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·|û¡G¥ý¶i10000164 µoªí®É¶¡:2014/7/22 ¤W¤È 09:05:58
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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
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·|û¡G©üÀY10134794 µoªí®É¶¡:2017/11/9 ¤U¤È 05:41:10²Ä 3069 ½g¦^À³
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Gºô¯uªº«Ü¦³·RC¡A²{¦b§ï½èºÃÃÄ»ù¤Ó¶Q¡A¦Ó¥B¬O®³¤@Ón»ù¤@¦~100¸U¬üª÷ªºÃĨӤñ¡A»¡ÃĵتºÃÄ¡¦µLªk¡¦ªv¡¡A20¡ã30¦~¤U¨Ón200-300¸U¬üª÷¡A¨Ó¥YÅã¤@¦~¤@¦Ê¸U¬üª÷ªºÃĤ£¶Q¡H ³oÅÞ¿è¡A§Ú¬Oı±o«Ü¦³½ì |
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·|û¡GAlan Liu10136094 µoªí®É¶¡:2017/11/9 ¤W¤È 11:51:10²Ä 3068 ½g¦^À³
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·PÁ¤pªL «e½úªº¤À¨É, ¯÷½Ķ¦p¤U¨Ñ¦U¦ì§ë¸ê¥ý¶i°Ñ¦Ò, ÁÂÁ¡C Less Frequent Treatment Schedule Feasible for Patients With PV ¸û¤ÖªºªvÀø¶g´Á¦¸¼Æ¹ïPV¯f±w¬O¥i¦æ¤è®× 2017.11.08 Giving ropeginterferon alfa-2b to patients with polycythemia vera (PV) every four weeks instead of every two weeks yielded similar efficacy and was more convenient for patients during a small European study. ¦b¼Ú¬wªº¤@Ó¤p«¬¸ÕÅ礤µo²{, ¨C¥|©Pª`®g¤@¦¸P1101©M¨C¨â©Pª`®g¤@¦¸P1101²£¥Í¬Û¦üªºÀø®Ä, ³o¹ï¯f¤H¦Ó¨¥§ó¤è«K¡C Investigators from Austria, Germany and the Czech Republic conducted the PEGINVERA phase 1/2, prospective, open-label, multicenter study to investigate the safety and efficacy of ropeginterferon alfa-2b (AOP Orphan) in the long-term treatment of patients with confirmed PV. ¨Ó¦Û¶ø¦a§Q¡B¼w°ê©M±¶§Jªº¬ã¨s¤Hû¶i¦æ¤FPEGINVERA 1/2´Á«e¤¡B¶}©ñ©Êªº¦h¤¤¤ß¬ã¨s, ÂÇ¥H¬ã¨s¦bPV½T¶E¯f±wªø´ÁªvÀø¤Uªº¦w¥þ©Ê©M¦³®Ä©Ê¬ã¨s¡C The PEGINVERA study includes data from PV patients treated with ropeginterferon alfa-2b for up to six years (median, four years). Patients were included whether or not they had received previous hydroxyurea therapy. The investigators evaluated patients older than 18 years of age, giving those responding well to every-two-week administration of ropeginterferon alfa-2b the option to switch to an every-four-week regimen, with a reduction in the monthly dose from approximately 300 to 165 mcg. All 29 patients switched to the less-frequent regimen, and no patients discontinued treatment. PEGINVERA¬ã¨s¥]§t¥ÎP1101ªvÀøªø¹F¤»¦~ªº¼Æ¾Ú(ªvÀø¤¤¦ì¼Æ¥§¡¬°4¦~)¡C¥]§t¥ý«e¬O§_¥Î¹LHUªvÀøªº¯f±w¡C¬ã¨sªÌµû¦ô¤F¶W¹L18·³ªº¯f±w¡A±N¨C¨â©P¤@°wªvÀø¦¨®Ä¨}¦nªº¯f±wÂà´«¦Ü¨C¥|©P¤@°wªº¾¯¶q, ¨C¤ëªº¾¯¶q¤]±q300 mcg°¦Ü165 mcg¡CÁ`¼Æ29¦W¯f±w§¡¦b¤Á´«¦ÜªvÀøÀW²v°§Cªº¾¯¶q«á, ¥þ¼Æ«ùÄòªvÀøµL°h¥X¡C All the patients who switched to the every-four-week schedule were able to continue therapy for at least an additional two years, with high rates of hematologic and molecular responses and stable disease. Some have reached six years of treatment in this ongoing trial. ©Ò¦³¯f±w¦bÂà´«¦Ü¨C¥|©P¤@°w«á§¡«ùÄò¬°´Á2¦~¥H¤WªºªvÀø, ºû«ù°ª¦å²G¤ÏÀ³²v¡B¤À¤l¤ÏÀ³¥H¤Îºû«ù¯fªpéw, ¥Ø«e¤´¶i¦æªºÁ{§É¸ÕÅ礤, ¬Y¨Ç¯f±w¤wªvÀøªø¹F¤»¦~®É¶¡¡C The percentage of patients maintaining their best hematologic response before and six months after switching to the once-monthly regimen was consistent with the two dosing regimens (51.7%). Similarly, the percentage of patients maintaining their best molecular response before and six months after switching to the every-four-week regimen was not significantly different (62.1% vs. 58.6%). ¯f±w¦bÂà´«¦Ü¨C¤ë¤@°wªºÀøµ{¤»Ó¤ë«á©M¨C¤ë¨â°wªºÆ[¹î¤ñ¸ûµo²{, ³Ì¨Î¦å²G¾Ç¤ÏÀ³¼Æ¾Ú¤@P(51.7%)¡C¦P¼Ëªº, ¦b³Ì¨Îªº¤À¤l¤ÏÀ³¤W, ¯f±wÂà´«¦¨¨C¥|©P¤@°w¤»Ó¤ë«á¼Æ¾Ú¤]µLÅãµÛ¤£¦P (62.1% vs. 58.6%)¡C In addition, the investigators reported that the majority of PV patients being treated long term with ropeginterferon alfa-2b developed a sustained reduction of mutant JAK2 allele burden to below 10%, and no progression to myelofibrosis or leukemic transformation, which was maintained before and after switching to the less-frequent dosing regimen. They suggest that this demonstrates ¡§the unique disease modification by ropeginterferon alfa-2b treatment.¡¨ ¦¹¥~, ¬ã¨s¤Hû³ø§iÅã¥Ü, ªø´Á¨Ï¥ÎP1101ªvÀø¥i¥Hªø´Á±N¬ðÅÜJAK2µ¥¦ì°ò¦]t¾á ºû«ù¦b10%¥H¤U¤ô·Ç, ¦¹¥~¯e¯f¤£·|´c¤Æ¦Ü°©ÅèÅÖºû¤Æ¥H¤ÎÂàÅܬ°¥Õ¦å¯f, ¦b¤Á´«¬°¸û§CÀW²vªºªvÀø¦¸¼Æ«á¤´ºû«ùÀø®Ä¡C¥LÌ»{¬°³o¥Nªí ¡§¥ÎP1101ªvÀøªº¿W¯S¯e¯f×´_¯à¤O¡¨¡C The investigators concluded that ¡§long-term maintenance treatment of PV patients using monthly injections of ropeginterferon alfa-2b is feasible, efficacious and well tolerated,¡¨ suggesting that the treatment ¡§holds the promise of disease modification and delay of disease progression.¡¨ ¬ã¨s¤Hûµ²½× ¡§PV¯f±w¦bP1101¨C¤ë¤@°wªºªø´Á«ùÄòªvÀø¬O¥i¦æªº¡B¦³®Äªº¤Î@¨ü«×°ªªº¡¨¡A³o¥NªíªvÀø ¡§¨ã¦³¯e¯f×´_©M©µ½w¯e¯f´c¤Æªº®ÄªG¡¨¡C ¡XSarah Tilyou Based on a study presented at the European Hematology Association 2017 Congress (abstract |
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·|û¡G¤p°¨10135228 µoªí®É¶¡:2017/11/9 ¤W¤È 10:24:57²Ä 3067 ½g¦^À³
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½×¾Â¤W¥»¨Ó´NºZ©Ò±ý¨¥ ¨î§O¤Hµo¨¥ ÁÙ¨ú¯º§O¤H¤£·|§ë¸êªÑ²¼... ³oºØ¦æ¬°¤£¦n§a µØ¤Í̹ïÃĵؤ]¬O¦]¥¦ªº»ùȳQ¥«³õ§C¦ô¤Ó¦h¤Ó¦h ¤~·|¦b½×¾Â¤W§çµo±¡ºü |
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·|û¡GAnderson10143089 µoªí®É¶¡:2017/11/9 ¤W¤È 09:17:14²Ä 3066 ½g¦^À³
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16.5¤¸¶R¶iªº¯uªºÁ¿¸Ü¦³¸ê®æ¥i¥H¤jÁn¡C |
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·|û¡GRussell10140734 µoªí®É¶¡:2017/11/9 ¤W¤È 08:22:10²Ä 3065 ½g¦^À³
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¤p°¨ô¡K ³£¤w¸g¶R¦b16.5¡Aº¦¤F¤Q¿¤FÁٱˤ£±o½æ¡K ¯uªº«Ü¬Ý¦n¤½¥q ¸ê®æ¦Ñ |
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·|û¡G¤pªL10142678 µoªí®É¶¡:2017/11/9 ¤W¤È 08:20:15²Ä 3064 ½g¦^À³
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Clinical Oncology News NOVEMBER 8, 2017 Less Frequent Treatment Schedule Feasible for Patients With PV www.clinicaloncology.com/Hematologic-Malignancies/Article/11-17/Less-Frequent-Treatment-Schedule-Feasible-for-Patients-With-PV-/45233 |
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·|û¡G¤p°¨10135228 µoªí®É¶¡:2017/11/9 ¤W¤È 07:42:43²Ä 3063 ½g¦^À³
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¥»¨Ó½×¾Â´N¬O¤@Ӧۥѵo¨¥ªºªÅ¶¡ ¤@Ó¤HÆ[¹î¨ì¤°»ò®³¥X¨Ó¤À¨É¤]¬OÓ¤Hªº¦Û¥Ñ Ãĵاڱq¥¼¤W¥«16.5¶R¨ì²{¦b¤@ª½³£¨S½æÁÙ³{§C¥[½X ·íÃĵتºªÑªF¸ê¾ú°÷²`¤F§a |
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·|û¡Gucss10142657 µoªí®É¶¡:2017/11/8 ¤U¤È 10:09:26²Ä 3062 ½g¦^À³
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MPN©MCML²Ä10©¡°ê»Ú¤j·|¡G¶EÂ_¡AºÞ²z©MÁ{§É·s¶i®i¡A±NÁ|¦æ¦b2017¦~11¤ë2-3¤é¡A¦b¬w»Ú¯Ã¬ù®É³ø¼s³õ¦b¯Ã¬ù¡A¯Ã¬ù 2017¦~11¤ë3¤é¨ä¤¤¤@Óijµ{ SESSION III - ªvÀøMPNs ¥D«ù¤H¡GHeinz Gisslinger©MSrdan Verstovsek 8¡G40- 9:10 AM ªø®Ä¤zÂZ¯Àªº³Ì·s¶i®i Heinz Gisslinger³Õ¤h (§Ú¦b·Q³oªø®Ä¤zÂZ¯ÀÀ³¸Ó´N¬Op1101¡A³oÓ°ê»Ú¤j·|Ãĵؤ]¦³ÃÙ§U) |
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·|û¡GRussell10140734 µoªí®É¶¡:2017/11/8 ¤U¤È 10:09:00²Ä 3061 ½g¦^À³
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·|û¡G¤p¦B¦B10145378 µoªí®É¶¡:2017/10/24 ¤U¤È 11:39:47²Ä 3045 ½g¦^À³ («e²¤) ¥t¥~Ãĵؤ£·|³o»ò§Ö´Nº¦°±°Õ §A¥i¯àn¥¢±æ¤F~ (§Ú§Æ±æ¥D¤O¦³¬Ý¨ì¥i¥H©ú¤Ñ©Ôº¦°±¥´§ÚÁy ÁÙ¬O§An©Ô??) ¦Û¤vÁÙ¤£¬O¬Ý¤£·Ç!!! ½×¾Â¬O¦Û¥Ñµo¨¥ªºªÅ¶¡...¤£¥Î¨î§O¤H»¡¤°»ò!! ´Nºâ¹ï¤½¥q/ªÑ»ù¤£º¡...¤W¨Ó§çµo¤@¤U.. ¦Ü¤Ö....¤ß±¡¤]¦nÂI µØ¤Í̯uªº´e¤Ó¤[¤F....§Ú§¹¥þ¥i¥HÅé½Ì^^ |
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»{¦P¼Ó¤Uªº»¡ªk¡A§O¶Ã²q´ú¥D¤OªºÄw½X¡I´Nºâ³Q§A»¡¤¤¤F ¨ººÝªº¥D¤O³Q§A¬Ý¯}¤â¸}¡A¸Õ·Q~¥D¤O·|¶¶§Aªº·N¶Ü¡H Ãĵؤ£¨ü¥D¤Oªº«C·ý¬O¨Æ¹ê¡A°ß¦³¨H¼çÀR«Ý¡K¡K´Nºâ³Ì®t®É¨è±oµ¥Ãĵض}©l¦³À禬 |
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·|û¡G¤p¦B¦B10145378 µoªí®É¶¡:2017/11/8 ¤U¤È 01:40:00²Ä 3058 ½g¦^À³
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§Ú«Øij§A¤£n¦A¤ÀªR¤F¡A ¤@¤U¬P¬Pº¦´N¬P¬P¡A ¤@¤U·à¤lº¦´N·à¤l¡A þ¨à¬Ý¨ì¤¤¸Î¸êª÷Âk¶¤¡A ·Pıªº¥X¨Ó§AÀ³¸Ó¾Þ§@ªÑ²¼¤£¤ÓÁÈ¿ú¡A ®É¶¡¥¼¨ì¡A¦ý¬Oªñ¤F¡AÁÙn¦Aµ¥µ¥¡A¡]©`¦Ì¤á¦p§Ú¤]±K¤ÁÆ[±æ¡^ «Ü·q¨Ø¤À¨É¾Ç³N¬ÛÃö¤Î¶i®iªº¤H¡A²¦³º¥»¤H«DÂå¾Ç¬ÛÃö±Mªù¡A ¤£¬O¥D¤O´N§O´¢´ú¥D¤O·Qªk¡A ¦wÀR¬Ý¦wÀRÅé·|¡A ¡]Ãø¹Dµ¥«Ýªº®É¶¡´N¤£¯à¬Ý¨ä¥LÀɪѲ¼¡H¬Ý¤[¤F¤@©w·|¦³©ÒÅé·|ªº°Õ¡^ |
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·|û¡GAnderson10143089 µoªí®É¶¡:2017/11/8 ¤U¤È 01:31:48²Ä 3057 ½g¦^À³
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·|û¡G¤p°¨10135228 µoªí®É¶¡:2017/11/8 ¤U¤È 12:15:29²Ä 3056 ½g¦^À³
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³s2¤ÑÀ£§C±µ¡A¥§¡¤@¤ÀÄÁ¦¨¥æl±i(¤@¦¸¥u¶R¤@±i) ¬O½Ö³o»ò¦³@¤ß¡H ÃĵؤwÂ\²æ¹L¥h´d±¡ªº¨«ªk ¨«¦Û¤vªº¸ô |
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¦UµØ¤Í§ë¸êªÌ¡A¦b¹L¥h³o¤@¦~¦h¨Ó¡A§Ú̪º¤ß±¡½T¹êº¡·P¶Ëªº¡AÁȤF«ü¼Æ½ß¤F®t»ù¡A»P©P¾DªB¤Í½Í½×ªÑ²¼¤SÁ`¬O¸G¤H¤@ºI¡A¨ä¹ê§Ṳ́§©Ò¥H·|¶R¥Í§ÞªÑ¡Aµ´¤£¬O§ë¾÷¡A²Ä¤@¬O¦³·P¤¤°ê¤j³°ªº±U°_¡A¥xÆW¦U²£·~¦pµLªk´x´¤¨ìÃöÁä©Ê§Þ³N¥Í¦s¤£©ö¡F²Ä¤G¬O¬Ý¤¤¥Í§Þ²£·~ªºÁͶեH¤Î¥¼¨Ó«e´º¡C ³o¤@¦~¨Ó¥Í§ÞÃþªÑ¥ÑÀéÄêÂk©ó¥ÀR¡A¦A¥Ñ¥ÀRÂk©ó¨I±I¡A´Á¶¡¨Ã¨ü¯S©w´CÅéµL±¡¥´À£¡A¥µ¯à°í¦u©£¦ìªÌ¤w¤£¦h¡C¦^·Q³o¤@¦~¨Ó¯u¬O«D±`¤H©Ò¯à§Ô¡A°£¤F¨C¤ëÆ[¹î¸³ºÊ«ùªÑÅܤơA¥H¼W¥[«ùªÑ«H¤ß¥~¡A·íµM³o´Á¶¡ÁÙn·PÁ¡§¤pªL¡B°]°È¦Û¥Ñ¤H¡BµL¤j¡B°¶¤j¤j¡BAlan Liu¡BBESREMi¡BRussell¡B¤p°¨¡B³Á§JªL¡B¤p¥¿¥¿¡BªÅ¤]ªÅªÅ¡B¤Ñ©R¡¨µ¥¤j¤j¡A¤£Â_ªº´£¨Ñ¸ê°T¤À¨É»P¸Ñ»¡¡A¤µcontinue-PVÁ{§É¸ÕÅçµ²ªG¼Æ¾Ú¤ñ¹w´Á¤¤ªº¦n¡A´Á«Ý¤é«á¯à¦uªº¶³¶}¨£¤ë©ú¡C ¥H¤U¬O§Ú´NÃĵص|«eEPSªº¬Ýªk¡A¦p¦³¿ù»~ÁٽЦU¦ì¤j¤j×¥¿«ü±Ð¡G PV¼Ú¬ü¯f±wÁ`¤H¼Æ300000¤H¡A«O¦u¦ôp¥H250000¤Hp¡C ¤µcontinue-PVÁ{§É¸ÕÅçµ²ªG¼Æ¾Ú¤ñ¹w´Á¤¤ªº¦n¡A3¦Ü5¦~¤º¥«¥e¦ôp10¢H¡C ¨C¦W¯f±w¨C¦~ªvÀø¶O¥Î«O¦u¦ôp¥H¬üª÷50000¤¸p¡C ¼Ú¬w¦]¤w±ÂÅv¤ò²v¥H20¢Hp¡A¬ü°ê«h¥H¤ò²v50¢Hp¡A¦Xp¥§¡¬°35¢H¡C 250000¤H ¡Ñ 0.1 ¡Ñ ¬üª÷50000¤¸ ¡Ñ 0.35 ¡×¬üª÷437500000¤¸¡C 437500000¤¸ ¡Ñ ¥x¹ô30¤¸ ¡Ò ªÑ¥»2200000000¡×5.96¡C EPS¬° 59.6¤¸¡]5.96¡Ñ10¡^¡C |
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·|û¡G¤p¥¿¥¿10141351 µoªí®É¶¡:2017/11/8 ¤W¤È 11:13:32²Ä 3054 ½g¦^À³
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9th INTERNATIONAL PATIENT SYMPOSIUM ON MYELOPROLIFERATIVE NEOPLASMS When: Wednesday, November 1, 2017 Where: Griffis Faculty Club, Weill Cornell Medical College 521 East 68th Street, New York, NY 10065 10:00 AM - Current Management of Polycythemia Vera Richard T. Silver, MD, Weill Cornell Medical College, New York, NY 11:00 AM - Current Management of Essential Thrombocythemia Carles Besses Raebel, MD, Hospital del Mar, Barcelona, Spain |
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·|û¡GAnderson10143089 µoªí®É¶¡:2017/11/8 ¤W¤È 11:05:51²Ä 3053 ½g¦^À³
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·|û¡GDreamtiger10145627 µoªí®É¶¡:2017/11/7 ¤U¤È 01:32:48²Ä 3051 ½g¦^À³
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§Ú´N¬O197½æ±¼µ¥¦^¤~n±µ¡Aµ²ªG©È½Ä°ª¤S200¶R¦^®M¤@¦~ªº°Ú¡A¦Û¤v±`±`½æ¤F´N½Ä°ª¡A©Ò¥H¬Ý½un¶^¤]¤£´±½æ....´N³o¼Ë¶^¤F60¤F¡A¤£¹L´N¬O¬Ý¦n¤~¤@ª½©ê¡A©È¼Q¥X¡A¬~Äw½Xªº¤j¤á¯uªº«Ü¼F®` |
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·|û¡GAnderson10143089 µoªí®É¶¡:2017/11/7 ¤U¤È 12:50:54²Ä 3050 ½g¦^À³
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Ãĵئh¼Æ³£¬O¥Í§Þ¶°¹Î·í¤Ñº¦©Ò¥H¤~«j±j¸òº¦ ¤µ¤Ñºâ¬O¤ñ¤¤¸Î¯E¹©±j¶Õ ¬O¤£¿ùªº¸ñ¶H ¦³±æ¶}©l¨«¥X¦Û¤vªº¸ô |
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Åwªï¤¤¸Î¯E¹©ªº¸êª÷Âk¶¤ 11ÂI©Ô¤F¤@ªi µ¥¤@¤U12ÂI¬O§_·|¦A©Ô²Ä¤Gªi ¬Ý¤U¥hÅo |
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·|û¡GRookie10143115 µoªí®É¶¡:2017/11/7 ¤U¤È 12:00:29²Ä 3048 ½g¦^À³
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¬O°Ú¡A§Ú·Q³\¦hµØ¤Í¸ò§Ú¤@¼Ë§ë¸ê¡]®M¡^¥Í§ÞªÑ³£¶W¹L¤@¦~¥H¤W¤F¡A ¦pªGèn°_º¦®É³Q¬~±¼¡A¨º¯uªº«Ü¥i±¤¡A¤×¨äºA¶Õ¶V¨Ó¶V©ú®Ô¤F¡A ©Ò¥H§Ú¿ï¾Ü©ê¨c |
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·|û¡G¤p°¨10135228 µoªí®É¶¡:2017/11/7 ¤W¤È 11:53:33²Ä 3047 ½g¦^À³
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´N¬O°Ú ¥Í§ÞªÑ¥i¥H3¦~¤£°Ê ¦ý¤@¥¹°Ê°_¨Ó¤S«æ¤S²r ©Ò¥H§Ú¤@ª½¤£´±°Ê ¦³°µ¨ì»ù®tªº¤H®¥³ß¤F ¦ý ¸U¤@³Q¬~±¼¤F¤]§O«èïÈ |
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·|û¡GAnderson10143089 µoªí®É¶¡:2017/11/7 ¤W¤È 11:47:17²Ä 3046 ½g¦^À³
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¶}©¹¬üÄR¥@¬Éªº¦C¨®n¶}¤F¡AÁÙ¨S¤W¨®ªº®È«È½Ð»°§Ö¤W¨®¡A¦C¨®§Y±NÃöªù¡C |
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Russell¤j¡A§Ú·Q¬O°OªÌµ§»~¤F EMA®Ö©wP1101ÃÄÃÒ°e¼fªºDAY 1¬O2017/2/23 DAY 120³q¹L²Ä1¶¥¬q¼f¬d+³Ìªø6Ó¤ëLOQ¦^ÂЮɶ¡ ®É¶¡¬O¸¨¦b106/12/22¡A¦b³o®É¶¡¤§«en°w¹ï´£°Ý¦^ÂÐ ¨Ã±Ò°Ê²Ä¤G¶¥¬q¼f¬d(DAY 121)¡A¦ÜDAY 210 CHMP·| ´£¥X¼f¬d·N¨£¸òµû¦ô³ø§i®Ñ¡A©Ò¥H¬ù¦b©ú¦~3¤ë©³¡AÃÄÃÒ ¥i§_®³¨ì¡AÀ³¸Ó´N¥i¥H©úÁA¤F¡C |
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most likely unrelated to IFNa treatment - were reported.¡¨ most likely....¤f»y¤W¥i¥H»¡¬O«Ü¥i¯à¡A¦ýºë½Tªº¦r±·N«ä¬O³Ì¦³¥i¯à©Î·¥¥i¯à ´N^¤å¼g§@¦Ó¨¥¡B©Î³\§@ªÌ·Qªí¹F»PIFNaªvÀøµLÃö¡A¦ý°ò»PµL¥¿¦¡ÃÒ©ú¡A¬°¨Dºë½T¬G¥Hmost likelyªí¹F¡C Ó¤H»{¬°«ÂI¬Owere reported...¬J¤w¦V¥DºÞ·í§½¥Ó³ø¡A·í§½µL·N¨£§Y¥i¡C ¦Ü©ó¤½¥q¤½§iªº¡§±©®Ú¾Ú³ø§iµ²ªGÅã¥Ü»P¤zÂZ¯ÀªvÀøµLÃö¡¨¡AÁö¦b½Ķ¤W¤£°÷ºë½T¡A¦ý©Î³\¤£¥¢¬°§@ªÌì·N¡C ³o¤~¬O§Ú©Ò»¡....±´¨D·í¨Æ¤H¯u·Nªº¥D¦]!! Anyway,¥Î¦r»ºµü¤]¤£¬O¨º»ò«n¡A¬Ý¨ì¤½¥¬ªº¼Æ¾Ú¡AµØ¤ÍÌÀ³¸Ó³£«Ü¶}¤ß¤~¬O¡C ¦Ü¤Ö¡B¨ì¥Ø«e¬°¤î¡A¥ý«e¨º¨Ç¢¤£¤Î«Ý¥´À£ªº´CÅé¡A±¹ï¼Æ¾Ú³£¤w¤£¦A¦h¨¥¡C »{¿ù........¦³®ÉÔ¤]¤£¬O¨º»òÃø.... ˬO....¦w¥S¡A¶R¤F¦h¤ÖÃĵءA¨º»òÃö¤ß¨«¶Õ....«¢«¢ µ¥«Ý¤j®aªº¥[¤J........ ÁÙ¦³...·s»D³zÅSªº12/22...¬O«ün°eFDA¥Ó½Ðªº®É¶¡¶Ü??? ÁÙ¬OEMAµ§»~/¤f»~¦¨FDA?? |
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ÃĵØÃÄP1101,¤µ¤Ñ¦¨¥æ¶q1101±i,¯u¥©! |
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¤ñ¸ûȱoÃöª`ªº¬O¥~¸ê©M§ë«H³£¨S¶R... ¥~¸êÁÙ¤p´T½æ¶W... ·Rµu½u¶i¥Xªº¦ÛÀç°Ó¤@ÀY¼ö |
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·|û¡G¤pªL10142678 µoªí®É¶¡:2017/11/3 ¤U¤È 08:06:10²Ä 3003 ½g¦^À³
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Àù¯g³¡¤À¡AªÅ¤]ªÅªÅ¤j¸ÑÄÀ±o«Ü²M·¡¥B¤¤ªÖ¡C ¸É¥R¤£¨}¤ÏÀ³¤ñ²vªº³¡¤À¡A²Ä12Ó¤ëP1101²Õ59.6%¡BHU²Õ75.6%¡A²Ä24Ó¤ëP1101²Õ70.1%¡BHU²Õ77.2%¡A¬°¯f¤H¼Æ¤ñ²v¡C¥Ñ©ó¦UÃþ¤j¤pªº°Æ§@¥Î³£»Ý¬ö¿ý¡Aªø´ÁÁ{§É¸ÕÅç®É¶¡·U¤[¡A²Ö¿n´¿¦³¤£¨}¤ÏÀ³ªº¯f¤H¼Æ·|«ùÄò¼W¥[¡C¦]¦¹¶i¤@¨B¤ÀªRÁ`¤£¨}¨Æ¥ó¼Æ(event)¡B¤£¨}¨Æ¥óµ¥¯Å(grade)¡B¦]¤£¨}¨Æ¥ó°§C¾¯¶q...µ¥¡A¤~¯àºî¦X¤ñ¸û¦w¥þ©Ê¡C ºKnµLªk§e²{³o»ò¦h¤º®e¡AÀ³·|¦b¦~·|®É¦A²³ø¡A°Ñ¦ÒProud-PV²Ä12Ӥ몺¦w¥þ©Ê¼Æ¾Ú¦p¤U¡C Any AE: P1101 81.9% vs HU 87.4% Treatment-related AE: P1101 59.6% vs HU 75.6% Grade 3 AE: P1101 16.5% (29 events in 21 patients) vs HU 20.5% (45 events in 26 patients) Discontinuation at Mo 12: P1101 16.5% vs HU 12.6% Dose reduction for AEs: P1101 25.2% vs HU 51.2% |
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¡§¨ä¹ê¬O¤¤¤ån½¦¨^¤å¡A¨S½ºë·Ç¦Ó¤w¡C¡¨ ¦bASH¦~·|µoªíªº½×¤å¡A¤£¯à¶Ã»¡¡C ¬°¦ó¬O¤¤Â½^¡H¬O§@ªÌ¤¤¤å¤ñ^¤å¦n¡A©Ò¥H¥ý¼g¤¤¤å¦A½^¤å¡H ÁÙ¬O·t¥Ü¦³¤H®»¤M¥Nµ§¡H ·sÃĬãµo¤½¥qªº¤½«H¤O«Ü«n! ·sÃĬãµo¤½¥qªº¤½«H¤O«Ü«n! ·sÃĬãµo¤½¥qªº¤½«H¤O«Ü«n! |
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·d¤£¦n¡K ¤H®a¨ä¹ê¬O¤¤¤ån½¦¨^¤å¡A¨S½ºë·Ç¦Ó¤w¡C «¢¡K¤£³£¬O¦Û¤v·Qªº¡K ¸òªk«ß¤@¼Ë¡An±´¨D·í¨Æ¤H¯u·N¡K |
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¡§whereas in the Ropeg cohort 3 malignancies (glioblastoma, seminoma, adrenal neoplasm) ¡V most likely unrelated to IFNa treatment - were reported.¡¨ ¤ñ¸ûºë·ÇªºÂ½Ä¶¬O¡G ¡§±©®Ú¾Ú¸ÕÅç³ø§i¡ARopeg²Õ¦³3¤Hµo¥Í´c©Ê¸~½F¡]½¦½è¥À²ÓM½F¡Aºëì²ÓM½F¡AµÇ¤W¸¢¸~½F¡^¡A³o«Ü¥i¯à¸ò¤zÂZ¯ÀªvÀøµLÃö¡¨ ¤½¥qªºÂ½Ä¶¡§±©®Ú¾Ú³ø§iµ²ªGÅã¥Ü»P¤zÂZ¯ÀªvÀøµLÃö¡¨¬O¦³ÂI¨«ÄÁ¡A¹ê¦b¨S¦³¥²n¡C §Æ±æ³o¥u¬O¤@®É²¨©¿¡A¤£¬O¬G·Nªº¦æ¬°¡C ¦b^½¤¤ªº¹Lµ{¡A°¾¦V¹ï¦Û¤v¦³§Qªº¤è¦V¡A¦b³oÓ¤j®a³£À´ªº^¤åªº®É¥N¡A¥u¯à»¡½Þ¶¤¤Í¡A·l®`¦Û¤vªº¤½«H¤O¡C ·sÃĬãµo³Ì«nªº¬O¤½«H¤O¡A¤p²Ó¸`²¨©¿¡AÅý¤H¯d¤UÃa¦L¶H¡A±N¨Ó¥i¯à¦Y¤jÁ«¡C ¥xÆW³oÓªÀ·|¡AªêµøÏàÏà¡A·QÄAˬO«Dªº¤H¤£¤Ö¡A©¹¦Û¤v¼âÁT¡A¤£ºÞ¦³·NµL·N¡A³£¬OÄø¡C ¤½¥q¦p¯à¶i¤@¨B¼á²M¦¹°ÝÃD¡A§ó¦n¡C ´N¥Ø«e¼Æ¾Ú¬Ý¨Ó¡AÀù¯g¤£¬O°ÝÃD¡C ´Nºâ¬OHU¡A¥é³æ¤W¤]¥u¦³»¡ªø´Á¨Ï¥Î¦³¦¸µo©Ê¦åÀù¤Î¥Ö½§Àù³ø§i¡C ¦Ü©óHU¬O§_·|PÀù¡Aªk³W³æ¦ì¤]µL¸Ñ¡CHU¥é³æ¥Î¦r¦p¤U¡G ¡¨In patients receiving long-term hydroxyurea for myeloproliferative disorders, secondary leukemia has been reported. Skin cancer has also been reported in patients receiving long-term hydroxyurea. Advise protection from sun exposure and monitor for the development of secondary malignancies.¡¨ ¦p¦P£~£~¤j»¡ªº¡¨n¥hÃÒ©ú³o¨Ç¸~½F©MP1101ªºÃöÁp©Ê¬O«Ü§xÃøªº¡¨¡A ±q¬ãµo»Pªk³WªºÆ[ÂI¨Ó¬Ý¡A¬Ý¨ì¬Æ»ò¡A´N»¡¬Æ»ò³Ì«OÀI¡C ¡¨»P¤zÂZ¯ÀªvÀøµLÃö¡¨ ¡B¡§«Ü¥i¯à¸ò¤zÂZ¯ÀªvÀøµLÃö¡¨¡A³£¬O¦h¾lªº¡C ±q¾ÇªÌµoªí½×¤åªº¥ß³õ¡A°£¤F´yz«ÈÆ[ªº¼Æ¾Ú¥~¡A¤]n»¡»¡¦Û¤vªº·Qªk¡C ¹ï¼Æ¾Úªº¸ÑŪ¡A§@ªÌ¦³³Ì°ªªº¨M©wÅv¡C ÃÙ§U¸ÕÅ窺¬ãµo¤½¥q¡A³q±`¤]¥u¯à»P§@ªÌ°Q½×«ÈÆ[ªº¼Æ¾Ú¥¿¤£¥¿½T¡A¹ï¥DÆ[ªº±À½×¬On´L«§@ªÌªº¡C ¤£¦Pªº§@ªÌ¹ï¬Û¦Pªº¼Æ¾Ú¡A·|¦³¤£¦Pªº½×ÂI¡Aťť´N¦n¡C ªk³W³æ¦ì¹ï¼Æ¾Úªº¸ÑŪ¤]¦³¦Û¤vªº¤@®M¼Ð·Ç¡C ¦Ü©ó¡¨¤£¨}¤ÏÀ³²v¡¨(¤£¨}¨Æ¥ó²v¤ñ¸ûºë·Ç¡A¤£¨}¤ÏÀ³(adverse reaction)»P¤£¨}¨Æ¥ó(adverse event)µy¦³®t§O)¡A ¡§P1101²Õ59.6%¡BHU²Õ75.6%¡C¦b24Ó¤ë®É¤£¨}¤ÏÀ³¤ñ²v¬ÛªñP1101 ¬°70.1¢H¡AHU¬°77.2¢H¡C¡¨³o¼Ëªº¼Æ¾Ú±`¨£¡A¤£¨¬¬°©_¡C ´L«§@ªÌªº±À½×¡A¤F¸Ñªk³W³æ¦ì¹ï¼Æ¾Ú¸ÑŪªº¤è¦¡¡A ¤ß¤¤¦³¦Û¤vªº¤@§â¤Ø¡A¤~¤£·|ÀHªi³v¬y¡A¤è¯àÁö¤£¤¤¥ç¤£»·¨o¡I |
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µØÃÄP1101ªø´ÁÀø®Ä¼Æ¾Ú«G¡A§U©Ý¼ç¦b¥«³õ MoneyDJ·s»D 2017-11-03 10:56:56 °OªÌ ¿½¿Pµ¾ ³ø¾É ÃĵØÃÄ(6446)¥Î©ó¯u©Ê¬õ¦å²y¼W¥Í¯gªº¯S®í¯e¯f·sÃÄP1101¡A¤½¥¬³Ì·s¸ÕÅçµ²ªG¡Aµ²ªGÅã¥Ü24Ӥ몺§¹¥þÀø®Ä¤ÏÀ³²v¡A»P¹ï·Ó²Õ®t¶Z©Ô¶}¡A¥B¹ïJACK2°ò¦]¬ðÅܪ̪ºÀø®Ä¦P¼Ë©úÅã¡AÅã¥Ü·íªì¸gÀç¹Î¶¤¹ï®É¶¡©Ôªø¤ÏÀ³²v®t¶Z±NÅãµÛ¤Æªº¹w´Á¹F°}¡Aªk¤H°é´¶¹M°¾¦h¸ÑŪ¸Ó¼Æ¦r¡A»{¬°¦³§U©ú¦~¼Ú¬wÃÄÃÒ¨ú±o»P«áÄò©w»ù¤Î¥«³õ±À¼s¡C ÃĵØÃĬO»EµJ¤j¤À¤lÃĪ«¬ãµo»P¥Í²£ªº·sÃļt°Ó¡A¬Û¸û©ó°ê¤º¨ä¥L·sÃļt¡A±q¬ãµo¨ì¥Í²£¡B¦æ¾Pªº¤@±øÀs¯à¤O¡A¬O¬°§Q°ò¡A¤£¶È¦³§U¸ê·½¾ã¦X¡A¹ï¤j¤À¤lÃĪ«±À¦V²£«~¤W¥««áºÝªº¥Í²£«~½è±±ºÞ¡A¤]¯à¥þÅv´x´¤¡C¦Ó¤½¥q¶i«×³Ì§ÖªºÃÄ«~¡A´N¬O¦¹¦¸¥Ñµ¦²¤¹Ù¦ñ¶ø¦a§Qºû¤]¯ÇAOP¤½¥qµoªí³Ì·s¼Æ¾Ú¥Î©ó¬õ¦å²y¼W¥Í¯gªºP1101¡A°£¥ý¤½¥¬ªº¥DnÀø®Ä¼Æ¾Ú¥~¡A¤]¹wp±N¦b¤µ¦~12¤ë10¸¹¬ü°ê¦å²G¯fÂå¾Ç¦~·|°µ¤fÀY³ø§i¡C ¨Æ¹ê¤W¡A¸ÓÃÄÁ{§Éªº³]p¡Aì²Ä¤T´ÁÁ{§É¸ÕÅ窺®É¶¡¬O¤@¦~¡A¦ý·í®É§Y¤w³Wµe¤T´ÁÁ{§É¸ÕÅç«á±N¦AÄ~ÄòÁ{§É¸ÕÅçªvÀø¤@¦~¡C¥~¬É¸ÑŪ¡A¦¹µ¥³]p¤@¬O¦Ò¼{°e¥ó¥Ó½ÐÃÄÃÒ¨ì¤W¥«ªº®É®Ä©Ê¡A¤@«h¤]¬O¦Ò¼{P1101»P¹ï·Ó²Õ»Ý¦³¸ûªøªºÀø®Ä¼Æ¾Ú¡A®t¶Z¤~·|©Ô¶}¡C ¦]¦¹¦bì¤T´ÁÁ{§É¼Æ¾Ú¡B¤]´N¬O¦b¥h¦~12¤ë5¤é¤½¥¬ªº¼Æ¦r¤W¡AP1101»P¹ï·Ó²Õ(HU)ªº§¹¥þÀø®Ä¤ÏÀ³²v(CHR)¡AP1101¬°43.1%¡AHU«h¦³45.6%¡AÁöPÈÅã¥Ü¸Ó¸ÕÅçµ²ªG¨ã·N¸q¡A¦ý«D¦H©Ê¸ÕÅ窺¹ï¤ñµLªkÅã¥ÜP1101Àu©ó²{¦æÀøªk¡A¥~¬É¤]¾á¼~HUªºÃÄ»ù¤£°ª¡A°²³]Àø®Ä¼Æ¾Ú¤£©ú¡AÂå¬ÉÂà¥Î·sÃĪº°Ê¾÷¤£±j¡A·í®É¥«³õ¦h°¾ªÅ¸ÑŪ¡C ¤£¹L·í®É¸gÀç¹Î¶¤§Y¸ÑÄÀ¡A®Ú¾ÚAOP»P¤º³¡ªºµû¦ô¡AY±N¸ÕÅçÆ[¹îªº®É¶¡©Ôªø¡A¨âªÌ½¦µÛªº¤ÏÀ³²v¦±½u§Y·|©Ô¶}¡C®Ú¾ÚAOP©óªñ¤é¤½¥¬ªº¼Æ¾Ú½T¹êÅã¥Ü¡A¥H¨Ï¥Î¤G¦~(24Ó¤ë)ªº¼Æ¾ÚÆ[¹î¡AP1101ªºÀø®Ä§¹¥þ¤ÏÀ³²v©Ô°ª¦Ü70.5%¡AÅãµÛÀu©ó¹ï·Ó²Õªº49.3%¡A¥B¹ïJAK2°ò¦]¬ðÅܪ̪ºÀø®Ä¼Æ¾Ú®t¶Z§ó¤j¡A¦b¤£¨}¤ÏÀ³²v¤W¨âªÌªí²{«h¬Û·í¡A¥Î¶qÁÙ¥i¸û¹ï·Ó²Õ´î¤Ö¡A³£Åã¥Ü¨ä¦w¥þ©Ê¡A¬Ò¬°ªk¤H¸ÑŪP1101ªº¥¿¦V¼Æ¾Ú¡C ªk¤H¸ÑŪ¡A¸Ó¼Æ¾Ú¥XÄl«á¡A°£¥i§ó¤ä«ùP1101¥Î©ó¬õ¦å²y¼W¥Í¯gªº¼Ú¬wÃÄÃÒ¡A©ú¦~¦³±æ¨úÃÒ¥~¡A§ó«nªº¬Oªø´Á¨Ï¥ÎªºÀø®Ä»P²{¦³¥ÎÃÄ®t¶Z¬Æ¤j¡A§ó¦³§Q©ó¥«³õ¦æ¾P»P©w»ù¡A¦³§U©ó·m§ð¸Ó©t¨àÃĪº¤@½uªvÀø¥«³õ¡AÂX¤j°Ó¾÷¡C °£¤F¼Ú¬w¥«³õ¡Aªk¤H¤]»{¬°¡AÃĵØÃĦb¬ü°ê¥«³õ±Nªu¥Î¼Ú¬w¼Æ¾Ú¡A¥B¦]ÄÝ©t¨àÃÄ¡AÃÄÃÒ¼f²z®É¶¡¥i±æÀ£ÁY¡A°£¼Ú¬wÃÄÃÒ©ú¦~¦³±æ¨ú±o¥~¡A¥ÑÃĵØÃĪ½À窺¬ü°ê¥«³õ¤]±N«Ü§Ö¸ò¶i¡A¼ç¦b¥«³õ¥i´Á¡C |
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¤W¶g¥«³õ¬ã½Õ¾÷ºcCoherent Market Insights¥Xª©¤F¤@¥÷MPN¯e¯fÂåÃÄ¥«³õªº¤ÀªR³ø§i¡A³ø§iºKn¤¤¦³´£¨ì¸û¨Î¤zÂZ¯À»s¾¯»P¼ç¦bÃĪ«¡A¤]´x´¤¨ì¤F«e°}¤lMPNRF±N¶}±Ò¤zÂZ¯À±M®×¬ã¨sªº°T®§¡C www.coherentmarketinsights.com/ongoing-insight/myeloproliferative-neoplasms-treatment-market-930 MYELOPROLIFERATIVE NEOPLASMS TREATMENT MARKET BY DRUG (JAKFI) - GLOBAL INDUSTRY INSIGHTS, TRENDS, OUTLOOK, AND OPPORTUNITY ANALYSIS, 2017-2025 |
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·|û¡G§ë¸ê¬ö«ß10145266 µoªí®É¶¡:2017/11/2 ¤U¤È 11:22:52²Ä 2987 ½g¦^À³
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ªê§ÀÀ°¥u¶R¤F28±iº¦°±»ù ¤£·|¦³Ô£¼vÅT ©ú¤Ñ¦½L¶}°ª¥L´N·|¨«¤F |
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·|û¡G¤p¥¿¥¿10141351 µoªí®É¶¡:2017/11/2 ¤U¤È 10:21:23²Ä 2986 ½g¦^À³
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Incyte Tops Q3 Earnings & Sales https://finance.yahoo.com/news/incyte-tops-q3-earnings-sales-190507738.html Incyte Corporation Quarterly revenues were $381.5 million, up 41.6% year over year and beat the Zacks Consensus Estimate of $360.2 million. The top line was driven by higher sales of Jakafi in the United States and Iclusig in Europe as well as royalties from sales of Jakavi and Olumiant outside the United States. Quarter in Detail Jakafi sales grew 36%, year over year to $304 million driven by strong patient demand for both indications. Net product revenue of Iclusig amounted to $18 million, up from $13 million in the year-ago quarter. Product royalty revenues from Novartis AG NVS for the commercialization of Jakafi in ex-U.S. markets grew 36.7% to $41 million. |
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·|û¡G¤p¥¿¥¿10141351 µoªí®É¶¡:2017/11/2 ¤U¤È 10:06:28²Ä 2985 ½g¦^À³
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More Than 30 Abstracts Highlighting Data from Incyte¡¦s Portfolio Accepted for Presentation at the 59th Annual ASH Meeting Jakafi (ruxolitinib) Saturday, December 9, 2017, 12:00-1:30 PM, Building B, Level 3, B312-B314, Oral Session 637, Myelodysplastic Syndromes¡XClinical Studies: Predicting Drug Response Using Novel Genomic Algorithms Examining The Treatment Patterns And Blood Counts Among Patients With Polycythemia Vera Treated With Hydroxyurea In The United States: An Analysis From The REVEAL Study (Abstract #1633) Saturday, December 9, 2017, 5:30-7:30 PM, Building A, Level 1, Hall A2, Poster Session I Results From The 208-Week (4-year) Follow-Up Of RESPONSE Trial, A Phase 3 Study Comparing Ruxolitinib (Rux) With Best Available Therapy (BAT) For The Treatment Of Polycythemia Vera (PV) (Abstract #322) Sunday, December 10, 2017, 8:15 AM, Building C, Level 2, C208-C210, Oral Session 634, Myeloproliferative Syndromes: Clinical: Phase III and Long-Term Outcome Studies in MPNs Patient-Reported Symptom Burden And Peripheral Blood Counts Among Patients With Polycythemia Vera: And Analysis From The REVEAL Study (Abstract #2924) Sunday, December 10, 2017, 8:15 AM, Building C, Level 2, C208-C210, Oral Session 634, Myeloproliferative Syndromes: Clinical: Phase III and Long-Term Outcome Studies in MPNs Patient-Reported Symptom Burden And Peripheral Blood Counts Among Patients With Polycythemia Vera: And Analysis From The REVEAL Study (Abstract #2924) |
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1.¨Æ¹êµo¥Í¤é:106/11/01 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: (1) ASH (American Society of Hematology¡A¬ü°ê¦å²G¯fÂå¾Ç¦~·|¡^ºô¯¸¦b ¬ü°ê®É¶¡2017¦~11¤ë1¤éµo§G¥»¤½¥qµ¦²¤¹Ù¦ñ¶ø¦a§Qºû¤]¯ÇAOP¤½¥q¦³Ãö²Ä¡@ III´ÁÁ{§É¸ÕÅçPROUD-PV«á¦AÄ~ÄòÁ{§É¸ÕÅç ¡]CONTI-PV¡^ ªvÀø¤@¦~ ¡]§tPROUD-PVÁ`¦@¤G¦~¡^µ²ªG¤§ºKn¡]Abstract¡^»¡©ú¡CASH¤j·|±ÆqAOP ¤½¥q©ó¬ü°ê®É¶¡2017¦~12¤ë10¤é7:45AM ¦b¬ü°ê¨È¯SÄõ¤jÁ|¦æªº¦~·|°µ¤fÀY ³ø§i¡C (2) ¦bPROUD-PV Á{§É¸ÕÅ礤¦³ 106¦ì§¹¦¨ P1101 12Ӥ몺Àøµ{¡A³o¨ä¤¤¦³95¤H ¡]89.6¢H¡^Âà¦Ü CONTI-PV ªºÁ{§É¸ÕÅç¡F¥t¹ï·Ó²Õ (HU) ¦³ 111 ¦ì§¹¦¨ HU 12 Ӥ몺Àøµ{¡A¦³76¤H¡]68.5¢H¡^Âà¦ÜCONTI-PV ªºÁ{§É¸ÕÅç¡C¹ï·Ó²Õªº HU ¸g Á{§ÉÂå®v¦P·N¥iÂର¨ä¥L³Ì¨ÎªvÀø¤è®×¡]BAT¡ABest Available Treatment¡^ ¡A¦ý¤£¤¹³\¨â²Õ¶¡¶i¦æ¥æ¤e¡]cross-over¡^¡C¦³®Ä©Ê«ü¼Ðµû¦ô¥]¬A®Ú¾Ú ELN (European Leukemia Net ¡^¼Ð·Çªº§¹¥þ¦å²G¾Ç¤ÏÀ³¡]CHR, Complete Hematological Response ¡^ªº¤ñ²v¡A¦P®É¤]µû¦ô°£ CHR ¥~¦A¥[¤W§ïµ½ PV ¬ÛÃö¯gª¬ ¡]¥]¬A:ÅãµÛµÊŦ¸~¤j¯gª¬ªº§ïµ½¡^¡C¦¸n«ü¼Ð¥]¬A¥H¬ðÅܵ¥¦ì°ò¦] t¾á( allelic burden ¡^µû¦ô¤À¤l½w¸Ñ¤ÏÀ³²v¡A¤]´N¥Nªí¯e¯fªº§ïµ½±¡§Î ¡]disease modification¡^¡C (3) ¥»ºKn¤¤ªºµ²ªG¡]Results¡^Åã¥Ü¡A¦@¦³ 88 ¦ì¡]P1101¡^©M 73 ¦ì¡]HU/BAT¡^ ¨ü¸ÕªÌªº¼Æ¾Ú¥Î¦bÖ× 24 Ӥ몺Àø®Ä¤ÀªR¡F¥t¦³Ãö¦w¥þ©Ê¤ÀªR³¡¤À¨äªvÀø®É¶¡ ªº¤¤¦ì¼Æ¬°2.7¦~¡A²Ä¤G¦~ªºÃĪ«¨Ï¥Î¾¯¶qªº¤¤¦ì¼Æ»P²Ä¤@¦~¬Û¦P¡A«Y¨C2©P¥´ ¤@¦¸450 £gg P1101 ©M¨C¤Ñ¨Ï¥Î1000 mg HU¡C¦b HU/BAT ²Õ¤¤¡A¤´µM±µ¨ü HU ªvÀøªº¨ü¸ÕªÌ¶W¹L98¢H¡C²Ä¤G¦~ªº¯f¤H°±¥Î²v¦b P1101 ¬° 8.4¢H ¡F HU/BAT ¬° 6.6¢H¡C ¦b24Ó¤ë®É¡A§¹¥þ¦å²G¾Ç¤ÏÀ³ªº¤ñ²v P1101 ¬° 70.5%¡A©úÅãÀu©ó HU/BAT ªº 49.3¢H¡]p = 0.0101)¡A³ÌÅãµÛ¬O¬Û¹ï©ó HU/BAT ²Õ¡AP1101 ²Õ¦b¨â ¦~ªvÀø´Á¶¡ªº¯e¯f½w¸Ñ²v¬Oéw«ùÄò¤W¤É¡C¦P®É¦b½Æ¦XºÝÂI«ü¼Ð¡] composite endpoint¡A§t§¹¥þ¦å²G¾Ç¤ÏÀ³ªº¤ñ²v¤Î¯e¯f¯gª¬ªº§ïµ½¡^P1101 ªº 49.5¢H ¤] ¸û¨Î©ó HU/BAT ªº 36.6¢H¡]p = 0.1183¡^¡CP1101 ³Ì¬°ÅãµÛªºÀu¶Õ¬O¹ï JAK2 ¬ðÅܪºµ¥¦ì°ò¦]t¾á¡]allelic burden )¤§¼vÅT¡A¸g¹L24Ó¤ëªvÀø¡AP1101 ²Õ¦³ 69.6¢H ¦³³¡¤À¤À¤l¤ÏÀ³¡]partial molecular response )¡A¦Ó HU/BAT ¶È¦³ 28.6¢H¡]p = 0.0046¡^¡C (4) ¦w¥þ©Ê³¡¤À¡A¨ü¸ÕªÌ¦]ªvÀø¦Ó¤Þ°_ªº¤£¨}¤ÏÀ³¤ñ²v¬Ûªñ¡]P1101 ¬°70.1¢H¡A HU¬°77.2¢H¡^¡C³h¦å¡B¦å¤pªO´î¤Ö¯g©M¥Õ¦å²y´î¤Ö¯gµo¥Í¦bHU¤¤¸û¦h¡A¦ÓGGT (¤þ³ÁÓi»ÄÂಾ×Q)ªº«ü¼Æ¼W¥[¦b¤@¨Ç P1101 ¨ü¸ÕªÌ¤¤¦³Æ[¹î¨ì¡C¦]¤zÂZ¯ÀªvÀø ¨ã¦³ªº¤£¨}¤ÏÀ³¡]¯S§O¬O¥]§t¥Òª¬¸¢¥\¯à»Ùê©M¼~Æ{¯g¡^¦b P1101 ²Õ§C©ó 5% ¡A ¦bªvÀø¹Lµ{¤¤²£¥ÍªºÄòµo©Ê´c©Ê¸~½F¥uµo¥Í¦b HU ²Õ¡A¥]¬A 2¤H¦³«æ©Ê¥Õ¦å¯f¡A 1¤H¶Â¦â¯À¸~½F©M2¤H°ò©³²ÓMÀù¡A¦Ó¦b P1101 ²Õ¦³3¤Hµo¥Í´c©Ê¸~½F¡]½¦½è¥À²Ó M½F¡Aºëì²ÓM½F¡AµÇ¤W¸¢¸~½F¡^¡A±©®Ú¾Ú³ø§iµ²ªGÅã¥Ü»P¤zÂZ¯ÀªvÀøµLÃö¡C (5) µ²½×¡G ¥H¤WÁ{§É¼Æ¾Ú½T»{ (a) P1101 ¤w¹F¨ì°ª«×«ù¤[©Êªº¦å²G¾Ç¤ÏÀ³¤Î¯gª¬ªº§ïµ½ (b) P1101 ¨ã¦³Àu²§ªº¦w¥þ©Ê©M@¨ü©Ê (c) P1101 ¹ï©ó¯e¯f§ïµ½¯à¤O¡]disease modification) «Y°ò©ó¨ã¦³ÅãµÛ°§C JAK2 ¬ðÅܪºµ¥¦ì°ò¦]t¾á¤§¯à¤O¡A½t¦¹¡AP1101 ±N¬° PV ¯f±w´£¨Ñ¤@¦³ »ùȪº¡B¦w¥þªº¦Ó¥B¬O¤@Ó·sªºªø´ÁªvÀø¿ï¶µ¡C 6.¦]À³±¹¬I: §ë¸ê¤j²³¥i³sµ²¤U¦Cºô§}¾\Äý¸Óµ²ªGºKn¤§¥þ¤å¡C ASHºô¶ ash.confex.com/ash/2017/webprogram/Paper106570.html 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 |
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·|û¡Gªü¹Å10138576 µoªí®É¶¡:2017/11/2 ¤W¤È 06:34:05²Ä 2962 ½g¦^À³
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¥Ø«e¬°¤î©Ò¦³´CÅé©|¥¼¦³ÃĵØÃij̷sÁ{§É°T®§¡C |
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·|û¡G°¶¤j¤j10136951 µoªí®É¶¡:2017/11/2 ¤W¤È 03:40:00²Ä 2961 ½g¦^À³
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1.¨â¦~¹êÅç¬O¤j³Ó¡A¬Û«HY®É¶¡¦A©Ôªø¬O§¹³Ó¡C 2.¼Ú·ù¤@½uÃÄÃÒÀ³©ó©ú¦~¤W¥b¦~¨ú±o¡C¬ü°ê³¡¥÷¤]±N¡§¥Ê¼ô¸¦¸¨¡A¤ô¨ì´ë¦¨¡¨¡C 3.p1101³oºØ¦w¥þ¡B¦³®Ä¡Aªø´ÁªvÀø¶VÅã¥ÜÀu¶V©Êªº¯S¦â¡A±N·|¬O¦hºØ¯e¯fªºÀ³¥Î»P·Q¹³¡C 4.PVªº¦¨¥\¡A¹ï©óÃĵإثe¶i¦æ¤¤ªºB,C¨x¹êÅç¡A¥H¤Î¥¼¨Ó¦å²G¬ÛÃö¯e¯f¹êÅç¶i¦æ¡A±N¬O¤@¤j¹ª»R¡C |
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·|û¡G¤pªL10142678 µoªí®É¶¡:2017/11/2 ¤W¤È 01:20:58²Ä 2960 ½g¦^À³
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¤µ¦~ªºCONTI-PVºKnª½±µ¤½¥¬¤F«Ü¦h¼Æ¾Ú¡Aµ²ªG½T¹ê«Ü¥¿±¡A12/10¥¿¦¡µoªí®ÉÀ³¸ÓÁÙ¥i¥H¬Ý¨ì²Ä2.7¦~ªºÁͶդñ¸û¡C P1101¦b²Ä¤G¦~ªº©µªøÁÉKO±¼¤FHU¡A¨ä¹ê¦´N¦³¸ñ¥i´`¡A¥u¬O¯S©w´CÅé¿ï¾Ü¨è·N©¿²¤¡C ¦¸n«ü¼Ðªº¤À¤l¤ÏÀ³¡A©Î³\¬O³y¦¨P1101»PHUªø´ÁÀø®Ä®t²§ªºÃöÁä¡A¦A·f°tEHAµoªíªº°©Åè·F²ÓM¤ÀªR¸ê®Æ¡A¥i¥H®i²{IFNa¿W¦³ªºMPN¯e¯f×´_¯à¤O¡A³oÂI´N¥i¥H§@¬°P1101·sÃĻݨDªº®Ä¯q®i²{¡C PROUD/CONTI-PVªº¨ü¸ÕªÌ¦~ÄÖ¤¤¦ì¼Æ¬°60·³¡A¦~Äֳ̰ª¹F85·³¡A¨â²Õ³£Æ[¹î¨ì¦³Ä~µo©Ê´c©Ê¸~½F¤£©ö¥~¡A«ÂI¬°¬O§_»PªvÀøÃĪ«¬ÛÃö¡C HU²ÕÆ[¹î¨ìªº2¨ÒAML¡B1¨Ò¶Â¦â¯À½F©M2¨Ò°ò©³²ÓM½F¡A³£¬O¹L¥hHUÁ{§É·|Æ[¹î¨ìªº´c©Ê¸~½F¡C(HU¼ôª¾ªº°Æ§@¥Î¤§¤@¬°¥Ö½§¼ìºÅ) P1101²ÕÆ[¹î¨ìªº1¨Ò½¦½è¥À²ÓM½F(¸£Àùªº¤@ºØ)¡A1¨Òºëì²ÓM½F(¸A¤YÀùªº¤@ºØ)¡A1¨ÒµÇ¤W¸¢¸~½F¡A«hÀ³¸Ó»P¤zÂZ¯ÀµLÃö¡C(²¦³º¨Å餺¥»¨Ó´N¦³¤zÂZ¯À¡AÀ³¸Ó¨S¤H·|½èºÃ¥´¤zÂZ¯À·|PÀù¡C) ¥t¥~¡AMPD-RC 112¤µ¦~¨S¦³µoªí¡AÀ³¸Ó¬O¤w¸g°±¤î¤F¡C ³Ì«á¡A¥h¦~¥ÎIncyteªÑ»ù¤jº¦¨Ó¬Ý°I¸ÑŪPROUD-PVµ²ªGªº¤ÀªR®v¡A½Ð¦A¬Ý¬Ý¤µ±ßIncyteµo¥¬ASHºKn·s»D½Z«áªºªÑ»ù¤ÏÀ³¡C(joking) |
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·|û¡Gªü¹Å10138576 µoªí®É¶¡:2017/11/1 ¤U¤È 11:33:48²Ä 2959 ½g¦^À³
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¦³½Ö¯à±N¥¦Â½Ä¶¦¨¸û³q¶¶ªº¤¤¤å¡A¨Ï§ó¦hªºªÑªF¬ÝÀ´¡C |
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·|û¡GRussell10140734 µoªí®É¶¡:2017/11/1 ¤U¤È 10:37:21²Ä 2958 ½g¦^À³
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Disease- or treatment-related secondary malignancies occurred only in the HU cohort, including 2 cases of acute leukemia, 1 melanoma and 2 basaliomas, whereas in the Ropeg cohort 3 malignancies (glioblastoma, seminoma, adrenal neoplasm) - most likely unrelated to IFNa treatment - were reported. À³¸Ó¬ORopeg²Õ©Òµo²{ªº±¡ªp¤£¬O¦å²G¯e¯f©Ò³y¦¨©Î´c¤Æ¤Þ°_ªº¡A©Ò¥H±À©w»PP1101ªvÀøµLÃö¡C ·Ó»y·N±À½×¡AÀ³¤w¥Ó³ø¥DºÞ¾÷Ãö¡A¥B¨ÃµL²§Ä³¡C |
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·|û¡Gªü¤¤10143502 µoªí®É¶¡:2017/11/1 ¤U¤È 10:21:30²Ä 2957 ½g¦^À³
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¦Ó¦bRopeg²Õ3¨Ò´c©Ê¸~½F¡]½¦½è¥À²ÓM½F¡Aºëì²ÓM½F¡AµÇ¤W¸¢¸~½F¡^¤¤ - ³Ì¦³¥i¯à»PIFNaªvÀøµLÃö ³o¥i¯àn½Ð¤½¥q¶}ªk»¡¸ÑÄÀ¤@¤U |
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·|û¡GRussell10140734 µoªí®É¶¡:2017/11/1 ¤U¤È 10:16:52²Ä 2956 ½g¦^À³
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¤W¤@¦¸....´N¯S©w´CÅé¦b°Û°I ¤@¤U¤l½èºÃÃÄ»ù¡F¤@¤U¤l¤S½èºÃ«D¦H©Ê¡A±j½ÕÀ³¸Óµ¥¤G¦~§¹¾ã¸ê®Æ¨Óµû»ù!! ²{¦b....¥i¥H³¬¼L¤F§a!! ¨ä¹ê±qµ¦²¤ªº¨¤«×¨Ó¬Ý¡AAOP¸òÃĵذµªº«Ü¦n¡A¥ý¥Î²Ä¤@¦~¨ÓÃÒ¹ê«D¦H©Ê¡A¨Ã¥ý°e¼f¼Ú·ùÃÄÃÒ¡C ²{¦b§¹¾ãªº¤G¦~µ²ªG¥X¨Ó¡AÃÄÃÒ¤w¥ý¼f¤@¥b....¸`¬Ù¤F¦h¤Ö®É¶¡.... ¤@°ï¥~¦æªº¤ÀªR®v¦b¸Ë¤º¦æ.....«¢.... |
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·|û¡GAnderson10143089 µoªí®É¶¡:2017/11/1 ¤U¤È 10:03:27²Ä 2955 ½g¦^À³
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P1101¥»¨Ó´N¦b¦w¥þ©Ê@¨ü©Ê§¹³Ó¡A´NÅýªÑ»ù¥h»¡¸Ü¡A¤£n¹³¤W¦¸¶}½L´X¥G´N¬O³Ì°ªÂI´N¦n¡C |
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·|û¡GRussell10140734 µoªí®É¶¡:2017/11/1 ¤U¤È 09:56:52²Ä 2954 ½g¦^À³
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³sµ².... ash.confex.com/ash/2017/webprogram/Session11562.html |
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·|û¡GRussell10140734 µoªí®É¶¡:2017/11/1 ¤U¤È 09:50:39²Ä 2953 ½g¦^À³
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À³¸Ó¬O³oÓ...¨S·N¥~ªº¤j³ÓHU Background: Interferon-alpha (IFNa) based therapies have been successfully used in myeloproliferative neoplasms (MPN) for over thirty years. Ropeginterferon alfa-2b (Ropeg) is a novel mono-pegylated IFNa, which is administered once every 2 weeks, or monthly during long-term maintenance. Ropeg is developed in polycythemia vera (PV), and 12-month data from the randomized controlled phase III PROUD-PV study comparing Ropeg with hydroxyurea (HU) have been presented. Here we report 2 years treatment data obtained from the follow-up phase III CONTI-PV study. Study design: 254 PV patients (WHO2008 criteria, naïve to cytoreduction or HU pretreated but not resistant) had been randomized to receive Ropeg or HU in the PROUD-PV study. After 12 months of treatment patients were rolled over to the CONTI-PV study: 95 of 106 (89.6%) patients completing the 12-month Ropeg arm, and 76 of 111 (68.5%) patients completing the 12-month HU arm continued in the second year. The latter cohort was also allowed to switch from the HU regimen to best available therapy (BAT) at the investigators discretion; a cross-over between groups was not allowed. Efficacy assessment consisted of complete hematological response (CHR) rate according to ELN criteria, and the CHR rate plus symptom improvement (PV-related symptoms and signs including clinically significant splenomegaly). Secondary endpoints included the effect of treatment on mutant JAK2 allele burden assessed as rate of molecular response (modified ELN criteria) as surrogate for disease modification. Results: 88 (Ropeg) and 73 (HU/BAT) patients completed the 24-month efficacy analysis time point, the mean treatment duration for safety analysis was 2.7 years (both after initial randomization in the PROUD study). Median drug doses in the second year remained at the same level as during the first year: 450 µg Ropeg every 2 weeks and 1000 mg HU per day. In the HU/BAT arm over 98% of patients remained treated with HU, a switch to other BAT was rare. Discontinuation rates during the second year were comparable with 8.4% in the Ropeg and 6.6% in the HU/BAT arm, respectively. At 24 months, treatment with Ropeg achieved a high CHR rate of 70.5%. This was significantly better than a CHR of 49.3% with HU/BAT, (p=0.0101, full-analysis-set). Importantly, in contrast to HU/BAT, response rates increased steadily in the Ropeg-treated group throughout the two-year treatment period. The composite endpoint CHR plus symptom improvement also favored Ropeg with 49.5% vs. 36.6% for HU/BAT (p=0.1183) at 24 months. The advantage of Ropeg was most pronounced in the effect on mutant JAK2 allele burden: at 24 months 69.6% of patients in the Ropeg arm but only 28.6% in the HU/BAT arm had achieved partial molecular response (p=0.0046). Regarding safety, a comparable number of patients (70.1% for Ropeg, 77.2% for HU) experienced treatment-related adverse events. Anemia, thrombocytopenia and leukopenia occurred more frequently with HU, whereas GGT increase was observed only with Ropeg in some patients. Events of special interest for the class of IFNa (in particular thyroid disorders and depression) were below 5% in the Ropeg arm. Disease- or treatment-related secondary malignancies occurred only in the HU cohort, including 2 cases of acute leukemia, 1 melanoma and 2 basaliomas, whereas in the Ropeg cohort 3 malignancies (glioblastoma, seminoma, adrenal neoplasm) - most likely unrelated to IFNa treatment - were reported. Conclusions: These data confirm a) the high and durable hematologic response and symptom improvement achieved with Ropeg, b) the excellent safety and tolerability profile of Ropeg, and c) the disease modification capability of Ropeg suggested by its ability to significantly reduce the mutant JAK2 allelic burden. Ropeginterferon alfa-2b will provide a valuable and safe new long-term treatment option for PV patients. Disclosures: Gisslinger: AOP Orphan Pharmaceutic |
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·|û¡G¤p´²¤á10028616 µoªí®É¶¡:2017/11/1 ¤U¤È 03:46:45²Ä 2952 ½g¦^À³
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¨ÌASHºô¯¸¤§¤½§i www.hematology.org/Annual-Meeting/Abstracts/ ºKnÀ³·|©ó¬üªF®É¶¡2017¦~11¤ë1¤é¤W¤È9ÂI¤½¥¬ ¤½¥q¤]·|µo«°T»¡©úºKnµ²ªG |
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·|û¡G¤pªL10142678 µoªí®É¶¡:2017/11/1 ¤U¤È 03:42:48²Ä 2951 ½g¦^À³
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November 1, 2017, 9:00 a.m. ET Abstracts available online ¥xÆW®É¶¡11/1±ß¤W9ÂI¡A¤½¥q¦b9ÂI«áÀ³¸Ó·|¤½§i¡C |
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·|û¡GRookie10143115 µoªí®É¶¡:2017/11/1 ¤U¤È 03:18:42²Ä 2950 ½g¦^À³
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½Ð°Ý¦³þ¦ì¤j¤j¡A¦³¬Ý¨ìcontinue-PV¸ÕÅçµ²ªG¦bASH 2017µoªíªººKn¡HºI¤î¤é¬°10/31 |
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·|û¡Gn¦³¦n¹B®ð10145611 µoªí®É¶¡:2017/11/1 ¤U¤È 02:04:32²Ä 2949 ½g¦^À³
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¨C¤Ñ³£´X¥G¬O¤p¶^0.5~1¤¸¦¬½L, §Y¨Ï¦³ÃÄÃÒ¤]¥i¯àµLªk®¾¦^¥¢¥h¤H®ðªºÀZ¶Õ~ |
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·|û¡GºÖ«°10145527 µoªí®É¶¡:2017/10/31 ¤U¤È 06:41:27²Ä 2948 ½g¦^À³
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¤w¸g§ë¸êÃĵؤ@¨â¦~¤F,¤]¤£®t³o´XӤ뮳ÃÄÃÒ,¶}©lÀò§Q«á,´N¤£·|³Q¬Y¨Ç¤H¬Ý¤£°_¤F...... |
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·|û¡GRussell10140734 µoªí®É¶¡:2017/10/31 ¤U¤È 06:13:47²Ä 2947 ½g¦^À³
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¦w¥S¡K ¦pªG»Õ¤UÁ¿ªº¦¨¥ß¡A¦b®Ä²v¥«³õ°²³]¤U¡A©Ò¦³ªÑ¥«§ë¸ê³£¬O¦h¾l¡K ¦]¬°ªÑ»ù³£¦¤w¥R¤À¤ÏÀ³¥¦À³¦³ªº»ùÈ¡C µM¦Ó¨Æ¹ê¤W¡A¤j¦h¼ÆªºªÑ»ù¡K¤£¬O©|¥¼¤ÏÀ³¡A¤£µM´N¬O¹L«×¤ÏÀ³¡K ¬O¥H¶R½æµ²ªG¡A¦³¤HÁÈ¿ú¡A¦³¤H½ß¿ú¡C ¨º¨ì©³ªÑ»ù¤ÏÀ³»ùȤF¨S¡K¦A§Ô§Ô ¤Q¤G¤ë¹L«áÀ³¸Ó·|¤ñ¸û©ú®Ô¤Æ |
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·|û¡GªÅ¤]ªÅªÅ10145331 µoªí®É¶¡:2017/10/31 ¤U¤È 06:12:00²Ä 2946 ½g¦^À³
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®¦·OÀøªkªºµo°ÊÅv¬OÂå®v¡C¥Ó½Ð¬yµ{·§z¦p¤U¡G Âå®v»{¬°¯f¤H¿©±w¯f±¡¦M«æ©Î«¤j¤§¯e¯f¡A¥BµL¥ô¦ó¤w®Ö㤧ÃÄ«~¡A¥i¨ÑªvÀø¡C °ò©óÂå®vªº±M·~¤Î¤H¹D¦Ò¶q¡A»{¬°¬Y¬ãµo¤¤¦ý¥¼®Öã¤W¥«¤§¸ÕÅç¥ÎÃÄ¡A¥i¯à¦³À°§U¡A ¦]¦¹¡A½Ð¬ãµo¼t°Ó´£¨Ñ¸Ó¸ÕÅç¥ÎÃÄ¡A¥H«KªvÀø¯f±w¡C ¬ãµo¼t°Ó°ò©ó¬ã¨s®Éµ{¡B¬J¦³²£¶qµ¥¦]¯À¦Ò¶q¡A¥i¯à¦P·N¤]¥i¯à¤£¦P·N´£¨ÑÃĪ«¡C ¼t°Ó¤@¥¹¦P·N¡AÂå®v·|´£pµe®Ñ¡A¸g¸Ó°|IRB¦P·N¡A¦V½ÃªA³¡¥Ó½Ð¡C ¸g½ÃªA³¡¦P·N«á¡AÂå®v©l¥i¥Î¸Ó¸ÕÅçÃĪ«ªvÀø¯f±w¡C ¾ãӥӽЬyµ{¡A¬ãµo¼t°Ó¬O³Q°Ê¨¤¦â¡C¬Y¨Ç°ê»Ú¤j¼t¡A¨p¤U¬Æ¦Ü»{¬°®¦·OÀøªk¬O³Â·Ð¨Æ¡C ®¦·OÀøªkÀ³µø¬°ÃĪ«¬ãµo¤½¥qªºªÀ·|³d¥ô¡A»PÃĵýªº®Öã»P§_¡A§¹¥þ¤£¬ÛÃö¡C |
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·|û¡Gn¦³¦n¹B®ð10145611 µoªí®É¶¡:2017/10/31 ¤U¤È 05:43:00²Ä 2945 ½g¦^À³
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Ãĵإ»½è«Ü¦n,¥i±¤´N¬O¨Sªk¤H¸ò¥~¸ê©ï·R,²¦³ºÃÄÃÒ³£ÁÙ¨S¨ì¤âªº±¡ªp¤U,¤]¥u¯àÆ[±æ |
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·|û¡GAnderson10143089 µoªí®É¶¡:2017/10/31 ¤U¤È 04:28:43²Ä 2944 ½g¦^À³
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Ä~Äò©ñªø½u....ªÅ¤¤¼Ó»Õ....¥ÃµL¤îºÉªºªø½u n¬O§AÌ·Qªº¨º¼Ë...ªk¤H¦§âªÑ»ù«ý¤W500 |
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·PÁÂAlan¤j´£¨Ñªº°Ñ¦Ò¸ê®ÆCurrent and future treatment options for polycythemia vera¡A ½T¹ê«Ü¦n¡A«Ü§Ö¥i¥H¤F¸ÑPVªº¯fµ{¤ÎªvÀø¡C Ãö©óJakafiªº¤£¨}¤ÏÀ³¡BJAK2V617F¬ðÅÜÅé¹ï°¸°ò¦]t²ü«ùÄò°§Cµ¥Ä³ÃD¡A ¦]¨S¦³head to headªº¸ÕÅç¡AµL½×¦w¥þ©Ê©ÎÀø®Ä¡A«ÜÃø¤ñ¸û¡C¥H¤UÂսסA¶È¨Ñ°Ñ¦Ò¡G 1.¨Ì¾ÚJakafi¥é³æSection 5. WARNINGS AND PRECAUTIONS¤Î6. ADVERSE REACTIONS¨Ó¬Ý¡C ¨S¦³Box Warning¡AGrade 3/4ªºAR»PBest Available Therapy¤ñ°_¨Ó¤]¨S¦³¬Û®t¬Æ¦h¡C dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f1c82580-87ae-11e0-bc84-0002a5d5c51b&audience=consumer 2. ¨Ì»PP1101³Ì¬ÛªñªºPegintron/Pegasys¥é³æ¨Ó²q´ú¡C ¦³Box Warning¡AWarnings and Precautionsªº¶µ¥Ø¤]¤£¤Ö¡C dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b70816bb-913a-467f-acb8-67ef62cf8dac&audience=consumer 3. P1101ªº¥é³æ©|¥¼¤½¥¬¡A¥HPegintron/Pegasys¥é³æ¨Ó²q´ú¬O¤£¤½¥ªº¡C ¤ñ¸û¤GªÌªº¦w¥þ©Ê¡B@¨ü©Ê¡AÁÙ¬Oµ¥P1101¥é³æ¤½¥¬«á¤ñ¸û¦n¡C ¦ý¦pªGFDA»{¬°¡¨cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders¡¨¬Oclass effect¡A P1101¥i¯à¤]n¥[¤W³oÓ Box Warning¡C 4. P1101»PJakafiªºpivotal trial¦¬ªº¨ü¸ÕªÌ±Ú¸s¤£¦P¡C ¤@Ó¬O¦´Á¯f±w¡B¤@Ó¬OHUªvÀø¥¢±Ñ©Î¤£@¨ü¡C«áªÌªº¯f±¡¤ñ«eªÌÄY«¡A¿©¯fªº®É¶¡¤]¸ûªø¡C ¯f±¡¤Î¿©¯f®É¶¡¥i¯à¼vÅTªvÀø«e«á¡AJAK2V617F¬ðÅÜÅé¹ï°¸°ò¦]t²ü°§C¤ÎµÇŦ¤j¤pªºÅܤƵ{«×¡C 5.¤j·§¬O¤£·|¦³head to headªº¸ÕÅç¡A«Ü¤Ö¦³¼t°ÓÄ@·N°µ³o¼Ëªº¬ã¨s¡C °£«D¬Oªk³Wªºn¨D¡B©Î¯uªº«Ü¦³«H¤ß·|¶W¹L¹ï¤è¡C Jakafi¦pªG±N¨Ó¤]¹Á¸Õ¥Ó½Ð²Ä¤@½u¾AÀ³¯g¡AÀ³¥u·|¸òHU¤ñ¡A¤£·|¸òP1101¤ñ¡C µL½×¦p¦ó¡A¤@½u¥ÎÃĸê®æ¬O¤ñ¤G½u¦n¡A ¯S§O¬O¦b¹ïoff label promotion»@´Ú«Ü«ªº°ê®a¡C |
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Ãö©óP1101¡BHU»PJakafi¤TªÌªºÄv¦XÃö«Y.... °]°È¦Û¥Ñ¤Hµoªí®É¶¡:2017/7/4 ¤U¤È 10:47:32²Ä 2584½g¦^À³¬O¤p§Ì»{¬°¤ÀªRªº³Ì¦nªº¤@½g... Âà¸ü¦p¤U: JAKAFI ¬O¤@ºØ°w¹ïJAK1, JAK2 ªº»Ã¯À§í¨î¾¯¥H§ïµ½¯f±¡¡A°Æ§@¥Î·|ÀHµÛ¾¯¶q¼W¥[¦ÓÅܤj¡A¤@¯ë¥ÎÃÄ¥u»Ý§ïµ½¯gª¬§Y¥i¡A¥B JAKAFI µLªk½w¸Ñ JAK2 °ò¦]ªº¬ðÅÜ¡A¥²¶·²×¨ªA¥Î¡CRELIEF Trial ¬O JAKAFI ¸ò HU PK °Æ§@¥Î¡A¥i¥H¬Ý¨ì JAKAFI °Æ§@¥Îªº¤ÏÀ³²v¤ñ HU ¤j¡A©Ò¥HÁ{§É³Ì«á¬O¨S¦³¹F¼Ðªº¡C JAKAFI °Æ§@¥Î¤j¥BµLªkÅý JAK2V617F ¬ðÅÜÅé¹ï°¸°ò¦]t²ü«ùÄò°§C¡A³o¤]¬O¬°¤°»ò JAKAFI ¥u¯à·í¤G½u¥ÎÃÄ¡CJAKAFI ªº°ß¤@ÀuÂI¡A´N¬OÃĮħ֡AªAÃĤ§«á«Ü§Ö´N¯à§âªº¯gª¬±±¨î¦í¡C ¥Ø«e¦³Á{§É JAKAFI + ¤zÂZ¯À ¡A¥ý¥ÎJAKAFI ±±¨î¦í¯f¯g¡A¦P®É¥´¤zÂZ¯À°§C JAK2 ¬ðÅÜÅé¹ï°¸°ò¦]t²ü¡A¤@¬q®É¶¡«á´N°±¥Î JAKAFI ¡A¦ý¤´«ùÄò¥´¤zÂZ¯Àª½¨ì½w¸Ñ¯f¯g¡C P1101 ªº AEs ¤ñ HU ¤p¡A¦P®É¯àÅý JAK2V617F ¬ðÅÜÅé¹ï°¸°ò¦]t²ü«ùÄò°§C¡A¥ú¬O³o¤G¶µ´N¨¬¥H»¡ªAÂå¥Í¨Ï¥ÎªvÀø PVªº²Ä¤@¿ï¾Ü¡C P1101 ªº¯ÊÂI´N¬O¤zÂZ¯ÀªºªvÀø»Ýnªø¤@ÂIªº®É¶¡¡A¤~¯à¬Ý¨ì©úÅ㪺Àø®Ä¡C ¦Ü©óÃÄ»ù»PÄvª§¤O.... ÁöµM³\¦h´CÅé»P³¡¥÷¤ÀªR®v§¡µÛ¾¥©óP1101»PHU¤§»ù®æ®t²§¡A¦ýY¥HJakafi»PP1101vsHU®t²§¨Ó¬Ý¡A³oºØÁ¿ªkÀ³¬O¦h¾l¡C¬Æ¦Ü¦³¯S©w´CÅé¥HJakafi¬G·N¥Î¤G½uÃĤW¥«¤§¥«³õ¤Îq»ùµ¦²¤°ª©ú¨Ó§j±·¡C ¯u¬O˪G¬°¦]....®³ªº¨ì¤@½u¥ÎÃĸê®æ...½Ö·Q®³¤G½u¥ÎÃÄ?? Jakafi¬O¦]¬°Á{§É¼Æ¾Ú¥¼¹F¼Ð...¹F¤£¨ì¤@½u¥ÎÃĸê®æ¡A¤~®³¤G½u¥ÎÃĦn¶Ü?? |
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·|û¡G·s¶i10143606 µoªí®É¶¡:2017/10/28 ¤W¤È 10:51:53²Ä 2924 ½g¦^À³
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AIan Liu¤j¡A¦U¥ý¶i¤j ¤j®a¦n¡AÁÂÁ¤j®aªº«ü¾É»P´£¨Ñ¦U¶µ¸ê®Æ¡C ¤p§Ì¦³¨ÇºÃ´b¡A¸Û½Ð¤j®a«ü±Ð... 1¡n¡GPegasysªvPV¯e¯f¤£¬O¥é³æ¥~¥ÎÃĶܡH ¬°¦óPV±wªÌ¹ï¸Ü³£¬O½Í¦¹ÃĦӫD¬O¥Î®Ö㪺jakafi¡H ¬O»ù®æªºÃö«Y¶Ü¡H 2¡n¡Gjakafi»PP1101¨âÃÄ®t²§¬O¤°»ò¡H ¬°¦óP1101¬O¥Ó½Ð¤@½u¥ÎÃÄ¡AµM¦Ójakafl¥u³Q®Öã2½u¥ÎÃÄ¡H 3¡n¡Gjakafi·íªìÁ{§É¦³¥ÎHU©ÎPegasys°µ¹ï·Ó²Õ¶Ü¡H ¢³¡n¡G¦pªG¥Îjakafi¸òP1101¨âÃÄPKÃĵط|Àu©ójakafi¶Ü¡H ¥H¤WÀµ½Ð¦U¦ì¥ý¶i«e½ú¤£§[«ü±Ð¡C ·PÁÂAlanLiu¤j»P¦U¦ì¥ý¶i¤j¡C |
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·|û¡G¤pªL10142678 µoªí®É¶¡:2017/10/27 ¤U¤È 12:16:07²Ä 2923 ½g¦^À³
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ÁÂÁÂAlan¤j´£¨Ñªº°T®§»P½Ķ¡C ¸É¥R¸Ó¹ï¸Ü¦ê¤¤ªº¤@«h¯f¤Í¦^ÂÐ(»Ýn¦AÂI¶}ªº¦¸¦^ÂÐ)¡A¦pÃĵطs»D½Z©Òz¡AÀq§JªºPegIntron¤w¸g°±²£¤F¡C ¡»Renate Wolf: I know. I was on Pegintron which had been stopped completely in May 2017 and I am now on Pegasys syringes. |
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ÃÄÃÒ¤~¬O¤ý¹D,¤£µM¦A¦hªº§Q¦h·s»D¸òº}«Gªº¹êÅç¼Æ¾Ú,¤]¥u¬OªÑ»ùº¦¶^ªº°Ñ¦Ò¦Ó¤w! ¨ä¥Lªº·sÃÄ¥i¥H¨Ó¾Þ§@,ÁÈ»ù®t! ¥\¤O¦nªº¤H©Î³\¯à°µ¨ì¹s¦¨¥»«ùªÑ! Ãĵتѻù¤]¸ÓªíºA¤@¤U¤F! |
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·|û¡GAlan Liu10136094 µoªí®É¶¡:2017/10/27 ¤W¤È 11:31:16²Ä 2920 ½g¦^À³
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¤À¨É ¯f¤Í¹ÎÅé MPN Interferon Forum - (Myeloproliferative Neoplasm) ©ó¬Q¤é¹ï¸Ü°Q½× Pegasys °±²£¥H¤ÎÃĵØÃÄP1101 °Q½×¤º®e, §¹¾ã¹ï¸Ü½Ķ¦p¤U¨Ñ¦U¦ì§ë¸ê¥ý¶i°Ñ¦Ò, ¨ü©ó¥²´IºôµLªk¤À¨É¹ÏÀÉ, ì¤å§¹¾ã¹ï¸Ü±N¤À¨É¦Ü¥H¤U³sµ², ÁÂÁ¡C (6446) ÃĵØÂåÃĪº§ë¸ê»ùȤÎÄ@´º www.mobile01.com/topicdetail.php?f=291&t=4919602&p=17 * Paul : §AÌPegasysªº¹L´Á¤é¬°¦ó? ±q§Ú6¤ë¶}©l¥hÃħ½¶RªºPegasys¦³®Ä´Á³£¦b2019¦~3¤ë, ³oÅý§Ú¾á¤ß¬O§_ Genetech ¶}©lpµe¦bªñ¦~´î²£©Î¬O°±²£, ¬O§_¦]¬°2019¦~ Ropeginterferon (P1101)¦b2019¦~n¤W¥«, ÁÙ¬O³o¥u¬O§Ú¦h¼{¤F, ÁÂÁ¡C * Ann: §Úªº¦³®Ä´Á¦b2019/09, ©Ò¥H¥Ø«e¬Ý°_¨Ó, §Ú¬Oı±o¨S°ÝÃD * Courtney: §Úªº¦³®Ä´Á¤]¬O 2019/09 * Jill: §Úªº¤]¬O2019/09 * Angie: 2018/07 * Debra: ³oºØ¾á¤ß¦ü¥G¸g±`¥X²{, ¦ý³Ìªñ±o¨ì¤½¥q«OÃÒªñ9-12Ó¤ë¥H¨Ó, ¤½¥q¥Ø«e¤´¨S¦³´î²£pµe¡C * Jill: §Ú¤W¦¸¦³¥´¹q¸Üµ¹¤½¥q, ¥LÌ»¡¨S¦³¥ô¦ó´î°±²£pµe, ¦Ó§Ú¦³¸ò¥LÌ´£¨ì±µ¤U¨Ó¦³Ó·sÃÄ·|¨ú¥N§AÌ, ¥L̸ò§Ú»¡ Pegasys ¦b¦å²G¯e¯f(MPN)¥H¥~ªº»â°ì¤´¦³³\¦h¯e¯f»Ýn¨Ï¥Î¡C * Barbara: §Úªº¤]¬O2019/09 * Win: ªñ¤TӤ뮳¨ìªºPegasys ¦³®Ä´Á³£¬O2019/09, ¦ý§Ú¦í¼Ú¬w, ¤ñ¸û±µªñ¨ú±oP1101 * Melissa : §Úªº¤]¬O 2019/06, ù¤ó¥Í²£ * Paul: ¨º¬Ý¨ÓÃħ½®³®w¦s«~µ¹§Ú, §Ú¨ì¤W©P¥h®³ªº³£ÁÙ¬O2019/03 * Susana: ¦³½ìªº°ÝÃD, §Ú³Ì·sªº¦³®Ä¤é´Á¤]¬O¦b2019/10¤ë, 90mcg¥Ñù¤ó¥Í²£ªºª`®g¾¹¡C * Cori: ¨â©P«e®³¨ìªº¨ì´Á¤é¬O2019¦~3¤ë, ¥ÑBriovaÁʶR¡C * Lourdes : §Ú¤WӤ뮳¨ìªº¨ì´Á¤é¬O2019/09, ¥Ñ Acreddo Pharmacy¨ú±o¡C * Bonnie: ©Ò¥H¥Ø«e§AÌ»{¬°Pegasys ¦b2019¦~¤£¦A´£¨Ñ? * Jill: ¹w¦ô¬O2019/2020¦~ * Elena: 2019/09 * Veronica: 2018/09 * Renate: §Úªº¬O2020/05, ¶Ç»DRocheªºPegasys±N·|¦b2023¦~³Q²^¨O, ©¡®É©Ò¦³¬ÛÃö°ê®a±N´£¨Ñ·s¤@¥Nªº¤zÂZ¯À, ¼w°ê¹w´Á2018¦~¥i¥H®³¨ìP1101¡C * Barbara: Paul, ©êºp§Ú¿ù¤F, §Úªº¨ì´Á¤é¬O2018/10¤ë, ¥Ø«e§Ú¨CӤ벣«~¨ì´Á¤é³£¦b¦¬¨ì²£«~«á¤@¦~¡C |
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Y¥HªÑ©Ê¦Ó¨¥,µu´Á¤º§Ú»{¦PAnderson¤jªº»¡ªk ¦ýµØ¤Íªø´Á¬Ý¦n§ë¸ê,À³¸Ó¬On¨äªø´Á¦¬¯q¨ÃÁȨúµu´Áªº»ù®t µ¥¼Q¥X¦A°l´N¬Ý°l¤£°lªº¨ì |
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·|û¡G¤p´²¤á10028616 µoªí®É¶¡:2017/10/26 ¤U¤È 03:54:43²Ä 2918 ½g¦^À³
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¾Ú¤F¸Ñ¡A11¤ë¤W¦¯½×¤å¤§ºKnµ²ªGÀ³¸Ó·|¥ý¤½¥¬©óASHºô¯¸¤Wªº¡A¦P¥h¦~¤è¦¡¡C ©¡®É¤j·§¥i¥Hª¾¹Dµ²ªG¦p¦ó¤F¡C |
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ªþµù¡G¼Æ¾Úµoªíªº®É¶¡¤è±¡A§Ú¬O®Ú¾Ú¥H©¹¯E¹©¦Ü°ê¥~µoªí¼Æ¾Ú¡A´£«e¤½§iªº®É¶¡±À¦ô¡C |
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·|û¡Gªü¹Å10138576 µoªí®É¶¡:2017/10/26 ¤U¤È 03:32:45²Ä 2916 ½g¦^À³
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TO°]°È¦Û¥Ñ¤H¤j¡G ´Á¬ß±z¦b¤½§iªº²Ä¤@®É¶¡¡A¯à°÷¬°¤j®a°µ¸ÔºÉªº¤ÀªR¡AÁÂÁ¡C¦Ó¬ÛÃö¼Æ¾Ú¤è±©Î³\·|´£¦¡q´£«e¤@Ӥ륪¥k¡r¦b¤Q¤@¤ë¤W¦¯©Î¤¤¦¯´Nµo¥¬¡A±z¦Aª`·N¬Ý¬Ý¡C |
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·|û¡G°]°È¦Û¥Ñ¤H10132540 µoªí®É¶¡:2017/10/26 ¤U¤È 03:05:18²Ä 2915 ½g¦^À³
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to ¤p´²¤á¡G ¤£¦n·N«ä¡A§Ú¤é´Á·d¿ù¤F¡C ³o¦¸ªº ASH Conti-PV ¼Æ¾Úµoªí¡A§Æ±æ¯à¦³§ó²`¤Jªº²Ó¶µ¡A¥]§t¤À¤l¤ÏÀ³¡C ¤À¤l¤ÏÀ³¤~¬O¥Î¤zÂZ¯ÀªvÀøªº«ÂI¡A¦P®É¤]¬O functional cure ªºÃöÁä¡C |
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·|û¡G¤p¦B¦B10145378 µoªí®É¶¡:2017/10/26 ¤U¤È 01:48:55²Ä 2914 ½g¦^À³
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³oÀ³¸Ó¬O¯uªº³Ì«á¤@µo¤F¡A ²Ä¤@¡A§Ú±q¨Ó¨S»¡§Ú¦³¯E§b ²Ä¤G¡A¯E§b±q¥h¦~¶^¸ò§Ú¤@ÂIÃö«Y¤]¨S¦³¡A¤Ï¥¿§Ú¨S¶R ²Ä¤T¡A§Ú¥u¬O´£¥Xn¥Í§Þº¦¤£¬O°ò¥»±¦n´N¥i¥H¡A¬On»âÀY¦Ï¡A¦Ó§Úªº¬Ýªk¨º°¦¦Ï¬O¯E§b¡C §Ú±q¨Ó³£¨S»¡6446¤£¦n¡A¦ý¬O6446ªº°ÝÃD«Ü©úÅã¬OÄw½X°ÝÃD¡B¬OªÑ©Ê°ÝÃD¡C ¦³¤H»¡¥ú¾ÇªÑ¡A¤j®a¥i¥H·Q·Q¦pªG®³¥ú¾ÇªÑ¨ÓÁp·Q¡A6446¥i¯à¤ñÀÀþ¤@°¦¡H µ´¹ï¤£¬O¥É´¹¡Bµ´¹ï¤£¬O¤j¥ß¥ú¡A6446³»¦h¥u·|Ãþ¦ü¨È¥úªºªÑ©Ê¡C µu´Á¶¡¬ÝK½u´N¬O¤£·|º¦°Ú ³oùعï©ó¤£¦P¨¥½×ªº¼Ä·N¤Ó«¡A³oùتº¤H¦Û¤vn¤p¤ß¡A §O§â¤£¦P½×ÂI³£n¥i¥H§á¦±¡C ¥hPTT·Pı¤ñ³o¸Ì¦³¬D¾Ô©Ê¦h¤F¡A¯¬§AÌ¥i¥H°í«ù³ø¨ì500Åo |
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·|û¡GAnderson10143089 µoªí®É¶¡:2017/10/26 ¤U¤È 01:30:17²Ä 2913 ½g¦^À³
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¯uªº¼o¨ì¯º ¤@°ïªÑ²¼³£¦bº¦ §â¸êª÷°±ªy¦bÃĵجO¤@ºØµL¿×ªº®ö¶O ¤pº¦¤@¤ÑµM«á´N¦A¶^¦^ì¦ì ¤£¦pµ¥¨ì¥X¶qªíºA¦A¨Ó°l¤]ÁÙ¨Óªº¤Î |
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·|û¡GRussell10140734 µoªí®É¶¡:2017/10/26 ¤U¤È 12:39:32²Ä 2912 ½g¦^À³
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¤£ºÞ°ÝÃD¦³¨SÃöÁp¨ìcontinue-PV ªLµ¦²¤ªø¤@¶}©l´N»¡¹L¦^µª°ÝÃD®É¶¡¬O¤TÓ¤ë ¦ý¬°¨D·V«¡A¤j³¡¥÷ªº¤½¥q·|¦A©µ¤TÓ¤ë ¤£¥Î·Q¤Ó¦h¡K |
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¦p°]°È¤j±À½×¥¿½Tªº¸Ü¡ACONTI-PVÀ³¦b¬ü°ê®É¶¡12¤ë10¤é7:45AM¤½¥¬¡C·íªì«°T¦p¤U¡C ÃĵØÂåÃıµÀò¥»¤½¥qµ¦²¤¹Ù¦ñAOP¤½¥q³qª¾±N©ó¬ü°ê®É¶¡12¤ë10¤é7:45AM¦b¬ü°ê ¨È¯SÄõ¤jÁ|¦æªº2017¦å²G¯fÂå¾Ç¦~·|(ASH)¡A¥H¤fÀY³ø§i§Î¦¡µoªí¦³ÃöP1101¥Î©ó ªvÀø¯u©Ê¬õ¦å²y¼W¥Í¯g(PV)¤§²Ä¤T´Á¤HÅéÁ{§É¸ÕÅçPROUD-PV«áÄ~ÄòÁ{§É¸ÕÅç CONTIUNATION-PVªvÀøµ²ªG(§tPROUD-PV¦@¤G¦~)¡CASH¦~·|±N©ó2017¦~12¤ë9¤é¦Ü 12¤é©ó¬ü°ê¨È¯SÄõ¤jÁ|¦æ¡C |
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·|û¡G°]°È¦Û¥Ñ¤H10132540 µoªí®É¶¡:2017/10/26 ¤W¤È 09:44:22²Ä 2910 ½g¦^À³
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¦X²z±À½×¡AEMA ªº 120 °ÝÃD¡A¥i¯à¯A¤Î¨ì COINTI-PV ªº³¡¥÷¡AY¬O¦p¦¹¦^ÂЪº®Éµ{·|µ¥¨ì 12/4 µoªí§¹²¦¤§«á¡C |
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·|û¡Gªü¤¤10143502 µoªí®É¶¡:2017/10/26 ¤W¤È 06:02:10²Ä 2909 ½g¦^À³
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.¨Æ¹êµo¥Í¤é:106/07/05 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: ¤½§i¥»¤½¥q±µÀò¼Ú¬w¹Ù¦ñAOP¤½¥q»¼¥æ¤§BESREMI ¼Ú·ù·sÃĤW¥«³\¥i¥Ó½Ð¤§²Ä120¤Ñ ¼Ú·ù¤HÅé¥ÎÃÄ©eû·|°ÝÃD·JÁ`²M³æ(CHMP day 120 list of questions) 6.¦]À³±¹¬I: ¼Ú¬wÃĪ«ºÞ²z§½(European Medicines Agency, EMA) ¤w©ó2017¦~2¤ë23¤é§¹¦¨½T »{¥»¤½¥q¼Ú¬w¹Ù¦ñAOP¤½¥q´£¥XBESREMI (P1101¡^·sÃĤW¥«³\¥i¥Ó½Ð ¡]marketing authorization application, MAA¡^¡A¾AÀ³¯g¬°ªvÀø¯u©Ê¬õ¦å²y¼W¥Í¯g (PV)²Ä¤@½u¥ÎÃÄ¡C¥»¤½¥q³¼±µÀòAOP¤½¥q»¼¥æ¤§EMA¼Ú·ù¤HÅé¥ÎÃÄ©eû·| ¡]Committee for Human Medicinal Products, CHMP¡^ªº²Ä120¤Ñ°ÝÃD·JÁ`²M³æ (CHMP day 120 list of questions)¡A¥»¤½¥q¥xÆW¹Î¶¤(¥x¤¤¼t¦P¤¯¡B¥x¥_¬ãµo¤Hû ¤ÎÅU°Ý¹Î)»P¼Ú¬w¦X§@¹Ù¦ñ¹Î¶¤(AOP Group)¤w¦@¦P¿n·¥§ë¤J¦U¶µ°ÝÃD¤§¦^ÂСC «öEMA ¼f®Öµ{§Ç¡A¹F120 ¤ÑCHMP·|´£¥X°ÝÃD·JÁ`²M³æ(CHMP day 120 list of questions)¡A¦bEMA¦¬¨ì¦^Âмf®Ö©Ò´£°ÝÃD¤§«e¡A®É¶¡¬O·|°±¤îpºâ¡]Clock off¡^ªº ¡A«·sp®É¡]Clock on¡^«hnµ¥¨ìEMA±µÀò©Ò¦³¦^ÂЪº¸ê®Æ«á¡A¦A°w¹ï©Ò´£¦^ÂЦA¦æ ¼f®Ö¡A³o°±¤îp®É´Á¶¡¥i¤¹³\¬O3-6 Ó¤ë¡C ¤£¦n·N«ä,½Ð°Ý¦U¦ìÃĵØÃĤ§¤Í¤@¤U,¬O¤£¬O³Ì±ßn¦b107¦~1¤ë5¤é¤§«e¦^µªEMAªº°ÝÃD, ÁÂÁ¦U¦ì¤j¤j |
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·|û¡G©üÀY10134794 µoªí®É¶¡:2017/10/25 ¤U¤È 03:07:06²Ä 2908 ½g¦^À³
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Gºô³Ìªñ¤@ª½±À³¯®Û«í³Õ¤hªººtÁ¿¡A½Ð°Ý¦³¤H¥hÅ¥¤F¶Ü?google¤]¥u¯àª¾¹D¥L¬O¬F¤jªº±Ð±Â |
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·|û¡GAlan Liu10136094 µoªí®É¶¡:2017/10/25 ¤U¤È 01:44:06²Ä 2907 ½g¦^À³
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Dr. Jean-Jacques Kiladjian explained the difference between HU and Interferon: youtu.be/UyKhws7pMFI Proud-PV was the first randomized trial comparing interferon [ropeginterferon] to hydroxyurea in patients with PV as a first line therapy. We had the opportunity to study the hematogenic progenitors before and after 1 year of treatment in both the ropeginterferon and hydroxyurea arms. We picked up [sampled] the bone marrow cells before and after starting the one year treatment, then grew colonies in vitro [in the lab] and looked at which colonies had the Jak2 mutation or not. Proud-PV ¬O²Ä¤@ÓHU©M¤zÂZ¯À¦bPV¯f±w¤W¤@½u¥ÎÃĪvÀøªºÀH¾÷¸ÕÅç¡A§Ú̦³¾÷·|Æ[¹î P1101 ©MHU ¦b¤@¦~«e«áªº°©Åè³y¦å²ÓMª¬ªp¡C§Ṳ́]¦b³o¤@¦~ªºªvÀø«e«á¦¬¶°¤F³o¨ÇÁ{§É¯f±wªº°©Åè²ÓM, Æ[¹îJAK2 Åܲ§ª¬ªp¡C What we could see in this trial was that patients receiving ropeginterferon had a very important decrease in the proportion of colonies with the [Jak2] mutation after 12 months of treatment. This proportion was reduced by more than 60% and in comparison patients who received hydroxyurea in this trial reduced only by only 10-20%. So we could confirm in vivo [in real life] the two drugs have a different impact although they reduce blood counts similarly, interferon could act on the bone marrow progenitors by reducing the malignant cells and promoting the restoration of normal hematopoiesis. §ÚÌÆ[¹î¨ì±µ¨üP1101ªvÀøªº¯f±w¦b12Ó¤ëªvÀø«á, JAK2 ¬ðÅܪº¤ñ«¤j´T¤U°, ¤U°¤ñ«¶W¹L60%, ¦Ó±µ¨üHUªvÀøªº¯f±w³o¦¹¸ÕÅ礤¶È°§C10-20%, ÁöµM¦b¦å²G¼Æ¶q¤ñªº±±¨î¤W¨âªÌªñ¦ü, ¦ý§ÚÌ¥i¥H²M·¡³o¨âÓÃĪ«¦b¯f±w¤¤¦³µÛ¤£¦Pªº¼vÅT, ¤zÂZ¯À¥i¥Hª½±µ§@¥Î°©Åè³y¦å²ÓM, ¼W¥[¥¿±`³y¦å²ÓM¨Ã´î¤Ö´c©Ê²ÓMªº¼W´Þ¡C So we hope this will on longer term translate into an operational cure on the patients taking interferon. Although hydroxyurea can allow the good control of counts if you stop the drug the malignant cells are still there and the disease can proliferate again. §Ú̧Ʊæªø´Á¥i¥HÅý±µ¨ü¤zÂZ¯Àªº¯f±w¹F¨ìªv¡ªº®ÄªG, ÁöµMHUªø´Á¥i¥H±±¨î¦å²G¼Æ¶q, ¤£¹L´c©Ê²ÓM¤´¦s¦bªº±¡ªp¤U, ¤@¥¹°±ÃÄ«h¯e¯f·|¦A«×´c¤Æ¡C |
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·|û¡GAnderson10143089 µoªí®É¶¡:2017/10/25 ¤U¤È 01:32:06²Ä 2906 ½g¦^À³
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ÃÄµØ¶Ü ¼È®É¤j·§´N³o³¾¼Ë ¤pº¦¤@¤ÑµM«á³sÄò¶^¨â¤T¤Ñ µ¥«Ý¤@®ÚªíºA ¦V¤W¦V¤U¤£ª¾¹D¡C |
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·|û¡Gªü®a®æ®æ10140412 µoªí®É¶¡:2017/10/21 ¤U¤È 06:01:02²Ä 2891 ½g¦^À³
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·|û¡G¤p¥¿¥¿10141351 µoªí®É¶¡:2017/10/21 ¤U¤È 04:29:14²Ä 2890 ½g¦^À³
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New drug trial for Polycythemia Vera initiated by Roche MPN News | October 18, 2017 http://www.mpnresearchfoundation.org/ Hoffman-La Roche has a new trial they have initiated for Polycythemia Vera, for those who are either resistant to or intolerant of Hydroxyurea. The drug - NP39761 or Idasanutlin - is being tested in a Phase 1, single arm trial. The drug is taken orally by patients, and disrupts certain cancer causing pathways relevant to the JAK2 mutation. Outcomes for this trial vary based on the patient criteria going in, such as spleen size, hematocrit level and other variables. More information about this tria, including expected outcomes, is available on ClinicalTrials.gov by clicking here. Genentech Roche also has an information page about this ttrial available here. |
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·|û¡G¤p¥¿¥¿10141351 µoªí®É¶¡:2017/10/19 ¤U¤È 09:11:26²Ä 2889 ½g¦^À³
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ÃĵØÂåÃıµÀò¬ü°ê¨x¯f¬ã¨s¦~·|(AASLD)³qª¾¡A¥»¤½¥qµû¦ôP1101¹ï©ó¥¼±µ¨ü¤zÂZ¯ÀªvÀø¤§ºC©ÊB«¬¨xª¢±wªÌªº§Ü¯f¬r¬¡©Ê»P¦w¥þ©Ê¤§¶}©ñ©Ê¡BÀH¾÷¤À°t¡B¦³®ÄÃĹï·Ó¡B¾¯¶q±´¯ÁªºÁ{§ÉI/II¸ÕÅç(A12-201)ªººKn¤w³Q±µ¨ü¨Ã¥B³Q¿ï¬°late breaking³ø§i¡C(µù¡Glate breaking¥u¦³³Ì·sªº¬ã¨s¤~¯à§ë½Z¡A¦]¦¹Ävª§¿E¯P)¡CAASLD¦~·|±N©ó2017¦~10¤ë20¤é¦Ü24¤é©ó¬ü°êµØ²±¹y¯S°ÏÁ|¦æ¡C¶À«³¤åÂå®v(²{¬°¥x¥_Âå¾Ç¤j¾ÇÂå¾Ç¨t¤º¬ì³¡©w§U²z±Ð±Â¡A»OÆW¤j¾ÇÂå¾Ç¨t¤º¬ì³¡©wÁ¿®v¡A°ê®õÂå°|G¸z¨xÁx¬ì¥DªvÂå®v¡A»O¤jÂå°|G¸z¨xÁx¬ìÝ¥ô¥DªvÂå®v)±N·|¦b2017¦~10¤ë23¤éµoªí¦¹Á{§É¸ÕÅç¸Ô²ÓªºÀø®Ä¤Î¦w¥þ©Ê¼Æ¾Ú¡C °Ñ·Óhttps://www.aasld.org/events-professional-development/liver-meeting/program-0/late-breaking-abstracts?utm_source=homepage&utm_medium=latebreakingsessions&utm_campaign=rotator Poster Sessions Monday, October 23, 8 am-5:30 pm LB-29:Every-two-week ropeginterferon alfa-2b is safe with better efficacy in interferon naïve patients with chronic hepatitis B virus infection: A phase 2, open-label, randomized, active control, dose finding study |
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·|û¡Gªü¹Å10138576 µoªí®É¶¡:2017/10/19 ¤W¤È 09:05:13²Ä 2888 ½g¦^À³
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§Ú¬Oªø½u§ë¸êªÌ¡A§Ú»{¬°³Ìªñªº§Q¦h¨Ã«D§Y®É§Q¦h¡A»Ýn®É¶¡ªº¤ÏÀ³¡A¦pªG¥H¤G½u¥ÎÃĪº¿ÕµØPV³æ¤@¥ÎÃÄ¡AÃÄÃÒ®³¨ì¨â¦~¤º¡A´N¥i³Ð³y¥X¤Q´X»õ¬ü¤¸¡q¥x¹ô¼Æ¦Ê»õ¡rªº¦~À禬¡A§ó¦óªp¬O¤@½u¥ÎÃĪºÃĵءAPV³æ¤@¥ÎÃÄÃÄÃÒ®³¨ì«á¨â¦~¤º¡An¹F¨ì¦~Àò§Q¨âӪѥ»À³¸Ó«Ü®e©ö¡A©¡®ÉªÑ»ùÀ³¬°²{¦bªº¿¼Æ¡CÃĵØÃĬO¥Ø«e½L±¤WªÑ»ù³Ì¦³¿¼Æ¤Wº¦¼ç¤OªºÓªÑ¡AªÑ»ùªº¤ÏÀ³¥u¬O¦b©ó®É¶¡¤Wªº°ÝÃD¡C |
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´Á¤¤¤ÀªR¦³¤TºØµ²ªG¡G 1. Åã¥Ü«Ü¦nªºªvÀø®ÄªG¡ADSMB°ò©óÅý¦³ªvÀø»Ýn¯f±w¦¤é¥ÎÃĪºÛ²z¦Ò¶q¡A·|«Øijµ²§ô¸ÕÅç¡A»°§Ö¥Ó½ÐÃÄÃÒ¡C 2. ¹êÅç¦A°µ¤U¥h¡A°Æ§@¥Î«Ü°ª©Î¤£¤Ó¥i¯àÅã¥ÜÀø®Ä¡ADSMB°ò©ó«OÅ@¨ü¸ÕªÌ¡A ¤]·|«Øijµ²§ô¸ÕÅç¡AÅý¨ü¸ÕªÌ¦³¾÷·|±µ¨ü¨ä¥L¥i¯à¼ç¦b¦³Àø®ÄªºªvÀø¡C 3. ¥¼Åã¥Ü«Ü¦nªºÀø®Ä¡A¤]¥¼Åã¥Ü°Æ§@¥Î«Ü°ª©Î¤£¤Ó¥i¯à¦³Àø®Ä¡ADSMB·|«Øij¸ÕÅçÄ~Äò°µ¤U¥h¡C ²Ä¤TºØ±¡ªp¹ïÁ{§É¸ÕÅçµ²ªGªº§PÂ_¡A¨Ã¥¼´£¨Ñ§ó¦hªº°T®§¡C ¦pªG»{¬°³o¦³§U©ó´£°ªÅã¥ÜÀø®Äªº¾÷·|¡A®£©È·ÀI¤j¤F¤@ÂI¡C |
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·|û¡GAnderson10143089 µoªí®É¶¡:2017/10/18 ¤U¤È 12:50:47²Ä 2880 ½g¦^À³
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·|û¡G¤pªL10142678 µoªí®É¶¡:2017/10/17 ¤W¤È 10:37:03²Ä 2878 ½g¦^À³
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¤Ñ©R¤j¡A Interferon¯à´£¤ÉPD-L1 expression¡AÃĵتº¹Î¶¤À³¸Óª¾¹D¡A¦Ó¬ãµoPD-1/PD-L1·f°tP1101¤]¦b¤½¥q¤¤ªø´Áªºµo®ipµe¤¤¡C ¤£¹L¦b¥Ø«eÀù¯g¥ÎÃÄ°ª«×Äv³v¤U¡A§Ú¬O»{¬°Ãĵؤ£¨£±on¦Û¦æ¬ãµoPD-1/PD-L1¡A¥HP1101¸ò°ê¤º¥~Ãļt·f°t¦X§@¬O¥i¥H¦Ò¼{ªº¡C |
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¡i¤½§i¡jÃĵØÂåÃıµÀò±ÂÅvOraxol©óÃĵØÂåÃĤ§¹Ù¦ñ¬ü°êAthenex¤½¥q·s»DOraxol¨ÅÀù¤T´ÁÁ{§É¸ÕÅ窺p¹º´Á¤¤¤ÀªR¥Ñ¿W¥ßÃĪ«¦w¥þºÊ·þ©eû·|¡]DSMB¡^¶i¦æ¼f¬d¨Ã¥þ¼Æ¦P·N«öp¹ºÄ~Äò¶i¦æ¸ÕÅç 2017/10/16 19:51 ¤¤¥¡ªÀ ¤é¡@¡@´Á¡G2017¦~10¤ë16¤é ¤½¥q¦WºÙ¡GÃĵØÂåÃÄ (6446) ¥D¡@¡@¦®¡GÃĵØÂåÃıµÀò±ÂÅvOraxol©óÃĵØÂåÃĤ§¹Ù¦ñ¬ü°êAthenex¤½¥q·s»DOraxol¨ÅÀù¤T´ÁÁ{§É¸ÕÅ窺p¹º´Á¤¤¤ÀªR¥Ñ¿W¥ßÃĪ«¦w¥þºÊ·þ©eû·|¡]DSMB¡^¶i¦æ¼f¬d¨Ã¥þ¼Æ¦P·N«öp¹ºÄ~Äò¶i¦æ¸ÕÅç µo¨¥¤H¡G¶À¥¿¨¦ »¡¡@¡@©ú¡G 1.¨Æ¹êµo¥Í¤é:106/10/16 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: ¥»¤½¥q±µÀò±ÂÅvOraxol©ó¥»¤½¥q¤§¹Ù¦ñ¬ü°êAthenex¤½¥q(«e¨¬°Kinex Pharmaceuticals) ·s»D¤½§iOraxol 001¨ÅÀù¤T´ÁÁ{§É¸ÕÅ窺p¹º´Á¤¤ ¤ÀªR¥Ñ¿W¥ßÃĪ«¦w¥þºÊ·þ©eû·|¡]DSMB¡^¶i¦æ¼f¬d¨Ã¥þ¼Æ¦P·N«öp¹ºÄ~ Äò¶i¦æ¸ÕÅç¡C 6.¦]À³±¹¬I: ¥»¤½¥q±µÀò±ÂÅvOraxol©ó¥»¤½¥q¤§¹Ù¦ñ¬ü°êAthenex¤½¥q·s»D¤½§i¦³Ãö¤w§¹¦¨ ì³W¹ºOraxol 001 ¤§¤T´ÁÁ{§É¸ÕÅ窺²Ä¤@¦¸´Á¤¤¤ÀªR¡A¦A¥Ñ¿W¥ßÃĪ«¦w¥þºÊ ·þ©eû·|¡]DSMB¡^¶i¦æ¼f¬d¡CDSMB¥þ¼Æ¦P·N«öp¹ºÄ~Äò¥B¹ªÀy¿n·¥©Û¶Ò¯f¤H¥H ºÉ§Ö¶i¦æ²Ä¤G¦¸180¤Hªº´Á¤¤¤ÀªR¡CAthenex¤½¥qªí¥ÜDSMB¹ï©ó¬ã¨s¾ãÅé¤ÏÀ³²v ¡]Overall response rate¡^²`·Pº¡·N¡C¦¹¸ÕÅçÅã¥Ü¤fªAOraxol©MÀR¯ßª`®gµµ§ü ¾J¶¡ªº¦w¥þ©Ê®t²§¦p¦P¹w´Á¡A¯S§O¬O¯kµh·P°ªªº¯«¸g¯fÅÜ(Neuropathy)©Ò³y¦¨ ªº¤£¨}¨Æ¥ó(adverse event)¦bOraxolªvÀø¤¤¤w¤£±`¨£¡C ¦¹¬ã¨s¬°¤ñ¸û¤fªAOraxol»PÀR¯ßª`®gµµ§ü¾J¥Î©óªvÀøÂಾ©Ê¨Å¸¢Àù±wªÌ¤§¬ã¨s¡A Oraxol 001 ¥Î©óÀH¾÷¤À°t¡Bª¼¤Æ¡B¦³®ÄÃĹï·Óªº¤T´ÁÁ{§É¸ÕÅç¡C¸Ó¸ÕÅç¥DnÆ[ ¹îOraxol¹ïÀR¯ßª`®gµµ§ü¾Jªº¦w¥þ©Ê¤ñ¸û©M¤Î¨äÀu¶V©Ê¡]superiority)¡A¨ä¤ÏÀ³ ²v¤§½T»{¤D®Ú¾ÚRECIST¼Ð·Ç¡]¬°¤@¯ë³q¥Î½T»{¸~½FÁY¤p¤§¥\®ÄªºÁ{§É¤ÏÀ³¼Ð·Ç¡^ ¶i¦æµû¦ô¦Ó±o¡C ¥»¤½¥q¦Û¬ü°êAthenex¤½¥q¨ú±o¥xÆW¡B·s¥[©Y¤Î¶V«n¦a°Ï±ÂÅv¤§·sÃÄOraxol (HM30181 tablets 15mg/Paclitaxel capsules 30mg)¡A¤w©ó105.07.18±µÀòTFDA ¨çÂЦP·NÁ{§É¸ÕÅç¥Î·sÃÄ(IND)¥Ó½Ð¡A¨Ã¤w¶i¦æ»Î±µ©Ê¤HÅéÁ{§É¸ÕÅç¡A¥»¤½¥q¦¬®× 24¤HªºPK¸ê®Æ¡A¥¼¨Ó±N¦X¨Ö¬ü°êAthenex¤½¥qOraxol 001¨ÅÀù¤T´ÁÁ{§É¸ÕÅç´Á¤¤¤À ªR¤§¼Æ¾Ú¨Ó¥Ó½Ð¥xÆW¥¼¨Ó·sÃĬdÅçµn°O¡C 7.¨ä¥LÀ³±Ô©ú¨Æ¶µ: ·sÃĶ}µo®Éµ{ªø¡B§ë¤J¸g¶O°ª¥B¨Ã¥¼«OÃÒ¤@©w¯à¦¨¥\¡A ¦¹µ¥¥i¯à¨Ï§ë¸ê± Á{·ÀI¡A§ë¸ê¤HÀ³¼f·V§PÂ_ÂÔ·V§ë¸ê¡C |
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·|û¡GAlan Liu10136094 µoªí®É¶¡:2017/10/16 ¤U¤È 05:21:42²Ä 2876 ½g¦^À³
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Mesa Highlights Guideline Updates in Myeloproliferative Neoplasms MesaÂå¥Í§ó·s°©Åè¼W¥Í©Ê¸~½F(MPN)ªvÀø«ü«n Angelica Welch Published Online: Tuesday, Oct 10, 2017 µoªí¤é´Á¡G2017¦~10¤ë10¤é©P¥| Ruben Mesa, MD The National Comprehensive Cancer Network (NCCN) guidelines for the management of polycythemia vera (PV) and essential thrombocythemia (ET) have been updated to create a more uniform system of management for healthcare providers to follow in clinical practice. ¬ü°ê°ê®aÀù¯g¸ê°Tºô(NCCN) §ó·sÃö©ó¯u©Ê¬õ¦å²y¯u¦h¯g(PV)©Mìµo©Ê¦å¤pªO¼W¦h¯g¡]ET¡^ªººÞ²z«ü«n, ³o®M²Î¤@ªººÞ²z¨t²Î¯à¬°ÂåÀø«O°·´£¨ÑªÌ´£¨Ñ¤@ÓÁ{§É¤W¨Ì´`ªº¨Ì¾Ú¡C Specifically in the guidelines, the needs of patients who progress on these myeloproliferative neoplasms (MPNs) are addressed. Although many patients with PV or ET can be treated with phlebotomy and aspirin, physicians must be aware that there is a population who will progress, says Ruben A. Mesa, MD. Ruben A. Mesa³Õ¤h´£¨ì¡G³o®M«ü«n¸Ñ¨M¤F¹ï°©Åè¼W¥Í©Ê¸~½F¡]MPN¡^´c¤Æ¯f±wªº»Ý¨D¡CÁöµM³\¦h±w¦³PV©ÎETªº¯f±w¥i¥H¨Ï¥ÎÀR¯ßª`®g©Mªü¥q¤ÇªL¶i¦æªvÀø¡A¦ýÂå¥Í¥²¶·¤F¸Ñ¦³¤@³¡¤Àªº¤H·|´c¤Æ¡C ¡§It is a big advance for these patients to finally have both the standardization, as well as the establishment of a standard of care with guidelines for therapy in the United States,¡¨ says Mesa. ¡§I would say that their management in the past has sometimes been more heterogeneous than would be ideal.¡¨ Mesa»¡¡G¡§§Ú̦b¬ü°ê«Ø¥ß¤F¤@ÓªvÀø¼Ð·Çªº«ü«n¡AÅý³o¸s¯f±w²×©ó¯à°÷¥Î¼Ð·Ç¤Æªº¤è¦¡ªvÀø¡A³o¬O¤@¤j¶i¨B¡C ¡§§Ú»{¬°, ³o¸s¯f±w¹L¥h¦bªvÀø¤WªººÞ²z¦³®É¤ñ§Ú̲z·Q»{ª¾ªº¤è¦¡§ó¬°½ÆÂø¡C¡¨ Additionally, the updated guidelines clarify the role of ruxolitinib (Jakafi), a JAK2 inhibitor used in the second-line setting for patients with PV. ¦¹¥~¡A³o¶µ«ü«n§ó·s³¡¤À§óÄÄ©ú¤Fruxolitinib (JAKAFi)ªº§@¥Î¡A¥¦¬O¤@ºØ¥Î©óPV¯f±w¤G½u¥ÎÃĪºJAK2§í¨î¾¯¡C In an interview with OncLive during the NCCN 12th Annual Congress on Hematologic Malignancies, Mesa, director, UT Health San Antonio Cancer Center, shed light on these recent updates in PV and ET, and discussed the proper therapeutic management of these diseases. ¦bNCCN²Ä¤Q¤G©¡¦å²G´c©Ê¸~½F¦~·|´Á¶¡, OncLive±Ä³X¤F¸t¦wªF¥§¶øÀù¯g¤¤¤ß°õ¦æªøMesa, ¥LÄÄz¤FPV©METªñ´ÁªºªvÀø§ó·s±¡§Î, ¨Ã¹ï©ó³o¨Ç¯e¯fªº¾A·íªvÀø¤è¦¡¶i¦æ¤F°Q½×¡C OncLive: What are the important updates in PV and ET? OncLive¡GPV & ET ¦³¬Æ»ò«nªº§ó·s¡H Mesa: These are the inaugural guidelines for the management of PV and ET coming out of the NCCN this summer. I am very excited, as the MPN panel chair, to be able to bring these to providers in the United States and elsewhere who are managing these patients. We are trying to bring some uniformity¡Xto set some standards in terms of care. MesaÂå¥Í¡G³o¬O¤µ¦~®L¤Ñ¬ü°ê°ê®aÀù¯g¸ê°Tºô(NCCN)¥Xª©ªºPV©METªººÞ²z«ü«n¡C§@¬°°©Åè¼W¥Í©Ê¸~½F¡]MPN¡^¥D®u¡A§Ú«Ü°ª¿³¯à°÷¦¨¬°¬ü°ê©M¨ä¥L¦a°Ï¥¿¦bºÞ²z³o¨Ç¯f±w©Ò´£¨Ñ¸ê°Tªº¤H¡C§ÚÌ¥¿¦b§V¤O¨î©w¤@¨Ç¼Ð·ÇÅýªvÀø¤W¯à°µ¨ì²Î¤@©Ê¡C Diseases such as PV and ET are unique in many ways. They are malignancies, but they are very chronic malignancies. Patients have a very long survival, and some patients may even have near-normal survival. All of that said, the diseases can progress and can really inflict morbidity on patients afflicted through risk of thrombosis, risk of hemorrhage, and risk of progression. ¹³PV©MET¬O«Ü¿W¯Sªº¯e¯f, ¥¦Ì¬O¤@ºØ´c©Ê¸~½F, ÄÝ©ó«D±`ºC©Êªº´c©Ê¸~½F¡C¯f±w¯à«ùÄò¦s¬¡«Ü¤[, ¬Y¨Ç¯f±w¬Æ¦Ü±µªñ¥¿±`¥Í¦s¡CºØºØ¸ñ¶HÅã¥Ü, ³oÃþ¯e¯f·|´c¤Æ¨Ã¥B³z¹L¦å®ê¡B¥X¦å©Î¬O´c¤Æ±aµ¹¯f¤H¹ê»Ú¯gª¬¡C Fundamentally, the guidelines try to first establish risks for a given patient such as thrombosis and bleeding¡Xthe morbidities that are suffering from. Additionally, they should be mindful of risk of progression. In both sets of diseases, our primary goals are the avoidance of thrombosis and bleeding in a risk-based fashion. Irrespective of risk, individuals likely start on baby aspirin. For individuals with PV, we try to control the hematocrit through phlebotomy. ®Ú¥»¨Ó»¡, º¥ý³o¥÷«ü«n´À³oÃþ«¬ªº¯f±w©w¸q· |
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·|û¡G¬K©M´º©ú10141799 µoªí®É¶¡:2017/10/16 ¤U¤È 02:57:22²Ä 2875 ½g¦^À³
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³°²M°£¥Í§Þ²Ì¸}¥Û ¥xÆW§Ö¸ò¤W money.udn.com/money/story/10162/2758908 ·s»D¸Ì¦³Ó©MÃĵئ³Ãöªº®ø®§ C¨xÄvª§¹ï¤â GileadªºSofosbuvir¤ÎAbbVieªºOmbitasvir¨â´ÚC«¬¨xª¢ÃĪ« ¦b¤¤°êªº¶i¤fµù¥U¥Ó½Ð¡ACFDA¤w©ó9¤ë21¤é¥¿¦¡®Ö§å§¹²¦ ÃĵØÃÄ106¦~9¤ë¥÷¤½¶}»¡©ú®Ñªº¸ê°T¸Ì ÁöµM±µ¤U¨Ó´X¦~³£·|±µ³s¦³¦n®ø®§¥X¨Ó ¦ý¦bC¨xÁÙ¬OºC¤F¡A·|¤ÖÁȦn¦h |
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Âd¶R¥Í§Þ®y½Í·|¡þÃĵØÃÄ °]°È³z©ú¤½¶} 2017-10-16 00:02¸gÀÙ¤é³ø °OªÌ¶À¤å©_¡þ¥x¥_³ø¾É • • ÃĵØÂåÃÄ°õ¦æªøªL°êÄÁ13¤é¥X®uÂd¶R¤¤¤ßÁ|¿ì¡u¥Í§Þ¤½¥q¶i¤J¸ê¥»¥«³õ¤§¾÷·|»P¬D¾Ô»¡©ú·|¡v¡A¾á¥ô²£·~¬É¥Nªí¡A¥L±j½Õ¡An¥un²Å¦Xªk¥O¡BÂd¶R¤¤¤ß³W½d¡A¥Í§Þ¤½¥qn¶¶§Q±¾µP¤£¬O°ÝÃD¡A¦ý³Ì«nªº¬O¥²¶·¿í¦u¨â¤jì«h¡A¤@¡B°]°È³z©ú¤½¶}¡A¤G¡B¸ê°T§Y®É´¦ÅS¡C ®y½Í·|¤¤¡A¥D«ù¤H¶Ô·~²³«H·|p®v¨Æ°È©Ò³¢¬F¥°¦VªL°êÄÁ´£°Ý¡A·í«e¥Í§Þ²£·~¬ÉÀW°Ý¡AÂd¶R¤¤¤ß¼fµ¥¥DºÞ¾÷Ãö¡A°w¥Í§Þ¤½¥q¥Ó½Ð±¾µP¨ì©³¦³µL¡u¼ç³W«h¡v¡A½ÐÃĵج°¨Ò¡A¦V¤j²³¤À¨É¤WÂd¹Lµ{¸I¨ìþ¨Ç°ÝÃD¡A¤½¥q¥Ó½Ð¹Lµ{¤¤¡Aªk¥O¦³µLÄYV¡B¤£¦X²zªº³¡¥÷¡C ªL°êÄÁ©Z¨¥¡AÃĵؤ½¥q¹L¥h¦]Y¤zªk«ß°ÝÃD¾ÉP¤WÂd«e½T¹ê¹J¨ìY¤z°ÝÃD¡A¥L©Z¨¥¡A®tÂI¤W¤£¤FÂd¡A¦ý¦b³Í°òÃҨ黲¾É¤U¡A¥[¤W¤½¥q»PÂd¶R¤¤¤ß¸Û¤ß·¾³q¡A¨Ì·ÓÂd¶R¤¤¤ß³W½d§¹¦¨¤WÂdµ{§Ç¡A²×©ó¦b2016¦~¶¶§Q±¾µP¤WÂd¡C ªL°êÄÁªí¥Ü¡A¥L1997¦~¦b¬F©²©Û¤â¤U¦^°ê¦¨¥ßÃĵØÂåÃÄ¡A2014¦~¿³Âd¡A¤¤¶¡ªÑ»ù¤@¸ô¤W¨ì250¤¸¥H¤W¡A¤S´¿¸g¤@«×¶^¨ì40¡B50¤¸ªþªñ¡A¥Ñ©óªÑ»ùªi°Ê¹L¤j¡A¥[¤W¹Lµ{¤½¥q¸gÀç¹Lµ{¤¤¾D¹Jªk«ß¨Æ¥ó¡A¾ÉP¤WÂd¥X²{ºÃ¼{¡A¥L¤@«×»{¬°¡u¤WÂdµL±æ¡v¡C «á¨Ó¡A¦b³Í°òÃҨ骺»²¾É¤U¡A¥L¿Ë¦Û¥X±»PÂd¶R¤¤¤ß©Ó¿ì¤Hû·¾³q¡A¬Ý¨ìÂd¶R¤¤¤ß¦³³\¦h±M·~ªº¤Hû¡A¤]Ä@·N¿n·¥À°¦£¡A¨º¤@¨è¡A¥L§Ï©»¬Ý¨ì¤½¥q¤WÂdªº§Æ±æ¡A¦]¦¹¿n·¥°t¦X¥DºÞ¾÷Ãöªºn¨D¡A¨Ì´`¤WÂdªk³W¡A²×©ó¦b¼h¼h§âÃö¤U¡A¶¶§Q¤WÂd¡C ¦¹¥~¡AªL°êÄÁ»¡¡An¯S§O·PÁ¥ͪ«²£·~µo®i¨ó·|²z¨Æªø§õÁ麳´Á¶¡ªºY¤z«Øij»PÀ°¦£¡AÁÙ¦³¤¤¸Î·sÃÄ°]°Èªø³¯©É¦¨µL¨pªº¤À¨É¡CÅý¥L±o¥H¨ú±o«e¤H¸gÅç¡A¶¶§Q¤WÂd¡C money.udn.com/money/story/10161/2758971 |
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·|û¡GAlan Liu10136094 µoªí®É¶¡:2017/10/16 ¤W¤È 10:05:46²Ä 2873 ½g¦^À³
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·PÁ¤pªL «e½ú¤À¨É, ¯÷½Ķ CEO MAGAZINE¹ïªL°êÄÁ³Õ¤hªº±M³X¥þ¤å¦p¤U, ¨Ñ¦U¦ì§ë¸ê¥ý¶i°Ñ¦Ò¡G The quest to prevent cancer: Ko-Chung Lin, Founder & MD of PharmaEssentia Àù¯g¹w¨¾ªº°l¨D¡GÃĵØÂåÃÄ PharmaEssentia ³Ð¿ì¤HÝÂå¾Ç¾ÇªÌªL°êÄÁ Dr Ko-Chung Lin heads a cohort of scientists at PharmaEssentia that has made a major breakthrough in the prevention of cancer. ªL°êÄÁ³Õ¤h±a»âÃĵØÂåÃĪº¤@¸s¬ì¾Ç®a, ¦bÀù¯g¹w¨¾¤W¦³¤F«¤j¬ð¯}¡C Elite executives are often asked, ¡¥What¡¦s the most rewarding aspect of your job?¡¦ It¡¦s a simple question, but due to the diverse nature of industries, it¡¦s not totally unheard of to be met with dead-air. Of course, that wasn¡¦t the case with Dr Ko-Chung Lin. How could it be, when the corporation he co-founded is on the verge of saving many, many lives? ³Ç¥XªººÞ²zªÌ³Ì±`³Q°Ý¨ìªº¬O¡G§Aªº¤u§@³Ì¦³»ùȪº³¡¤À¬°¦ó? ³o¬Oӫܲ³æªº°ÝÃD, ¦ý¦]¬°¦U¦æ¦U·~ªº»â°ì¤£¦P, ¾ÉP¦³®É·|¹J¨ì®ðª^«Ü»øªº®ÉÔ¡C·íµM, ³o¥ó¨Æ¨Ã¤£·|µo¥Í¦bªL°êÄÁ³Õ¤h¨¤W, ¦]¬°¥L³Ð¿ìªº¤½¥q¥¿»Ýn¬@±Ï³\¦h¡B³\¦hªº¥Í©R¡C PharmaEssentia was established in 2003 by Ko-Chung and a group of Taiwanese-American executives and scientists, aiming to develop effective, safe and cost-effective pharmaceutical products for the treatment of human diseases. Fourteen years and countless clinical tests later, and in cooperation with Austrian multinational pharmaceutical company AOP Orphan, the team is using a game-changing drug candidate called Ropeginterferon alfa-2b (P1101) to prevent cancer. ÃĵØÂåÃÄ©ó 2003 ¦~¥ÑªL°êÄÁ©M¤@¸s¥xÆW-¬ü°êªººÞ²zªÌ©M¬ì¾Ç®a©Ò¦¨¥ß, ¦¨¥ß©v¦®¦b©ó¬ãµo¥X¦³®Ä¡B¦w¥þ©M¨ã¦³¦¨¥»®Ä¯qªºÃĪ«¥HªvÀø¤HÃþ¯e¯f¡C¦b 14 ¦~¶¡»P¶ø¦a§Qªº¸ó°ê»sÃĤ½¥q AOP Orphan ¦X§@¶i¦æµL¼ÆªºÁ{§É¸ÕÅç«á¡A³oӹ椬ãµo¥X¥O¤H¦Õ¥Ø¤@·sªº·sÃĺ٧@ Ropeginterferon alfa-2b (P1101)¥Î¨Ó¹w¨¾Àù¯g¡C Ko-Chung Lin is living a scientist¡¦s dream ªL°êÄÁªº¬ì¾Ç¹Ú The diseases PharmaEssentia are targeting with P1101 are rare blood cancers, such as Polycythemia Vera. And after years of intensive trials, only a final sign-off from the governing medical bodies in Europe and the US stands between patients and the drug. ÃĵØÃÄ©Ò¬ãµoªº P1101 ¥Dn¥Î¨ÓªvÀø¨u¨£ªº¦åÀù¯e¯f¡A¦p¯u©Ê¬õ¦å²y¼W¦h¯g(PV)¡C¸g¹L¦h¦~ªº±K¶°ªºÁ{§ÉÁ{§É¡A²{¦b¥u»Ýn¼Ú·ù¥H¤Î¬ü°ê³Ì²×ªºÃÄÃÒ³\¥i§Y¥iÅý¯f±w¥ÎÃÄ¡C ¡§We have conceptualised an idea, and now we¡¦re making it a reality through Ropeginterferon alfa-2b,¡¨ Ko-Chung smiles. ¡§We found out it works in the treatment of Polycythemia Vera, and now we¡¦re just waiting on the final approval to save patients¡¦ lives. I¡¦ve been a scientist for 40 years, and it¡¦s the dream of any scientist to be in this position. It¡¦s very rewarding.¡¨ ªL°êÄÁ¯ºµÛ»¡ §ÚÌÂÇ¥Ñ Ropeginterferon alfa-2b ±Nì¥ýªº·§©À¨ãÅé¤Æ, §Ú̵o²{ P1101 ¦b PV ªºªvÀø¤W«Ü¦³®Ä, ¦Ó§Ú̲{¦b¦bµ¥«Ý³Ì«áªº§åã§Y¥i¥Î¨Ó¬@±Ï¯f±wªº©Ê©R¡C§Ú¾á¥ô¬ì¾Ç®a¤w 40 ¦~, ³o¬O¥ô¦ó¤@Ó¬ì¾Ç®a¦b¦¹¹Ú´K¥H¨Dªº, ³o¤@¤Á¬O¦³·N¸qªº¡C I¡¦ve been a scientist for 40 years, and it¡¦s the dream of any scientist to be in this position. It¡¦s very rewarding. Testing has revealed that P1101 delays disease progression, has limited side effects, and has the potential to deliver a curative response. Patients can also self-administer at home, and on a monthly rather than fortnightly basis ¡V a significant improvement in both convenience and comfort from current treatment options. Á{§É¸ÕÅçÅã¥Ü¥X P1101 ¥i´î½w¯e¯f´c¤Æ¡B°Æ§@¥Î·¥§C¡A¥B¦³ªv¡ªº¥i¯à¡C¯f±w¥i¥H¦b®a¦Û¦æ¬I¥´, ©P´Á¬°¨CÓ¤ë¤@°w¡A¦Ó«D¨C¨â¶g¤@°w, ©M²{¦³ªvÀø¤è®×¬Û¤ñ, ³oÓÅãµÛªº§ï¨}¤£¶ÈÅý¯f±w·P¨ì§ó«K§Q¥B§óµÎ¾A¡C Most excitingly, PharmaEssentia¡¦s potential is limitless. It has received another US$125 million in funding after being listed last year, has set up subsidiaries in the US, Japan and China, has more than 150 employees, and carried out its own manufacturing at the Central Taiwan Science Park. ³Ì¥O¤H¿³¾Äªº¬O¡AÃĵØÂåÃÄ PharmaEssentia ªº¼ç¤OµL¡C¦Û¥h¦~±¾µP¤WÂd«á, ÃB¥~¶Ò¶°¤F 1.25 »õ¬ü¤¸ªº¸êª÷¡AÃĵئb¬ü°ê¡B¤é¥»©M¤¤°ê³]¦³¤l¤½¥q¡A¾Ö¦³¶W¹L 150 ¦Wû¤u¡A¨Ã¦b¥xÆW¤¤³¡¬ì§Þ¶é°Ï¾Ö¦³¦Û¤vªº»s³y¤u¼t¡C ¡§Tha |
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ÃÙ¦P¡G ¡¨¤@Áû·sÃįàÁȤj¿ú ,³Ì¦n¯à¤£©öªv¡,¦ý»Ý²×¨ªAÃÄ ,p1101¬O³J¥Õ½èÃÄ¥é»sÃø«×°ª,¥Ø«e¬Ý¨Ó¤]²Å¦X¤£©öªv¡,¦ý»Ý²×¨ªAÃÄ¡¨ ¦³Ó«e¨Ò¡G ¡u°ò§Q§J¡v¡]Glivec ¥xÆW¦W, Gleevec ¬ü°ê¦W¡^ªvÀø¦PÄÝMPN®a±ÚCMLªºÀù¯g¥ÎÃÄ¡A´N¬O²Å¦X³o¨Ç±ø¥ó¡C ¡u°ò§Q§J¡v±q2005¦Ü¤µ³£¬O°·«Oµ¹¥IÃÄ«~¥Ó³øª÷ÃB«e¤Q¦WªºÃĪ«¡C ¥¼¨ÓBESREMi (P1101)¦æ¾P¡B¾P°â¼Ò¦¡¥i°Ñ¦Ò¦¹ÃÄ¡C |
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