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·|û¡Gªü¹Å10138576 µoªí®É¶¡:2017/12/11 ¤W¤È 07:55:32²Ä 3232 ½g¦^À³
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1.¨Æ¹êµo¥Í¤é:106/12/10 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: ¥»¤½¥qµ¦²¤¹Ù¦ñAOP¤½¥q¤w©ó¬ü°ê®É¶¡12¤ë10¤é7:45AM¦b¬ü°ê¨È¯SÄõ¤jÁ|¦æªº 2017¦å²G¯fÂå¾Ç¦~·|(ASH)¡A¥H¤fÀY³ø§i§Î¦¡(Oral and Poster Abstracts 320¸¹)µoªí¦³Ãö²ÄIII´ÁÁ{§É¸ÕÅçPROUD-PV«á¦AÄ~ÄòÁ{§É¸ÕÅç(CONTI-PV) ªvÀø¤@¦~(§tPROUD-PVÁ`¦@¤G¦~)µ²ªG¤§»¡©ú¡C¥»¤½¥q¯÷´N¸Ó¤fÀY³ø§i³Ì²× µ²ªG»¡©ú¦p¤U¡G ¤@¡BÁ{§É¸ÕÅç³]p¤¶²Ð (¤@)¸ÕÅçpµe¦WºÙ¡GCONTI-PV¬°²ÄIII´ÁÁ{§É¸ÕÅçPROUD-PV«á¦AÄ~ÄòÁ{§É¸ÕÅç ¡A±Ä¶}©ñ©Ê¡A¦h°ê¦hÁ{§É¤¤¡AIIIb´ÁÁ{§É¬ã¨s¡Aµû¦ôP1101©MHydroxyurea (HU)©Î³Ì¨Î¥i¥ÎªvÀø(Best Available Therapy, BAT)ªºªø´ÁÀø®Ä©Ê©M ¦w¥þ©Ê¡C (¤G)¸ÕÅç¥Øªº¡G¥»¸ÕÅ窺¥Øªº¬O¬ã¨s(P1101)¦bªø´Á±±¨î¯e¯f¤è±¨ã¦³Àø®Ä©Ê ©M¦w¥þ©Ê¡C¤ñ¸û²Õ¬°Hydroxyurea (HU)©Î¥ÑÁ{§ÉÂå®v¿ï¾Üªº³Ì¨Î¥i¥ÎªvÀø (BAT)¡C (¤T)¸ÕÅ綥¬q¤À¯Å¡G²ÄIIIb´ÁÁ{§É¸ÕÅç(PROUD-PV«á¦AÄ~ÄòÁ{§É¸ÕÅç)ªvÀø¤@¦~ (§tPROUD-PVÁ`¦@¤G¦~)¤§µ²ªG¡C (¥|)ÃÄ«~¦WºÙ¡G 1.ÃĦW¡GRopeginterferon alfa-2b (Á{§É¸ÕÅç¥ÎÃÄ¥N¸¹¬°P1101) 2.¾¯«¬¡G¥Ö¤Uª`®g(Subcutaneous) 3.¾¯¶q¡G¤¤¾¯¶q450 £gg 4.¥Îªk¡G¨C¨â¶g¬I¥´¤@¾¯ (¤)«Å¶Ç¾AÀ³¯g¡G¯u©Ê¬õ¦å²y¼W¥Í¯g(PV)ªº²Ä¤@½u(First Line)ªvÀø¥ÎÃÄ (¤»)µû¦ô«ü¼Ð: ¥DnÀø®Ä«ü¼Ð(Primary Endpoint)«Y¡G (1)¦å²y®e¿n¤ñ«ü¼Æ<45%¡A¤TÓ¤ëªvÀø¤¤¤£»Ýn©ñ¦å (2)¦å¤pªO«ü¼Æ<400 G/L (3)¥Õ¦å²y«ü¼Æ <10 G/L (4)«ì´_¥¿±`ªºµÊŦ¤j¤p (¤C)¸ÕÅçpµe¨ü¸ÕªÌ¤H¼Æ¡G¦@170¦ì¨ü¸ÕªÌ¡A¦h°ê¦h¤¤¤ßÀH¾÷¨ú¼Ë¡C ¤G¡B¥DnÀø®Ä«ü¼Ð¤§²Îpµ²ªG¤Î²Îp·N¸q 1.¦b24Ó¤ë®É¡A¦b±µ¨üP1101²Õªº§¹¥þ¦å²G¤ÏÀ³²v(CHR)¹F¨ì70.5%¡A©úÅãÀu¶V ©óHU/BATªº49.3% (p = 0.0101)¡A¹F¨ì²Îp¤WªºÅãµÛ·N¸q¡C§ó«nªº¬O¬Û ¸û©óHU/BAT¡AP1101²Õ¦b¨â¦~ªvÀø´Á¶¡Á{§É¯gª¬§ïµ½©M¦å²G¤ÏÀ³²v§¡Ã©w «ùÄò¤W¤É¡C 2.½Æ¦XºÝÂI«ü¼Ð(composite endpoint¡A§t§¹¥þ¦å²G¤ÏÀ³²v(CHR)¤Î¯e¯f¯gª¬ªº §ïµ½)¡AP1101²Õªº½Æ¦XºÝÂI«ü¼Ð¹F49.5%¡A¤]©úÅãÀu¶V©ó HU/BATªº36.6% (p= 0.1183)¡C 3.P1101³Ì¬°ÅãµÛªºªvÀøÀu¶Õ¬O¹ïJAK2¬ðÅܪºµ¥¦ì°ò¦]t¾á (allele burden) ¤§¼vÅT¡A¸g¹L24Ó¤ëªvÀø¡AP1101 ²Õ¦³69.6% ¦³³¡¤À¤À¤l¤ÏÀ³(partial molecular response)¡A¦Ó HU/BAT ¶È¦³28.6% (p = 0.0046)¡A¹F¨ì²Îp¤W ªºÅãµÛ·N¸q¡C 4.¦]¥Ø«e¥«±¤W«¬¤zÂZ¯ÀªvÀø¦Ó²£¥Íªº¤£¨}¤ÏÀ³¤¤¡A¯S§O¬O¦b¥Òª¬¸¢¥\¯à »Ùê¤Î¼~Æ{¯g¤è±¡A P1101²Õ¬Ò§C©ó5%¡C¨ü¸ÕªÌ¦]ªvÀø¦Ó¤Þ°_ªº¤£¨}¤ÏÀ³ ²v¨â²Õ¬Ûªñ(P1101 ¬°70.1%¡AHU¬°77.2%)¡Cȱoª`·Nªº¬O¡AªvÀø¹Lµ{¤¤ ²£¥Íªº´c©Ê¸~½F¥]¬A2¨Ò¥Õ¦å¯f(Leukemia)¡A¶Èµo¥Í¦bHU²Õ¡C ¤T¡B³æ¤@Á{§É¸ÕÅçµ²ªG(¥]§t¥D¡B¦¸nµû¦ô«ü¼Ð¤§²Îp¾Ç¤W¬O§_¹FÅãµÛ·N¸q)¡A¨Ã ¤£¨¬¥H¥R¤À¤Ï¬M¥¼¨Ó·sÃĶ}µo¤W¥«¤§¦¨±Ñ¡A§ë¸ê¤HÀ³¼f·V§PÂ_ÂÔ·V§ë¸ê¡C ¥|¡B¥¼¨Ó·sÃÄ¥´¤J¥«³õpµe ¼Ú¬w¦a°ÏªvÀø¯u©Ê¬õ¦å²y¼W¥Í¯g¤§¾P°âÅv±ÂÅv¤©AOP¤½¥q¡AAOP¤½¥q¥Ø«e¥¿¬° P1101¥¼¨Ó¤W¥«§G«Ø¦æ¾P³q¸ô¡A¨Ì¾Ú±ÂÅv¦X¬ù¥»¤½¥q¦¬¨ú¾P°âÅv§Qª÷¤Î¥X°âÃÄ «~¦¬¤J¡F¥»¤½¥q¬ü°ê¦a°Ï¨ÃµL±ÂÅv¥L¤½¥q¡A¹wp©Û¶Ò¨ã¦³·sÃÄ¥«³õ¦æ¾P¸gÅç ¤§¤H¤~«Ø¥ß¹Î¶¤¡A¦Û¦æ«Ø¥ß¾P°â³q¸ô¡B´M¨Dµ¦²¤¹Ù¦ñ¶i¦æ¦X§@©Î¹ï¥~±ÂÅvµ¥ ¤è¦V¡A¥H°l¨DªÑªFªø´Á³Ì¤jªºÅv¯q¬°¥Ø¼Ð¡C 6.¦]À³±¹¬I:µL 7.¨ä¥LÀ³±Ô©ú¨Æ¶µ: ¤@¡B¬ãµo·sÃĦWºÙ©Î¥N¸¹¡GP1101 ¤G¡B¥Î³~¡GP1101«Y·s¤@¥Nªø®Ä«¬¤zÂZ¯ÀÃĪ«¡A²{¥¿¶i¦æ¥Î©óªvÀø¯u©Ê¬õ¦å²y¼W ¥Í¯g(PV)µ¥¤HÅéÁ{§É¸ÕÅç ¤T¡B¹wp¶i¦æ¤§©Ò¦³¬ãµo¶¥¬q¡G¼Ú·ùEMA¥Íª«»s¾¯·sÃĬdÅçµn°O¥Ó½Ð(MAA) ¥|¡B¥Ø«e¶i¦æ¤¤¤§¬ãµo¶¥¬q¡G (¤@)´£¥X¥Ó½Ð/³q¹L®Öã/¤£³q¹L®Öã¡G·sÃÄP1101¥Î©óªvÀø¯u©Ê¬õ¦å²y¼W¥Í¯g (PV)±wªÌªº¥þ²y©Ê²ÄIII´ÁÁ{§É¸ÕÅçPROUD-PV«á¦AÄ~ÄòÁ{§É¸ÕÅçIIIb (CONTI-PV)¡A¦¹Á{§É¸ÕÅç¤D¬°¨ú±oªø´ÁÀø®Ä¤Î¦w¥þ©ÊªºÁ{§É¼Æ¾Ú¡A¹wp Á{§É¸ÕÅç±N©ó2019¦~6¤ëµ²§ô¡CP1101¤w©ó2017¦~2¤ë¥Ñ±ÂÅv¹Ù¦ñAOP¦V¼Ú ·ùÃĪ«ºÞ²z§½(EMA)´£¥XÃÄÃҥӽСA¥Ø«e¥¿¦b¼f²z¤¤¡C ºô¶¡Gclinicaltrials.gov/ct2/show/NCT02218047?term=AOP2014&rank=3 (¤G)¥¼³q¹L¥Øªº¨Æ·~¥DºÞ¾÷Ãö³\¥iªÌ¡A¤½¥q©Ò±Á{¤§·ÀI¤Î¦]À³±¹¬I¡G¤£¾A¥Î (¤T)¤w³q¹L¥Øªº¨Æ·~¥DºÞ³\¥iªÌ¡A¥¼¨Ó¸gÀç¤è¦V¡G¤£¾A¥Î (¥|)¤w§ë¤J¤§²Ö¿n¬ãµo¶O¥Î¡GCONTI-PV©ó¼Ú¬w¶i¦æÁ{§É¸ÕÅç¶O¥Î¥Ø«e¼È¥ÑAOP ¤½¥q¥ý¦æ¤ä¥I¡C ¤¡B±N¦A¶i¦æ¤§¤U¤@¬ãµo¶¥¬q¡G ·sÃÄP1101¥Î©óªvÀø¯u©Ê¬õ¦å²y¼W¥Í¯g(PV)±wªÌªº¥þ²y©Ê²ÄIII´ÁÁ{§É¸ÕÅç
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·|û¡GªÅ¤]ªÅªÅ10145331 µoªí®É¶¡:2017/12/11 ¤W¤È 07:38:49²Ä 3231 ½g¦^À³
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CONTI-PVªºµ²ªG½T¹ê¤£¿ù¡A ¸ÕÅ窺«~½è¦pªG¤]±o¨ìFDAªº»{¥i(¨Ò¦p¡A¸ÕÅç²Õ»P¹ï·Ó²Õªº¤H¤f¾Ç(demography)¸ê®Æ¬Û·í¡K)¡A ³oÓµ²ªG«Ü¦³¥i¯à¼g¤J¥é³æ(lable)¡F ¦pªG¯u¼g¤J¥é³æ¡A¨ºZimmerman¤j»¡ªº¡G ¡¨a valuable, long-term first-line treatment option for PV¡¨¡A ³o¥y¸Ü³Q¯f±w¡BÂå¬É¤Î«OÀI·~±µ¨üªº¸ô¡AÀ³¸Ó´N·|¥©Z³\¦h¡A¤£¦Ü©ó¥Rº¡¯ð´Æ¡C Craig Zimmerman, PhD, Vice President Operations, PharmaEssentia USA, added, that these substantial results go beyond our phase III study findings at 12 months to further validate Ropeginterferon alfa-2b as a valuable, long-term first-line treatment option for PV, which affects more than 100 thousand people in the U.S alone. We look forward to providing updates and next steps for PharmaEssentia¡¦s submission of a BLA to the FDA. |
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·|û¡GAnderson10143089 µoªí®É¶¡:2017/12/11 ¤W¤È 06:51:13²Ä 3230 ½g¦^À³
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§Æ±æ¤£·|¤S¬O¶}°ª¨«§C.... |
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·|û¡GµLµß®ñ10021927 µoªí®É¶¡:2017/12/10 ¤U¤È 10:42:17²Ä 3229 ½g¦^À³
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JAK°ò¦]¬ðÅÜ»P¯e¯f JAK1¦bSH2¤ÎJH2 domain¬ðÅܮɡA·|¾ÉP¿©±w«æ©Ê°©ÀH¥Õ¦å¯f (Acute myeloid leukemia, AML)¡B«æ©Ê²O¤Ú©Ê¥Õ¦å¯f (Acute lymphoblastic leukemia, ALL)¡B¨Å¸¢¾ÉºÞÀù (Breast ductal carcinoma) ¤Î«D¤p²ÓMÀù (Non-small cell lung cancer, NSCLC) ªº¾÷²v¼W¥[¡C JAK2¦bexon 12ªº¦ì¸m¦³¶W¹L¤T¤QÓ¬ðÅÜ·|¾ÉP¬õ¦å²y¼W¦h¯g (Polycythemia vera, PV)¡A¥t¥~¦bJH2 domain¬ðÅܤ]·|¾ÉP«æ©Ê²O¤Ú©Ê¥Õ¦å¯f¥H¤Î¬õ¦å²y¼W¦h¯g¡C |
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·|û¡GµLµß®ñ10021927 µoªí®É¶¡:2017/12/10 ¤U¤È 10:24:19²Ä 3228 ½g¦^À³
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CHR:70.5% : 49.3% ,P=0.0101 CHR& Improvement in disease burden at M24 : 49.5% :36.6% ,P=0.1183 JAK2: 69.6%:28.6 ,P=0.0046 ¤£§Q¨Æ¥ó: 70.1%:77.2% ============================================== JAK2³o¶µ³Ì©úÅã¡C |
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·|û¡GRussell10140734 µoªí®É¶¡:2017/12/10 ¤U¤È 10:04:15²Ä 3227 ½g¦^À³
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·PÁ¤p¥¿¥¿¤j»P¤p¥øÃZ¤jªº¤À¨É^^ ¬Ý´¦ÅS¥X¨Óªº¼Æ¾Ú... ¤£¤î¬OÀu©ó À³¸Ó¬O»·Àu©ó!!!! ¬Ý¨Ó@¤ßµ¥«Ý¯uªº¬Oȱoªº....¥[ªo¤F |
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·|û¡GµLµß®ñ10021927 µoªí®É¶¡:2017/12/10 ¤U¤È 10:03:39²Ä 3226 ½g¦^À³
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PharmaEssentia Announces Favorable Two-year Results of Ropeginterferon Alfa-2b in Polycythemia Vera at the American Society of Hematology (ASH) Annual Meeting 2017 - At 24 months Ropeginterferon alfa-2b: Demonstrated superiority over best available treatment Achieved high rates and durable clinical and hematological response Confirmed favorable safety and tolerability profile beyond 24 months Further demonstrated disease modifying capability - PharmaEssentia is currently working with the U.S. FDA for submission of a biologics license application (BLA) for Ropeginterferon alfa-2b for Polycythemia Vera (PV) in the U.S. - AOP Orphan¡¦s submission for marketing authorization of Ropeginterferon alfa-2b in the EU is currently under review by EMA WALTHAM, Mass., Dec. 10, 2017 /PRNewswire/ -- PharmaEssentia USA, a subsidiary of PharmaEssentia Corporation (Taipei Exchange: 6446), today announced the latest follow-up results of Ropeginterferon alfa-2b from the ongoing, long-term, follow-up trial CONTINUATION-PV (CONTI-PV) for patients with Polycythemia Vera presented during an oral presentation at ASH 2017. The CONTI-PV trial is being conducted by AOP Orphan Pharmaceuticals AG (AOP Orphan) in Europe. PharmaEssentia¦b¬ü°ê¦å²G¾Ç·|¡]ASH¡^2017¦~¦~·|¤W«Å¥¬¤FRopeginterferon Alfa-2b¦b¬õ²ÓM¼W¦h¯gVera¤¤ªº¦³§Q¨â¦~µ²ªG - 24Ó¤ë®ÉRopeginterferon alfa-2b¡G ÃÒ©úÀu©ó³Ì¨Î¥i¥ÎªvÀø ¹ê²{°ª§Q²v©M«ù¤[ªºÁ{§É©M¦å²G¾Ç¤ÏÀ³ ½T»{24Ó¤ë¥H¤Wªº¦³§Q¦w¥þ©Ê©M@¨ü©Ê ¶i¤@¨BÃÒ¹ê¤F¯e¯fªº×´_¯à - PharmaEssentia¥Ø«e¥¿¦b»P¬ü°êFDA¦X§@¡A´£¥æ¦b¬ü°ê´£¥æªº¥Î©ó¬õ²ÓM¼W¦h¯g¡]PV¡^ªºRopeginterferon alfa-2b¥Íª«»s¾¯³\¥iÃҥӽС]BLA¡^¡C - AOP©t¨à´£¥æªº¦b¼Ú·ùªºRopeginterferon alfa-2bªº¤W¥«³\¥i¥¿¦b¥ÑEMA¼f¬d ¬ü°ê°¨ÂĽѶë¦{¨Uº¸·æ©i2017¦~12¤ë10¤é¹q/¬ü³qªÀ¨È¬w/ - PharmaEssentia Corporation¡]¥x¥_¥«¥æ©ö©Ò¡G6446¡^ªº¤l¤½¥qPharmaEssentia USA¤µ¤Ñ¤½§G¤Fªø´Á«ùÄòªºRopeginterferon alfa-2b³Ì·sÀH³Xµ²ªG¡]AOP©t¨à¡^¦b¼Ú¬w¶i¦æªºCONTI-PV¸ÕÅç¡A¬O¦b2013¦~ASH 2017¦~¤fÀY³ø§i´Á¶¡´£¥Xªº¡A¥Î©ó±w¦³¯u©Ê¬õ²ÓM¼W¦h¯gªº±wªÌªº«áÄò¸ÕÅçCONTIUATION-PV¡]CONTI-PV¡^¡CCONTI-PV¸ÕÅç¥ÑAOP©t¨àÃÄ·~¤½¥q¡]AOP©t¨à¡^ Ropeginterferon alfa-2b is a novel, long-acting, mono-pegylated proline interferon. It is administered once every two weeks, or monthly during long-term maintenance, and is expected to be the first interferon approved for PV worldwide. PharmaEssentia discovered and manufactures Ropeginterferon alfa-2b and has exclusively licensed the rights for the novel molecule in the field of Myeloproliferative Neoplasms (MPNs) to AOP Orphan for European, Commonwealth of Independent States (CIS), and Middle Eastern markets. CONTI-PV is an open-label, multicenter, phase IIIb study assessing the long-term efficacy and safety of Ropeginterferon alfa-2b versus hydroxyurea (HU) or best available treatment (BAT) in patients with PV who previously participated in the pivotal phase III PROUD-PV study. Results reported last year at ASH 2016 showed that at 12 months (PROUD-PV study), Ropeginterferon alfa-2b demonstrated non-inferiority to hydroxyurea (HU) in Complete Hematologic Response (CHR). Ropeginterferon demonstrated a significantly better safety and tolerability profile to hydroxyurea. At 24 months, as demonstrated by the CONTI-PV study, treatment with Ropeginterferon alfa-2b achieved a significantly higher CHR of 70.5%, compared to CHR of 49.3% with HU/BAT (p=0.0101). Importantly, durable clinical and hematological response rates increased steadily in the Ropeginterferon alfa-2b-treated patients over the two-year treatment period, in contrast to HU/BAT. Additionally, the composite endpoint, CHR including disease symptom improvement, was higher in patients treated with Ropeginterferon alfa-2b versus HU/BAT at 24 months (49.5% versus 36.6%, p=0.1183). A pronounced treatment effect of Ropeginterferon alfa-2b was also observed on the mutant JAK2 allele burden at 24 months: 69.6% of patients treated with Ropeginterferon alfa-2b compared to only 28.6% on HU/BAT achieved partial molecular response (p=0 |
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·|û¡G¤pªL10142678 µoªí®É¶¡:2017/12/10 ¤U¤È 09:54:04²Ä 3225 ½g¦^À³
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www.prnewswire.com/news-releases/pharmaessentia-announces-favorable-two-year-results-of-ropeginterferon-alfa-2b-in-polycythemia-vera-at-the-american-society-of-hematology-ash-annual-meeting-2017-300569364.html PharmaEssentia Announces Favorable Two-year Results of Ropeginterferon Alfa-2b in Polycythemia Vera at the American Society of Hematology (ASH) Annual Meeting 2017 - At 24 months Ropeginterferon alfa-2b: Demonstrated superiority over best available treatment Achieved high rates and durable clinical and hematological response Confirmed favorable safety and tolerability profile beyond 24 months Further demonstrated disease modifying capability - PharmaEssentia is currently working with the U.S. FDA for submission of a biologics license application (BLA) for Ropeginterferon alfa-2b for Polycythemia Vera (PV) in the U.S. - AOP Orphan¡¦s submission for marketing authorization of Ropeginterferon alfa-2b in the EU is currently under review by EMA WALTHAM, Mass., Dec. 10, 2017 /PRNewswire/ -- PharmaEssentia USA, a subsidiary of PharmaEssentia Corporation (Taipei Exchange: 6446), today announced the latest follow-up results of Ropeginterferon alfa-2b from the ongoing, long-term, follow-up trial CONTINUATION-PV (CONTI-PV) for patients with Polycythemia Vera presented during an oral presentation at ASH 2017. The CONTI-PV trial is being conducted by AOP Orphan Pharmaceuticals AG (AOP Orphan) in Europe. Ropeginterferon alfa-2b is a novel, long-acting, mono-pegylated proline interferon. It is administered once every two weeks, or monthly during long-term maintenance, and is expected to be the first interferon approved for PV worldwide. PharmaEssentia discovered and manufactures Ropeginterferon alfa-2b and has exclusively licensed the rights for the novel molecule in the field of Myeloproliferative Neoplasms (MPNs) to AOP Orphan for European, Commonwealth of Independent States (CIS), and Middle Eastern markets. CONTI-PV is an open-label, multicenter, phase IIIb study assessing the long-term efficacy and safety of Ropeginterferon alfa-2b versus hydroxyurea (HU) or best available treatment (BAT) in patients with PV who previously participated in the pivotal phase III PROUD-PV study. Results reported last year at ASH 2016 showed that at 12 months (PROUD-PV study), Ropeginterferon alfa-2b demonstrated non-inferiority to hydroxyurea (HU) in Complete Hematologic Response (CHR). Ropeginterferon demonstrated a significantly better safety and tolerability profile to hydroxyurea. At 24 months, as demonstrated by the CONTI-PV study, treatment with Ropeginterferon alfa-2b achieved a significantly higher CHR of 70.5%, compared to CHR of 49.3% with HU/BAT (p=0.0101). Importantly, durable clinical and hematological response rates increased steadily in the Ropeginterferon alfa-2b-treated patients over the two-year treatment period, in contrast to HU/BAT. Additionally, the composite endpoint, CHR including disease symptom improvement, was higher in patients treated with Ropeginterferon alfa-2b versus HU/BAT at 24 months (49.5% versus 36.6%, p=0.1183). A pronounced treatment effect of Ropeginterferon alfa-2b was also observed on the mutant JAK2 allele burden at 24 months: 69.6% of patients treated with Ropeginterferon alfa-2b compared to only 28.6% on HU/BAT achieved partial molecular response (p=0.0046). Events of special interest for the interferon alfa-class, in particular thyroid disorders and depression were below 5% in the Ropeginterferon alfa-2b arm. A comparable number of patients experienced treatment-related adverse events (70.1% for Ropeginterferon alfa-2b and 77.2% for HU). Notably, disease, or treatment, related secondary malignancies, including two incidents of leukemia, occurred only in the HU cohort. Professor Heinz Gisslinger from the Medical University of Vienna, presented the results at ASH, stating that the observed superior efficacy of Ropeginterferon alfa-2b over hydroxyurea/best availa |
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·|û¡G¤p¥¿¥¿10141351 µoªí®É¶¡:2017/12/10 ¤U¤È 09:48:34²Ä 3224 ½g¦^À³
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Efficacy Results (24 month analyis) ( CHR at M24 ) AOP2014 (70.5%)/ Control(49.3%) ( CHR& Improvement in disease burden at M24 ) AOP2014 (49.5%) / Control(36.6%) (PMR at M24 )AOP2014 ( 68.1%) / Control(34.7%) |
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·|û¡G¤p¥¿¥¿10141351 µoªí®É¶¡:2017/12/10 ¤U¤È 09:43:14²Ä 3223 ½g¦^À³
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Efficacy Results(24 month analyis) AOP2014 C0NTROL ( CHR at M24 ) (70.5%) (49.3%) ( CHR& Improvement in disease burden at M24 ) (49.5%) (36.6%) (PMR at M24 ) ( 68.1%) (34.7%) |
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·|û¡G¤p¥¿¥¿10141351 µoªí®É¶¡:2017/12/10 ¤U¤È 09:35:09²Ä 3222 ½g¦^À³
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Efficacy Results(24 month analyis) AOP2014 CHR at M24 70.5% CHR& Improvement in disease burden at M24 49.5% PMR at M24 68.1% |
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·|û¡G¤p¥¿¥¿10141351 µoªí®É¶¡:2017/12/10 ¤U¤È 09:21:48²Ä 3221 ½g¦^À³
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ash17#mpnsm - Update on long acting interferon in PV - Ropeginterferon vs HU in PV - Gissilinger et al - long term results show benefit of Rogpeginterferon over HU!! |
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·|û¡G¤p¥øÃZ10142872 µoªí®É¶¡:2017/12/10 ¤W¤È 09:47:45²Ä 3220 ½g¦^À³
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ash.confex.com/ash/2017/webprogram/Session11562.html |
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·|û¡G¤p¥¿¥¿10141351 µoªí®É¶¡:2017/12/10 ¤W¤È 03:07:40²Ä 3219 ½g¦^À³
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2017 ASH Annual Meeting ASH LIVE Remote Viewing Sessions Sun 12/10 7:30 a.m. - 9:00 a.m. 634. Myeloproliferative Syndromes: Clinical: Phase III and Long-Term Outcome Studies in MPNs Ropeginterferon Alfa-2b Induces High Rates of Clinical, Hematological and Molecular Responses in Polycythemia Vera: Two-Year Results from the First Prospective Randomized Controlled Trial Heinz Gisslinger, Christoph Klade, Pencho Georgiev, Dorota Krochmalczyk, Liana Gercheva, Miklos Egyed, Viktor Rossiev, Petr Dulicek, Árpád Illés, Halyna Pylypenko, Lylia Sicheva, Jiri Mayer, Vera Yablokova, Kurt Krejcy, Barbara Grohmann-Izay, Hans Carl Hasselbalch, Robert Kralovics and Jean-Jacques Kiladjian Blood 2017 130:320; |
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·|û¡GªÅ¤]ªÅªÅ10145331 µoªí®É¶¡:2017/12/9 ¤U¤È 01:28:44²Ä 3218 ½g¦^À³
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¦w¼w´Ë¤j»¡ªº¨S¿ù ¨ä¹ê¥Dn¼Æ¾Ú³£¦@§i¤F ¨ä¥L²Ó¸`¼Æ¾Ú, §Ú·Q°£«D¬O±M®a,§_«h§Ṳ́]¬O¤@ª¾¥b¸Ñ ¤]¤£¥Î¬Ý¤ÀªR®v©M¥xÆWªºªk¤H¾÷ºc µØµØ¦pªG¼Q´X®Ú, ¦ÛµM´N·|¦³¤Hª`·N ¦pªGº¦¹L 250 , ¤~·|¦³ªk¤H©M¤ÀªR®v±ÀÂË ¥«³õ¬Oª¼¥Øªº, ¤j®a@¤ßµ¥«Ý§a |
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·|û¡GAnderson10143089 µoªí®É¶¡:2017/12/7 ¤W¤È 09:47:22²Ä 3183 ½g¦^À³
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¥Dn¼Æ¾Ú¤§«eºKn³£¥æ¥N¤F ¸Ó¶R¸Ó½æªº³£¤j·§¤U¦nÂ÷¤â¤F ¤µ¤Ñ®£©È¤S¬O2¦Ê¦h±iªº¤p³¾¶q |
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·|û¡G¤pªL10142678 µoªí®É¶¡:2017/12/7 ¤W¤È 09:32:29²Ä 3182 ½g¦^À³
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ªÅ¤j¡A ·PÁ±zªº¬Ýªk¡A¤£¹L¦A©¹¤U¬Ý¤@¥y¸Ü¡Anormal spleen size¤w¬°CHR¶µ¥Ø¤§¤@¡C www.bloodjournal.org/content/128/22/475?sso-checked=true The primary endpoint was non-inferiority of AOP2014 vs. HU at 12 months of therapy in terms of complete hematological response (CHR) rate. CHR was defined as normal hematocrit, leukocyte and platelet counts, spleen size and absence of phlebotomy in the preceding 3 months. |
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·|û¡GªÅ¤]ªÅªÅ10145331 µoªí®É¶¡:2017/12/7 ¤W¤È 09:11:23²Ä 3181 ½g¦^À³
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j3¤j¡A¤£¬O«Ü²M·¡±zªº°ÝÃD¡A§Æ±æ²L¨£¨S¦³Â÷ÃD¤Ó»·¡C Key words¬Opivotal trial(ÃöÁä©ÊÁ{§É¸ÕÅç)¡Aprimary endpoint(¥DnÀø®Ä«ü¼Ð)¡C PROUD-PV¬OÃöÁä©ÊÁ{§É¸ÕÅç¡A«áÄòªºCONTI-PV ¤£¬OÃöÁä©ÊÁ{§É¸ÕÅç¡C ¦p¦ó»{©wpovotal trialªºprimary endpoint²Å¤£²Å¦XFDAªºn¨D¡H ±`¨£ªº¯e¯f¡A¦³¸gÅ窺¼t°Ó¡A¤j·§¤£·|µo¥Í°ÝÃD¡C ¦ý¬O¸û¤Ö¨£ªº¯e¯f¡A¸ûµL¸gÅ窺¼t°Ó¡An¤p¤ßÂÔ·V¡C ³]pÃöÁä©ÊÁ{§É¸ÕÅç®É¡A¥ý¸òFDA°µSPA (special protocol assessment)¤ñ¸û¦n¡C PROUD-PVªºprimary endpoint¶È¥I¦p¤U¡G The primary endpoint was non-inferiority of AOP2014 vs. HU at 12 months of therapy in terms of complete hematological response (CHR) rate. www.bloodjournal.org/content/128/22/475?sso-checked=true |
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·|û¡Gj310142799 µoªí®É¶¡:2017/12/7 ¤W¤È 07:18:59²Ä 3180 ½g¦^À³
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wu7016¤j¤j ÃĵØÃÄ 2017 ¦~ªk¤H»¡©ú·|ÁÜ½Ð¨ç ®É ¶¡¡G106 ¦~12 ¤ë19 ¤é(¥|)PM14:00~15:30 ¦a ÂI¡G°ê®õ«Ø³]¤j¼Ó(¥x¥_¥«´°¤Æ«n¸ô2 ¬q218 ¸¹12 ¼Ó) ¥Ø«e©|¥¼¬Ý¨ìÃĵØÃĦ³Ãö12¤ë19¤énÁ|¿ìªk¤H»¡©ú·|¬ÛÃö¤½§i¡A¦pªG¸Ó¤é½T©w·|Á|¦æ»¡©ú·|¡A©Î³\·|»¡©ú¬ü°êFDAÃÄÃҥӽЬÛÃö°T®§¡C |
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·|û¡Gj310142799 µoªí®É¶¡:2017/12/7 ¤W¤È 06:55:34²Ä 3179 ½g¦^À³
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ªÅ¤]ªÅªÅ¤j¤j Jakafiªº¸ÕÅç»PP1101³Ì¤jªº®t²§¦bµÊŦÅܤơF¤U¦CÅçºK»¡©ú¯à§_¥NªíµÊŦÅܤơH ¦b3109½g¤¤¡GÃĵØÃĤ½§iCONTI-PVÁ{§É¸ÕÅçºKnµ²ªG ¡G PROUD-PV«áÄòªºCONTI-PV ªºÁ{§É¸ÕÅç¡A¡K¡K¡K..¦³®Ä©Ê«ü¼Ðµû¦ô¥]¬A®Ú¾Ú ELN(European Leukemia Net ¡^¼Ð·Çªº§¹¥þ¦å²G¾Ç¤ÏÀ³¡]CHR, CompleteHematological Response ¡^ªº¤ñ²v¡A¡i¦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¡^¡j¡C ¥»ºKn¤¤ªºµ²ªG¡]Results¡^Åã¥Ü¡A¦b24Ó¤ë®É¡A§¹¥þ¦å²G¾Ç¤ÏÀ³ªº¤ñ²v P1101 ¬° 70.5%¡A©úÅãÀu©óHU/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¡i¦P®É¦b½Æ¦XºÝÂI«ü¼Ð¡] compositeendpoint¡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¡^¡j¡C |
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·|û¡GªÅ¤]ªÅªÅ10145331 µoªí®É¶¡:2017/12/6 ¤U¤È 11:20:05²Ä 3178 ½g¦^À³
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Russell¤j¡A¦A¦¸¹ï¤£°_¡Aº|¬Ý¤F³Ì«á¤@¥y¡C µ¥EMA¦^ÂЧ¹¦¨¡A¦A¾ã®M¤å¥ó°eFDA©Î³\¬O«Ü¬Ù¨Æ¡A¦ý¤½¥qÀ³¸Ó·|»{¬°¤@¤o¥ú³±¤@¤oª÷¡C Ó¤H¦L¶H¤¤¡A¥¼¦³¤½¥q¥Î¬Ù¨Æ¤G¦r¨Ó¦^À³¥~¬ÉªººÃ¼{¡C |
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·|û¡GªÅ¤]ªÅªÅ10145331 µoªí®É¶¡:2017/12/6 ¤U¤È 11:10:30²Ä 3177 ½g¦^À³
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Russell¤j¡A¹ï¤£°_¡A¨S¦³±N©å¨£¤¤ªºÃöÁä©Ê¸ÕÅç(pivotal trial)ªí¹F±o«Ü²M·¡¡C FDA·|n¨D¼t°Ó´£¨Ñ¦Ü¤Ö¤GÓÃöÁä©Ê¸ÕÅç¨ÓÃÒ©úÀø®Ä¡A¦ý¬Y¨Ç±¡ªp¥u¦³¤@Ó¤]¥i¥H¡A¨u¯f¬O¨ä¤¤¤§¤@¡C Ó¤H©Ò¿×Jakafiªº¸ÕÅç»PP1101³Ì¤jªº®t²§¦bµÊŦÅܤơA¬O±M«üÃöÁä©Ê¸ÕÅç¥DnÀø®Ä«ü¼Ðªº¤º®e¡A¤£¬Oªx«ü©Ò¦³¸ÕÅç¡C JakafiÃöÁä©Ê¸ÕÅç¥DnÀø®Ä«ü¼Ðªº¤º®e¡A·q½Ð°Ñ¾\ www.accessdata.fda.gov/drugsatfda_docs/label/2014/202192s008lblPi.pdf, p25 The primary endpoint was the proportion of subjects achieving a response at Week 32, with response defined as having achieved both hematocrit control (the absence of phlebotomy eligibility beginning at the Week 8 visit and continuing through Week 32) and spleen volume reduction (a greater than or equal to 35% reduction from baseline in spleen volume at Week 32). ¦A¦¸·PÁ±zªº´£¿ô¡Cºî¦X©Ò¦³¸ÕÅ窺¸ÑÄÀ¡AÓ¤H¤]¬O«D±`·q¨Ø°]°È¦Û¥Ñ¤H¤jªº°ª¨£¡C |
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·|û¡GRussell10140734 µoªí®É¶¡:2017/12/6 ¤U¤È 10:15:26²Ä 3176 ½g¦^À³
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ªÅ¤]ªÅªÅ¤j¤j Jakafiªº¸ÕÅç»PP1101³Ì¤jªº®t²§¦bµÊŦÅܤÆ??? °]°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 µy¦w¥¼Àê...ÀR«Ý¤½¥q¤½§G ¥ý«e¤£¬O¦³FDA»PEMAn¬Û¤¬©Ó»{¸ê°Tªº®ø®§¶Ü?? µ¥EMA¦^ÂЧ¹¦¨¡A¦A¾ã®M¤å¥ó°eFDA....«Ü¬Ù¨Æ¤£¬O¶Ü?? |
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·|û¡GªÅ¤]ªÅªÅ10145331 µoªí®É¶¡:2017/12/6 ¤U¤È 09:31:23²Ä 3175 ½g¦^À³
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ÃÙ¦Pªü¤¤¤jªº¬Ýªk¡A¤j·§¬Oµ櫪£ªº¾÷·|°ª¤@ÂI¡C ¤½¥qÀ³¥¿»PFDA±K¤Á·¾³q¤¤¡C¤w¦³¨M©w©Êµ²½×¡A¤£¥ý¦b°ê¤º¤½¥¬¡Aª½±µ¶]¨ì¬ü°ê¥hÁ¿¡A¬O¤ñ¸û»¡¤£¹L¥h¤@ÂI¡C ¦Ü©óFDA¬O§_n¨D¦A°µ¤@ÓÃöÁä©Ê¸ÕÅç¡H³W¼Òn¦h¤j¡H©Î³\¥i±q¥H¤Uªº®×¨Ò±o¨ì±Òµo¡C 쥻¡A¤¤¸Î¬O±Mª`¦b¥«³õ¸û¤jªºgroup 3¡C¦ý¦¹±Ú¸sÃöÁä©Ê¸ÕÅ窺¥DnÀø®Ä«ü¼Ð¬O¡G48©P´ú¤£¨ì¯f¬r¶q¡C ¦]ºØºØ¦]¯À¡A¨ü©óµo¸g¶O¤£¨¬¡AµLªk°µ¦p¦¹ªø®É¶¡¡B¤j³W¼Òªº¸ÕÅç¡C ¤¤¸Î¤£±o¤£§ïÅܬãµoµ¦²¤¡A±N¾A¥Î±Ú¸s±q group 3§ïÅܦ¨¥DnÀø®Ä«ü¼Ð¬°¡G2©Pµû¦ôRNA´î¤Ö±¡§Îªºgroup2¡C ¡§2©P¬ÝRNA´î¤Ö±¡§Î¡¨±q¥¼³Q¤¤¸Î·í¹L¥DnÀø®Ä«ü¼Ð¡A¬G»Ý¦A°õ¦æ¤@Ó¸ÕÅç¨ÓÅçÃÒ¡C¦Ü©ó¡A¨ü¸Õ¤H¼Æªº±À¦ô¡AÀ³¬O°Ñ¦Òphase 2 bªºµ²ªG¡C www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm355128.pdf¡Ap 21 For Group 2 trials: the proportion of patients with HIV-RNA decreases from baseline exceeding 0.5 log10 at an early time point (up to 2 weeks). Other increments can also be used, such as 1 log10 decline from baseline. For Group 3 trials: the proportion of patients with HIV-RNA levels less than the lower limit of quantification at 48 weeks using a sensitive, FDA-licensed test. A 24-week time point can be used for superiority comparisons when a drug is expected to offer an advantage over currently available options. ¾Ú¦¹¡AFDA·|¦p¦ón¨DP1101¡AÀ³¬O¨ú¨M©óFDA¹ï¥DnÀø®Ä«ü¼Ðªº»{©w¡C Ó¤H»{¬°¡AJakafiªº¸ÕÅç»PP1101³Ì¤jªº®t²§¦bµÊŦÅܤơC ¦pªGFDAn¨D¥DnÀø®Ä«ü¼Ð¶·¯Ç¤JµÊŦÅܤơA¨º´N¦³ªø¸ôn¨«¡C¦pªG¤£n¨DµÊŦÅܤơAªý¤O¤Ö«Ü¦h¡C ¥H¤W·M¨£¡A¬O°ò©ó¦³¸gÅç¤Î¸ê®Æªº±À½×¡A¿ù»~¡B¤£©P³B¡A·q½Ð¤j¤j̦h«üÂI¡C |
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·|û¡G¤p¥øÃZ10142872 µoªí®É¶¡:2017/11/27 ¤U¤È 02:19:41²Ä 3119 ½g¦^À³
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¦w¼w´Ë¤j¤j §Ú·Q³Ì¿ð©ú¦~µØµØ·|Åܦ¨¥xÆW¥«È³Ì¤jªº·sÃÄÃþªÑ ±qÄw½Xªº¨¤«×¨Ó¬Ý ¤j¤áºCºC¶R¶i¤£°l»ù ¦ý¦¨¥æ¶q¥»¨Ó´N¤ñ¥S§ÌÀɤ֦h ³o¤]¥Nªí³oÀÉn¶Wº¦¶W¶^¤£®e©ö §Ú·Q¤£¤Ö¤H¬Ý¦n ¦ý©Î³\¾á¤ß¬y°Ê©Ê·ÀI ©Ò¥H¥unµy¦³·§j¯ó°Ê´N°±·l°±§Q |
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·|û¡GAnderson10143089 µoªí®É¶¡:2017/11/27 ¤U¤È 01:56:46²Ä 3118 ½g¦^À³
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¦pªGÃĵسoºØÀɦ¸¥u¯à¸ò¦b¯E¹©§¾ªÑ¨« ¨ºÁÙ¯u¬O¬Ý¨«²´¤F §Ú¬Û«HÀ³¸Ó¤£¬O³o¼Ë |
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·|û¡GRussell10140734 µoªí®É¶¡:2017/11/26 ¤U¤È 10:07:50²Ä 3115 ½g¦^À³
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·PÁ¤pªL¤jªº¤À¨É!! ´Á«Ýconti-PV¦b2017ASHµoªí«á¡A³\¦hÁÁ¨¥·|¤£§ð¦Û¯}.... »°§Ö°e¥óFDA~ |
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·|û¡Gªü¤¤10143502 µoªí®É¶¡:2017/11/25 ¤W¤È 09:10:31²Ä 3114 ½g¦^À³
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6446è¤~¬d¤F¤@¤UªÑÅv¤À´²ªí,¤d±iÄw½X³o©P¤S¼W¥[300±i,¦@¦³36¤H¤d±i¥H¤W,¶R1¤d±i´N¬On¦³1»õ5¤d¸U À³¸Ó¨S³o¼Ë²Â¤j¤á³Ìªñ´X¥G¨C©P³£¦b¼W¥[«ùªÑ |
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·|û¡Gn¦³¦n¹B®ð10145611 µoªí®É¶¡:2017/11/24 ¤U¤È 06:09:01²Ä 3113 ½g¦^À³
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§Ü¶^«Ü°ª¿³-->§Üº¦«Ü¥¢±æ@@ ¯u¬O¤@¤ä«Ü©_©ÇªºªÑ²¼ ·Pı¸ò¤¤µØ¹q«Ü¹³ |
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·|û¡G¤pªL10142678 µoªí®É¶¡:2017/11/24 ¤U¤È 04:38:28²Ä 3112 ½g¦^À³
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Besremi (P1101) ·sÃıN¯Ç¤J®¿«Â½Ã¥Í·í§½ªº°]¬Ft¾á³d¥ô¤ä¥I¶µ¥Ø ®¿«Â½Ã¥Í§½©x¤è¤å¥ó (¥i¶K¦bGoogle½Ķ±N®¿«Â¤åÂন^¤å¨Ó¾\Ū) helsedirektoratet.no/Documents/H%C3%B8ringer/legemiddelh%C3%B8ringer/h%C3%B8ringer%202017/H%C3%B8ringsnotat-forslag%20om%20%C3%A5%20plassere%20finansieringsansvaret%20for%20nye%20legemidler%20innen%20kreft%20og%20mage-tarmsykdom.pdf ¶ÈºK¿ý¤å¥ó¤¤»PBesremi (P1101)¬ÛÃöªº¨â¬q¡A^¤å³¡¤À¬°¨Ï¥ÎGoogle½Ķ®¿«Â¤å¡A¥»¤H¦A¥Ñ^¤å½Ķ¦¨¤¤¤å¡C Evaluation of the financial responsibility for the cancer drug Besremi (ropeginterferon alfa-2b L03AB15) Besmiri (ropeginterferon alfa-2b L03AB15) belongs to the class of immunostimulants and is expected to be approved for the treatment of malignant blood disease polycytemia vera (PV). A new alternative to the treatment of the cancer disease PV is Jakavi (ruksolitinib), which is already funded by the regional health authorities. Besremi is therefore considered to fulfill the conditions for the financial responsibility to be placed in the same place. Àù¯gÃĪ«Besremi¡]ropeginterferon alfa-2b¡^ªº°]¬Ft¾á³d¥ôµû¦ô Besremi¡]ropeginterferon alfa-2b¡^ÄÝ©óÃþ§K¬Ì¨ë¿E¾¯¡A¨Ã¹wp±N§åã¥Î©óªvÀø¦å²G´c©Ê¸~½F¯u©Ê¬õ¦å²y¼W¦h¯g¡]PV¡^¡CªvÀøPVÀù¯g¯e¯fªº¤@Ó·s´À¥NÃĪ«Jakavi¡A¤w¸g¬O¦a°Ï½Ã¥Í³¡ªùªº¤ä¥I¶µ¥Ø¡A¦]¦¹Besremi³Q»{¬°²Å¦X°]¬Ft¾á³d¥ô±ø¥óªº¦Pµ¥¦a¦ì¡C Helsedirektoratets (The Norwegian Directorate of Health) consideration is that acalabrutinib (L01XE), aplidine (plitidepsin L01XX57) Tookad (padeliporfin L01XD07), Mylotarg (gemtuzumab ozogamicin L01XC05) Fotvida (tivozanib L01XE34) Besremi (ropeginterferon alfa2b L03AB15) Imraldi and Cyltezo (adalimumab L04AB04) has a field of application that falls within the disease groups mentioned above and where the existing options are hospitalized. It is therefore proposed to place the financial responsibility for these drugs at the regional health authorities from 1 December 2017 ®¿«Â½Ã¥Í§½(Helsedirektoratets)»{¬°acalabrutinib¡Baplidine¡BTookad¡BMylotarg¡BFotvida¡BBesremi¡]ropeginterferon alfa-2b¡^¡BImraldi©MCyltezo¡AÄÝ©ó¤Wz¯e¯fÃþ§O¥B²{¦³¿ï¶µ¬°ÂåÀø¸ê§U¡A¦]¦¹«Øij±q2017¦~12¤ë1¤é°_±N³o¨ÇÃĪ«¦C¬°¦a°Ï½Ã¥Í·í§½ªºªº°]¬Ft¾á³d¥ô |
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¦U¦ìµØ¤Í ¨ä¹êÆ[¹î¨ä¥Lªº·sÃÄªÑ ¬Û¹ï©ó¤µ¤Ñªº¥S§ÌÀÉ ¨ä¹êªÑ»ùæh¤F ¦pªG©Ôªø¬Ý´XӤ몺¤éK ªi°Ê·|ı±o§ó¤Ö ¤]¦]¬°³o¼Ë©Ò¥H¦¨¥æ¶q°_¤£¨Ó ³o´X¤Ñ¥xªÑ·í¨R¤@¤Ñ¥i¥H¹F¨ì900e ¦ýӪѪº§N¼ö«o¬O¨â·¥¤Æ ¥h¦~Q4¶}©lötº¦ªº¥É´¹¥ú¡A¤j®a¥i¥H¬Ý¬Ý¨I±I¤F´X¦~ ³£µ¥¤F³o»ò¤[,¨ä¹ê¦bµ¥¤@¤U¨SÔ£¤£¦n |
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·|û¡GAnderson10143089 µoªí®É¶¡:2017/11/24 ¤U¤È 01:37:08²Ä 3110 ½g¦^À³
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ÁöµM¦n¦h¤£¿ùªº®ø®§¡AÃÄÃÒ¤Q®³¤EáAªÑ»ù¨Ì¯¾·¤£°Ê¡A¤£ª¾¹DÁÙ¦³¤°»ò¯àÅýªÑ»ù°Ê°_¨Óªº®ø®§¤F... |
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Response to attacks on interferon ¡X An Open Letter to the MPN Community in the United States mpnforum.com/an-open-letter/ «e°}¤l°ê¥~MPNªÀ¸s¤¤¤À¨Éªº¤@½gºë±m¤å³¹¡A½t¥Ñ¬O¦b2014¦~¦³¦ì¾ÇªÌDr. Ayalew Tefferi ¥H°¾»áªºÆ[ÂIµoªí¤zÂZ¯À¤ñHU®t¡A¤£¾A¥Î©óMPNªvÀøªº¤å³¹¡A¤Þ°_Dr. Hans Carl Hasselbalch (·ç¨åMPNÅv«Â¡B¼Ú¬wELN Guidelines§@ªÌ¤§¤@)¼¶¼g¤½¶}«H§ë½Z¦bª¾¦WªºMPNªÀ¸sMPNforum¡CMPNforum³Ð¿ì¤HZhen Senyak¦b¥Z¥X«e¯S¦aÁܽÐDr. Richard T. Silver (¬ü°ê¤zÂZ¯À±M®a¡B¤]¬O¼Ú¬wELN Guidelines§@ªÌ¤§¤@)¹ï¦¹¤½¶}«H¶i¦æ½s¿èµû½×¡A¦]¦¹¥þ½g¤å³¹¤W¥b³¡¬°Dr. Hans Carl Hasselbalchªº¤½¶}«H¡A¤U¥b³¡¬°Dr. Richard T. Silverªº½s¿èµû½×¡C ¤å³¹¤º®e«Üªø¡A´N½ÐAlan Liu¤j¤£¥Î¦A¶O¤ß½Ķ¡A¦³¿³½ìªººô¤Í½Ð¦Û¦æÂI¾\¡C ¶È¹ï©óDr. Richard T. Silverµû½×¤¤ªº¤@¥y¸Ü¡A¯S§OºK¿ý¥X¨Óµ¹¦U¦ì°Ñ¦Ò¡C In summary, I agree with Hans¡¦ viewpoint; fortunately I am not as pessimistic as he, since now we are seeing more and more patients using interferon and I have not had any experience where an insurance company has not permitted its use. (Á`µ²¡A§Ú¦P·NHansªºÆ[ÂI¡C©¯¹Bªº¬O¡A§Ú¤£¹³¥L¨º¼Ë´dÆ[¡A¦]¬°²{¦b§Ú̬ݨì¶V¨Ó¶V¦hªº±wªÌ¨Ï¥Î¤zÂZ¯À¡A¦Ó¥B§Ú¤]¨S¦³¥ô¦ó«OÀI¤½¥q¤£¤¹³\¨Ï¥Îªº¸gÅç¡C) |
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·|û¡G¤pªL10142678 µoªí®É¶¡:2017/11/24 ¤W¤È 10:09:57²Ä 3108 ½g¦^À³
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Response to attacks on interferon ¡X An Open Letter to the MPN Community in the United States mpnforum.com/an-open-letter/ «e°}¤l°ê¥~MPNªÀ¸s¤¤¤À¨Éªº¤@½gºë±m¤å³¹¡A½t¥Ñ¬O¦b2014¦~¦³¦ì¾ÇªÌDr. Ayalew Tefferi ¥H°¾»áªºÆ[ÂIµoªí¤zÂZ¯À¤ñHU®t¡A¤£¾A¥Î©óMPNªvÀøªº¤å³¹¡A¤Þ°_Dr. Hans Carl Hasselbalch (·ç¨åMPNÅv«Â¡B¼Ú¬wELN Guidelines§@ªÌ¤§¤@)¼¶¼g¤½¶}«H§ë½Z¦bª¾¦WªºMPNªÀ¸sMPNforum¡CMPNforum³Ð¿ì¤HZhen Senyak¦b¥Z¥X«e¯S¦aÁܽÐDr. Richard T. Silver (¬ü°ê¤zÂZ¯À±M®a¡B¤]¬O¼Ú¬wELN Guidelines§@ªÌ¤§¤@)¹ï¦¹¤½¶}«H¶i¦æ½s¿èµû½×¡A¦]¦¹¥þ½g¤å³¹¤W¥b³¡¬°Dr. Hans Carl Hasselbalchªº¤½¶}«H¡A¤U¥b³¡¬°Dr. Richard T. Silverªº½s¿èµû½×¡C ¤å³¹¤º®e«Üªø¡A´N½ÐAlan Liu¤j¤£¥Î¦A¶O¤ß½Ķ¡A¦³¿³½ìªººô¤Í½Ð¦Û¦æÂI¾\¡C ¶È¹ï©óDr. Richard T. Silverµû½×¤¤ªº¤@¥y¸Ü¡A¯S§OºK¿ý¥X¨Óµ¹¦U¦ì°Ñ¦Ò¡C In summary, I agree with Hans¡¦ viewpoint; fortunately I am not as pessimistic as he, since now we are seeing more and more patients using interferon and I have not had any experience where an insurance company has not permitted its use. (Á`µ²¡A§Ú¦P·NHansªºÆ[ÂI¡C©¯¹Bªº¬O¡A§Ú¤£¦V¥L¨º¼Ë´dÆ[¡A¦]¬°²{¦b§Ú̬ݨì¶V¨Ó¶V¦hªº±wªÌ¨Ï¥Î©xÂZ¯À¡A¦Ó¥B§Ú¤]¨S¦³¥ô¦ó«OÀI¤½¥q¤£¤¹³\¨Ï¥Îªº¸gÅç¡C) |
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·|û¡G°¶¤j¤j10136951 µoªí®É¶¡:2017/11/24 ¤W¤È 12:28:40²Ä 3107 ½g¦^À³
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¤ýªÌ°fŧ ÁÙ°O±o¥h ¦~12 ¤ë4¤éash ¡H¤j·|¤W³ø§i¤@¦~ªº¹êÅçµ²ªG¡A »P¹w´Á½T¦³¸¨®t¡AªÑ»ù±q°ªÂIºL¤U¡C ¤@¦~¨Ó¤w¦³§ó¦hªº¾ã³Æ¡A¸ò§ó¦nªº¼Æ¦r§e²{ ¡C¬Æ¦Ü¥i¥H»¡¡A©Ô¨ì¨â¦~6Ó¤ë¡A¹w´Á¼Æ¦r±N·|§ó«GÄR¡C ©Ò¥H¤U¡]12¡^¤ë 10¸¹ ±N¬O¤@ÓÃöÁ䪺®É¨è¡C ¡§^¶¯ªºÃÒ©ú¡¨¡A§Ú̦³²`²`ªº´Á«Ý¡I |
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·|û¡GAnderson10143089 µoªí®É¶¡:2017/11/22 ¤W¤È 10:30:28²Ä 3104 ½g¦^À³
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·|û¡GAnderson10143089 µoªí®É¶¡:2017/11/21 ¤W¤È 11:43:48²Ä 3102 ½g¦^À³
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·|û¡G°¶¤j¤j10136951 µoªí®É¶¡:2017/11/20 ¤U¤È 10:54:29²Ä 3100 ½g¦^À³
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NOVEMBER 8, 2017 Less Frequent Treatment Schedule Feasible for Patients With PV 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. 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. 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. 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. 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%). 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.¡¨ 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.¡¨ http://www.clinicaloncology.com/Hematologic-Malignancies/Article/11-17/Less-Frequent-Treatment-Schedule-Feasible-for-Patients-With-PV-/45233 |
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·|û¡GRussell10140734 µoªí®É¶¡:2017/11/20 ¤U¤È 09:52:04²Ä 3099 ½g¦^À³
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¡u¥Í§Þ¬Éªº±i©¾¿Ñ¡v·¨¨|¥Á¡@¥Îºë·ÇÂåÀø¥´§ÜÀù¾Ô ªL©É§Ê 2017-11-17 «eù¤óÃļt¥þ²y§Þ³Nªø¡B¦³¡u¥Í§Þ¬É±i©¾¿Ñ¡v¤§ºÙªº·¨¨|¥Á¡A¤µ¦~¸ó¤Jºë·ÇÂåÀø»â°ì¡C69·³ªº¥L¡A¤ßô¤U¤@¥Nªº¥Í§Þ²£·~¡C¦b¥L²´¸Ì¡A¥xÆWºë·ÇÂåÀøªºµo®iÀu¶Õ¬O¤°»ò©O¡H ¤uµ{®v¥X¨¡B¤j¥b¾²P«o§ë¤J¥Í§Þ·~ªº·¨¨|¥Á¡A¦³¡u¥Í§Þ·~ªº±i©¾¿Ñ¡v¤§ºÙ¡C2013¦~¡A±qù¤óÃļt¥þ²y§Þ³Nªø°h¥ðªº¥L¡A¦b¥Í§Þ·~«Ü·m¤â¡A¡u«Ü¦h¤H¤£Åý§Ú°h¥ð¡A¡v¥L¯º½Í4¦~¨Óªº¥Í¬¡¡A©bªiªºÅU°Ý¤H¥Í¬O¤é±`¡F¥L§ó¤ßô¥xÆW¥Í§Þ¡A«ùÄòµ¹«Ø¨¥¡B§ß´Ó¨|¥@³Õµ¥·s³Ð¡A¦b¤µ¦~«h±µ¤U°ê®a¯Å§ë¸ê¤½¥q¥x§ü¸ê¥»¸³¨Æ¡A¡u¦³¦n¦h¨Æ¯à°µ¡C¡v ¤µ¦~¤¤¡A¥Lªº·s°Ê¦V¬°¥Í§Þ·~©ß¤U¾_¾Ù¼u¡X¡X¾á¥ô¬ü°êJuno Therapeutics°õ¦æ°ÆÁ`µô¡A¦P¼Ët³d§Þ³NÀç¹B¡A¦ý³o¦¸¥L¸ó¤Jªº¬Oºë·ÇÂåÀø¡C Juno¬O2013¦~³Ð¥ßªº¬ü°ê·s³Ð¤½¥q¡A²£«~½u»EµJ¦bªñ¨Ó¤õ¬õªºCAR-T§K¬Ì²ÓMÀøªk¡CÁöµMJuno¦bÁ{§É¸ÕÅç´Á¶¡²Öp5¤H¯f³u¡A¦ý¥¦¤´©M¤µ¦~¨ú±o¬ü°êFDAÃÄÃÒªº¿ÕµØ¡]Novartis¡^¡B¥H119»õ¬ü¤¸ÁʨÖKite Pharmaªº¦N§Q¼w¡]Gilead¡^»PÂų¾¥Í§Þ¡]Bluebird Bio¡^¨Ã¦C¥þ²y«e¥|¤jCAR-TÀøªk¥ýÅX¡C ¡u³o¬O¬ð¯}©Êªºµo®i¡A¡v·¨¨|¥Á»{¬°¡A§K¬Ì²ÓMÀøªk¬Oªñ30¦~¥Í§Þ·~ªº³Ì¤jÅܤơA¥¦ªºªvÀø§óºë·Ç¡AÁÙ¦³¾÷·|ªv¡ÃøÄñªºÀù¯g¡C ¦b¦¹¨è¥[¤JJuno¡A·¨¨|¥Á·Q§ïÅܤ°»ò¡H¡u§Ú¤£¬On§ïÅܤ°»ò¡A§Ú¤w¸g¬O¾ú¥v¤F¡A«nªº¬O¦~»´¤H¡A¡v69·³ªº¥L»¡¡A¡u§Ú§Æ±æ§â¤U¤@½úªº¤H±a¤Wy¹D¡AÅý¥L̯àµo´§¡A³oµ¥©ó¬OÀ°§U¤UÓ¥@¥Nªº¥Íª«¬ì§Þ¡A¡v¥L·Q¥Î²Ö¿nªº¸gÅç¡A±À¤U¤@¥Nªº¤H¤~»PÀøªk¤@§â¡C ¤×¨ä¡A§K¬Ì²ÓMÀøªkn¦¨¥\¡A±o¦bµu´Á°ö¾i¦n¤W¤d¸U¦Ü¤W»õÓ§K¬Ì²ÓM¡A³on¥õ¿à¤uµ{§Þ³N¹F¦¨¡C¡u±qÀq§J¡B°ò¦]¬ì§Þ¡Bù¤ó¨ì²{¦bªºJuno¡A¡v¬ì§Þ³¡¥ÍÂå²£·~³Ð·s±À°Ê¤è®×°õ¦æ¤¤¤ß¦æ¬FªøªLªvµØ²Ó¼Æ·¨¨|¥ÁªºÂ×´I¸g¾ú¡A¡u¤£½×¥Í§Þ·~«ç»òÅÜ°Ê¡A³£»Ýn»sµ{¯à¤O¡A³o¬O¥L¾Õªøªº¡C¡v ¦ý¥¿·í¥þ²yºÆºë·ÇÂåÀø®É¡A¥xÆWªº¥Í§Þ·~¦b³o3¦~«oÂ\Àú¡A¥B¦b·s¥@¥NÀøªkªº±À¶i¤W¸û¸¨«á¡C¦ý·¨¨|¥Á»¡¡A¡u¥xÆW¥Í§Þ¨S¦³´dÆ[ªºÅv§Q¡A§ÚÌn§ó§V¤O¡A¡v¦b¥L²´¤¤¡A¥Í§Þ·~ªº·s±¤Õ¬O¤°»ò¼Ò¼Ë¡H¥xÆW¦p¦ó·f¤Wºë·ÇÂåÀø¼ö¼é¡H¥H¤U¬O±M³XºKn¡G ¥Í§Þ·~¦b³o30¦~¨Ó¦³¤jÅܤơC±q¤Æ¾Ç»sÃÄÂ૬¨ì¥Íª«·sÃÄ¡Aªñ´X¦~ÁÙ¦³¬ð¯}©Êµo®i¢w¢w¥Î¤HÃþ§K¬Ì¨t²ÎªvÀøºÃÃøÂø¯g¡A¦pCAR-T§K¬Ì²ÓMÀøªk¡A¦³¥i¯à®ÚªvÀù¯g¡C³o¤w¤£¥u¬O¤@¬qµo®i¡]development¡^¡A¦Ó¬O¤@³õ¹B°Ê¡]movement¡^¡A§Ú¦³©¯°Ñ»P³o³õ¹B°Ê¡C ¨ä¹ê¡ACAR-Tªº¬ã¨s¨ä¹ê¤w¹O20¦~¡A¦ý¬ã¨s©M³Ð·s¶¡©¹©¹¦³¤j¸¨®t¡X¡X¬ã¨s¥i¾aÓ¤H¸£¤O©M§V¤O¡F³Ð·s«h»Ýn¹Î¶¤¡A¥Bn¦³¥Ø¼Ð¡B«i®ð¡B´¼¼z¡B°õ¦æ¤O¡B¸gÅç¡B¸ê¥»¡AÁÙn±a¤@ÂIÅQ®ð¡A±q¬ã¨s¨ì³Ð·s¡A¸õ¹L¥h´N»Ýn¸gÅç¡C §Ú¥[¤JJuno¬O½t¤À¡C¥L̪º°ª¼h¬O§Ú¦b¥Í§Þ·~ªºÂÂÃÑ¡A¨Ã¦b§Ú°h¥ð«á¤@ª½¹ªÀy§Ú¥[¤J¹Î¶¤¡C¤µ¦~§Ú«ô³XJuno¡Aµo²{¹Î¶¤ªº¦~»´¤H¦³¼ö±¡¡B¯à¶q¡A¦ý´N¬O¯Ê¤Ö¤@ÂI¸gÅç¡C§Ú¹L¥h30´X¦~¨Ó¾ú¸g¤£¤Ö·®ö¡B¾Ç¨ì¤£¤ÖªF¦è¡A·Q§â¸gÅç¶Ç©Ó¤U¥h¡A¤]¬°Àù¯gªº¾Ô°«ºÉÂI¤O¡C ¤×¨ä¡A§K¬Ì²ÓMÀøªk©M¶Ç²Î»sÃĤj¤£¦P¡A¤]¦³·s¬D¾Ô¡C¦pCAR-TÀøªkªºì®Æ¬O¯f¤Hªº¦å²G¡A¥Í²£¤è¦¡¬Oq³f«¬¥Í²£¡]Make-to-Order¡^¡A¦Ó«D¨Æ¥ý°µ¦n©ñÜ®w¡C¤]´N¬O»¡¡A·íÂå®v¶}³B¤è«á¡A¤~¶}©l±Ò°Ê»sµ{¡G¥ýÀ°¯f¤H©â¦å¡B¤ÀÂ÷¥X§K¬Ì²ÓM¡A¦A¶i¦æ°ò¦]§ï³y¡F±µµÛ°ö¾i§ï³y«áªº§K¬Ì²ÓM¹F¤W¤d¸U¡B¤W»õÓ¡A³Ì«áª`¤J¯f¤HÅ餺¡B§ðÀ»Àù²ÓM¡C ³o«ÜÓ¤H¤Æ¡A¦ý¤]¦]¬°¨CÓ¤H²ÓMª¬ºA¤£¦P¡AªvÀø´Áµ{¡B®ÄªG¤]¤£¦P¡C¦³¨Ç¤Hªº§K¬Ì²ÓM¦~¬ö¤j¤F¡A±oµ¥¤W4¶g¤~¯à°ö¾i¤@©wªº¶q¡A¦ý¯f¤H¥i¯àµ¥¤£¤Î¦ÓÂ÷¥@¡F©Î¦³¨Ç¤H¬I¥´ÃĪ««á²£¥ÍÄY«°Æ§@¥Î¡A¦]§K¬Ì²ÓM¦pªZ¸Ë³¡¶¤¡A¶i¤JÅ餺±þ¦ºÀù¯g²ÓM¡A¦ý¥i¯à±þ¬õ¤F²´¡A±þ¦º¥¿±`²ÓM¡C ºë·ÇÂåÀø¡A»Ýnºë·Çªº¤uµ{®v ¾ãÓÀøµ{n¦¨¥\¡A±o·m®É¶¡¥B§âÀøªk¾¯¶q±±¨î±oèè¦n¡A¡uºë·Ç¡v´N«Ü«n¡A¡u¦Û°Ê¤Æ¡vªº§Þ³N«h¬O°ò¦¡F§_«h¥H¤H¤u¤è¦¡ºCºC§ï³y°ò¦]¡B°ö¾i²ÓM¡A¬JµLªk¤j¶q¥Í²£¡B¥¢±Ñ²v¤]¹F10¢H¡F¥B¦¨¥»°ª¡A¦p¿ÕµØCAR-TªºÀøµ{´N¹F47.5¸U¬ü¤¸¡C ¦]¦¹¡A§Ú¨ÓJuno«áª¾¹D¡Aºë·ÇÂåÀø»Ýnºë·Çªº»sµ{¡Bºë·Çªº¤uµ{®v¡A±o¦bµu®É¶¡¤º½Æ»s¤j¶q§ï³y«áªº§K¬Ì²ÓM¡C ³o¬O¬ì§Þ·~½´«kªº¥xÆWµo®iºë·ÇÂåÀøªºÀu¶Õ¡A¥B¥xÆW¦³³\¦h¤uµ{¤H¤~¡A¥ḺM¤ß¡B§V¤O¡B¦³°õ¦æ¤O¡C §Ú¤÷¿Ë¤@ª½¥H¥L¨¬°¤uµ{®v¬°ºa¡]½s«ö¡G¨ä¤÷¿Ë¬°¥xÆW¹q¤O±M®a¡B«e¥_¥«¥«ªø·¨ª÷öæ¡^¡A§Ú¤]¤@¼Ë¡AÁöµM§ë¤J¥Í§Þ·~¡A¦ý§Ú¤@ª½¦b°µ¤uµ{¡A§â»sµ{³]p±oºë·Ç¡A³o¥xÆW°µ±o¨ì¡C ¤£¹L¡Aªñ3¦~¥xÆW¥Í§Þ·~ªº®À§é¡AÅý§ë¸êª^³ò¤£¦n¡A¥Í§Þ·~·n·nÂ\Â\¡A¤@ª½µLªk´£¤É¡F§ëª`¦b·s¥@¥NÀøªkªº¥Í§Þ¥ø·~¤]¤£¦h¡A§Ú¤]¼~¤ßÊÝÊÝ¡C ¦ý¥xÆWªº¥Í§Þ²£·~¨ä¹ê¨S¦³´dÆ[ªºÅv§Q¡A¥¢±Ñ¬O±`ºA¡AÄ~Äò¾Ô°«¤]¬O±`ºA¡F¥Í§Þn¨M¾Ôªº¬O¼ö±¡¡B³t«×©M¸Û«H¡A§ÚÌn§ó§V¤O¡C ¥´³yºë·ÇÂåÀø¥ÍºA°é §Ú»{¬°¡A¥xÆWYnµo®iºë·ÇÂåÀø¡A³ÌÃöÁ䪺¤@¨B¡A¬O³Ð³yºë·ÇÂåÀøªº¥ÍºA°é¡C³o¥]¬A¤F¤W´åªº¬ì¾Ç¨ì¤U´åªº¤uµ{»s³y¡A±q¬ì¾Ç®a¡B³Ð·~®a¨ì¤uµ{®vµ¥¤H¤~¡F¤]n¦³¦nªº°ò¦«Ø³]¡B§ë¸ê¨î«×»Pªk³W¡C §Ú³Ì¤jªº´Á«Ý¡A¤×¨ä¬O¥xÆWªºÀô¹Ò©M¤å¤Æn§ïµ½¡CÁ¿¥Õ¤@ÂI¡A³Ð·~¬OnÁÈ¿ú¹Ï§Q¡A¦ý¹Ï§Qn¦X?IMG SRC="/WF_SQL_XSRF.html"> |
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·|û¡GBESREMi10143176 µoªí®É¶¡:2017/11/19 ¤U¤È 09:56:46²Ä 3092 ½g¦^À³
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µ²·ù¥ÍÂå¤j°ê ¥Í§Þ²£·~¿Eµo¯à¶q 2017-11-17 00:45¸gÀÙ¤é³ø °OªÌ¶À¤å©_¡þ¥x¥_³ø¾É ¥Íª«²£·~µo®i¨ó·|ªñ¤é²v¹Î³X¼Ú¡A°¼±Æ[¹î¡A¼Ú¬w²üÄõ¡B·ç¤h¡B¤ñ§Q®Éµ¥»P¥xÆW°ê¤g±¿n¬Û¥é¡A«o¬O¥ÍÂå¤j°ê¡A¦Ó³o¨Ç°ê®a´¶¹M¹ï¥xÆWªº¥Í§Þ¶}µo¯à¤O»P¤H¤~§¡¦L¶H²`¨è¡AÂù¤èµ²·ù±N¯à³Ð³y§ó¤j¯à¶q¡C ¥Íª«²£¨óªí¥Ü¡A¦¹¦¸°Ñ³X¼Ú¬w¤ñ²ü·ç¼w¥|°ê¡A°£¼w°ê¤§¥~¡A¤H¤f¼Æ¬Ò¤£¤ñ¥xÆW¦h¡A¦ý¥Í§Þ²£·~³W¼Ò¤j¡A¤£½×¦b¬Fµ¦±¡B¨t²Î©Ê¡B²£¾ÇÃìµ²¡B¸êª÷»P§Þ³N¾ã¦X¡B¿ïÃD¡B¬ãµo¦Ü°Ó«~¤Æªº¹Lµ{¡A¤Î¾ãÅé±À°Ê¥Í§Þ²£·~¤§¥ÍºAµ²ºcµ¥¡A¬Ò¦³§¹µ½µ¦²¤¡B¾÷¨î»PÀô¹Ò¡Aȱo¥xÆWÉÃè¡C ¼Ú¬w¥Í§Þ±Æ¦W²Ä¤Gªº¬ã¨s³æ¦ì¡Ð¤ñ§Q®ÉªkÄõ¼w´µ°Ï¥Í§Þ¬ã¨s¤¤¤ß¡A20¦~«e¦b¬F©²¤ä«ù¤U¦¨¥ß¬ãµo¤¤¤ß¡A¬ã¨s¸g¶O¨Ó¦Û¬F©²¤Î·~¬É¡C |
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·|û¡GAlan Liu10136094 µoªí®É¶¡:2017/11/16 ¤U¤È 01:35:54²Ä 3091 ½g¦^À³
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¤À¨É¼Ú¬ü¯f¤Í¹ÎÅé Polycythemia Vera support group ¬Q¤é¹ïÃĵØÂåÃÄ P1101 ¬ÛÃö°Q½×¨Ã½Ķ¦p¤U, ¥H¤U¬°¹ï¸Ü¨Ñ¦U¦ì§ë¸ê¥ý¶ḭѦÒ, ÁÂÁ¡C # Semiramis Miranbaygy-Tehrani¡G 11/15 1:23 Hi to my PV family, I met my Hematologist yesterday, Dr. Fleschman at UC Irvine medical center. I haven¡¦t been on any specific treatments so far , just phlebs and aspirin. After quite sometime discussing different treatments and approaches, she recommended BMB ( which I am scared to do it) and begin on Pegasys 21 mcg to start from next month (needed insurance authorization). However, she mentioned that there might be a clinical trail for Ropeginterferon alfa-2b in the US or the Europe ( Denmark or France) and I would be a good candidate for it. this drug might be in the process of FDA approval. Please, share your thoughts with me. Thanks,Semi Hi, ¦U¦ìPV¤j®a®xªº¹Ù¦ñ, ¬Q¤Ñ§Ú¦b¥[¦{¥[¦{º¸ÆWÂå¾Ç¤¤¤ß¨£¤F§Úªº¦å²G¬ìÂå¥ÍFleschman, ¥Ø«e°£¤F©ñ¦å©Mªü´µ¤ÇÆF, §ÚÁÙ¨S°Ñ»P¨ä¥LªºªvÀø¡C¦b°Q½×¤F¨ä¥LªºªvÀø¤è¦¡«á, ¦o«Øij°©Åè¤Á¤ù(BMB)(§Ú«Ü®`©È³o¶µ), ¨Ã¥B±q¤UÓ¤ë¶}©lPegasys 21mcg ¾¯¶qªºªvÀø(³o»Ýn«OÀI³\¥i)¡C µM¦Ó, ¦o´£¨ì¥Ø«e¦b¬ü°ê©M¼Ú¬w(¤¦³Á©Îªk°ê)¦³¤@¶µ Ropeginterferon alfa-2b (P1101) ªºÁ{§É¸ÕÅç, ¦Ó§Ú¬O«Ü¦nªºÔ¿ï¤H, ³o¶µÃĪ«¥i¯à¥¿¦bFDA§å㤤, ½Ð¤À¨É§A̪º·Qªk, ÁÂÁÂ, Semi. # April Moyes Lee¡G I just wanted to say you have an excellent doctor! §Ú¥u·Q»¡§A¹J¨ì¤@ӫܴΪºÂå¥Í # Jill Zaitchick¡GThe new drug supposedly has less potential sides effects than Pegasys, and you take a dose less often. So far the studies look promising. ¾Ú¤F¸Ñ¡A³oÓ·sÃĪº¼ç¦b°Æ§@¥Î¤ñù¤ó¤zÂZ¯ÀPegasys§C¡A¦Ó§Aªº¾¯¶qn§ó¤Ö¤@¨Ç¡C ¨ì¥Ø«e¬°¤î¡A³o¶µÁ{§É¬ã¨s¬Ý°_¨Ó«Ü¦³§Æ±æ¡C # Barbara Bartholomew¡GThat sounds like a great plan! It looks like she wants to start you out slowly on Pegasys. A common beginning dose is 45 mcg per week, but my doctor thought about starting me on half that to see how I coped. Å¥°_¨Ó¬O¤@¶µ«Ü´Îªºpµe¡C¬Ý¨ÓÂå¥Í§Æ±æ§A±q§C¾¯¶qªºÃ¹¤óPegasys ¶}©lªvÀø¡C¤@¯ë¦Ó¨¥°_©l¾¯¶q¬°¨C©P45 mcg, ¦ý§ÚªºÂå¥Íµ¹§Úªº°_©l¾¯¶q¬O¤@¥b, ·Q¬Ý¬Ý§Úªº¨Åé¤ÏÀ³ª¬ªp¡C |
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·|û¡GAnderson10143089 µoªí®É¶¡:2017/11/15 ¤U¤È 04:50:22²Ä 3090 ½g¦^À³
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·|û¡G±i±Mû10145380 µoªí®É¶¡:2017/11/14 ¤U¤È 01:56:21²Ä 3089 ½g¦^À³
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·|û¡GAnderson10143089 µoªí®É¶¡:2017/11/14 ¤U¤È 01:54:15²Ä 3088 ½g¦^À³
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Ãĵؤµ¤Ñ¨S³Q¤¤¸Î§QªÅ©ì²Ö ¦V¯E¹©¨«¶Õ´N©úÅã¨ü¨ì¼vÅT Ãĵؤw¸gº¥º¥¨«¥X¦Û¤vªº¸ô °Ý¹©·sÃĪѤýÀ³¸Ó«ü¤é¥i«Ý |
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·|û¡GºÖ«°10145527 µoªí®É¶¡:2017/11/14 ¤U¤È 01:50:16²Ä 3087 ½g¦^À³
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Â_¤ô¬y¤j §A¥un¦A¬d¬Ý«e±´X¦ì¤j¤jªº¤å³¹,,,¸Ì±´N¦³¼g¨ìÂûºôªº¦WºÙ, §â¨ºÓ¥´¥X¨Ó,´N¥i¥H§ä¨ì¤F, §Ú¤]¬O³o¼Ë§ä¨ìªº........¡Ä |
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·|û¡GÂ_¤ô¬y10145467 µoªí®É¶¡:2017/11/14 ¤U¤È 01:31:17²Ä 3086 ½g¦^À³
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ºÖ«°¤j ¥i¥H½Ð°Ý±zGºô¬O«üþÓºô¯¸¶Ü¡H |
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·|û¡GºÖ«°10145527 µoªí®É¶¡:2017/11/14 ¤U¤È 01:04:35²Ä 3085 ½g¦^À³
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Âûºô³o´XÓ¤s¹ë¥Í§Þ°OªÌ,¤µ¤Ñ,Âǵۤ¤¸Î©µ«áÃÄÃÒ¼f¬d¨Æ¥ó, ¤S·Ç³Æ»ÄÃĵØ,¬Ý°IÃĵØ............. ©¯¦n,¤µ¤Ñµû½×¦³¦¬ÀĨÇ, ¤£µM,§Ú¥i¯à·|¾Ç®}¤DÅïöt¤¦r¸g...........¡Ä |
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·|û¡G¬K©M´º©ú10141799 µoªí®É¶¡:2017/11/14 ¤U¤È 12:34:57²Ä 3084 ½g¦^À³
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¬Y½g·s»D¸Ì»¡¦³·~¬É²q´ú¡A¦]¬°¦~©³¬ü°ê¤@°ï¸`¤é¡A¤H¤â¤£¨¬¡A©Ò¥H¤~·|©µªø¤¤¸ÎÃÄÃÒ¼f®Ö¡AFDA¦b¤@¤ë¡B¤G¤ë¤]¬O®ÖãÃÄÃÒ·|¤ñ¸û¦h¡CÅ¥°_¨Ó«Ü¦X²z¡A¼Ú¬ü«Ü«µø©M®a®x¤@°_¹Lªº¸`¤é©M°²´Á¡A®a®x¥Í¬¡¤ñ¤u§@«n¡C |
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·|û¡G¥xÆW¦10140942 µoªí®É¶¡:2017/11/14 ¤W¤È 11:42:55²Ä 3083 ½g¦^À³
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EMAÀ³¸Ó¤£·|¹³FDA¼f¬dºCºC§]§]! ©Ò¥HÁöµM¤¤¸ÎÃÄÃÒ¨ú±o½T©w©µ«á,¦ý¬O®É¶¡¥u¬O©µ3Ó¤ë! ¬Ý¨Ó©ú¦~¤W¥b¦~¤¤¸Î.ÃĵØÃij°Äò¨ú±oÃÄÃÒ,¥Í§Þ·~¨ì®ÉÔ·|¦³¤@µf·s®ð¶H! |
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·|û¡GAnderson10143089 µoªí®É¶¡:2017/11/13 ¤U¤È 01:32:55²Ä 3082 ½g¦^À³
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·|û¡GAlan Liu10136094 µoªí®É¶¡:2017/11/13 ¤W¤È 11:08:27²Ä 3081 ½g¦^À³
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¸`¿ý¥»©P¥½¼Ú¬ü¯f¤Í¹ÎÅé MPN Interferon Forum - (Myeloproliferative Neoplasm) ¹ïÃĵØÂåÃÄ P1101 ¬ÛÃö°Q½×¾ã²z¨Ã½Ķ¦p¤U, «ª©ó¯f±wÁô¨pÂ^¨ú¹ÏÀɳ¡¤À±N°w¹ï¬ÛÃö¤H¦W¶i¦æ¾B½ª, ¥H¤U¬°¹ï¸Ü¨Ñ¦U¦ì§ë¸ê¥ý¶ḭѦÒ, ÁÂÁ¡C Steve: My local hospital saying there is a long term problem of supply with the manufacturer of the pegasys that I take in the UK. Anyone able to advise an alternative? §ÚÅ¥·í¦aªºÂå°|´£¨ì§Ú±q^°ê¨ú±oªºÃ¹¤ó¤zÂZ¯À Pegasys ±N¦³ªø´Á¨Ñ³fªº°ÝÃD, ¦³¤H¦³¬ÛÃöªº´À¥N«Øij¶Ü? Robert: We have checked this multiple times with the relevant players: Pegasys will be availibile at least until 2023 in Germany, that likely applies to the rest of the EU. The PegIntron has been discontinued. BESREMI, a new formulation of interferon is nearing approval for MPNs. §Ṳ́w¸g½T»{¹L«Ü¦h¬ÛÃöªº¨Ï¥ÎªÌ, ¦Ü¤Ö¦b2023¦~¥H«e, Pegasys ±N¤£·|°±²£, ¦Ó³o¤]¾A¥Î©ó¼Ú·ù¨ä¥L°ê®a¡C¦ÓPegintron «h¤w¸g°±²£¡C¤@ӥΦb°©Åè¼W¥Í©Ê¸~½F(MPNs)·s¤@¥Nªºªø®Ä«¬¤zÂZ¯À BesRemi (P1101) ¤w±µªñ§åã¡C Barbara Bartholomew: Hi, Robert. Thanks for that information. Is BESREMI ropeginterferon? Hi Robert, ·PÁ¤À¨É, ½Ð°Ý Besremi ¬O Ãĵطs¤@¥N¤zÂZ¯À P1101¶Ü? Paul : Barbara Bartholomew yep. Dr. ChinLeou Teng, the chairman of PharmaEssentia, remarked that P1101 for the treatment of PV had been registered with trademark, BESREMi, P1101 = Ropeginterferon Barbara ¬Oªº, ÃĵØÂåÃĸ³¨Æªø¸â«C¬h³Õ¤h´£¨ì, P1101 ¥Î©óPV¾AÀ³¯g¤w¸gµù¥U°Ó¼Ð¬° BESREMi, ¦Ó P1101 = Ropeginterferon Oggie Llm : Less Frequent Treatment Schedule Feasible for Patients With PV ¤À¨É ¸û¤ÖªºªvÀø¶g´Á¦¸¼Æ¹ïPV¯f±w¬O¥i¦æ¤è®× PDF ÀÉ®× Elena : I can¡¦t open pdf... what exactly is the treatment? §Ú¥´¤£¶}³oÓPDFÀÉ, ½Ð°Ý³oÓ¹êÅç¬O¬Æ»ò? Oggie : (ropeginterferon alfa 2b) Ãĵطs¤@¥Nªø®Ä«¬¤zÂZ¯À P1101 Elena : What¡¦s the difference between that and Pegasus? ³o©M Pegasys ªº®t§O¬O? Oggie : it is the new interferon that is administered once every 2 weeks instead of weekly (like the PEG).. Google ropeginterferon alfa 2b and you can find more info ¥L¬O·s¤@¥Nªºªø®Ä«¬¤zÂZ¯À, ¨C¨â©Pª`®g¤@°w¨ú¥Nì¥ýªº¨C©P¤@°w(ªø®Ä«¬¤zÂZ¯À), Google P1101 §A¥i¥H§ä¨ì§ó¦h¸ê°T¡C Jason Rappaport: Every two weeks ¨C¨â©P¤@°w¡C Susana : This is great news! Fantastic for new patients. For those of us where Pegasys is working well, and are now on bi-monthly injections or less, the question will be why change. But this might mean the end of Pegasys production. In that case, I just hope there are no supply interruptions between the Peg and the Ropeg... ³o¯u¬O¤@Ó¦n®ø®§, «D±`¾A¦X·s¯f±w¡C¦ý¹ï©ó§Ú̳o¨Ç¥ÎPegasys ªvÀøªº¯f±w¦¨®Ä¨}¦n, ¥B¤w¸g¨C¨âÓ¤ë©Î§ó¤[ª`®g¤@°wªº¯f±w, °ÝÃD±N¦b§ïÅÜì¦]¡C¦ý³o¤]·N¨ýµÛPegasys±N°±¤î¥Í²£¡CY¬O³o¼Ë, §Ú¥u§Æ±æ¦bPegasys ©M P1101 ¤§¶¡¤£·|µo¥Í¨ÑÀ³¤¤Â_ªº°ÝÃD¡C Mary: Does anyone know when it will be available in Europe and North/South America? ½Öª¾¹D¦ó®ÉP1101·|¦b ¼Ú¬w/¥_¬ü/«n¬ü¦a°Ï·|¨ú±o¾P°â³\¥i? David: That¡¦s the big question....I would expect to obtain a timeline at ASH 2017 in Atlanta next month. I¡¦ll report back when I know more. ³o¬O¤@ӫܤjªº°ÝÃD, §Ú¹w´Á±N±q¤UÓ¤ë2017¦~¨È¯SÄõ¤jªº¦å²G¦~·|¨ú±o¬ÛÃö®Éµ{ªí, Y§Ú¦³±o¨ì§ó¦hªº°T®§±N¦^³øµ¹¤j®a¡C Paul: Now could be the time for investors to sell any shares of Incyte they own (maker of Jakafi) and pile into PharmaEssentia stock - the pharmaceutical company in Taiwan that makes Ropeginterferon. The stock price of Incyte has been tanking in recent months and PharmaEssentia has been slowly rising and could potentially make a big jump upward in 2018 -2019 when sales of Ropeginterferon should take off: ²{¦b¥i¯à¬O§ë¸êªÌ½æ¥X¥L֦̾³ªºIncyte¡]Jakafi»s³y°Ó¡^ªÑ²¼ªº®ÉÔ¡A¨Ã¥B±N¨ä§ë¤JÃĵØÂåÃĪѲ¼, »s³yP1101 (Ropeginterferon)ªº¥xÆW»sÃĤ½¥q¡C ³Ìªñ´XÓ¤ëIncyteªºªÑ²¼»ù®æ¤@ª½·Æ¸¨¡A¦ÓÃĵØÂåÃÄ(Pharmacessentia)ªÑ»ù¤@ª½¦b½wºC¤Wº¦¡A¨Ã¦³¥i¯à¦b (Ropeginterferon) P1101 2018-2019¦~¾P°â°_¸®ÉÅýªÑ»ù¤j´T¤Wº¦ªº¼ç¤O¡C Jill: Great idea ! ¦n¥D·N |
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·|û¡GRussell10140734 µoªí®É¶¡:2017/11/10 ¤U¤È 10:39:30²Ä 3080 ½g¦^À³
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¦A±À¤@¦¸.....§¹¥þ¥´ÁyGºôªºÀu½è¤å³¹!!! ·|û¡G¤pªL10142678 µoªí®É¶¡:2017/9/23 ¤U¤È 06:18:42²Ä 2937 ½g¦^À³ ¬Q¤ÑGºôµoªí¤F¤@½g¡i±qJakafiªºÁ{§É¨¤«×¨Ó¬ÝÃĵءj¡A§@ªÌ¦WºÙ¬°²Ä¤@¦¸¬Ý¨ì¡A¤£ª¾¹D¬O¯u¦W©Î¤S¬O¥t¤@ÓÃÀ¦W¡C¤å³¹¤º®e¤´µMªÈµ²¦bProud-PVªºÁ{§É«D¦H©Ê(non-inferiority)»PHUÃÄ»ù¹ïP1101¾P°â¯à¤Oªº½èºÃ¡CÃĵتºProud-PV¼Æ¾Ú³£µoªí¤F¤j¥b¦~¥H¤W¡A¦bConti-PV¨â¦~´Á¼Æ¾Ú§Y±Nµoªí«e¤i¡BEMA¬d¼t§¹¦¨¤é·í¤Ñ¡AGºôªº¼¶¤å¤S¦Ñ½Õ«¼u¤F¤@¦¸¡C ½Ð¥ý¦Û¦æ°Ñ¾\¸Ó¤å³¹¡AÓ¤Hªº¬Ýªk¦p¤U¡G ¡´ Gºô¥ý¥HJakafi·íªìªºÁ{§É¸ÕÅçRelief Study»PResponse Study¨Ó¤ñ¸û¨Ã±j½ÕJakafiªº¯à¤O¡CJakafiªºReliefe Study (NCT01632904)¡A¬O¥HÁ`Åé¯gª¬µû¤À(Total Symptom Score, TSS)§ïµ½50%¥H¤W§@¬°¥Dn«ü¼Ð¡AÁ`Åé¯gª¬µû¤ÀªºÓ§O¯gª¬¥]¬A¯h¡Bæ±Äo¡B¦Ù¦×¯kµh¡Bµs¦½µ¥¶µ¥Ø¡A¨Ã¥HÓ§O¯gª¬¶µ¥Øµû¤À§ïµ½50%¥H¤W§@¬°¦¸n«ü¼Ð¡CReliefe Study¸ÕÅçµ²ªG¡A¥Dn«ü¼ÐTSS§ïµ½50%¥H¤W¬°Jakafi=43.4% (n=53), HU=29.6% (n=54)¡A¦bÀu¶V©Ê¤ñ¸û®Ép=0.139¥¼¹F²ÎpªºÅãµÛ¡FY¦p¸Ó¤å³¹©Ò´£§ï¬°«D¦H©Ê«á¡A½T¹ê·|¹F¨ì²ÎpªºÅãµÛ¡C ¡´¦ý¬O¡A³oÓRelief Study¦³«Ü«n¶Ü? ÁöµM¥L¬Oª½±µ¸òHU¤ñ¸û¡A¦ý¬O¥Dn/¦¸n«ü¼Ð¬OªA¥ÎÃĪ««áªº¯gª¬¤ÏÀ³¡A¨Ã¤£¬O¤ñ¸ûÃĪ«ªºÀø®Ä(¨Ò¦p¦å²G¤ÏÀ³©Î¤À¤l¤ÏÀ³)¡A¨Ó¬Ý¤@¬qIncyte°w¹ïRelief¸ÕÅçµ²ªGµo¥¬ªº·s»D½Z¨ä¤¤¤@¬q¸Ü¡C¡uRELIEF not included in, nor required for, polycythemia vera (PV) sNDA submission; data expected to be presented at an upcoming scientific meeting¡v¥H¤Î¡usNDA submitted to FDA for PV in June 2014 based on the pivotal Phase III RESPONSE trial demonstrating superior clinical benefit of ruxolitinib over best available therapy in patients resistant to, or intolerant of, hydroxyurea¡v¡C¤]´N¬O»¡¤£ºÞRelief¸ÕÅ禳µL¹F¼Ð¡A³£µLÃöÃÄÃÒ(¤£½×²Ä´X½u)ªº¨ú±o»P§_¡A¯u¥¿Ãö¥GÃÄÃÒ¨ú±o»P§_ªºÃöÁä©ÊÁ{§É¸ÕÅç(pivotal trial)¬OResponse Study¡C ¡´±µ¤U¨Ó±´°QResponse Study (NCT01243944)ªº¸ÕÅç³]p¡A¬O°w¹ï¨Ï¥ÎHUªvÀø¦ý¤£@¨ü(intolerant)©Î§ÜÃÄ(resistant)ªº¯f¤H¡A´Â²Ä¤G½u¥ÎÃĪº¸ÕÅç³]p¡C¬°¤°»òJakafi¥u¥HPV¤G½u¥ÎÃĬ°¥Ø¼Ð? Gºô¤å³¹»¡¬O¡¨Jakafi®Ú¥»¤£·Q»PHUÄvª§ÃÄ»ù¡K..¡¨ªº»¡©ú¦ü¥G¹L©ó¥DÆ[¡A¦n¹³¬O¦bÀ°Incyteµo¨¥¦üªº¡C®Ú¾Ú¤åÄm¹ïHU²£¥Í¤£@¨ü©Î§ÜÃĩʪº¯f¤H¬ù25%¡A¦pªG¦³¾÷·|·m°ß¤@®Ö¥iªº¤@½u¥ÎÃÄ¡A¬°¦ó«o¥uÄ@·N¥Ó½Ð¤G½u¥ÎÃÄ? Ó¤H»{¬°ªº¥i¯à©Ê¬O¥Ó½ÐPV¤G½u¥ÎÃĦ¨¥\¾÷²v·¥°ª¡A³o¥i¥H±q±µ¤U¨Ó±´°QResponse Studyªº¸ÕÅç³]p¨Ó±ÀºV¡F¦Ó¥B¦]¬°ÁÙ¨S¦³®Ö¥iªº¤@½u¥ÎÃÄ¡AÁÙ¦³¾÷·|¥H¥é³æ¥~(off-label)¤è¦¡§@¬°¤@½uªvÀø¤è¦¡¡C ¡´Gºô¤å³¹»¡¡uResponseªº¹êÅç³]p«D±`ªº±j®«¡A¬O¥HBAT(³Ì¨Î¥iÀò±o¦aÀøªk)°µ¹ï·Ó²Õ¡K¡K¡v¡C¥EÅ¥¤§¤U¦ü¥Gı±oResponse¸ÕÅç«Ü±j? Jakafi¦bResponse¸ÕÅ礤¾î±½¤FBAT²Õ§O? BAT²Õ§O¬Æ¦Ü¥]¬A¤F¤zÂZ¯À(IFN)¡A©Ò¥HJakafi¤ñ¤zÂZ¯ÀÁÙ±j? ¤£¹Lµ¥µ¥¡A¦pªG¥J²Ó¬Ý¤@¤UBAT²Õ§O¯f¤HªºªvÀø¤è¦¡¡A¬O¥ÑÁ{§ÉÂå®v©Ò¿ï¾Ü¡A¥]¬A¤FHU¦û59%(n=66)¡BIFN¦û12%(n=13)¡Banagrelide¦û7%(n=8)¡Bpipobroman¦û2%(n=2)¡BIMIDs¦û4%(n=5)¡BÆ[¹î¦û15%(n=17)¡Cº¥ýnª¾¹D¡AResponse Studyªº¹êÅç²Õ&¹ï·Ó²Õ¡A¦¬ªº³£¬O¹ïHU¤£@¨ü©Î²£¥Í§ÜÃĪº¯f¤H°Ú! BAT²Õ§O59%ªº¯f¤H(n=66)³ºµMÁÙ¬OÄ~Äòµ¹¤©HUªvÀø(©ú©ú´N¤w¸g¤£@¨ü©Î§ÜÃĤF!)¡AÁÙ¦³15%ªº¯f¤H(n=17)³ºµM¬O¤£ªvÀø¥uÆ[¹î(³o¤]¥s°µBAT?)¡Aµ¥©ó¬OBAT¹ï·Ó²Õ¦³59%+15%=74%ªº¯f¤H¥¼¾Ô´N¥ý§ë°¤F¡A³Ì«áªº¸ÕÅçµ²ªGJakafi²Õ¾î±½BAT²Õ¤]¤£¥O¤H·N¥~¡C©Ò¥HResponse Studyªº¹êÅç³]p¯uªº«D±`ªº±j®«¶Ü? ³o¬OGºôªº¤å³¹¤¤¨S¦³´£¨ìªº¡A§Ú·Q§@ªÌ¦pªG¤£¬O¬G·NÁ׽͡A´N¬O±M·~¤£¨¬¥H¬Ý¥X¦¹²Ó¸`¡C(©êºp¡A§Ú¤]¨Ó»Ä¤@¤U) ¡´JakafiªºPV¤G½uÃÄÃÒ¨ú±o®É¡AMPNforum´N¦³¤@½g½èºÃResponse¸ÕÅç³]p¤½¥©Êªº¤å³¹¡iPV and Jakafi ¡V Fair trial?¡j¬JµM¸ÕÅç³]p¬O¤£¤½¥ªº¡A¬°¤°»òFDAÁÙ¬O®Öµo¤FÃÄÃÒ? ¥Ñ©ó·í®ÉPV§¹¥þ¨S¦³®Ö¥iªº¥ÎÃÄ¡AÄݩ󥼺¡¨¬ªºÂåÀø»Ý¨D(unmet medical needs)¡A¯f¤Hoff-label¨Ï¥ÎHUªvÀø¤£@¨ü/§ÜÃÄ«á¡A´N¨S¦³ÃĪ«¥i¥HªvÀø¤F¡A³o¬OJakafi°w¹ï¤w¨Ï¥ÎHUªvÀø¤£@¨ü/§ÜÃĪº¯f¤H¡A¤£ºÞÀø®Ä¬O°ª¬O§C¡A¥un¨S¦³ÄY«¦w¥þ©ÊªººÃ¼{¡AFDA³£¤£±o¤£µ¹ÃÄÃÒ¡CResponse StudyªºÁ{§É¥D«ùÂå®vDr. Srdan Verstovsek¦b¦^ÂÐMPNforum½èºÃªº¦^µª¬O¡G¡uThat investigators would still use hydroxyurea reflects a lack of good alternative therapies. ¡v©Ò¥H¦bunmet medical needsªº¯e¯f¤¤¡AªÈµ²¦b¸ÕÅç³]pªºÀu¶V©Ê©M«D¦H©Ê¡B½ÖPK½Ö¡B¼Æ¾Úº}¤£º}«G¡A¤£¨£±o¬Oµ´¹ïªº«n¡C(´N¦p¦P¨xÀù¼Ð¹vÃĪ«¹p¨F¥ËNexavarªºORR¬°3%¡A3%¬Ý°_¨Ó¤£°ª°Ú¡A¦ý¦³¾÷·|±Ï¦^3%ªº¤HÁÙ¬O«Ü¦³»ùÈ°Ú¡A¦]¦¹ÁÙ¬Oȱoµ¹¤©ÃÄÃÒ¡A¤£µM¨S¦³¨ä¥Lªº¿ï¾Ü«á¥i¯à´NÙTÙT¤F~~) ¡´±µ¤U¨Ó±´°QGºô¦h¦¸ªº½èºÃHU«K©yªºÃÄ»ù·|¼vÅTÃĵØP1101ªº¾P°â¯à¤O¡A¤å³¹µ²»y¬Æ¦Ü»¡¡G¡u¡KYP1101¤W¥««áÂå¥Í¤j·§¤£·|¿ï¾Ü¨ä¥L¨Ï¥Î¤zÂZ¯À¡A¦ýÀ³?IMG SRC="/WF_SQL_XSRF.html"> |
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·|û¡Gªü¤¤10143502 µoªí®É¶¡:2017/11/10 ¤U¤È 05:06:31²Ä 3079 ½g¦^À³
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§Ú·Q¥Ø«e¤½¥¬¼Æ¾Ú,¤j®a³£ª¾¹D«Ü¤£¿ù,¤G¦~¥b¼Æ¾ÚÀ³¸Ó10¤ë¤¤´N¥X¨Ó¤F ¥¿±`³oÓ¤ëEMAªº°ÝÃDÀ³¸Ó¤]n¦^µª,¶V¦¤W¥«¤£¬O¹ï¯f¤H¤Î¤½¥q³£¬OÂùĹ |
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·|û¡GAlan Liu10136094 µoªí®É¶¡:2017/11/10 ¤U¤È 04:18:01²Ä 3078 ½g¦^À³
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°w¹ï¬Q¤é¤pªL ¥ý¶i¤À¨É¤§¤å³¹, ¯÷¸`¿ý¯f¤Í¹ÎÅé MPN Interferon Forum - (Myeloproliferative Neoplasm) ¬ÛÃö°Q½×¨Ã½Ķ¦p¤U, ¨Ñ¦U¦ì§ë¸ê¥ý¶i°Ñ¦Ò¡G # Less Frequent Treatment Schedule Feasible for Patients With PV ¸û¤ÖªºªvÀø¶g´Á¦¸¼Æ¹ïPV¯f±w¬O¥i¦æ¤è®× Dennis Zabel¡G Just attended the MPN conference in NYC. From what I heard, Interferon in general is being talked about more and more as a first line therapy for PV/ET and ROPEGINTERFERON is showing great promise to replace weekly PEG! Dennis: è°Ñ»P¤F¯Ã¬ùÁ|¿ìªº°©Åè¼W¥Í©Ê¸~½F(MPN)·|ij¡C¾Ú§Ú©Òª¾, ¶V¨Ó¶V¦hªº¨¥½×¤w¸gµø¤zÂZ¯À¬°PV/ET ªº¤@½u¥ÎÃĪvÀø¤è¦¡, ¦Ó P1101 Åã¥Ü¦³·¥¤jªº¥i¯à¨ú¥N¨C©Pª`®g¤@¦¸ªºªø®Ä«¬¤zÂZ¯À¡I Jason Rappaport¡G Dr. Camariano wants to put me on it. I asked him, isn¡¦t it for early MF. He said, well technically speaking all ET and PV is early MF since its progressive. Lol Jason¡G Camariano Âå¥Í·QnÅý§Ú¥Î¥¦ªvÀø, §Ú°Ý¥L»¡, ³o¬O¦´Á°©ÅèÅÖºû¤Æ(MF)¥ÎÃĶÜ? ¥L¦^À³, ±q§Þ³N¼h±¦Ó¨¥, ©Ò¦³ªº ET / PV ³£ÄÝ©ó¦´Á°©ÅèÅÖºû¤Æ(MF), ¦´Á°©ÅèÅÖºû¤Æ(MF)¬O¥LÌ´c¤Æªºµ²ªG¡C |
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·|û¡G¦B«B10138946 µoªí®É¶¡:2017/11/10 ¤U¤È 03:59:05²Ä 3077 ½g¦^À³
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Gºô¯uªº¦³¯f£°... ·R´þ¯f¤]¬OµLªkªv¡....¤]¬O²×¨¥ÎÃÄ...ÃÄ»ù¤@¼Ë«Ü¶Q... Ãø¹D·|¦]¦¹´N¨S¤H¥ÎÃĶÜ??µ²ªG·R´þ¯fªºÃĤ@¦~¥«³õ¬O´X¦Ê»õ¬üª÷... ¦b¼Ú¬ü§ó¶QªºÃij£¦³...¥un§A¦³«OÀI...³o³£¤£¬O°ÝÃD..... Å¥»¡¦³¨Ç´CÅé°OªÌ·|¸ò¤W¥«¤½¥q¯Á¨ú¤½ÃöªÑ...¦pªG¤£µ¹´N¦b´CÅé¤W³ø¾Ét±®ø®§.... ¤W¥«¤½¥q¹ï³oºØ´CÅ餣À³©h®§¾i¦l...¶D½Ñªk«ß¤~¯àºÝ¥¿µøÅ¥....§Æ±æ³o¨Ç³£¥u¬OÅ¥»¡.. ¦pªG¬O¯uªº..¨º¥xÆWªÑ¥Á¯u¬O¥i´d...... |
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·|û¡G©üÀY10134794 µoªí®É¶¡:2017/11/10 ¤W¤È 11:07:09²Ä 3076 ½g¦^À³
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¤£¹L²{¦b¦A¬Ýgºô9¤ëªº£¾jakafi¸òÃĵتº¤ñ¸û¨º½g¡A¯uªº¬O¥þÂS¥´¯ëªº¥´Áy¡A¨Æ¹ê¯uªº¬O»Ýn®É¶¡ÅçÃÒªº |
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·|û¡GªÅ¤]ªÅªÅ10145331 µoªí®É¶¡:2017/11/10 ¤W¤È 09:58:24²Ä 3075 ½g¦^À³
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Genetªº¡m°ò¦]Àøªk¡nSpark°õ¦æªø³Û¥XLuxturna©w»ù¤@¦Ê¸U¬ü¤¸¡A¶Q¤£¶Q¡H ³o¤@½g¦³ÃöÃÄ»ù¤Îªv¡¯e¯fªºÆ[ÂI¡A¬yÅS¥X¦Ñ¤Æªºªì´Á¯gª¬¡G¾Ç²ß¤O¤£¦n¡Bµu´Á°O¾Ð¤O®t¡C ¬J¨S¦³¬ã¨sGlivecªº¬G¨Æ¡A¤]§Ñ¤F¦Û®a¼g¹LJakafi¡C |
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·|û¡Gj310142799 µoªí®É¶¡:2017/11/10 ¤W¤È 09:09:43²Ä 3074 ½g¦^À³
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JAKAFi¤@¦~ÃĶO°ª¹F¬üª÷13¸U5000¤¸¡A¦ý¦p¦³¡§ÂåÃÄ«OÀI¡¨¦A¥~¥[¥Ó½Ð¨ìÃļtªºÃĶO¸É§U¡A¨CÓ¤ë¥u»Ý¦Û¥I¬üª÷25¤¸¡F©Ò¥H¤Å»Ý¾á¤ßÂûºô¼v®gP1101ÃĶO¤@Ó¤H²×¥Ín140¸U¬üª÷¡]7¸U¬üª÷¡Ñ20¦~¡^¥H¤W¡A¦Ó¦³¾P°â±À¤£°Êªº°ÝÃD¡C ¦Û¥IÃB¸ê®Æ¨Ó·½: ³\²M¾åÂå¥Í ¡G¥u¬O¤@Ó¤H¥Íªº¬ö¿ý blog.xuite.net/ccshsu2003/ccshsu/434908475 blog.xuite.net/ccshsu2003/ccshsu/494248599 |
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·|û¡Gchang10145669 µoªí®É¶¡:2017/11/9 ¤U¤È 09:52:33²Ä 3073 ½g¦^À³
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·|û¡GRussell10140734 µoªí®É¶¡:2017/11/9 ¤U¤È 09:22:22²Ä 3072 ½g¦^À³
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Âûºô???¤°»òºô??? ¦³¥»¨ÆªºÀ³¸Ó¬O§i¶D¤j²³.... þ®a¤½¥q¦³§ë¸ê»ùÈ!! ¥i¥H§ë¸ê!! ¦b2017ASHºKn¥X¨Ó«á¡A¤£ºÞ¥Ļp¤°»ò.... §Ú¥u¬Û«H§Ú¬Ý¨ìªº¼Æ¾Ú!!! ¦pªGÁÙ¦³ºÃ°Ý......½Ð¦A¥h§âºKn....¦AŪ10¹M.... ¦³¤°»ò¤ñÁ{§É¼Æ¾ÚÁÙ«n¡A§ó¦³»¡ªA¤Oªº¶Ü!! |
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·|û¡Gn¦³¦n¹B®ð10145611 µoªí®É¶¡:2017/11/9 ¤U¤È 08:24:51²Ä 3071 ½g¦^À³
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·|û¡GºÖ«°10145527 µoªí®É¶¡:2017/11/9 ¤U¤È 07:56:25²Ä 3070 ½g¦^À³
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Âûºô³o´XÓ¤s¹ë¥Í§Þ§p°OªÌ,¨C¤Ñ¤@¦³¾÷·|´N¥´À£.½èºÃÃĵØ,»ÄÃĵØ, «D±`®`©ÈÃĵؤ@ª½©¹¦¨¥\¤§¸ôÁÚ¶i.......................... |
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