ù©t¨àÃÄ«ü©w¸ê®æ¡A¥¢¥h10¦~¿W½æ´Áªº¼vÅT¦p¦ó)

(¤p§Ì¤£©úÁA)

-->½Ð¤ÏÂЫä¦Ò§Ú»¡ªº³o¥y¸Ü¡i¦ÒÅ窺¬O§A¹ïPV¤w®Ö­ãÃĪ«©M­Ô¿ïÃĪ«¶}µo²{ªpªº´x´¤«×¡C¡j

-->¥hÁA¸ÑJakavi¦b¼Ú·ù®Ö­ã¤W¥«®É¡APV¤w®Ö­ã¤G½uÃĪ«©M­Ô¿ïÃĪ«¶}µo²{ªp¡ANovartis¬O¸Óªá®É¶¡Ä~Äò¥h¸òCOMP½×­z?ÁÙ¬OºM¦^©t¨àÃĸê®æÅýJakavi¾¨§Ö¤W¥«?

-->¥hÁA¸ÑBesremi¦b¼Ú·ù®Ö­ã¤W¥«®É¡APV¤w®Ö­ã¤@½uÃĪ«©M­Ô¿ïÃĪ«¶}µo²{ªp¡AAOP¬O¸Óªá®É¶¡Ä~Äò¥h¸òCOMP½×­z?ÁÙ¬OºM¦^©t¨àÃĸê®æÅýBesremi¾¨§Ö¤W¥«?

(§Y¨Ï¹L¤F¿W½æ´Á, ©Î¨S¦³¿W½æ«OÅ@, ¦ý¨ä¥LÃļt¥i¥H¤£ºÞ±M§Q´N¦Û¦æ¥Í²£¶Ü?)

-->·íµM¤£¦æ¡A©t¨àÃÄ¿W½æ´Á©M·sÃıM§Q«OÅ@´Á¬O¨â¦^¨Æ¡C

(¦pªG±M§Q¤´¦³®Ä, §Ú¤£À´§ë¸ê¤H¤ÏÀ³¦p¦¹¿E¯Pªº­ì¦]¬O¤°?)

-->³o¬O¡u¥«³õ¾÷¨î¡v¡A§Ú¤£«K¥h²q­ì¦]¡C

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GAT10147586  µoªí®É¶¡:2019/5/13 ¤U¤È 02:20:47²Ä 6747 ½g¦^À³
M ¤j µû½× ­È±o ¬Ù«ä¡C

¤£±M·~¡H¨è·N¡H¹ï·Ó¹L¥h´X­Ó¨Æ¥óªº®É¶¡ÂI¡A¤]³\´N¦³µª®×¤F¡C

§ë¸ê¤w¸g­±Á{¡u®£Às®É¥N¡v¡A°ê¤º¥~¬ÒµM¡C®£Às·íµM°£¤F$$¦h¡A¦p¦P¡u¤t¡v¦Ñ¤j¤@¼Ë¡A¥ý¶ì³y¥«³õª^³ò¡A±À¯S­n¶RÁÙ¬O½æ¥ô¥Ñ¥L­Ì±±¨î¡C©Ò¿× µØº¸µó«ü´§¥þ²yÁ`³¡ µ×­^­Ì µ´¹ï¬O¡u±M·~ªº®£Às¡v

Á|¨Ò¡A¦p¦³¹p¦P¡A¯ÂÄÝ¥©¦X¡C

12/11/2018 °ê¤º®£Às®Äªk°ê¥~®£Às¡A»¡­n¼W¸ê¡G

±`²z¡G°w¹ï¤j®a¹ïÃÄÃÒ¨ú±o°ª¾÷²v»P¹ï °ê¥~2½u Jxxxx ¤W¥««áªÑ»ù¤£Â_¨«°ª¼¥¼©¡A®£Às«o¿ï¾Ü¦¹®É¤£Â_ÄÀ©ñÄw½X¡H¡I¥Øªº¡H ­n·d©wªº°Ó°È¿µ«ü©w®uÁÙ¨S¤J®y§¤º¡¡H

2/18/2019 §ó§ï¼W¸ê±ÂÅv»ù from 160-180 ÁÙ¤W½Õ160-200¡C¦¹®É¡A¤p³Â»e¸Á­Ì¤´µM«ùÄò¡u¬Ý¦n¡v¡A®£Às¤´µM«ùÄò¡uÄÀªÑ¡v

2/20/2019 ¤½§i¨ú±oEUÃÄÃÒ

3/13/2019

¤W¥«°s·|¡G

¶m¿Ë§r¡A¡u¦]¬°½pÀq´Á¡A¤£¯à»¡¡A¦ý¦b¥x¤W§Ú¥i¥H§i¶D§A¡A½pÀq¤§«á¤@©w¦³¡u¤£¯à»¡¡vªº²¢¥Ê°Õ¡A­n¶R²¢¥Êªº­n¶X¦­³á¡C§C½Õ¨Æ«á¨S¦³·s»Dµo§G«o«a»\¶³¶°ªº¤W¥«¡u°s·|¡v¤§«á¡A½æ¤è¤O¹D«ùÄòÀ£¹L¶R¤è¡C

3/14: ®£Às¤½§i¨ú®ø¼W¸ê¡C¡u¦]ºî¦X¦Ò¶q¥»¤½¥q¾ãÅéÀç¹B³W¹º¤Î¥¼¨Óµo®i¡AÀÀ¦Û¦æºM¦^107¦~«×¥Ó³ø¤§²{ª÷¼W¸êµo¦æ·sªÑ®×¥ó¡A¾Ü´Á¦A¥t¦æ¥Ó³ø¤Îµo¦æ¡v

¦ý¬O¤U­±³o¬q¸Ü¬O³z¹L·s»D´CÅ骺¡u¶Ç¸Ü¡v¡A«D¥¿¦¡¤½§i¡C

........¡uê©ó²{¼W½pÀq´ÁµLªk²M·¡»¡©ú·sÃĨú±o¼ÚÃÄÃÒ«áµ¥¶i®i¡A¬°ÅU¤ÎªÑªF»P§ë¸ê¤HÅv¯q¡A®ø«Ú¸ê°Tªº¤£¹ïºÙ©Ê¡A¨M©w¾Ü´Á¶i¦æ²{ª÷¼W¸êµo¦æ·sªÑ®×¥ó¡v

4/17: ¹ïFDA·|ij¬ö¿ý§tº±³J»¡¸Ü¡A¤£²M¤£·¡¡C¡u.......FDA ¤]¦³´£¨ì±N¨Ó

©Î³\¦³¥i¯à·|¸g¥Ñ FDA ªºÅU°Ý©e­û·|³w¦æ®Ö­ã BLA Ãĵý¡C

4/21 ¸É¥¿4/17¤½§i

5/5 ¸É¥¿ 4/17¤½§i¡C

5/13: ¦]À³±¹¬I: AXX¤½¥qªººM¦^«Y¦] AXX ¤½¥q¦b¦³ÃöÅãµÛ®Ä¯q¦p¦w¥þ©Ê¤Î¦³®Ä©ÊªºÄ³ÃD¤W¤£Ä@·N´£¥X§ó¦h½×­z¡C

¡u©ú©ú°ê¤º®£Às«Ü²M·¡¦Û¤vªº½æÂI´N¬O¦w¥þ©Ê»PÅãµÛ¦³®Ä¬Æ¦Ü¬O´î½w®ø«Ú´c¤Æ±¡§Î vs HU¡v¡A¬Ý­¾°Ú¡A­YCHMP ®Ä¯q­·ÀI¤ÀªR»¡©ú¤£»{¥i¨ä¦w¥þ»P¦³®Ä¡A¬Æ¦Ü¥i¥H½w¸Ñ Jak2 progress.....ÃÄÃÒ«ç»ò·|¦P·N®Öµo¡H

²¨©¿ ¥G¡H ±M·~ ¥G¡H ¤­­Ó¦h¤ë¥H¨Ó¡A®£Às ¬Û·í ¡u±M·~¡v¡I

¥ô¦ó§ë¸ê¼Ðªº­n¤£³Q®£Às½ò¦º¡A°£¤FÁקK¿Ä¸ê¨é¡A¬Ý¨Ó¤p»e¸Á¥²»Ý±q¡u¥¢±Ñ¡v¤¤­«·s»{ÃÑ®£Às»P¨ä¦æ®|¡C

¥t¥~¡A¤§«eµ§ªÌ´¿´£¿ô¡A°£¤F±M·~ª¾ÃÑ¥æ¬y¡AÁקKªO¤W¤Ó¦h±¡ºü¤å¦r¡A¦ý³o¸Ì¬O¡u¥Á¥D¡v¬ÝªO¡A©Î³\®£Às²´½u¦b¤º¤]¤£©w¡A«ÜÃø «ÜÃø ÁקK¡C

±¡ºü¡uÁn­µ¡v¶V¤j¡A®£Às¶Vª¾¹D§A¦b·Q¤°»ò¡C

®£Às¡Awe are watching u! ¤£­n·d¨ìÅý§ë¸ê¤H¥Ó¶D.......

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GLibad10145748  µoªí®É¶¡:2019/5/13 ¤U¤È 02:07:01²Ä 6746 ½g¦^À³
500½×¾Â

¤Ö¤FºÊ·þªº¤O¶q

¦h¬O±·±o¦h

ÃĪº½T¬O¦nÃÄ

¸gÀç¹Î¶¤¤]­n¦n

¤£¯à¤Ñ¤Ñ¥´²V

³sºM¾P¼Ú¬w©t¨àÃĤ½§i

¤]¯à§â¥¦»~¾É¦Ü

¦]¦w¥þ©Ê¦³®Ä©Ê°ÝÃD

ÅýªÑ¥Á¥H¬°ºM¾P¼Ú¬wÃÄÃÒ

³y¦¨ªÑ»ù¶^°±

»¡¹ê¦bªº

¶û³f¤~¬O¶R³f¤H

¤µ¤Ñ¶X§C¤S¶R¤F¤G±i

Ãĵذò¥»­±¤£¿ù

¥u­n¸gÀç¹Î¶¤¤£­n

¤Ñ¤Ñ¥´²V

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GROGER588910148151  µoªí®É¶¡:2019/5/13 ¤U¤È 02:01:39²Ä 6745 ½g¦^À³
¬ü°ê©t¨àÃĸê®æ»{©w¡GFDAÃöª`¨â¤jµû¼f­«ÂI

....¦b³o8¶µ¸ê®Æ¤¤¡AFDAÃöª`ªº¨â¤jµû¼f­«ÂI¬O¡G¡u(4)¬ì¾Ç®Ú¾Ú¡v©M¡u(8)¼vÅT¤H¤f ¡v¡C

..

kknews.cc/zh-tw/health/v8e6xxl.html

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GROGER588910148151  µoªí®É¶¡:2019/5/13 ¤U¤È 01:53:15²Ä 6744 ½g¦^À³
¤w§å­ãªº药«~¬O§_¤´¨ã¦³©t¤I药资®æ¡HEMA开©l对¨ä发¥¬报§inew.qq.com/omn/20180119/20180119G01QR1.html

...©t¤I药©e员会(Committee for Orphan Medicinal Products, COMP) ¥Ø«e会两¦¸评¦ô¤@Ïú药ª«¦b产«~开发过µ{¤¤¬O§_达¨ì©t¤I«ü©wªº标­ã¡A¤@¦¸¦b¬ã发过µ{¤¤¡A¤@¦¸¦b获±o¤W¥«±Â权时¡A¦ý这¨Ç评¦ô¦b¦¹¤§«e没¦³¦C¤J¤½众评¦ô报§i¡C

­^¤å:www.ema.europa.eu/en/news/orphan-medicine-still-orphan-once-it-gets-market

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¤pÃC10147871  µoªí®É¶¡:2019/5/13 ¤U¤È 01:49:04²Ä 6743 ½g¦^À³
ÁÂÁ¤pªL¤j´£¨Ñ¤Faop¬°¦óºM¦^©t¨àÃĪº¸ê®Æ ¥H¨Ñ¤j®a¤£­n¦Û¤v²q¨Ó²q¥hªº¡A¤j®a¬JµM³£¦³§ë¸ê¡A¨S¥¿½T¸ê°T¡A¬Ý¨ì¶Â¼v´N¶}ºj¡A¹ï¦Û¤v¦³¤°»ò¦n³B¡C¦A±j½Õ ¥»¤H¬O³æ¯Â§ë¸ê¤H¡C
¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GµØ½ü10141250  µoªí®É¶¡:2019/5/13 ¤U¤È 01:45:59²Ä 6742 ½g¦^À³
¤pªL¤j:

ºM¦^¼Ú·ù©t¨àÃÄ«ü©w¸ê®æ¡A¥¢¥h10¦~¿W½æ´Áªº¼vÅT¦p¦ó

¤p§Ì¤£©úÁA

§Y¨Ï¹L¤F¿W½æ´Á, ©Î¨S¦³¿W½æ«OÅ@, ¦ý¨ä¥LÃļt¥i¥H¤£ºÞ±M§Q´N¦Û¦æ¥Í²£¶Ü?

¦pªG±M§Q¤´¦³®Ä, §Ú¤£À´§ë¸ê¤H¤ÏÀ³¦p¦¹¿E¯Pªº­ì¦]¬O¤°?

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¤pÃC10147871  µoªí®É¶¡:2019/5/13 ¤U¤È 01:39:35²Ä 6741 ½g¦^À³
Libad¤j ·Q¤Ó¦h¤F¡A¥»¤Hªº±¾µP«á¶Rªºªø´Á§ë¸ê¡AÃ@µ¦¤½¥q¬O¹ïªº¡A¤j®a³£¬O§ë¸ê¤H ¤]§Æ±æ¤½¥q¦n ªÑ»ùº¦¡A¥u§Æ±æ¤j®a¥Î¥¿­±«ä¦Ò¡A¸Ø ¶S¤½¥q³£¦n¡A­Ó¤Hı±o­t­±±¡ºü¤£­n¦³¡A´N¹³§Ú¤]³QÃhºÃ¬O¬O­Óª×©³¡CÅ¥¤F¦n¯º
¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¤pªL10142678  µoªí®É¶¡:2019/5/13 ¤U¤È 01:35:04²Ä 6740 ½g¦^À³
2018¦~¼Ú·ùEMA®Ö­ã­ì¥ý¨ã³Æ©t¨àÃÄ«ü©w(OD)ªº·sÃÄ¡A¬ù¦³¥b¼Æ¦b®Ö­ã·í¤U¥Ñsponsor¦Û¦æºM¦^¡A

³o¨ÇÃļt¤j¦h¤£Ä@¦Aªá®É¶¡¸òCOMP¶i¦æ½×­z¡A¥HÁקK©µ«áCHMP®Ö­ã®Éµ{¡C

BMSªºEmpliciti¡A¬O¹L¥h¤@­Ó¤Ö¼Æ·|¸òEMA¥Ó¶Dªº®×¤l(¦ýBMS¥Ó¶D³Q»é¦^)¡AÄ~¦Ó¤S´£°_¶D³^(ªk°|ÁÙ¬O§P©wBMS±Ñ¶D)¡C

www.mayerbrown.com/en/perspectives-events/publications/2018/12/europegeneral-court-confirms-obligation-to-prove-s

¨ì©³COMPªºsignificant benefit©Mbroader safety profile±ø¥ó¡A¸òCHMPªºbenefit-riskµû¦ô·Ç«h¦³¦ó¤£¦P? ©¼¦¹¶¡¬O§_·|¦³ÃöÁp?

(¦h¬Ý¨ÇEMAªk³W¤å¥ó´N¥i¥H§ËÀ´)

ºM¦^¼Ú·ù©t¨àÃÄ«ü©w¸ê®æ¡A¥¢¥h10¦~¿W½æ´Áªº¼vÅT¦p¦ó? ¦ÒÅ窺¬O§A¹ïPV¤w®Ö­ãÃĪ«©M­Ô¿ïÃĪ«¶}µo²{ªpªº´x´¤«×¡C

(¦ý­n¥ý¯u¥¿§ËÀ´¼Ú·ù©t¨àÃÄ¿W½æ´Áªº½dÃ¥)

¦Ü©ó¬ü°êFDA·|¤£·|¦³¦P¼Ëªºª¬ªp? ¥i¥H¥hÁA¸Ñ¨â¦aªº©t¨àÃĪk¥O¡A¬ü°ê¬O§_¦³©t¨àÃĸê®æªº¦sÄòµû¦ô¨î«×?

(µª®×¤£³zº|¡A¥i¦Û¦æ¬d¸ß¨â¦aªk³W¡A³Ì²³æ¤è¦¡´N¬O¬d¸ßJakavi©MJakafiªº©t¨àÃĸê®æ¡C)

¼Ú·ùºM¦^©t¨àÃĸê®æ¡A¹ï©ó¼Ú¬wÃÄ»ù¡B«OÀIµ¹¥I¡Bº¯³z²v¡B¾P°âªº¼vÅT¦p¦ó?

³o¨S¦³¼Ð·Çµª®×¡A¦ý¤£Ãø§ä¨ì¤@¨Ç¸ê°T¡A¦Ó¯à«Ø¥ß¤j­Pªºµû¦ô½ü¹ø¡C

(§âNovartis©MIncyte¦Û2015¦~¥H¨Óªº¦~«×°]³ø½¥X¨Ó¤ñ¹ï¡A¤]¬OºÞ¹D¤§¤@¡C)

³o¨Ç´£°Ý¡A¤£¬O§Aªá¤@¨â­Ó¤p®É´N¯àµû¦ô¥X¨Ó¡A§ó¤£¬O¤@½g®£·W¦¡¼ÐÃDªº´CÅé³ø¾ÉÄ@·N§i¶D§Aªº¡C

¶È´£¨Ñ´X­Ó­±¦V«ä¦Ò¡Aµ¹ª©¤W¤Ö¼Æ»{¯uªº§ë¸ê¤H¥h§äµª®×¡C

(·íµM§A¥i¥H§â³o¨Ç´£°Ý¥á¨ìªk»¡·|¤W¡A¦ý­«­nªº¬O­n¦³¦Û¤vªº¬Ýªk¡C)

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GµØ½ü10141250  µoªí®É¶¡:2019/5/13 ¤U¤È 01:31:11²Ä 6739 ½g¦^À³
½Ð°Ý¤j®a:

ºM¦^©t¨àÃĹï¾P°âªº¼vÅT¬O¤°»ò?

AOPºÙ¨Ì´`¿ÕµØ¹ïJakavi ¥Î©óPV©t¨àÃÄ»{ÃÒªº³B²z¤è¦¡, Jakavi¨Ì¬O°ª»ù¦b½æÃÄ°Ú?

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GLibad10145748  µoªí®É¶¡:2019/5/13 ¤U¤È 01:30:43²Ä 6738 ½g¦^À³
ÃĵتºªÑªF

­n¹ïÃĵظgÀç¹Î¶¤ºÊ·þ

´£¥X¤£¦P·N¨£

´N³Q©Ù¦¨»¡­t­±ªº¸Ü

¦³¤H¦¹®É´N¦b´À¥L­Ì±»Å@

·|¤£·|¤Ó¶Ì

©Î®Ú¥»´N¬OÃĵؤº³¡­û¤u

Å¥©RÅ@¯è

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡Gmtalps200110147181  µoªí®É¶¡:2019/5/13 ¤U¤È 01:02:47²Ä 6737 ½g¦^À³
¤£±M·~¡H¨è·N¡H¹ï·Ó¹L¥h´X­Ó¨Æ¥óªº®É¶¡ÂI¡A¤]³\´N¦³µª®×¤F¡C
¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GAnderson10143089  µoªí®É¶¡:2019/5/13 ¤U¤È 01:01:05²Ä 6736 ½g¦^À³
¼W¸ê¨Ó¦^·d¤£©w¡A¨C¦¸¤½§i´X¥G³£»¡¤£²M¡A³o¼Ëªº¤½¥q­È¦h¤Ö? ÃP´²¦Ü·¥¡A¤f¤fÁnÁnªÑªFÅv¯q¡A§Ú¬Ý¨Ó¬Ý¥h³£¬O§¾¡C
¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G§ë¸ê¬ö«ß10145266  µoªí®É¶¡:2019/5/13 ¤U¤È 12:59:16²Ä 6735 ½g¦^À³
§Ú¤]»{¦P¤½¥qªºIR¤£±M·~

¤½§i³y¦¨»~¸Ñ«á¦A¸É¥R±ýÀ±¸É¶Ë®`¤w¨Ó¤£¤Î

¦n¦nª£¤@¹Dµæ¡A¤£­n¨C¦¸³£¥Xµæ«á¤~­n©ñªo¥[ÆQ¤Ú..

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡Gmtalps200110147181  µoªí®É¶¡:2019/5/13 ¤U¤È 12:24:05²Ä 6734 ½g¦^À³
§ó¥¿¤@¤U¡A¬O¬~¯B¸ê¡C¥H¤W¬O­Ó¤H¥DÆ[ªº·Qªk¡A¨S¦ó°Ñ¦Ò¨Ì¾Ú¡C¶^°±¤@ª½Âꤣ¦º¡C¡C«á­±ÁÙ¦³À¸

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡Gmtalps200110147181  µoªí®É¶¡:2019/5/13 ¤U¤È 12:17:46²Ä 6733 ½g¦^À³
¬~´²¤á°Ú¡I

¤£¯à©ñªÅªºªÑ²¼¡A¥Î§QªÅ¬~´²¤á¡C

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GLibad10145748  µoªí®É¶¡:2019/5/13 ¤U¤È 12:12:26²Ä 6732 ½g¦^À³
Ãĵج°¬Æ»ò

¤£¯à§â·s»D½Z·í¤½§i

²M²M·¡·¡»¡©ú

ºM¾P©t¨àÃĪº­ì¥Ñ

¤@©w­n±N¤½§i§â

ºM¾P©t¨àÃÄ»~¾É­P¦w¥þ©Ê¤Î¦³®Ä©Ê

ÅýªÑ»ù¶^°±

¥O¤HÃhºÃ¤£¸Ñ

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡Gwu701610136601  µoªí®É¶¡:2019/5/13 ¤U¤È 12:06:01²Ä 6731 ½g¦^À³
ÃĵØÃÄ¡GAOPºM¦^©t¨àÃĸê®æ ¨Ã«DºMÃÄÃÒ

³Ì·s§ó·s¡G2019/05/13 11:50

¡]¤¤¥¡ªÀ°OªÌÁú´@´@¥x¥_13¤é¹q¡^ÃĵØÃĪí¥Ü¡A¦X§@¹Ù¦ñAOP¤½¥qºM¦^¥HÃĵØÃĪº·sÃÄBesremiªvÀø¯u©Ê¬õ¦å²y¼W¥Í¯g¡]PV¡^ªº©t¨àÃÄ»{ÃÒ¡A¶È¬OºM¦^©t¨àÃĸê®æ¡A¤£¬OºM¦^BesremiÃÄÃÒ¡A¼Ú¬w¾P°â¦p´Á±Ò°Ê¡C

ÃĵØÃĤµ¤Ñµo¥¬·s»D½Z¼á²Mªí¥Ü¡AAOP¤½¥q»PÃĵØÃĪºBesremiÃÄÃÒ¡]Marketing Authorization¡^ªº®Ö­ã¬O¸g¥Ñ¼Ú·ù¤HÅé¥ÎÃÄ©e­û·|¡]Committee for Medicinal Products for Human Use¡A²ºÙCHMP¡^±ÀÂ˵¹¼Ú·ù°õ©e·|¡]European Commission¡A²ºÙEC¡^®Öµo¡C¸Ó¶µÃÄÃÒ©ó108¦~2¤ë19¤é¥¿¦¡®Öµo¡A¼Ú¬w¦æ¾P¥¬§½¦h®É¡B¾P°â¦p´Á±Ò°Ê¡C

ÃĵØÃÄ»¡©ú¡AAOPªº©t¨àÃÄ»{ÃÒ©ó2011¦~¨ú±o¡A2018¦~12¤ë©e­û·|¼f¬d©t¨àÃĸê®æ«ùÄò©Ê®É¡A«ØijAOP¤½¥q´£¥X§ó¦hªº¼Æ¾Ú¥Hºû«ù¸Ó¶µ¸ê®æ¡CAOP¨Ì´`¿ÕµØ¤½¥q¹ïJakavi¥Î©óPV¯e¯f©t¨àÃÄ»{ÃÒªº³B²z¤è¦¡¡A¨M©wºM¦^©t¨àÃĸê®æ¡C

ÃĵØÃĪí¥Ü¡ABesremiÃÄÃÒ¡]MA¡^ªº®Ö­ã¬O¸g¥Ñ¼Ú·ù¤HÅé¥ÎÃÄ©e­û·|¡]CHMP¡^±ÀÂ˵¹¼Ú·ù°õ©e·|¡]EC¡^®Öµo¡CºM¦^©t¨àÃÄ»{ÃҶȬOºM¦^©t¨àÃĸê®æ¡ABesremi¦æ¾PÃÄÃÒ§¹¥þ¤£¨ü¼vÅT¡A¼Ú¬w¾P°â¦p´Á±Ò°Ê¡C

ÃĵØÃÄ«ü¥X¡A©t¨àÃÄ»{ÃÒÁö½T«O²£«~¤W¥««á¾Ö¦³10¦~ªº¥«³õ±M½æÅv¡A¦ý¦]ÃĵØÃľ֦³¦¹²£«~ªº¬ÛÃö±M§QÅv¦Ü2034¦~¡A¥B¤½¥q«ùÄò§ë¤J¸Ó²£«~¬ãµo¡B¥Ó½Ð±M§Q¥H©µªø«OÅ@¡C©Ò¥HAOP¤½¥qºM¦^¼Ú¬wPV©t¨àÃÄ»{ÃÒ¹ïBesremi¾P°â§¹¥þ¤£³y¦¨¼vÅT¡C¡]½s¿è¡G·¨³Íµ¾¡^1080513

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¤pÃC10147871  µoªí®É¶¡:2019/5/13 ¤U¤È 12:01:15²Ä 6730 ½g¦^À³
¤j®a³£«Ü±M·~ªº§ä¸ê®Æ¥X¨Ó¡A¤S¦³¤£¦Pªº¸ÑŪ¡A­t­±±¡ºü¤S¿Ä¤J¸Ì­±¡A³o­Óª©­±«Ü¦hª©¤Í¦b¬Ý ·|¤¬¬Û·P¬V¦h±þ¦h ¡A´N¬Ý¦Û¤v¹ï³oÁûÃĪº«H¤ß¹Æ¡C
¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G°¶¤j¤j10136951  µoªí®É¶¡:2019/5/13 ¤W¤È 11:57:50²Ä 6729 ½g¦^À³
ÃĵءGAOP¶È¬OºM¦^©t¨àÃĸê®æ¡ABesremi¼Ú¬w¾P°â¦p´Á±Ò°Ê

§ù¿·»T/¥x¥_³ø¾É 2019/05/13 11:01

ÃĵØÃÄ¡]6446¡^ªí¥Ü¡A±ÂÅv¹Ù¦ñAOP¤½¥qºM¦^©t¨àÃÄ»{ÃÒ¡A¶È¬OºM¦^©t¨àÃĸê®æ¡A¤£¬OºM¦^BesremiÃÄÃÒ¡A¸Ó·sÃĥثe¦b¼Ú¬w¾P°â¦p´Á±Ò°Ê¡C

Ãĵتí¥Ü¡ABesremiRÃÄÃÒ (Marketing Authorization) ªº®Ö­ã,¬O¸g¥Ñ¼Ú·ù¤HÅé¥ÎÃÄ©e­û·| (Committee for Medicinal Products for Human Use¡A²ºÙCHMP) ±ÀÂ˵¹¼Ú·ù°õ©e·| (European Commission¡A²ºÙEC) ®Öµo¡C¸Ó¶µÃÄÃÒ«Y©ó108¦~2¤ë19¤é¥¿¦¡®Öµo¡A½t¦¹¡A¼Ú¬w¦æ¾P§G§½¦h®É¡B¾P°â¦p´Á±Ò°Ê¡C

©t¨àÃÄ»{ÃÒ (Orphan Drug Designation) ¬O¸g¥Ñ¼Ú·ù©t¨àÃÄ«~©e­û·| (Committee for Orphan Medicinal Products¡AEuropean¡A²ºÙCOMP) ·|­û°ê³q¹L¡CAOPªº©t¨àÃÄ»{ÃÒ«Y©ó2011¦~¨ú±o¡AµM©ó2018¦~12¤ë©e­û·|¼f¬d©t¨àÃĸê®æ«ùÄò©Ê®É¡A«ØijAOP ¤½¥q´£¥X§ó¦hªº¼Æ¾Ú¥Hºû«ù¸Ó¶µ¸ê®æ¡C

AOP¨Ì´`¿ÕµØ¤½¥q¹ïJakavi¥Î©óPV¯e¯f©t¨àÃÄ»{ÃÒªº³B²z¤è¦¡¡A¨M©wºM¦^©t¨àÃĸê®æ¡C BesremiR ÃÄÃÒ (MA) ªº®Ö­ã¬O¸g¥Ñ¼Ú·ù¤HÅé¥ÎÃÄ©e­û·| (CHMP) ±ÀÂ˵¹¼Ú·ù°õ©e·| (EC) ®Öµo¡CºM¦^©t¨àÃÄ»{ÃҶȬOºM¦^©t¨àÃĸê®æ¡ABesremiR ¦æ¾PÃÄÃÒ§¹¥þ¤£¨ü¼vÅT¡C?©t¨àÃÄ»{ÃÒÁö½T«O²£«~¤W¥««á¾Ö¦³10¦~ªº¥«³õ±M½æÅv¡A¦ý¦]¥»¤½¥q¾Ö¦³¦¹²£«~ªº¬ÛÃö±M§QÅv¦Ü2034¦~¡A¥B¤½¥q«ùÄò§ë¤J¸Ó²£«~¬ãµo¡B¥Ó½Ð±M§Q¥H©µªø«OÅ@¡C©Ò¥HAOP¤½¥qºM¦^¼Ú¬wPV©t¨àÃÄ»{ÃÒ¹ïBesremiR ¾P°â§¹¥þ¤£¨ü¼vÅT¡C

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GLibad10145748  µoªí®É¶¡:2019/5/13 ¤W¤È 11:53:35²Ä 6728 ½g¦^À³
¤£¬O²z©Êªº±þ½L

¥X¦bÃĵتº¤½§i¤W

§âºM¾P©t¨àÃÄ»~¾É¦Ü¦w¥þ©Ê¤Î¦³®Ä©Êªº°ÝÃD

³y¦¨ªÑ¥Á®£·W ªÑ»ù¶^°±

¨ä¹ê¼Ú¬w¤w¸g®³¨ì¤@½uÃÄÃÒ

¦w¥þ©Ê¤Î¦³®Ä©Êµ´¹ï¨S¦³°ÝÃD

°ÝÃD¥X¦b«D±`­t­±ªº¤½§i¤W

¯à§â§Q¦h¤½§i¦¨¶^°±

§Ú¬Ý¥u¦³Ãĵسo­Ó¤Ñ§L

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡Gwu701610136601  µoªí®É¶¡:2019/5/13 ¤W¤È 11:43:27²Ä 6727 ½g¦^À³
¡m¥ÍÂåªÑ¡n©t¨àÃÄ»{ÃÒºM¦^¡AÃĵØÃÄÀ~·w½ö¥­

2019/05/13 11:20 ®É³ø¸ê°T

¡i®É³ø°OªÌ³¢ÂE¼z¥x¥_³ø¾É¡jEMA©xºôµn¿ýAOPºM¦^¥HBESREMIªvÀø¯u©Ê¬õ¦å²y¼W¥Í¯g(PV)ªº©t¨àÃÄ»{ÃÒ¡AÃĵØÃÄ (6446) ªÅ¤è¤j­x¶É±_¦Ó¥X¡A¤µ¤éªÑ»ù¶}¨«§CÂê¦b¶^°±ªO128¤¸¡A§ë¸ê¤H«sÂE¹M³¥¡CÃĵØÃĺò«æ»¡©ú¡AAOPºM¦^©t¨àÃÄ»{ÃҶȬOºM¦^©t¨àÃĸê®æ¡A¤£¬OºM¦^BesremiÃÄÃÒ¡A¼Ú¬w¾P°â±N¦p´Á±Ò°Ê¡C

ÃĵØÃÄ»¡¡AAOP¤½¥q»PÃĵØÃĪºBesremiÃÄÃÒ(Marketing Authorization)ªº®Ö­ã¬O¸g¥Ñ¼Ú·ù¤HÅé¥ÎÃÄ©e­û·|±ÀÂ˵¹¼Ú·ù°õ©e·|(EC)®Öµo¡C¸Ó¶µÃÄÃÒ¬O¦b108¦~2¤ë19¤é¥¿¦¡®Öµo¡A½t¦¹¡A¼Ú¬w¦æ¾P§G§½¦h®É¡B¾P°â¦p´Á±Ò°Ê¡C

©t¨àÃÄ»{ÃÒ¬O¸g¥Ñ¼Ú·ù©t¨àÃÄ«~©e­û·|(Committee for Orphan Medicinal Products¡AEuropean¡A²ºÙCOMP)·|­û°ê³q¹L¡CAOPªº©t¨àÃÄ»{ÃÒ«Y©ó2011¦~¨ú±o¡A¤£¹L¡A2018¦~12¤ë©e­û·|¼f¬d©t¨àÃĸê®æ«ùÄò©Ê®É¡A«ØijAOP¤½¥q´£¥X§ó¦hªº¼Æ¾Ú¥Hºû«ù¸Ó¶µ¸ê®æ¡CAOP¨Ì´`¿ÕµØ¤½¥q¹ïJakavi¥Î©óPV¯e¯f©t¨àÃÄ»{ÃÒªº³B²z¤è¦¡¡A¨M©wºM¦^©t¨àÃĸê®æ¡CBesremiÃÄÃÒ(MA)ªº®Ö­ã¬O¸g¥Ñ¼Ú·ù¤HÅé¥ÎÃÄ©e­û·|(CHMP)±ÀÂ˵¹¼Ú·ù°õ©e·|(EC)®Öµo¡CºM¦^©t¨àÃÄ»{ÃҶȬOºM¦^©t¨àÃĸê®æ¡ABesremi¦æ¾PÃÄÃÒ§¹¥þ¤£¨ü¼vÅT¡A¼Ú¬w¾P°â¦p´Á±Ò°Ê¡C

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G§õªü½÷10147886  µoªí®É¶¡:2019/5/13 ¤W¤È 11:36:31²Ä 6726 ½g¦^À³
¥D°ÊºM¦^©t¨àÃĸê®æ¤@©w¬O¦³¥«³õ¦Ò¶q

AOP¥i¥H®³P1101¤K¦¨¥H¤W¾P°âª÷ÃB

·|·h¥ÛÀY¯{¦Û¤vªº¸}¡H

¿ÕµØºM¦^Jakafiªº©t¨àÃĸê®æ

Ãø¤£¦¨¸òAOP¤@°_·F¶Ì¨Æ¦³¿ú¤£ÁÈ¡H

¥J²Ó«ä¦Ò´N¥i¥Hª¾¹D¬O¤£¬O²z©Êªº±þ½L

­Ó¤H¶^°±»ù¦A¶i15±i

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GLibad10145748  µoªí®É¶¡:2019/5/13 ¤W¤È 11:33:53²Ä 6725 ½g¦^À³
µLµß®ñ¥S,

»¡±z»¡­·²D¸Ü

¬O»¡±z¥u«ùªÑ¤G±i

¤µ¤Ñ¶^°±¹ï±z

¤£µh¤£Äo

§Ú?

¨x¸z­ÑÂ_

©Ò¥H±z´N¤£­n¦A»¡,ÃĦh¦n¦h¦n ¦b¶Ë¤fÅxÆQ

­Y¨S¦³¦nªº¸gÀç¹Î¶¤

¦nÃÄÅܬrÃÄ

®`¦ºªÑ¥Á ¦³¥i¯à¶É®a¿º²£

©Ò¥H¹ïÃĵحn¦n¦nºÊ·þ

¤£¯àÅý¥L¬°©Ò±ý¬°

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GROGER588910148151  µoªí®É¶¡:2019/5/13 ¤W¤È 11:24:12²Ä 6724 ½g¦^À³
¤½¥q¬£¦³¨Ç¹³§ß¤£°_ªºªü¤æ,­Y²Ä¤G§å¸û¤j¥X³f¶q¨S¹F¨ì­Ó¤H¤ß¸Ì¥Ø¼Ð­È.¥»¤H·|°±·l¥X³õ.

[·|­û¡Gªü¤¤10143502 µoªí®É¶¡:2019/5/11 ¤U¤È 02:47:56²Ä 6699 ½g¦^À³

...³Í°ò³ø§i­º§å¥X³f±N°µ¬°´ú¸Õª«¬y¨ÑÀ³Ã줧¥Î¥D­n¬OÆ[¬d¦U¤è­±·Ç³Æ¬O§_§´·í²Ä¤G§å¸û¤j¥X³f¶q©ó¤»¤ë«e±Ò°Ê]

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GµLµß®ñ10021927  µoªí®É¶¡:2019/5/13 ¤W¤È 11:19:44²Ä 6723 ½g¦^À³
§Ú¨Ã¤£¬O»¡­·²D¸Ü,§Ú¬O»¡¹ê¸Ü¡C¸Õ·Q,¤µ¤Ñ·|®£·W±þ¶^°±¬O¬°¤°»ò?

§Ú¥u¯à·Q¨ì¨â­Ó­ì¦]:

¨ä¤@,¥|¥ÎÀ禬5.5¸U,¦ý¬O,ÁÙ¨S¶}©l½æ,³oÀ禬§¹¥þ¤£¨ã¥Nªí©Ê¡C

¨ä¤G,ºM¾P©t¨àÃĪº¤½§i,³o¬OAOP¥D°Ê´£¥XºM¾P,ÁöµM¤½¥q¸É¥R»¡AOP ¤½¥qªººM¦^«Y¦] AOP ¤½¥q¦b¦³ÃöÅãµÛ®Ä¯q¦p¦w¥þ©Ê¤Î¦³®Ä©ÊªºÄ³ÃD¤W¤£Ä@·N´£¥X§ó¦h½×­z¡C³o¨Ã¤£¬O»¡¦w¥þ©Ê¦³°ÝÃD©Î¦³®Ä©Ê¦³°ÝÃD¡C¦pªG³o¨âªÌ¦³°ÝÃDÁÙ±o¤F,³sÃÄÃÒ³£¤£¥i¯à¤F¡C

©Ò¥H,·sÃĪѥͤH¤Åªñ¡C

Gºôªº½×­z§Ú¤]¬Ý¹L¤F,§Ú»{¬°¦³¨Ç¬O¦ü¬O¦Ó«D¡C

ÁÙ¬O¦Ñ¸Ü¤@¥y,µ¥½æ¥b¦~¦AÆ[¹î¡C´Nºâ«Ü®`©È,¬JµM¤w¸g½ä¤F,¦Ü¤Ö¤]¶}©l½æ¨â­Ó¤ë¦A¬Ý¬Ý¡C

²{¦bªº±þ½L¤£¤@©w²z©Ê¡C

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GLibad10145748  µoªí®É¶¡:2019/5/13 ¤W¤È 11:07:52²Ä 6722 ½g¦^À³
500³o­Ó½×¾Â

¦³«Ü¦h¬OÃĵتº¦«( ¦Û¤v¦b©ß ¤Ï»¡Ãĵئh¦n¦h¦n)

¤p¤ß¤ÀÅG ¤£­n¤W·í

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GLibad10145748  µoªí®É¶¡:2019/5/13 ¤W¤È 10:59:30²Ä 6721 ½g¦^À³
µLµß®ñ¥S

±z»¡­·²D¸Ü

§A¥»¨Ó»¡¥u¦³¤@±i

²{¦A¶R¤@±i

Á`¦@¤G±i

¼vÅT¤£¤jªü!

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GµLµß®ñ10021927  µoªí®É¶¡:2019/5/13 ¤W¤È 10:50:45²Ä 6720 ½g¦^À³
ÁöµM¶^°±Âê¦í¤@¦Ê¦h±i,§Ú¤´¤£·|¨üªÑ»ùÅܤƦӼvÅT,²{¦b¨Ó¥[½X1±i¡C

§ÚÁ}¨¯¥L·|½æ±o¤ñJAKAVI¦n,­ì¦]¦³¨â­Ó:1.¥¦·|ÅýJAK2°ò¦] burden¤]´N¬O¦³ªv¡ªº¥i¯à©Ê,¬Oªv¥»¤£¬Oªv¼Ð,2.HU¦³­PÀùªº¶É¦V,¥L¨S¦³­PÀùªº®×¨Ò¡CÁÙ¨S¶}©l½æ,ªí¥ÜÁÙ¨S½µP,4¤ëÀ禬®t¨Ã¨S¦³¥Nªí¤°»ò,¥Ó½ÐºM¾P©t¨àÃĤ]¬O¸òjakavi¤§«e©Ò¬°¤@¼Ë¨S¤°»ò¡C

===========================================================

m.ctee.com.tw/livenews/aj/20180109003490-260410

ÃĵØÃÄ¡]6446¡^¤µ¡]9)¤éªí¥Ü¡A¸Ó¤½¥q¤w§¹¦¨¬ü°êFDA«Øij°w¹ï¯u©Ê¬õ¦å²y¼W¥Í¯g(PV)ªºRopeg¡]P1101¡^¤T´ÁÁ{§É¼Æ¾Ú¦A¤ÀªR¡AÅã¥Ü«ùÄò©Ê¤ÏÀ³²v¹ï¨Ï¥ÎHU±wªÌ·¥¨Î¡C

PV¦b¼Ú¬ü¦U¬ù¦³¤Q¦h¸U¯f±w¤H¼Æ¡A¥Ø«eªºªvÀø¤èªk°£¤F¾a©w´Á©ñ¦å©Î¬OªA¥Î¦³ªºÀù¯g¥ÎÃÄHU¨Ó¼È®É±±¨î¯f±¡¥~¡A©|µL¦³®ÄªºªvÀø¤è¦¡¡C¦ýªA¥ÎHU«h·|¤Þ°_¨ä¥L¨Öµo¯gªººÃ¼{¡Aªø´Á¨Ï¥ÎÄY­«ªº§ó¦³¥i¯à¾É­P¦åÀù (Leukemia)¡C

¦b¬ü°ê¡A¨Ï¥Î²Ä¤G½u¥ÎÃÄ Jakafi ªº PV ¯f±w¬ù¦³ªñ3,000¤H¡A¦~¾P°â¤w¹F4»õ¬ü¤¸¡C

®Ú¾ÚÃĵظu¥Î¬ü°êÅU°Ý¤½¥q©Ò°µªº¥«³õ¬ã½Õ¡A¥H Ropeg ¥Ø«eªºÁ{§É³]­p¡A¥iÀ³¥Î©ó²Ä¤@½u¥ÎÃĪºPV¯f±w¡A¥Ø«e¦³±µ¨üªvÀøªº¯f±w¤wªñ8¸U¤H¡A¨ä¤¤¥]¬A¦³¬ù 1 ¸U¦h¤H¨Ï¥Î¶Ç²Î¤zÂZ¯À©Î Pegasys¡A¤Î¶W¹L5¸U¤H¨Ï¥ÎHU¡C

Ãĵتí¥Ü¡Aªñ´Á»PFDA¶i¦æ­±¹ï­±·¾³q¡A¤w§¹¦¨®Ú¾ÚFDA­ì¥ý©Ò«Øijªº­«·s¤ÀªRPROUD-PV¤ÎCONTI-PV¼Æ¾Ú¡A¨Ã¯S§OÀ˵øRopeg¡]P1101¡^¦b¯f¤H±Ú¸s¤¤21-24­Ó¤ë´Á¶¡¦³µL¹F¨ì«ùÄò©Ê¤ÏÀ³²v (Durable Response)¡C

®Ú¾Ú¤½¥q©Ò©e¥~ªº²Î­p±M®aÅU°Ý¤½¥q©Ò°µ¤ÀªRÅã¥ÜRopeg«ùÄò©Ê¤ÏÀ³²v¹F¼Ð¡A§Y 21-24­Ó¤ë«ùÄò©Ê¤ÏÀ³²vRopeg¬°66.3%¡A©úÅãÀu©óHU/BATªº47.4%¡]p = 0.0126¡^¡A¦b²Î­p¾Ç¤W¹FÅãµÛ·N¸q¡C

­È±o¯S§Oª`·Nªº¬O¡A¦b¦¸±Ú¸s¤ÀªR¤¤¡A¦³±µ¨ü¹LHUªvÀø¹Lªº¯f¤H®ÄªG³Ì¬°ÅãµÛ¡ARopegªº«ùÄò¤ÏÀ³²v¹F74.2%¡A¦Ó¦b¹ï·Ó²ÕHU/BAT¤¤«h¬°32%¡]p = 0.0016¡^¡A³o¥i¯à¦]¦h¦~¨Ï¥ÎHU­P¨Ï«ùÄò©Ê¤Î¦³®Ä©Ê­°§C¡A¥B¦³¤Þµo¦åÀùªººÃ¼{¡A½t¦¹¡A¦A¦¸ÃÒ©úRopeg¥i¬°±w¦³ PV¯e¯f¥B¥¿¦b¨Ï¥ÎHU¯f±w´£¨Ñ¤@­Ó¦³®Ä¥B«ùÄò©ÊÀu¶Vªºªø´ÁªvÀø¿ï¶µ¡C

Ãĵثü¥X¡A¦b¥h¦~ASHµoªíªºPROUD-P¤ÎCONTI-PV ÖפT´ÁÁ{§É¸ÕÅçµ²ªG¤w¬°MPN±M·~Âå¥Í¤Î¼s¤j¯f±w©Òª¾¾å¡A§Y±wªÌ¦b¨Ï¥Î Ropeg ¹F 24 ­Ó¤ë®É¤£¦ý¹F¨ì¹w´ÁÀø®Ä«ü¼Ð¡A§¹¥þ¦å²G¤ÏÀ³²v (CHR) ¦b 24 ­Ó¤ë®É¹F¨ì 70.5%¡A©úÅãÀu¶V©ó HU/BAT ªº 49.3% (p = 0.0101)¡C

¦¹¥~¡A®Ú¾Úªø´Á°lÂܪº CONTI-PV Á{§É¸ÕÅçµ²ªG§óÆ[¹î¨ì Ropeg ¨ã¦³¿W¯Sªº½Õ¸`¯e¯f¯à¤O¡A§Y JAK2 ¬ðÅܪºµ¥¦ì°ò¦]­t¾á (allele burden) ¦b¸g¹L24­Ó¤ëªvÀø¡AP1101²Õ¦³ 69.6% ¦³³¡¤À¤À¤l¤ÏÀ³ (partial molecular response)¡A¦Ó HU/BAT¶È¦³ 28.6% (p = 0.0046)¡C

¤½¥q¶i¤@¨Bªí¥Ü¡A³Ìªñ¤½§Gªº CONTI-PV Á{§É¸ÕÅçµ²ªG·¥¬°¥¿­±¡A¹F¨ìÀu¶V©Êªºµ²ªG¡CÃĵØÃÄ°£¤w°e¥æ¸Óµ¥¼Æ¾Ú¦Ü¼Ú·ù EMA¶i¦æÃÄÃÒ¼f¬d¥~¡A¥ç¿n·¥¦V¬ü°ê FDA ¿Ô¸ß¥H¶i¦æÃÄÃÒ°e¥ó¥Ó½Ð¡A¥Ñ©ó¤½¥q¤w®Ú¾ÚFDA­ì¥ý©Ò«Øijªº­«·s¤ÀªR¼Æ¾Ú¡C

ÃĵØÃÄ«ü¥X¡A¯u©Ê¬õ¦å²y¼W¥Í¯g(PV)¬°°©Åè³y¦å²Ó­Mªø´Á¤£¥¿±`¦a»s³y¹L¦hªº¬õ¦å²y²Ó­M©Ò²£¥Íªº¯e¯f¡A­Y¥¼¦³®ÄªvÀø¥i¯à¤Þµo¦å®ê¡A¤]¥i¯à·|ÂàÅܦ¨°©ÅèÅÖºû¤Æ©Î¦åÀù¡A¬O¤£¥i»´©¿ªº¦MÀI¯e¯f¡C¦Ó¤zÂZ¯À±q 1980 ¦~´N¤w¶}©lÀ³¥Î¦b PVªºÁ{§É¤W¡A¦ý¦]¨ä­@¨ü©Ê¤Î°Æ§@¥Îªº°ÝÃD¡A¥H­P©óµLªk¨Ï¥Î¨ì³Ì¦³®Äªº¾¯¶q¥H¹F¨ì¹ïPV¯e¯fªvÀøªº³Ì¨Î®ÄªG¬Æ©ÎÀ³¥Î¨ì»Ýªø´Á¨Ï¥ÎªººC©Ê¯f¤H¤W¡C

¬ü°ê FDA ©ó 2014 ¦~®Ö­ã²Ä¤@­ÓMPN¥ÎÃÄ Jakafi«YIncyte¡]¬ü°ê¥«³õ¡^¤Î¿ÕµØ¡]¬ü°ê¥H¥~¥«³õ¡^ªº²£«~¡C¸ÓÃÄ«Y®Ö­ã¨Ï¥Î©óªvÀø PVªº²Ä¤G½u¥ÎÃÄ¡A¦ý³Ìªñ®Ú¾Ú¬ü°ê¡B¼Ú¬w¤Î¥xÆWµ¥¦aªº¦å²G¯e¯f»â°ìÅv«ÂÂå¥Í¬ÛÃöÁ{§Éµo²{¡AJakafi ÁöµM¦bµ¹ÃÄ«á¯à©úÅã§ïµ½¯gª¬¡A¦ý¬O¦b°±Ãī᪺¯e¯f¯gª¬¤£¦ý¦^´_¥B·|§ó¬°´c¤Æ¡C

¬°¸Ñ¨M³o¥Ø«e©|µLªkº¡¨¬ªºÁ{§É»Ý¨D¡AÃĵØÃĬãµo³Ð·sªºªø®Ä¤zÂZ¯À Ropeginterferon (Ropeg) §ï¨}¤F¥Ø«e¥«­±¤W¤£½×¬Oµu®Ä¤Î¤w¤W¥«ªºªø®Ä¤zÂZ¯ÀÃĪ«¡]¬Ò¨ã¦³¦]°Æ§@¥Î¤j¦Ó¾É­P¾¯¶qÃø¥H½Õ¤Éªº¯ÊÂI¡^¡A¥i¤j´T­°§C°Æ§@¥Î¡B´£¤É¦w¥þ©Ê¡B¯f¤H­@¨ü«×°ª¡A¾¯¶q½Õ¾ã´T«×¤j¡A¨Ã¯à¶i¤@¨B¤j´T´£°ªªv¡²v¡C

¦¹¥~¡ARopeg±ÄÂù©Pª`®g¤@¦¸¡A´£¤É­@¨ü©Ê¥~§ó¼W¥[¤F¤è«K¡A¤@¥¹¨ú±oÃÄÃÒ¡A±N¬O¥þ²y²Ä¤@­Ó³Q®Ö­ã¥Î©óªvÀø PV ¯f±wªº°ß¤@²Ä¤@½u¥ÎÃĪº³Ì¦n¿ï¶µ¡A©¡®ÉÂå®vªº¥ÎÃĤ覡±N·|¥X²{¤j´T«×ªº§ïÅÜ¡A¤]¬OPV¯f±wªº³Ì¤jºÖ­µ¡C

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GAnderson10143089  µoªí®É¶¡:2019/5/13 ¤W¤È 10:32:24²Ä 6719 ½g¦^À³
¤@¯ë¤½¥q³£·|¦³ªk»¡·|¦æ±¡¡A6446¬O°l«ä·|¦æ±¡¡C
¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GÂŤÑ10143709  µoªí®É¶¡:2019/5/13 ¤W¤È 10:30:46²Ä 6718 ½g¦^À³
¼ÐÃDÀ³¸Ó§ï¦¨:ªø´Á«ù¦³¥Ø¼Ð»ù50¤¸¥H¤W
¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¤p¤ß10139342  µoªí®É¶¡:2019/5/13 ¤W¤È 10:24:46²Ä 6717 ½g¦^À³
°k©Rªi¥Ø»ù·|¨Ó¨ì50¤¸
¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GLibad10145748  µoªí®É¶¡:2019/5/13 ¤W¤È 10:21:19²Ä 6716 ½g¦^À³
¥ý¶i¥S,

±z¤U³o¼ÐÃD ®£·|³Q¨DÀv

¼ÐÃD¡Gªø´Á«ù¦³¥Ø¼Ð»ù500¤¸¥H¤W

¤£ª¾±z¬O§_¦³ÃÒú³¤ÀªR®vÃÒ·Ó ? ©Î¦³µoªí¤ÀªR³ø§i ?

¦n·N´£¿ô

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GSunfive10145942  µoªí®É¶¡:2019/5/13 ¤W¤È 10:08:09²Ä 6715 ½g¦^À³
¤½¥q¥H¬°»PAOP¶D³^¬OÀ°ªÑªF¿Ñ¨D³Ì¤jÀò§Q, ¨ä¹ê³oºØ·M²Âªº¦æ¬°¥u·|¾ð¥ß¼Ä¤H! ³y¦¨¦U¦ìªÑªF·¥¤jªº·l¥¢!! §¹¥þ¤£ª¾©M®ð¤è¯à¥Í°]ªº¹D²z!!!
¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GAnderson10143089  µoªí®É¶¡:2019/5/13 ¤W¤È 09:58:47²Ä 6714 ½g¦^À³
¤@¥y¸Ü¡GÄêªd§ß¤£¤WÀð¡AªÑ»ùµ´¹ï¯à¤Ï¬M¤@®a¤½¥qªºÅé½è©M¸Û«H¡C
¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GLibad10145748  µoªí®É¶¡:2019/5/13 ¤W¤È 09:56:23²Ä 6713 ½g¦^À³
°ÝÃD¥X¦b¤½§i»¡©ú¤£·í³y¦¨§QªÅ½æÀ£:

1.AOP ¤½¥qªººM¦^«Y¦] AOP ¤½¥q¦b¦³ÃöÅãµÛ®Ä¯q¦p¦w¥þ©Ê¤Î¦³®Ä©ÊªºÄ³ÃD

¤W¤£Ä@·N´£¥X§ó¦h½×­z. ÃĵØIR À³¸ÓÃã¾, ¬°¤£·í­t­±»¡©ú­t³d

2. AOP ¤½¥qªººM¦^©t¨àÃÄ ,Ãĵإu¯à±q AOPºô¯¸³Q°Ê±oª¾ ,¥i¨£»PAOPÃö«Y¤´Â¤£¨Î.

3.Ãĵظ۫H¤w³QÃhºÃ: ¥]¬A¥Î¦Û¤v¿Ë¤H,¨à¤l·í°ª©x, Á«·l¤FÁÙ®³ªÑ²¼°µ­û¤u»{ªÑ,¶O¥Î´N¦hªá¤T»õ¦h¤¸.

ÃĵظgÀç¹Î¶¤»Ý­n§ï²Õ ­«·s²Õ«Ø·s¹Î¶¤ ¹jµ´¸È±aÃö«Y

Ãĵذò¥»­±¤´Â¬ݦn

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GROGER588910148151  µoªí®É¶¡:2019/5/13 ¤W¤È 09:46:50²Ä 6712 ½g¦^À³
¦³©ú½TÃÒ¾Ú¯uªº¨«?

½æªÑ®É¶¡¹ê¦b¤Ó¥©¦X,·QÀËÁ|¤º½u¥æ©ö¤§¶û,ÅýªÑªF·|§ó¥[¼ö¼ö¾x¾x!

[·|­û¡GÃƪѥÁ10147162 µoªí®É¶¡:2019/5/2 ¤W¤È 09:44:09²Ä 6577 ½g¦^À³

¯Âºé¤K¨ö¤@¤U §Ú¹ê¦b«Ü¨ü¤£¤F²Î¤@ªº½æªk ¬Q¤Ñ¨ì³B¥´Å¥¤@¤U ³ºµMÅ¥¨ì ²Î¤@¤j¤á¦ü¥G¬O¨«¤F­C... (¤£¬O½æ¥úªº¨«.. ¬O¯uªº¨«ªº¨«) ¦Ó¥BÅ¥»¡«Ü¬ðµM ]

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¥Í§Þ¤p­ô10148048  µoªí®É¶¡:2019/5/13 ¤W¤È 09:24:37²Ä 6711 ½g¦^À³
³£ªÅÀY±Æ¦C¦¨¦p¦¹¤F¡A«ç»òÁÙ¦³¤H­n¶R¡H§Þ³N¤ÀªRÁ`¬O¨«¦b°ò¥»­±«e­±ªº¡I
¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GAnderson10143089  µoªí®É¶¡:2019/5/13 ¤W¤È 09:16:14²Ä 6710 ½g¦^À³
§Ú©l²×ÃhºÃ³o®a¤½¥q¦³°­¡A¥´±q§Ú¶i¤J³o­Óª©¶}©l¡A©Ò¥H¤@¸ô³Q½|¡A¦ý¬O¦n¹³®É¶¡ÁÙ§Ú¤½¹D? ÁöµM§Ú©l²×§Æ±æ§Ú¬O¿ùªº¡C
¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GAnderson10143089  µoªí®É¶¡:2019/5/13 ¤W¤È 09:08:34²Ä 6709 ½g¦^À³
§A¬Ý¬Ý§A¡Aª¼¥Ø¼ÖÆ[¬O¨S¥Îªº¡A100¥H¤U«ü¤é¥i«Ý³á¡C
¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¤ý¸I¥J10148138  µoªí®É¶¡:2019/5/13 ¤W¤È 09:08:10²Ä 6708 ½g¦^À³
§Ú¤]³o¼Ëıªº ¥«³õµ¹ªº¤À¼Æ¬O¤£¤Î®æ
¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GROGER588910148151  µoªí®É¶¡:2019/5/13 ¤W¤È 09:05:09²Ä 6707 ½g¦^À³
³o®a¤½¥q¸Û«H¤@±Ñ¶î¦a!

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GµLµß®ñ10021927  µoªí®É¶¡:2019/5/13 ¤W¤È 07:18:37²Ä 6706 ½g¦^À³
www.sam.ee/2019-i-kvartalis-euroopa-komisjoni-m%C3%BC%C3%BCgiloa-saanud-uued-ravimid

=============================================================================

2019/05/07¤~¤½§i¡C

¬O§_5¤ë¶}½æ?

¼Ú·ù³q¹L¬O§_Áٻݭn¤@°ê¤@°ê¥Ó½Ð?

«OÀI½Í±o¦p¦ó?

§Æ±æ©ú¤Ñªk»¡·|¦³µª®×¡C

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GµLµß®ñ10021927  µoªí®É¶¡:2019/5/13 ¤W¤È 07:08:21²Ä 6705 ½g¦^À³
1.¨Æ¹êµo¥Í¤é:108/05/10

2.¤½¥q¦WºÙ:ÃĵØÂåÃĪѥ÷¦³­­¤½¥q

3.»P¤½¥qÃö«Y(½Ð¿é¤J¥»¤½¥q©Î¤l¤½¥q):¥»¤½¥q

4.¬Û¤¬«ùªÑ¤ñ¨Ò:¤£¾A¥Î

5.µo¥Í½t¥Ñ:

®Ú¾Ú EMA ©ó 5 ¤ë 10 ¤é©xºôµn¿ý¨ä©ó 5 ¤ë 9 ¤éµo¥¬©t¨àÃÄ«~©e­û·|

(Committee for Orphan Medicinal Products, COMP) ªº©t¨àÃÄ»{ÃÒªº

¦sÄòµû¦ô³ø§i¡]Withdrawal Assessment Report - Orphan Maintenance¡^

6.¦]À³±¹¬I:

AOP ¤½¥qªººM¦^«Y¦] AOP ¤½¥q¦b¦³ÃöÅãµÛ®Ä¯q¦p¦w¥þ©Ê¤Î¦³®Ä©ÊªºÄ³ÃD

¤W¤£Ä@·N´£¥X§ó¦h½×­z¡C

¨Ì EMA 2000-2018 ¦~ Orphan Medicines ³ø§i¡Aªñ¦~¨Ó©t¨àÃÄÃÒºM¦^¤ñ¨Ò

³v¦~¼W¥[¡C¸g¬dÃþ¦ü±¡§Î¦p¥«­±¤W PV ²Ä¤G½u¥ÎÃÄ Jakavi ©ó 2015¦~ 3 ¤ë

Àò±o¼Ú·ùÃÄÃÒ¡AEMA¥ç¦b 2015 ¦~ 4 ¤ë¤½¥¬¿ÕµØ¤½¥qºM¦^©t¨àÃÄ»{ÃÒ¡C

¸ê®Æ¨Ó·½www.ema.europa.eu/en/documents/orphan-designation/eu/

3/14/1244-public-summary-opinion-orphan-designation-ruxolitinib-treatment

-polycythaemia-vera_en.pdf

7.¨ä¥LÀ³±Ô©ú¨Æ¶µ:

·sÃĶ}µo®Éµ{ªø¡B§ë¤J¸g¶O°ª¥B¨Ã¥¼«OÃÒ¯à¤@©w¦¨¥\¡A¦¹µ¥¥i¯à¨Ï§ë¸ê­±Á{­·ÀI¡A

§ë¸ê¤HÀ³¼f·V§PÂ_ÂÔ·V§ë¸ê¡C

============================================================================

AOP ¤½¥q¦b¦³ÃöÅãµÛ®Ä¯q¦p¦w¥þ©Ê¤Î¦³®Ä©ÊªºÄ³ÃD

¤W¤£Ä@·N´£¥X§ó¦h½×­z¡C

===========================================================================

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G§õªü½÷10147886  µoªí®É¶¡:2019/5/12 ¤W¤È 10:45:02²Ä 6704 ½g¦^À³
¥Ø«e¬O±N­ì®ÆÃÄ¥æ¥Ñ¼w°êªº°w¾¯¼t¶i¦æ¥R¶ñ

Ãĵتº°w¾¯¼t¬O¥h¦~¤~¸¨¦¨

©|¥¼³q¹L»{ÃÒ

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GµLµß®ñ10021927  µoªí®É¶¡:2019/5/12 ¤W¤È 10:08:56²Ä 6703 ½g¦^À³
½Ð°ÝROGER5889¤j¤j,

¦]¬°§Ú¥u¬O«ù¦³¤@±i,Á«±¼´Nºâ¤F,©Ò¥H§Ú¤£·|¦b·NªÑ»ùªºÅܤơC

¦ý¬O¤å¤¤¦³¨Ç§Ú¯uªº«Üª¬ªp¥~,©Ò¥H·Q°Ý­Ó²M·¡¡C

½Ð°Ý:Ãĵؤ£¬OÃÄ«~»s³y¥Í²£³£¦b¥x¤¤¼t¶Ü?¬°¦óÁÙ­n¥X°â­ì®ÆÃÄ?¬O¾P°â¨ì­þ¸Ì?

Ãø¹D¥¦¬OÃþ¦ü¤¤¾óªºÃe¨©¤ó¯gÃĤ@¼Ë,¬O½æ­ì®ÆÃĵ¹¥t¤@Ãļt§¹¦¨³Ì²×ªºÃÄ«~?

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GROGER588910148151  µoªí®É¶¡:2019/5/12 ¤W¤È 09:01:44²Ä 6702 ½g¦^À³
¨Ì¦X¬ù,ÃÄ«~ªº»sµ{¦¨¥»¥ÑAOP»{¦C!(ex¤¤¸Î»{¬°ÃÄ©ú±d¼w¨}²v§C¦¨¥»°ªÂà³æ¤T¬P)

­ì®Æ¾P°â­pºâ¤è¦¡¬O:¥Í²£¦¨¥»+§Q¼í(20~30%???),

¥Ø«eÃĵػPAOPª§Ä³¬O­n¥H²Ä¤@¥N»sµ{©Î²Ä¤G¥N»sµ{ªº¥Í²£¦¨¥»­p»ù(®t»ù50%+)....

www.investor.com.tw/onlineNews/freeColArticle.asp?articleNo=5101

3¤ë2600¸U*N­¿=AOPÃÄ«~¾P°âÃB,N=?

»PAOPÃÄ«~¾P°âÃB*¾P°â¤À¼í(%?)ªºª÷ÃB¤ñ¸û,­ì®Æ¾P°âªº§Q¼í¤£¹L¬O¤p¿ú!

[·|­û¡GDreamtiger10145627 µoªí®É¶¡:2019/5/11 ¤W¤È 08:48:52²Ä 6697 ½g¦^À³

§Ú¬Ýgºô12¤ëÀ禬¬O2300¸U¡AÀ³¸Ó¬O©uÀ禬¨S¿ù¡Aªì¦ô¤@¦~¬ù¤@»õ¥X³fÃB¡A¦©±¼¦¨¥»¯àÁÈ?]

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¤pÃC10147871  µoªí®É¶¡:2019/5/11 ¤U¤È 06:02:56²Ä 6701 ½g¦^À³
«Ü¦h¤H³£®³¤¤¸Î§@¤ñ¸û¡A­Ó¤Hı±o¤£¾A¦X¡C1.¨âºØ¤£¦P¯f²zªºÃÄ 2.¦Û¦³Ãļt±±¨î¤U³y¥Í²£©M©e°U¥¦¼t¥N¤u¡A§Q¼í¬O®t«Ü¤j¡C3.ÃÄ®Ä °Æ§@¥Î¤p ¨SªvÀù­·ÀI ¦³ªv¡¾÷·|µ¥¡C³o¨Ç¤~¬O«OÀI¤½¥q©M¯f±w¯à±µ¨üªºÂI¡C¬Ýª©¤Wªº¤j¤j­Ì«Ü¥Î¤ß ¤]±M·~¡CªÃ«ù·í®É¬Ý¦nªº²z¥Ñ«ù¦³¡C
¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡Gªü¤¤10143502  µoªí®É¶¡:2019/5/11 ¤U¤È 05:41:45²Ä 6700 ½g¦^À³
¥h³Í°ò§ëÅU

¬ã¨s­û·¨¤S¿o

¦oÀ³¸Ó¬O°Ý¤½¥qµo¨¥¤H

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡Gmtalps200110147181  µoªí®É¶¡:2019/5/11 ¤U¤È 05:06:36²Ä 6699 ½g¦^À³
½Ð±Ð¤@¤Uªü¤¤¤j¡A³Í°òªº³ø§i¬O­þ¸Ì¥i¥H§äªº¨ì¡H

=======================================================================

¥t¥~¡AÀ禬ªº³¡¤À¡A¤£¬O¤@¶}©l³£ª¾¹D·sÃĶ}½æ«e¥b¦~³£·|¬O³o¼Ë¶Ü¡H

°Ñ¦Ò4147¦b2018¦~¶}½æ«á¡A¨ì¥Ø«e¬°¤îªº¾P°âÃB¡A¥i¥Hª¾¹D¡A4147¨ì2018²Ä4©u¤~¦³©úÅ㪺ÁͶաC¦Ó¤é«e4147ªÑ»ù¤@ª½¤W¤£¥hªº­ì¦]¡A¥D­n¬O¤j®a¹ï©ó¥L¤µ¦~ªºÀ禬¦¨ªø±×²v¦³ºÃ¼{¡C¡]2018Q4¡G129M¡A2019Q1¡G128M¡A¥H¤Î2019 Apriªº¦Ûµ²¡G41M¡^¡C

2018 April: NTD 31M

2018 May: NTD 0

2018 June: NTD 7.3M

2018 July: NTD 13M

2018 Aug: NTD 23M

2018 Sept: NTD 37M

2018 Oct: NTD 53M

2018 Nov: NTD 39M

2018 Dec: NTD 36M

2019 Jan: NTD 38M

2019 Feb: NTD 23M

2019 Mar¡G NTD 66M

2019 April: NTD 41M

===================================================================

°O±o¦b¤Íª©¬Ý¨ì¤@¦ì¥ý¶i´£¨ì¡G

4147©Ò¦³¹J¨ìªº°ÝÃD¡A·|¦b6446¦A¶]¹L¤@¦¸¡G

©Ò¥H·í¤j®a¦b¼J¯º4147³s¼ÐÅÒ¾÷³£·d¤£©wªº®É­Ô¡C6446¤£¤]¬O³s­Ó­«°T³£¼g¤£¦n¡A­×¨Ó§ï¥h¡AÁÙ³Q»@¤F5¸U¤¸¡C

­Ó¤H¥H¬°¡A¥¼¨ÓªºÆ[¹î­«ÂI¡G

1. ´X­Ó­«­nªºmilestone¬O§_¦p´Á¡C¤£­n¦³©_©Çªº¦]¯À³y¦¨©µ´Á©ÎÅܧó¡I¡]¦b¿D¬wªº¾ô±µÁ{§É¡A¬O¤£¬O¤]¸Ó­n¦³®ø®§¤F¡H¡^

2. ³o¦^¼W¸ê®×¬O§_¥i¥Hµ½¤F¡C

3. ¬O¤£¬O¸Ó¦h°Ñ¥[ªk¤H»¡©ú·|¡A¦h©Mªk¤H°é±À¼s¥Ø«e¤½¥qªº¶i«×ÁÙ¦³»ù­È¡C

4. 4147©ó®³¨ìÃÄÃÒ«á¤jº¦¡A±µ¤U¨Ó¨«¤F¤@¦~ªºªÅÀY¨«¶Õ. 6446®³¨ìÃÄÃÒ«á¡A¨ì¥Ø«e¤]¨«¤F3­Ó¤ëªºªÅÀY¨«¶Õ¡C°²³]2019Q3¥i¥H¦³¾ã­Ó©u«×ªºÀ禬¶i¨Ó¡A¦AÆ[¹î2­Ó©u«×¡C ¬O§_6446ªºªÑ»ù¦³¾÷·|¦b¤µ¦~¦~©³¶}©lÂà§é¦³ªí²{¡H

§ë¸ê·sÃĪѡA¯uªº­n«Ü¦³­@¤ß¡A¦Ó¥B­n¦³±j§§ªº¤ßŦ¡I¤]­n©R°÷ªø¡I

Ä«·§ªÑ¬O¤@¦~¦³2¡ã3¦¸ªº´`Àô¶g´Á¡C

·sÃĪѬO2¡ã3¦~¤~¦³¤@¦¸¤ñ¸û¤jªº´`Àô¶g´Á¡C

§ì¦í¶g´Á´`Àô¡A¤ß¸Ì¤]´N·|½ñ¹ê¨Ç¡I¦@«j¤§¡ã

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡Gªü¤¤10143502  µoªí®É¶¡:2019/5/11 ¤U¤È 02:47:56²Ä 6698 ½g¦^À³
°Ñ¦Ò³Í°ò³ø§i

­º§å¥X³f±N°µ¬°´ú¸Õª«¬y¨ÑÀ³Ã줧¥Î

¥D­n¬OÆ[¬d¦U¤è­±·Ç³Æ¬O§_§´·í

²Ä¤G§å¸û¤j¥X³f¶q©ó¤»¤ë«e±Ò°Ê

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¤pªL10142678  µoªí®É¶¡:2019/5/11 ¤W¤È 10:25:44²Ä 6697 ½g¦^À³
12¤ëªºÀ禬¤½§i¦³³Æµù¬O¬ã¨s¦¬¤J¡A¤]´N¬OÁ{§É¸Õ¾¯¥X³f¦¬¤J¡A

À³¬°AOPÄ~Äò°õ¦æCONTI-PV¸ÕÅç¡A¥H¤ÎAOP¨ÑÃĵ¹¤@­Óªñ´Á±Ò°ÊªºCMLÁp¦X¥ÎÃĸÕÅç©Ò»Ý¡C

(¦³¿³½ìªº¥i¥H¦Û¦æ¤Wclinicaltrials.gov¬d¸ß¡A¦¹¬°¬ã¨s¾÷ºcªºIIT¸ÕÅç)

3¤ëÀ禬¤~¬OEC®Ö­ã¥ÎÃĪºfirst shipment¡A­ì®ÆÃÄ¥X³f«á·|¨ì­þ¸Ì¶i¦æ¬Æ»òµ{§Ç? shelf life¦h¤[? SmPC¥é³æ³£¦³°O¸ü¡C

¦pªG»{¬°­ì®ÆÃÄfirst shipment«á´N¥ß¨è¾Q³f¨ì²×ºÝ¶}©l¾P°â¡Aºò±µ´N¶}©l¸É³f¡A¨ºÀ³¸Ó³£¬O§â·sÃÄ·í¦¨·s´ÚiPhone¤W¥«¤F¡C

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GDreamtiger10145627  µoªí®É¶¡:2019/5/11 ¤W¤È 08:48:52²Ä 6696 ½g¦^À³
§Ú¬Ýgºô12¤ëÀ禬¬O2300¸U¡AÀ³¸Ó¬O©uÀ禬¨S¿ù¡Aªì¦ô¤@¦~¬ù¤@»õ¥X³fÃB¡A¦©±¼¦¨¥»¯àÁÈ?´N­n¬Ý¤À¼í¯à¤À¦h¤Ö°Õ¡A§ó¦óªp¥u¬O­è­è¾Q³fªº¤@­ÓÃÄ¡A«e´º¥i´Á

·íªì§Ú¬ã¨s«á¤~ÂàªÑ²¼(íÀ·¸ò¥Í®i)¡AÁÙ¶R¦b±µªñ200¡A¦pªG¤£­n½æ²{¦b¦^¨Ó¶R¡A¥i¥H¶R¤T­¿ªº¶q¡A¤£¹L³o¬O§Ú­Ì¦Û¤v¬ã¨sªº¡A´N¥h¬Û«H¥L§a¡A±qÃÄÁÙ¨S¹Lµ¥¤F¨º»ò¦h¦~

¦Aµ¥¤]¨S¦h¤[§a¡A §Æ±æ¤½¥q¯à¬Û«H~!!!

¬Ý³o´X¦~¯uªº¨C¦¸¦n®ø®§´N¬O¥X³fªº®É¶¡¡A¯u·|Åý¤H®ð¾k

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G§õªü½÷10147886  µoªí®É¶¡:2019/5/11 ¤W¤È 08:16:59²Ä 6695 ½g¦^À³
¤T¤ëÀ禬¤£¥]§tAOP¤À¼í

¦]¬°®Ú¥»ÁÙ¨S¥¿¦¡¶}½æ

³Ì§Ö¤]­n¤»¤ë¤~·|¦³AOP¤À¼í¶i¨Ó

­ì®ÆÃÄ©u¥X³f¤]¬O­n¤»¤ë¤~·|¦A¥X³f§a

¦]¦¹6/10¤j®a¤j·§¤S·|¦A±Y¼ì¤@¦¸¤­¤ë¹sÀ禬

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¤pÃC10147871  µoªí®É¶¡:2019/5/11 ¤W¤È 06:26:54²Ä 6694 ½g¦^À³
¬O­ì®ÆÃĪº¥X³fÃB
¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GROGER588910148151  µoªí®É¶¡:2019/5/11 ¤W¤È 06:19:25²Ä 6693 ½g¦^À³
´N®t1¤ÑÅý¤j®a±¡ºü¤Æ¤F!

4¤ë9¤é:3¤ëÀ禬26,369¤d¤¸ /5¤ë10¤é:4¤ëÀ禬55¤d¤¸(³o¼Æ¦r¬O¥t¤@¤ä²£«~À禬)

¥t¥~,¦³¤H¸ò¤½¥q½T»{3¤ëÀ禬=¥Í²£¦¨¥»(+§Q¼í)©Î¬O3¤ëÀ禬=¥Í²£¦¨¥»(+§Q¼í)+AOP¾P°â¤À¼í¶Ü? ÁÂÁÂ~

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¤ý¸I¥J10148138  µoªí®É¶¡:2019/5/11 ¤W¤È 12:16:29²Ä 6692 ½g¦^À³
¦p±`

§A·í³o­Ó¬O¦b½æ­¹«~©Î¬Oª««~³á ²{¦b¨Ó»¡ÁÙ¦­ªº«Ü ªO¤Í´N¦³¤H´£°_¤¤¸Î¤]¬O¥ý¶i³f⋯⋯

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¦p±`10145350  µoªí®É¶¡:2019/5/10 ¤U¤È 11:58:52²Ä 6691 ½g¦^À³
ÃĽ椣±¼´N¬O½æ¤£±¼¡Aµ¥¨ì«e­±ªº1¤£¨£¤F¡A¦A¨Ó¬Ý¬Ý¦³¦h¤Ö¤H¿ô¨Ó
¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G§ë¸ê¬ö«ß10145266  µoªí®É¶¡:2019/5/10 ¤U¤È 11:40:51²Ä 6690 ½g¦^À³
Ãö©ó¤½¥q¥»¤ë³Ì«á¤@¤Ñ¤~¤½§GÀ禬

¤p§Ì«e´X¤Ñ´N«Ü·Q»¡¤F

±j¯P«Øij¤½¥q¤£ºÞ·~ÁZ¦nÃa¡A½Ð©T©w¤é´Á¤½¥¬À禬

¤£­nÅý§ë¸ê¤H¦³·~ÁZ¦n·m¤ëªì¤½§G¡A¤£¦n©ì¨ì±µªñ10¸¹¤½§GªºÆ[·P

³o«OÃÒ¬O¯à°µ¨ìªº..

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¤ý¸I¥J10148138  µoªí®É¶¡:2019/5/10 ¤U¤È 09:56:59²Ä 6689 ½g¦^À³
£¸½u¥ÎÃÄ£¸©w¤£·|®t¨ì¨º¸Ìªº

¥u¬O¤½¥q³Ìªñ´X¦¸°µ¬°¯uªºÅý§Ú«D±`¥¢±æ

¨­¬°¤@­Óªø´Á«ù¦³ªÌ§Ú¨M©w¤£¥[½X¤F

³o100¸U´N·í»¨½ä¤@³õ Åý®É¶¡¥hÃÒ©ú¤@¤Á

¡]£¸¶}©l·|¶R³oÀɤ]¬O½ÄµÛ¤@½uÃÄÀu¶Õ¤~¤U¤âªº¡^

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¤p¥øÃZ10142872  µoªí®É¶¡:2019/5/10 ¤U¤È 09:38:47²Ä 6688 ½g¦^À³
¦^´_ Anderson

­n¹À¬O¤@¸s³æ¯Âµ½¨}¬ì¾Ç®a±Mª`¸gÀ礣ºÞªÑ»ùªº¤½¥q¡A

­n¹À¬O¤@¶¡¤ñ¤¤¸Î°ò¨È¯E¹©§óÀ´±oª£ªÑ¤£µÛ²ª¸ñ¥X³fªº¤½¥q¡C

¤G¿ï¤@¡C

======================================

§ÚÁöµM¹ï¥Ø«eªÑ»ù¤£¤Óº¡·N

¦ýÁÙ¬O­n«ÈÆ[²z©Ê¦a»¡

¦U¦ì¬Ý¯E¹©¤¤¸Îªºªi°Ê³o»ò¤j, §A»¡ª£ªÑÁÙ¦³ÂI¾÷·|

ÃĵØIPO¤§«á,ªÑ»ù´X¥G³£¦b 160¤W¤U20%¥H¤º

³o¼Ë¥u¯à»¡ªÑ©Ê¤Ó¤û, ©Mª£ªÑ®t¤Ó»·

¤£ºÞ¬O¤½¥q©Î¬O¥D¤O

³o¼Ë®Ú¥»³£«ÜÃøª£

¦Ü©ó¬O¤£¬O¤@

§Ú¤£´±¤U©w½×

²¦³º¦pªG¤½¥q¨M©w­n¨Ó¸ê¥»¥«³õ

´N­n¹ïªÑªF­t³d

©Ò¥H¤º³¡ºÞ²z©MIR³£­n­«·sÀË°Q

§Ú«Ü¤Ö¹ï³o®a¤½¥qÁ¿³o»ò­«ªº¸Ü,

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¤pÃC10147871  µoªí®É¶¡:2019/5/10 ¤U¤È 09:14:38²Ä 6687 ½g¦^À³
´N§Ú­Ó¤H¬Ýªk¡AÃĵجO©u¥X³f(­ì®ÆÃÄ)¥i¸Õºâ¯f±w¨Ï¥Î¤H¼Æ(¯f±wªº¨Ï¥Î¤H¤~¬O­«ÂI¡A©¹«áÁÙ¦³¾P³f¤À¼í)
¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GµLµß®ñ10021927  µoªí®É¶¡:2019/5/10 ¤U¤È 09:02:51²Ä 6686 ½g¦^À³
µL¿W¦³°¸,¤¤¸Î¥h¦~3¤ë¨ú±o¬ü°êÃÄÃÒ,4¤ëÀ禬31,105¤d¤¸,5¤ëÀ禬±¾0,6¤ëÀ禬7,311¤d¤¸....¤§«á¨C¤ë³£¦³À禬¡C

Ãĵثh¤µ¦~2¤ë¨ú±o¼Ú·ùÃÄÃÒ,3¤ëÀ禬26,369¤d¤¸,4¤ë55¤d¤¸(¸ò±¾0®t¤£¦h)¡C

²{¦bªºÃĵر¡ªp´N¦n¤ñ¥h¦~6¤ëªº¤¤¸Î¤@¼Ë,·íµM¦pªG©¹«á¤]¤@¼Ë´NÁV¿|¤F¡C

¦nÃaÁÙ¬O­n¬Ý¤§«áªº¦¨ªø©Ê,¦Ü¤Ö½æ¥b¦~¨Ó¬Ý¤ñ¸û·Ç½T,­n§ó·Ç½T¥i¯àµ¥¬ü°ê¶}½æ¥b¦~,¦ý¼Ú¬w¶}½æ¥b¦~®ÉÀ³¥i¥H¥ý°µ¬°Æ[¹îÂI¡C

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¤pÃC10147871  µoªí®É¶¡:2019/5/10 ¤U¤È 08:49:55²Ä 6685 ½g¦^À³
¬Ý¬Ý2017¦~©³ªº¯E¹© ¤¤¸Î Àº ÃĵتºªÑ»ù©M²{¦bªºªÑ»ù´N¥i©úÁA¡CÁÙ¬O¨º¥y¸Ü ¬Û«H³oÁûÃĪº¥«³õ»ù­È´N¦w¤ß©ê¡A¥~¸êªk¤H¥¼¦ó¥u¶i¤£¥X¡C
¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¤pÃC10147871  µoªí®É¶¡:2019/5/10 ¤U¤È 08:39:49²Ä 6684 ½g¦^À³
·sÃĪѶ^ªº¤j®a´Á«Ýªº¤ß±¡¨ü¼vÅT¤F¡A¨u¨£ÃĤ£¹³¾Ç¦WÃħ󤣹³®ø¶O¹q¤l²£«~ ¦Y¤F¥Î¤F¤°»ò®É­Ô¦A¦^ÀY®ø¶O¤£ª¾¡A¥H«e²£«~§@¤ñ¸û¬O¦Û§ä·Ð´o¡C§NÀR §NÀR ¡C
¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GAnderson10143089  µoªí®É¶¡:2019/5/10 ¤U¤È 08:35:44²Ä 6683 ½g¦^À³
­n¹À¬O¤@¸s³æ¯Âµ½¨}¬ì¾Ç®a±Mª`¸gÀ礣ºÞªÑ»ùªº¤½¥q¡A

­n¹À¬O¤@¶¡¤ñ¤¤¸Î°ò¨È¯E¹©§óÀ´±oª£ªÑ¤£µÛ²ª¸ñ¥X³fªº¤½¥q¡C

¤G¿ï¤@¡C

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GDarren10146466  µoªí®É¶¡:2019/5/10 ¤U¤È 08:17:39²Ä 6682 ½g¦^À³
«s ¤w¸g³Qpo¨ì pttª©¼J¯º¤F

¤­¸U¦¬¤J¤­¸U»@´Ú

¤j·§¤U­±¯d¨¥

·|¬O¶VÄê¶V¼Q ³oÃþªº¸Ü§a....«s

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GUPGO99910144849  µoªí®É¶¡:2019/5/10 ¤U¤È 08:16:14²Ä 6681 ½g¦^À³
¥u¦³5.5¸U¡C ¸ò¹s®t¤£¦h¡C¤ñ¥h¦~¦P´ÁÁÙ­n¤Ö¡C
¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GDarren10146466  µoªí®É¶¡:2019/5/10 ¤U¤È 08:10:55²Ä 6680 ½g¦^À³
ªk»¡·|¬O©P¤G .... ©P¤@ ªÑ¥«¶}½L ªÑ»ù¥«³õ´N·|¦³¸ÑŪ¤F....

¨ì©³¬O§QªÅ¥XºÉ.... ÁÙ¬O....

³o°¦­«ÂIÁÙ¬O¦bªk¤H¸ò¤j¤á¨­¤W ¦]¬°¶q¯uªº«Ü¤Ö

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¤ý¸I¥J10148138  µoªí®É¶¡:2019/5/10 ¤U¤È 08:05:35²Ä 6679 ½g¦^À³
Anderson³o¥y¸Ü¥»¨Ó§Ú·QÁ¿¥X¨Óªº³Q§A·m¥ý¤F

»¡¯uªº«Ü¥¢±æ ·~ÁZ¤£¦n¤]­n©ì¨ì³Ì«á¤~¤½§G ³oºØ·Pı¯uªº«Ü®t

¤½¥q¤º³¡ºÞ²z¯uªº¦³°ÝÃD §O¤H¤¤¸Î·~ÁZ¤½§i³£«Ü¦­

¦n¤£¦n¬O¥t¥~£¸¦^¨Æ

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GAnderson10143089  µoªí®É¶¡:2019/5/10 ¤U¤È 07:41:01²Ä 6678 ½g¦^À³
³o­Ó¤ëÀ禬¢´¸U­è¦nú»@´Ú¢´¸U¡A¯u¶K¤ß¡C
¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¤pÃC10147871  µoªí®É¶¡:2019/5/10 ¤U¤È 06:58:09²Ä 6677 ½g¦^À³
³o«Ü¥¿±`ªü¡A·sÃĭ讳ÃÄÃÒ¡A»Ý­n¾Q³f ¤@­Ó°ê®a¤@­Ó°ê®a½Í¡Aaop¬O¦³µ¦²¤ªº½Í¡A²Ä¤@½ü¼w°ê ¶ø¦a§Q¡A¦A¨Ó¥_¼Ú·ç¤h¡Aªk°ê ­^°êµ¥¡A·sÃĪùÂe°ª¡C­Ó¤H»{¬°Âл\²v·|«Ü§Ö¡A©MÂå¬É ¯f±w¹ÎÅ骺¤¬°Ê«Å¶Ç¦­¤w¸g¦bÁ{§É¡A¦å²G·|ij¤W®i¶}¤F¡C
¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GDarren10146466  µoªí®É¶¡:2019/5/10 ¤U¤È 06:28:52²Ä 6676 ½g¦^À³
³o¼Ëªº·~ÁZ ©ú©ú«Ü¦­´N¥i¥H¤½§G ©ì¨ì10¸¹ ±ß¤W¤»ÂI¦h......¯u¬OÅý¤H·Pı«Ü¬G·N...
¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GDarren10146466  µoªí®É¶¡:2019/5/10 ¤U¤È 06:23:29²Ä 6675 ½g¦^À³
¤]¤Ó¸Ø±i¤F§a.........Ãø©Ç©ì¨ì³Ì«á¤~¤½§G....³o¼Ëªº·~ÁZ »Ý­nºâ³o»ò¤[.........¶Ì²´
¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¤ßºC10141111  µoªí®É¶¡:2019/5/10 ¤U¤È 06:08:43²Ä 6674 ½g¦^À³
4¤ë55
¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¤jÀY10147868  µoªí®É¶¡:2019/5/10 ¤U¤È 05:28:24²Ä 6673 ½g¦^À³
¤p§Ì¯S¦a¯B¥X¤ô­±¨Ó±À¤@­Ó¡AÁÂÁ¦U¦ì«e½ú¤À¨É!
¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G§ë¸ê¬ö«ß10145266  µoªí®É¶¡:2019/5/10 ¤U¤È 05:16:49²Ä 6672 ½g¦^À³
¤Q¤À·PÁÂROGER5889¡BAlan Liu¡BAT¤Î°]°È¦Û¥Ñ¤H¤j´£¨Ñ¸ê®Æ!!
¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GAT10147586  µoªí®É¶¡:2019/5/10 ¤U¤È 05:12:00²Ä 6671 ½g¦^À³
ÁÂÁ°]°È¦Û¥Ñ¤H°T®§: Good to hear that...

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GAT10147586  µoªí®É¶¡:2019/5/10 ¤U¤È 05:05:19²Ä 6670 ½g¦^À³
¦³¿³½ìªº¤j¤j, ¥i¥H¬Ý¬Ý¼Ú·ù¬ÛÃöRemove an orphan designation ³W©w.....

µ§ªÌ¤~²¨µLªk§PÂ_¬O¦]¬°¤½¥qBesremi¤w¸g­n¤W¥«¤F¥BÁ{§É¬ã¨s¤]§i¤@¬q¸¨,...µLªk¦A©w´Áµ¹¤©«Ü¦hÁcº¾ªº³ø§i...(¨Ì·Ó³W©w¬O»Ý­nªº)....½Ñ¦p¦¹Ãþªº³W©w©Î¬O¥Ó½Ð¤H¦Ò¶q¨ä¥L­ì¦]......

¤£¹L, ¦b«e­±POªº§¹¾ãµû¦ô³ø§i¤¤, ©Î³\±o¥H¿sª¾¤wµLê©ó¨ä©t¨àÃĵo®i¶¥¬q¨ì¤W¥«¤§«á¥«³õÀ³¦³ªº«OÅ@¾÷¨î.

¬Û¤¬¾Ç²ß, ¶È¨Ñ°Ñ¦Ò!!!

ƒÞ Removing an orphan designation

www.ema.europa.eu/en/human-regulatory/research-development/orphan-designation/removing-orphan-designation

ƒÞ Removal of an orphan designation is in accordance with Article 5(12) of the Orphan Regulation.

·íÂI¿ïOrphan regulation ®É, «h¥i¥H¬Ý¨ì¤å¥ó:

REGULATION (EC) No 141/2000 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 December 1999 on orphan medicinal products

ƒÞ ª`·N¸Ó¤å¥óArticle #5 ªº²Ä12ÂI: (Page L 18/4) ´£¨ìorphan shall be removed ¦b¤U­z´X­Óª¬ªp:

Article 5 Procedure for designation and removal from the register

eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2000:018:0001:0005:en:PDF

#5-12: A designated orphan medicinal product shall be removed from the Community Register of Orphan Medicinal Products:

(a) at the request of the sponsor;

(b) if it is established before the market authorisation is granted that the criteria laid down in Article 3 are no longer met in respect of the medicinal product concerned; (¦pªG¦b±Â¤©¥«³õ±ÂÅv¤§«e½T¥ß¤£¦A²Å¦X¦³ÃöÂåÃIJ£«~ªº²Ä3±ø³W©wªº¼Ð·Ç)

(c) at the end of the period of market exclusivity as laid down in Article 8.

¦A½T»{¤@¤UArticle #3 ²Ä¤T±ø³W©w:

Article 3

Criteria for designation

1. A medicinal product shall be designated as an orphan medicinal product if its sponsor can establish:

(a) that it is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition affecting not more than five in 10 thousand persons in the Community when the application is made, or that it is intended for the diagnosis, prevention or treatment of a life-threatening, seriously debilitating or serious and chronic condition in the Community and that without incentives it is unlikely that the marketing of the medicinal product in the Community would generate sufficient return to justify the necessary investment;

and,

(b) that there exists no satisfactory method of diagnosis, prevention or treatment of the condition in question that has been authorised in the Community or, if such method exists, that the medicinal product will be of significant benefit to those affected by that condition.

2. The Commission shall adopt the necessary provisions for implementing this Article in the form of an implementing Regulation in accordance with the procedure laid down in Article 72 of Council Regulation (EEC) No 2309/93 (1).

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
²Ä¤@­¶¤W¤Q­¶¤W¤@­¶131415161718192021¤U¤@­¶¤U¤Q­¶

         

¡@

§Ú¡@¡@­n¡@¡@¦^¡@¡@À³¡@¡@¥»¡@¡@¸Ü¡@¡@ÃD

·| ¡@­û¡G

  

§@ ªÌ ¡G

 

¬ÛÃöªÑ²¼¤½¥q¦WºÙ ¡G

ÃĵØÂåÃÄ

¤º¡@ ®e¡G

¡@
½Ð¥ýµn¤J ­Y±z©|µL·|­û¨­¤À¡A½Ð¥ý¥Ó½Ð±b¸¹ ¡@
¡@

°Q½×°Ï¬ÛÃö³W©w¡G
    1.­Y±b¸¹¶¢¸m¹L¤[¨t²Î·|¦Û°Êµn¥X¡A«Øij¦b¼g¦n¤å³¹¨Ã¥B©|¥¼µo°e¤§«e¥ý¦æ½Æ»s¡A¥H§Kµo°e¥¢±Ñ«á¾É­P¤º¤å®ø¥¢¡I
    2.½Ð¤Å°Q½×ªÑ²¼¶R½æ©Î´£¤Î¦¨¥æ»ù¦ìµ¥¨Æ©y¡A¤Z¬O¯d¤U¬ÛÃö¥æ©ö°T®§¡A¥»ºô±N¦Û°Ê§R°£¡A¹HªÌ±NµLªkÄ~Äò°Ñ»P°Q½×¡I
    3.ÄY¸T¯d¤UÁpµ¸¤è¦¡¡A½Ñ¦pLINE¡BFB¡BE-mail¡B¹q¸Ü..µ¥¡A©Î¥H¥ô¦ó©ú¥Ü¡B·t¥Üµ¥¤âªk¶i¦æÁpµ¸¡A¹HªÌ±NµLªkÄ~Äò°Ñ»P°Q½×¡I
    4.¬°ÁקK®ö¶Oºô¸ô¸ê·½¡A½Ð¤Å±N¬Û¦P¤º®e³sÄòµo¦b¦h­Ó¤£¦P¥DÃD¤º¡A©ÎªÌ³sÄòµo°e¦h­Ó·s¥DÃD¡A­Y¦³¦¹Ãþ¬~ª©¤§¦æ¬°±NµLªkÄ~Äò°Ñ»P°Q½×¡I
    5.ÄY¸T·N¹ÏÂǥΥ»ºô¥­¥x¤½µM´²¥¬¤å¦r©ó²³¡A¦Ó«üÂÖ¡B«V°d©Î¶Ç­z¨¬¥H·´·l¥L¤H¦WÅA¤§¨ÆªÌ¡A­Y¦]¦Ó¯A¤Îªk«ß°ÝÃD¡A·§»P¥»¤½¥qµLÃö¡A·q½Ð¿í¦u¡C

·q½Ð´L­«¥»ºô¤§¸gÀç²z©À¨Ã¿í¦uª©³W¡AÁÂÁ¡C


¼s§i¦X§@ ¥¼¤W¥«ÂdªÑ²¼¬d¸ß ¥¼¤W¥«ºô¯¸¾ÉÄý ¥¼¤W¥«ÂdªÑ²¼±MÃD ¿³ÂdªÑ²¼±MÃD ¥¼¤W¥«ªÑ²¼-¶°¹Î¤ÀÃþ ²§·~Âà§ë¸ê¥Í§Þ·~ ¤U³æ±Ð¾Ç
¥¼¤W¥«|¥¼¤W¥«ªÑ²¼|³Ì±M·~ªº  ¥xÆW¥¼¤W¥«ªÑ²¼  °]¸gºô¯¸-Copyright©2022¡£¥²´Iºô¡¤ §K¥I¶OªA°È±M½u:0800-035-178   ªA°È«H½c:postmaster@berich.com.tw
¥»ºô¯¸¬° ¥¼¤W¥«ÂdªÑ²¼¬d¸ß,¥¼¤W¥«ªÑ²¼§Y®É·s»D,¥¼¤W¥«¤½¥q¤½§i,¿³ÂdªÑ²¼¶R½æ,·Ç¤W¥«ªÑ²¼,¤¤ÅҪѠ ¬ÛÃö¸ê°T¤À¨É¥æ¬yªÀ¸sºô¯¸,¸ê®Æ¶È¨Ñ°Ñ¦Ò,¨Ï¥ÎªÌ½Ð¦Û¦æ·r°u!
¥»ºô¯¸¤£¤¶¤J·|­û¶¡¤§¥¼¤W¥«ªÑ²¼¶R½æ,³æ¯Â´£¨Ñ  ¥¼¤W¥«ªÑ²¼¦æ±¡,«ùªÑÂàÅý,¥¼¤W¥«ªÑ²¼¹L¤á¿Ô¸ß  ¶È´£¨Ñ¥¼¤W¥«ªÑ²¼¥æ©ö¥­¥xµ¹·|­û¨Ï¥Î,¨Ì¥»¸ê®Æ¥æ©ö«á¬ÕÁ«¦Û­t!