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ASLAN004(IL-13R£\1)¦A¥[ºò¸}¨B,¨È·à±d«Ü¦³¾÷·|¦¨¬°COPDÅQ¥D! 1.2016ªº¤å³¹ www.nature.com/articles/mi201556 ....IL-13 receptor (R) £\1 and are key pharmacological targets in fibrotic diseases. However, the roles of IL-13R£\1 in mediating lung injury/repair are unclear........ These data highlight underappreciated protective roles for IL-13R£\1 in lung injury and homeostasis. 2. But COPD is different, and Schleifer said Regeneron doesn¡¦t have a ¡§high degree of confidence in Dupixent¡¦s ability to conquer that disease. Researchers saw ¡§clear-cut effects¡¨ in Dupixent¡¦s asthma studies, but ¡§COPD is much tougher,¡¨ Schleifer said. Regeneron¡¦s not giving up on the indication, ¡§but we wouldn¡¦t rank this as something we have high degree of confidence in,¡¨ he said. ¡§COPD is a very complex disease,¡¨ echoed Yancopoulos. Many patients who have COPDs worsened with other Type 2 inflammations, and ¡§the problem is finding the right patients to treat, and also negotiating with the FDA who likes to study cleaner diseases,¡¨ he explained. COPD is indeed a tough nut to crack, previous studies have shown. Dupixent¡¦s biologics competitors, GlaxoSmithKline¡¦s Nucala and AstraZeneca¡¦s Fasenra, have both turned up failure in the field. |
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¤@³õ¥@¬ö¤jÁɺVÆr¤F!!! ¥Ò¶¤:¨È·à±d+CSL,ASLAN004 ¤A¶¤:ù¤ó+Dermira, Lebrikizumab ¤þ¶¤:Dermira+ Almirall¼Ú¬w°Ï, Lebrikizumab ¤A¶¤/¤þ¶¤¹ï»ù»P¹ê¤O²¤¶: ù¤óªºlebrikizumab(anti-IL13)¬O·½¦Ûð«n¬À»P±i¤l¤å³Ð«ØªºTANOX¤½¥qªºTNX650. www.immunwork.com/edcontent_d.php?lang=tw&tb=1&id=20 1.DermiraÀò±où¤ó¥Ö½§¯fÃĪ«Lebrikizumab¿W®a¶}µoÅv zi.media/@yidianzixun/post/sJwWwt 2.20190319:¥Íª«¬ì§Þ¤½¥qDermira(DERM.US)¥Ö肤ª¢ªv疗试验¨ú±o¬ð¯} ªÑɲ涨¶W80% 3.Almirall hands over $50M for European rights to Dermira¡¦s Dupixent challenger www.fiercebiotech.com/biotech/almirall-hands-over-50m-for-european-rights-to-dermira-s-dupixent-challenger |
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¨È·à±d-KY ¤½¥¬ 2019 ¦~²Ä¤G©u°]°È·~ÁZ¤Î§ó·s¬ãµo¶i«×¡@ 2019 ¦~ 8 ¤ë 12 ¤é¡A·s¥[©Y ¡V »EµJ©óÁ{§É¶¥¬q¸~½F¤Î§K¬Ì¾Ç¤§Á{§É¶¥¬q¥Íª«»sÃĤ½¥q¨È·à±d-KY (NASDAQ:ASLN, TPEx:6497)¤µ¤é¤½¥¬ºI¦Ü 2019 ¦~ 6 ¤ë 30 ¤é¤§©u«×°]°È³ø§i¥H¤Î³Ì·sÁ{§É¬ãµo¶i«×¡C ¨È·à±d-KY °õ¦æªø³Å«i³Õ¤hªí¥Ü:¡u¨È·à±d¦b²Ä¤G©u¨ú±o¤F«¤j¶i®i¡A¥]¬A§ÚÌ»P K-MASTER q©w¦X§@¶}µo varlitinib ©óÂಾ©ÊGÀù¤§¨óij¡B§ó·s¶i¦æ¤¤ªº ASLAN003 «æ©Ê°©Åè©Ê¥Õ¦å¯f¸ÕÅçµ²ªG¥H¤Î©ó ASLAN004 ³æ¤@¾¯ ¶q»¼¼W¸ÕÅç¨ú±oµ²ªG¡AÅã¥Ü»P¨ä¥L IL4/IL13 §í¨î¾¯¬Û¤ñ¯à°÷«P¶i²ÓM¤À¤Æ¡Cų©ó¤Wz¥O¤H¹ª»Rªº·s¼Æ¾Ú¡A§Ú ̶i¦Ó»P CSL ×q¨óij¡AÂX®i¨óij½dÃ¥¨ú±o³o¶µ²§¦ì©Ê¥Ö½§ª¢¦P¯Åº¨£ªvÀø§ÜÅ餧¥þ²y¶}µo¡B»s³y»P°Ó«~¤Æ Åv§Q¡C®i±æ¤U¥b¦~¡A§Ú̹wp©ó²Ä¥|©u¨ú±o varlitinib ©óÁx¹DÀù¤G½u¼Ï¯Ã©Ê¸ÕÅç(TreeTopp)¤§ªì¨B¼Æ¾Ú¡C¡v 2019 ¦~²Ä¤G©u©Mªñ´Á·~°È«GÂI Á{§É¬ã¨sµo®i Varlitinib • ¨È·à±d-KY »P Korean Cancer Diagnosis & Treatment Enterprise (K-MASTER)ñ¸p¨óij¡A¶i¦æ varlitinib ¦X¨Ö¨C©P¤@¦¸ paclitaxel ©ó HER1/HER2 ¦@¦Pªí²{¡B±ß´Á©ÎÂಾ©Ê¤G½uGÀù¤§ 1b/2 ´Á¦h¤¤¤ß³Ê§Î¸ÕÅç¡A¦®¦b µû¦ôÃĪ«¦w¥þ©Ê©M¦³®Ä©Ê¡C³o¶µ¶}©ñ©Ê¡B¦h¤¤¤ß¸ÕÅç±N©Û¦¬¬ù 400 ¦ì¨ü¸ÕªÌ¡A¨Ì¥Íª«¼Ð°O¯S©Ê¤À¬° 4 Ó¸ÕÅç²Õ¥H¤Î¤@²Õ¹ï·Ó²Õ¡C ASLAN003 ( • ASLAN003 ©ó´_µo/Ãøªv©Ê«æ©Ê°©Åè©Ê¥Õ¦å¯f¤G´Á²Ä¤@³¡¤À¸ÕÅç¤w§¹¦¨¦¬®×¡A¥H³æ¿WªvÀø¤§¤è¦¡´ú¸Õ ASLAN003 ¥|ºØ¤£¦P¾¯¶q(100mg QD¡B200mg QD¡B100mg BID¡B200mg BID)¤§Àø®Ä¡C©PÃä¦å²GªÞ²ÓM¼Æ ¥Ø¤j´T°§C¹F 98%¡A¨Ã¦b¼Æ¦ì¯f±w¤¤Æ[¹î¨ìªÞ²ÓM¦bµu®É¶¡¤º¤U°¡AASLAN003 ©ó«æ©Ê°©Åè©Ê¥Õ¦å¯f ¯f±w¦³¨}¦n@¨ü©Ê¡A24 ¦ì¨ü¸ÕªÌ¤¤¥u¦³¤@¦ì¥X²{³QÂkÃþ¬°¸ÕÅçÃÄ«~¬ÛÃöÄY«¤£¨}¨Æ¥ó¤§¶Ý¤¤©Ê¥Õ¦å²y §C¤Uµo¿N»P¸~½F·»¸Ñ¯gÔ¸s¡C¨È·à±d-KY ¥Ø«e¥¿¦b°w¹ï ASLAN003 ¤U¤@¶¥¬q¬ãµo¤è¦V¶i¦æµû¦ô¡C ASLAN004 • §¹¦¨ ASLAN004 ©ó°·±d¨ü¸ÕªÌ¤§³æ¤@¾¯¶q»¼¼W¸ÕÅç(SAD)¡A¨Ã¤½¥¬¸Ó¸ÕÅç²Ä¤G³¡¤À ASALN004 ¥H¥Ö¤Uª` ®g¤§µ¹ÃĤ覡¤§Á{§É¼Æ¾Ú¡C³æ¤@¾¯¶q»¼¼W¸ÕÅ礧µ²ªGÅã¥Ü ASLAN004 @¨ü©Ê¨}¦n¡A¥i§¹¥þ§í¨î¤U´å¤¶ ½è¡A¥ÎÃÄÀW²v¥i±æ¬°¨C¤ë¤@¦¸¡C • »P CSL Limited ×q±ÂÅv¨óij¡A¨ú±o ASLAN004 ©Ò¦³¾AÀ³¯g¤§¥þ²y¶}µo¡B»s³y»P°Ó«~¤ÆÅv§Q¡C³o¶µ×q ¨óij±N¨ú¥NÂù¤è¥ý«e©ó 2014 ¦~¤¤ë©Òñq¤§¦X¬ù¡C®Ú¾Ú×q¨óij±ø´Ú¡A¨È·à±d-KY ±N©ó ASLAN004 ¤T ´Á¸ÕÅç±Ò°Ê®É¦V CSL º¦¸¤ä¥I 3,000 ¸U¬üª÷¡CCSL ±N¥i¦¬¨ú³Ì°ª¹F 9,500 ¸U¬üª÷¤§ªk³W¥Ó½Ð¶i«×¨½µ{ ª÷¡A³Ì°ª¹F 6.55 »õ¬üª÷¤§¾P°â¨½µ{ª÷¥H¤Î¨Ì¾P°â²bÃB¤À¼h¦¬¨úÓ¦ì¼Æ¤¤¦ì¼Æ¦Ü 10%¤§Åv§Qª÷¡C ¤½¥qÀç¹Bªv²z§ó·s • ¥»¤½¥q¿ï¥ô Andrew Howden ¬°¸³¨Æªø¡C¦Û¤½¥q 2010 ¦~³Ð¥ß¥H¨Ó¾á¥ô¸³¨Æªøº[°õ¦æªøªº Carl Firth ³Õ¤h ±N«ùÄò¾á¥ô¥»¤½¥q°õ¦æªø¤Î¸³¨Æ·|¦¨û¡C¥»¤½¥q¸³¨Æªø©M°õ¦æªøªºÂ¾°È±N¥Ñ¤£¦P¤H¿ï¤À¦Ó¥ô¤§¥H¸¨¹ê ¨}¦nªº¤½¥qªv²z¨î«×¡C ¹wp¹F¦¨¤§¨½µ{¸O • ©ó¤E¤ë©³©ó¼Ú¬w¸~½FÂå¾Ç·|(ESMO) 2019 ¦~¦~·|µoªí varlitinib ¦X¨Ö mFOLFIRI ©ó±ß´Á¹êÅé½F¤§¤@´ÁÁ{§É ¸ÕÅç·s¼Æ¾Ú¡C • ©ó 2019 ¦~¤U¥b¦~®i¶} ASLAN004 ©ó¤¤««×²§¦ì©Ê¥Ö½§ª¢±wªÌ¤§¦h¾¯¶q»¼¼W¸ÕÅç¡C • ©ó 2019 ¦~²Ä¥|©u¨ú±o varlitinib ¤G½uÁx¹DÀù¥þ²y©Ê¼Ï¯Ã¸ÕÅç(TREETOPP)ªì¨BÁ{§É¸ÕÅç¼Æ¾Ú¡C¡@ 2019 ¦~²Ä¤G©u°]°È«GÂI • 2019 ¦~²Ä¤G©u¡AÀç¹B¬¡°Ê©Ò¥Î²{ª÷¬° 650 ¸U¬ü¤¸¡A2018 ¦~¦P´Á¬° 1,000 ¸U¬ü¤¸¡C • 2019 ¦~²Ä¤G©u¬ãµo¶O¥Î¬° 530 ¸U¬ü¤¸¡AºÞ²z¶O¥Î¬° 190 ¸U¬ü¤¸¡A2018 ¦~¦P´Á¤À§O¬° 830 ¸U¬ü¤¸»P 310 ¸U¬ü¤¸¡C¬ãµo¶O¥Î¤U°¤§ì¦]¬°³¡¤ÀÁ{§É¸ÕÅ秹¦¨¥H¤Î»s³y¶O¥Î°§C¡CºÞ²z¶O¥Î¤U°¤§ì¦]«h¬° ¤½¥q©ó 2019 ¦~ 1 ¤ë¶i¦æ¤º³¡¬[ºc«¾ã¡C • 2019 ¦~²Ä¤G©u²b·l¬° 790 ¸U¬ü¤¸¡A2018 ¦~¦P´Á²b·l¬° 1,100 ¸U¬ü¤¸¡C • ºI¦Ü 2019 ¦~ 6 ¤ë 30 ¤é¡A²{ª÷¡B¬ù·í²{ª÷©Mµu´Á§ë¸êÁ`ÃB¬° 1,510 ¸U¬ü¤¸ ¡A¥h¦~ºI¦Ü 2018 ¦~ 12 ¤ë 31 ¤é¬° 2,890 ¸U¬ü¤¸¡C2019 ¦~²Ä¤G©u¥[Åv¥§¡流³q¦b¥~ªÑ¼Æ¬° 1.6 »õªÑ¡A2018 ¦~¦P´Á¬° 1.48 »õªÑ¡C ¨C³æ¦ì¬ü°ê¦s°U¾ÌÃÒªí¹ü¨È·à±d-KY ´¶³qªÑ 5 ªÑ |
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·|û¡GROGER588910148151 µoªí®É¶¡:2019/8/13 ¤U¤È 05:26:13²Ä 1190 ½g¦^À³
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[..as well as results from our ASLAN004 single ascending dose study supporting differentiation versus other IL4/IL13 receptor inhibitors. Based on this exciting new data, we amended the agreement with CSL Limited to include full global rights to develop, manufacture, and commercialise this first in class therapeutic antibody for atopic dermatitis and other indications. ] ®ÇÆ[¤w¤[,·Pı¥H¤W®×±¡¤£³æ¯Â,»ù¦ì±q64©¹¤Uªø¹F16Ó¤ë,À³¸Ó¬O°µ¹Ú³£·|¯º¿ôªº¾÷·|°ª¤@¨Ç! ¦~©³«e³°Äò¤½¥¬¤@¨ÇÁ{§Éµ²ªG,¤pÀ£¤â®ðÅo! |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2019/8/13 ¤U¤È 04:15:46²Ä 1189 ½g¦^À³
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finance.yahoo.com/news/aslan-pharmaceuticals-reports-second-quarter-080320228.html ASLAN Pharmaceuticals Reports Second Quarter 2019 Financial Results and Provides Corporate Update we await topline data from our pivotal TreeTopp trial as second line treatment for biliary tract cancer, in the fourth quarter.¡¨ |
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·|û¡GÀ³µL©Ò¦í10144738 µoªí®É¶¡:2019/8/13 ¤U¤È 02:51:35²Ä 1188 ½g¦^À³
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°]³ø--¶O¥Î¦³¤j´T¤U° ¦ý ²bÈ ¥u³Ñ3.56 ³oÓ°ÝÃD«Ü¤j §C»ù ¦pªGn¶Ò¸ê ªÑ¥»±N¤j¤j¤j¿±µÈ °£«D ¦nªº±ÂÅv Á`Âk ¥[ªo |
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·|û¡GÀ³µL©Ò¦í10144738 µoªí®É¶¡:2019/8/13 ¤W¤È 11:21:41²Ä 1187 ½g¦^À³
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2019/8/13 ¤W¤È 11:09:11²Ä 1186 ½g¦^À³
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ºC©Êªý¶ë©ÊªÍ¯e¯f COPD Primary Outcome Measures : Annual rate of acute COPD exacerbation (AECOPD) [ Time Frame: Baseline to Week 52 ] Annualized rate of moderate or severe COPD exacerbations over the 52-week treatment period compared to placebo clinicaltrials.gov/ct2/show/NCT03930732?term=Dupilumab&draw=2&rank=23 Experimental: Dupilumab Dupilumab administered every 2 weeks COPD (Chronic Obstructive Pulmonary Disease )±wªÌ¶·ªvÀø¤@¦~¡A¬O¤@¦ì²§¦ì©Ê¥Ö½§ª¢ªvÀø4Ӥ몺3¿¥Î¶q¡C COPD ¥«³õ¨S¦³¯«ÃÄ! ¾Ú¦ôp¡A¸Ó¯f¼vÅT¥þ²y¬ù3.84»õ¤H¡A¹wp¨ì2020±N¦¨¬°²Ä¤T¤jP¦º¦]¯À¡Cªì¦¸¶EÂ_®É¡A¬ù1/3¬°ÄY«©Î«D±`ÄY«ªºCOPDÃþ«¬¡C¥t¥~¡A¬ù¦³30-40%ªº¤¤«×¦Ü««×COPD±wªÌ§Y«K±µ¨ü¤TÁp§l¤JÀøªk¡]ICS/LAMA/LABA¡^¯f±¡¤´¤£¨ü±±¨î¨ÃÄ~Äò´c¤Æ¡C In 2015, 3.2 million people died from COPD worldwide, an increase of 11.6 percent compared with 1990. During that same time period, the prevalence of COPD increased by 44.2 percent to 174.5 million individuals. In the United States, an estimated 16 million adults have COPD.2018¦~9¤ë21¤é ¬ü°ê1600¸U¤H±wCOPD , 30%¤¤¡Ð««×, ¥«³õ480¸U¤H , ¬ü°ê700¸U¤H¡A±w²§¦ì©Ê¥Ö½§ª¢. ªì²¤¦ô¤¤««× COPD¤H¼Æ ¡A¬O¤¤««×²§¦ì¥Ö½§ª¢¤H¼Æ,2.4¿(1700/700=2.4) Dupilumab ¥«³õ¦ô¬ü°ê¤¤««×¥i½æ¥X50»õ¬ü¤¸(2024¦~), ¦ô COPD ¬ü°ê¥«³õ= 50»õ¬ü¤¸x2.4X3=360»õ¬ü¤¸¡C(¤T´ÁÁ{§É¤¤) |
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·|û¡G¥xÁÞ10138776 µoªí®É¶¡:2019/8/13 ¤W¤È 10:35:05²Ä 1185 ½g¦^À³
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¤j®a«Ü¥Î¥\¨Ã«Ü¼ö¯Pªº°Q½× ASLAN 004 À³¥Î¦bCOPD ¯f±w¤W, ³o¬O¤@ӫܦ³¼ç¤Oªº¾AÀ³¯g ¤E¦~«eªº¬ã¨s Interleukin-13: prospects for new treatments www.ncbi.nlm.nih.gov/pmc/articles/PMC3992377/ ¤å³¹«Üªø ¨S®É¶¡¥i¬Ý³Ì«á --- ¥¼¨Óªº¼vÅT ¥¼¨Óªº¼vÅT §Ú̲{¦b¥¿¶i¤J®ð¹D¯e¯fªº·sªvÀø¦~¥N¡C¦b±µ¤U¨Óªº2 - 3¦~¤¤¡AÁ{§É¸ÕÅ窺µ²ªG±N½T©w§ÜIL-13µ¦²¤ªº§@¥Î¡C»P¦¹¦P®É¡A¨ä¥L·sÀøªkªº©w¦ì¡A¥]¬A°w¹ï¨ä¥L²ÓM¦]¤l¡AÁͤƦ]¤l¨üÅé¡A§K¬Ì½Õ¸`¾¯[90]©M¼ö¦¨§Î³N[91]ªº©w¦ì±N¬°§ÚÌ´£¨Ñ¿ï¾Ü¡A¯S§O¬O¦b±w¦³ÄY«ý³Ýªº±wªÌ¤¤¡C³o¨ÇªvÀø¤èªk¤£¤Ó¥i¯à¾A¦X©Ò¦³±wªÌ¡A¦]¦¹±Ný³Ý©MCOPDÃѧO¬°²§½è©Ê¯e¯f±NÅܱo¶V¨Ó¶V«n[92]¡C¥Ø«eÀ³¥Î¨Ã¶}µo·sªºµ²ªG´ú¶q©M¥Íª«¼Ð°Oª«¥H½T«O¬°±wªÌ¿ï¾Ü³Ì¦X¾AªºªvÀø©ÎªvÀø²Õ¦X¡C §t¦³IL-13§@¬°ý³Ýµo¯f¾÷¨î¤¤ÃöÁä²ÓM¦]¤lªº¤j¶q¼Æ¾Ú´£¨Ñ¤F¤@Ó¥O¤H«HªAªº®×¨Ò¡A¥i¥H¹w´úÁ{§É¤W§ÜIL-13ªº¥i¯à¦¨¥\¡C¦b¤£¤[ªº±N¨Ó¡A§ÚÌn¤£¬O°÷¬°ý³Ý±wªÌ¨Ï¥Î·sÀøªk¡A´N¬O§ÚÌ»Ýn×¥¿ý³Ýªº°ò¥»²z½× ¥H¤W¤À¨É ¶È¨Ñ°Ñ¦Ò |
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·|û¡GROGER588910148151 µoªí®É¶¡:2019/8/13 ¤W¤È 09:43:58²Ä 1184 ½g¦^À³
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°²YDupilumab¦bCOPD¤]Àò§å,¨º»ò°ª®p¾P°âÃB>100»õ¬ü¤¸¥i¤£¬O¹Ú. 赛诺µá/¦A¥Í¤¸Dupixentý³ÝÓì应¯g¦A获§å 2024¦~销°â将达80亿med.sina.com/article_detail_100_2_54516.html 该药¦b2024¦~将¦¨为继¦ã§B维׬ü乐¡]Humira¡^¤§¦Zªº¥þ²y²Ä¤G¤j畅销§Üª¢药¡A销°â额将达¨ì80.58亿¬ü¤¸¡A2018-2024¦~ªºÎ`¦X¦~¼W长²v¡]CAGR¡^°ª达64%¡F¨ä¤¤¬ü国¥«场2024¦~销°â额将达¨ì53.7亿¬ü¤¸¡A |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2019/8/13 ¤W¤È 09:26:31²Ä 1183 ½g¦^À³
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Study Design Go to sections Dupilumab in Patients With Moderate-to-severe COPD ,924¤H, ¤T´ÁÁ{§É Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate-to-severe COPD With Type 2 Inflammation (BOREAS) Study Type ƒÊ : Interventional (Clinical Trial) Estimated Enrollment ƒÊ : 924 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment Official Title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) With Type 2 Inflammation Actual Study Start Date ƒÊ : April 15, 2019 Estimated Primary Completion Date ƒÊ : January 2022 Estimated Study Completion Date ƒÊ : April 2022 clinicaltrials.gov/ct2/show/NCT03930732?term=Dupilumab&draw=2&rank=23 |
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·|û¡G©t¨àÃÄ10140658 µoªí®É¶¡:2019/8/13 ¤W¤È 09:09:44²Ä 1182 ½g¦^À³
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To:¥ß§»¤j ²{¶¥¬q¥u¯àµ¥¤F,¤£¹L§A»EµJ¦bASLN001ªº¦¨±Ñ¬O¹ïªº,³oÃö¥G¦Ñ·à95%ªº¥¼¨Ó,§Æ±æ¯à¤G½uÁx¹DÀù¯à¸Ñª¼¹LÃö... ¥H¤W¨Ñ°Ñ¦Ò |
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·|û¡GROGER588910148151 µoªí®É¶¡:2019/8/13 ¤W¤È 08:35:00²Ä 1181 ½g¦^À³
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¤@°{¤@°{ªº¤p«GÂI! ¤½¥qºô¶:¥¼¨Ó¥ç¥i¯à±NASLAN004(IL-13R£\1)°w¹ï¨ä¥Lµoª¢©Ê¾AÀ³¯g¶i¦æ¬ã¨s¡A¨Ò¦pºC©Êªý¶ë©ÊªÍ¯f (COPD)¡C COPD(¤£¬O®ð³Ý/ý³Ý)¥«³õ¨S¦³¯«ÃĤ]ÁÙ¨S¦³§ÜÅéÃĪ«Àò§å¤W¥«!(Y¦³§ÜÅéÃĪ«Àò§å½Ð¤£§[§ó¥¿) ¾Ú¦ôp¡A¸Ó¯f¼vÅT¥þ²y¬ù3.84»õ¤H¡A¹wp¨ì2020±N¦¨¬°²Ä¤T¤jP¦º¦]¯À¡Cªì¦¸¶EÂ_®É¡A¬ù1/3¬°ÄY«©Î«D±`ÄY«ªºCOPDÃþ«¬¡C¥t¥~¡A¬ù¦³30-40%ªº¤¤«×¦Ü««×COPD±wªÌ§Y«K±µ¨ü¤TÁp§l¤JÀøªk¡]ICS/LAMA/LABA¡^¯f±¡¤´¤£¨ü±±¨î¨ÃÄ~Äò´c¤Æ¡C 2016ªº¤å³¹ www.nature.com/articles/mi201556 ....IL-13 receptor (R) £\1 and are key pharmacological targets in fibrotic diseases. However, the roles of IL-13R£\1 in mediating lung injury/repair are unclear........ |
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·|û¡G¥ß§»10147985 µoªí®É¶¡:2019/8/12 ¤U¤È 08:31:28²Ä 1180 ½g¦^À³
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ÁÂÁ¦U¦ì¤j¤jªº»¡©ú¡A¦ý¬OªÑ»ù¤@ª½¯}§C¡AÁ`n½Ð¤½¥q»¡©ú¤@¤U§a¡I |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2019/8/12 ¤U¤È 04:50:28²Ä 1179 ½g¦^À³
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Dupixent¤W¥«²Ä5¦~¬D¾Ô100»õ¬ü¤¸ªº¾P°â¤£¬O¹Ú ¨C©u¼W¥[1.7»õ¬ü¤¸ªº¥þ²y¾P°â. ¦ô¥¼¨Ó¾P°â (2019 Q1 3.7(2019,3¤ë¨Ó·Ç¤W¥«) 2019 Q2 5.6 2019 Q3 7.3 2019 Q4 9.0 ¦Xp 25.3(³æ¦ì:»õ¬ü¤¸) 2020 Q1~Q4= 10.7+12.4+14.1+15.8=53(»õ¬ü¤¸) 2021 Q1~Q4= 17.5+19.2+20.9+22.6=80(»õ¬ü¤¸) 2022 Q1~Q4= 24.3+26+27.7+29.4+41.1=106(»õ¬ü¤¸) ª÷Âû¥À --------------------------------- investor.regeneron.com/news-releases/news-release-details/regeneron-reports-second-quarter-2019-financial-and-operating TABLE 5 REGENERON PHARMACEUTICALS, INC. NET PRODUCT SALES OF REGENERON-DISCOVERED PRODUCTS (Unaudited) (In millions) Six Months Ended June 30,(2019,«e6¤ë¾P°â) --------------------------------- Net product sales recorded by Sanofi*: Dupixent $(¦Ê¸U¬ü¤¸) 757.7(¬ü°ê¾P°â)¦~¼W²v254% 173.3(¹Ò¥~¾P°â)¦~¼W²v408% 931.0(¥þ²y¾P°â) ¦~¼W²v273% ----------------------------- 2018¦~(«e6¤ë¾P°â) 298.1(¬ü°ê¾P°â) 42.5(¹Ò¥~¾P°â) 340.6(¥þ²y¾P°â) ------------------------------------------------- Three Months Ended June 30,(4-6¤ë¾P°â) Net product sales recorded by Sanofi*: Dupixent $ 454.7(¬ü°ê¾P°â) $ 102.6(¹Ò¥~¾P°â) $ 557.3(¥þ²y¾P°â), -------- 2018¦~4-6¤ë $ 180.9(¬ü°ê¾P°â) $ 28.3(¹Ò¥~¾P°â) $ 209.2(¥þ²y¾P°â) |
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²§¦ì©Ê¥Ö½§ª¢¥«³õ¦³§l¤Þ¤O,¤µ¤Ñªº»ù¦ì©ãÄ_´X±i¤p¸Õ¤â®ð! ª¾¤vª¾©¼¤@¤U,ASLAN004»Pdupilumab/Lebrikizumab /Tralokinumabµ²¦XÂI¥i°Ñ¦Ò1/2¤º¦a¹Ïªí: 1.§Ü¤¶¥Õ¯À - Taiwan Society of Internal Medicine(www.tsim.org.tw/journal/jour29-6/02.PDF) 2. cancerres.aacrjournals.org/content/72/24/6338 ²Ä¤@«¬¨üÅé¬O¥Ñ IL-4R£\ ¤Î £^C ²Õ¦¨¡A¥u¯à©M IL-4 µ²¦X¡C ²Ä¤G«¬¨üÅé¬O¥Ñ IL-4R£\ ¤Î IL-13R£\1 ²Õ¦¨¡A¥i¥H©M IL-4 ©Î IL-13 µ²¦X¡C ASLAN004Âê©w IL-13 ¨üÅé£\1 ¦¸³æ¦ì (IL-13R£\1)¥HªýÂ_¨âºØ«P¶iµoª¢ªº²ÓM¿E¯À IL-4 ©M IL-13¡C Dupilumab §@¥Î¾÷Âà»P IL-4R£\ µ²¦X¡A©Ò¥H¯à¦P®ÉªýÂ_ IL-4 ¤Î IL-13 »P²Ä¤@«¬¤Î²Ä¤G«¬¨üÅ骺µ²¦X¡C LebrikizumabÂǥѻPIL-13¦b B¡BC Á³±Û¤Wªº§Üìªí¦ìµ²¦X¡A¨¾¤î IL-4R£\ »P IL-13R£\1 µ²¦X«á°T®§¶Ç¾É¡C TralokinumabÂǥѻP IL-13 ªº A ¤Î D Á³±Ûªº§Üìªí¦ìµ²¦X¡AªýÂ_IL-13 »P IL-13R£\1 ¤Î IL-13R£\2 µ²¦X¡C |
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¦¨¤H¤¤««×²§¦ì©Ê¥Ö½§ª¢¥u¯à±±¨îµLªk®Úªv¡AÄÝ©óunmet medical need ¬ü°êFDA ¥Ø«e¹ï¦´Á¦³¯S§OÀø®ÄªºADÃĪ«±`µ¹¤©¬ð¯}©ÊªvÀø®Öã©Î¥[³t¼f¬d¡AÓ¤H»{¬°¤j®a¤£À³¦A¦³»ø¤Æªº«äºû¥h¬ÝASLAN 001»P003¡A¨Ì¾Ú·à¤l107¦~«×¦~³ø¤]¦³´£¨ìÁ{§É¸õ¯Å¨Æ©y ¥H¤W¤À¨É ¶È¨Ñ°Ñ¦Ò |
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¤Ñ©R¤j ²Ä¤@´ÁÁ{§É¸ÕÅç¥Øªº¬O¤F¸Ñ¦¹ÃĪ«©ó¤HÅ餧ÃĪ«°Ê¤O¾Ç¡A±´°QÃĪ«ªº§l¦¬¡B¤À¥¬¡B¥NÁ¤Ψä©óÅ餺§@¥Îªº®É¶¡¥H¦ôºâÃĪ«ªº°Ê¤O¾Ç°Ñ¼Æ¡A¥]¬A¥b°I´Á¡B¹F¨ì³Ì°ª¿@«×ªº®É¶¡¡A©Ò¥H004 ·|´ú¸Õ¤£¦P®É¶¡ÃĪ«¦³®Ä¿@«× ½Ð°Ñ¦Ò¬ì¾Ç¤ë¥Z Á{§É¸ÕÅ粤¶ |
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¥xÁÞ¤j, Study of ASLAN004 in Healthy Subjects(Last Update Posted ƒÊ : July 3, 2019) Secondary Outcome Measures: ¦¸n«ü¼Ð ³Ì«áÆ[¹î®É¶¡¬Ò§ï¬°up to 3 months (¤§«e¬°>=240¤p®É), ¥»¦¸Á{§É¬O§_¦b´ú¸Õ3Ó¤ë¥ÎÃĤ@¦¸ªº¥i¯à©Ê? (¤W¦¸6¤ëªì«Å§i¤@´ÁÁ{§É¼Æ¾Ú¹F¼Ðªº¬O¤@Ó¤ë¤@¦¸¥ÎÃÄ) clinicaltrials.gov/ct2/show/NCT03721263 Secondary Outcome Measures ƒÊ : 1.PK parameters: Area under the curve (AUC) from time zero to the time of the last quantifiable concentration [AUC(0-last)] [ Time Frame: Predose,1 hour, 2 hour, 4 hour, 8 hour, 24 hour, 72 hour, 168 hour, 240 hour and up to 3 months ] To assess the pharmacokinetics of ASLAN004 in healthy volunteers following single dose administration via IV or SC route (16 timepoints) 2.PK parameters: Estimate of volume of distribution at steady state (Vss) [ Time Frame: Predose,1 hour, 2 hour, 4 hour, 8 hour, 24 hour, 72 hour, 168 hour, 240 hour and up to 3 months ] To assess the pharmacokinetics of ASLAN004 in healthy volunteers following single dose administration via IV or SC route (16 timepoints) 3.PK parameters: Subcutaneous bioavailability (F) [ Time Frame: Predose,1 hour, 2 hour, 4 hour, 8 hour, 24 hour, 72 hour, 168 hour, 240 hour and up to 3 months ] To assess the pharmacokinetics of ASLAN004 in healthy volunteers following single dose administration via SC route only (16 timepoints) 4.PK parameters: Dose-normalized Cmax (Cmax/dose) [ Time Frame: Predose,1 hour, 2 hour, 4 hour, 8 hour, 24 hour, 72 hour, 168 hour, 240 hour and up to 3 months ] To assess the pharmacokinetics of ASLAN004 in healthy volunteers following single dose administration via IV or SC route (16 timepoints) 5.PK parameters: AUC (AUC(0-inf)/dose) [ Time Frame: Predose,1 hour, 2 hour, 4 hour, 8 hour, 24 hour, 72 hour, 168 hour, 240 hour and up to 3 months ] To assess the pharmacokinetics of ASLAN004 in healthy volunteers following single dose administration via IV or SC route (16 timepoints) ------------------------------------------------------- |
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2019¦~6¤ë4¤é¤½§iªº ASLAN004 ²§¦ì©Ê¥Ö½§ª¢¤@´ÁÁ{§É¸ÕÅç ¥ÎÃÄÀW²v¸û§CªºªvÀø¤è¦¡+ °§C¾ãÅéÂåÀøÅé¨tªºt¾á + °Æ§@¥Î§C+ Àx¦sÄâ±a¤è«K ASLAN004 ¤@´Á¸ÕÅ窺³Ì«á¼Æªº½TÅý§Ú̹ï©ó¦¨¬°²§¦ì©Ê¥Ö½§ª¢¦P¯Å³Ì¨ÎÀøªkªº«H¤ß ¤½§i¤º¤å¦³¨âÓ±M¦³¦Wµü trough level »P ¼Æ¶q¯Å ? trough level Àò±oªi¨¦(trough level )¿@«×ªº¥Øªº¬O¤°»ò¡H trough level¬O±wªÌ¦å¬y¤¤ÃĪ«ªº³Ì§C¤ô¥¡A¨Ã¥B¦b¬I¥Î¤U¤@¾¯ÃĪ«¤§«e´ú¶q¡C ø»sªi¨¦¤ô¥ªº¥Øªº¬O½T«O±wªÌ¦å¬y¤¤ªºÃĪ«¶q¤´µM°ª¨ì¨¬¥HªvÀø¡C ´úªi®p(peak level )¿@«×®É¡AÀ³¦bÃĪ«§¹¦¨§l¦¬¤Î¤À§G´Á«á©â¦å¡C ´úªi¨¦(trough level )¿@«×®É¡AÀ³¦b¤U¤@¦¸µ¹ÃÄ«e©â¦å site.jah.org.tw/pha/pha_web/c11_drugsafe/pdf/%E8%97%A5%E7%89%A9%E6%B2%BB%E7%99%82%E7%9B%A3%E6%B8%AC%E6%8C%87%E5%BC%9510400708.pdf ¼Æ¶q¯Å ³q±`±¡ªp¤U¡A¼Æ¶q¯Å«ü¤@¨t¦C 10 ªº¾(¦¸¤è)¡A§Y¬Û¾F¨âӼƶq¯Å¤§¶¡¤ñ¬° 10¡C¨Ò¦p»¡¨â¼Æ¬Û®t¤TӼƶq¯Å¡A¨ä¹ê´N¬O»¡¤@ӼƤñ¥t¤@Ó¤j 1000 ¿¡C ¦p»¡¨â¼Æ¬Û®t¤GӼƶq¯Å¡A¨ä¹ê´N¬O»¡¤@ӼƤñ¥t¤@Ó¤j 100 ¿ ¦p»¡¨â¼Æ¬Û®t¤@Ӽƶq¯Å¡A¨ä¹ê´N¬O»¡¤@ӼƤñ¥t¤@Ó¤j 10¿ zh.wikipedia.org/wiki/%E6%95%B0%E9%87%8F%E7%BA%A7 µ²½×: ¸ÕÅç¼Æ¾Ú«ü¥X ASLAN004 §¹¥þ§í¨î¨ü¾¹°T¸¹¶Ç»¼©Ò»Ýªº³Ì§C¿@«×(trough level)¤ñ²{¦³ªvÀø¤è¦¡©Ò»Ýªº¿@«×§C¡A¿@«×®t¶Z¶W¹L¤@Ӽƶq¯Å (®t¶Z¤j©ó10¿ ) ÁöµMªi¨¦¤ô¥¤ñ²{¦³ªvÀø¤è¦¡©Ò»Ýªº¿@«×§C ¦ý±wªÌ¦å¬y¤¤ªºÃĪ«¶q¤´µM°ª¨ì¨¬¥HªvÀø ³o¬OASLAN004 ¦b²§¦ì©Ê¥Ö½§ª¢¤£»ÝÀWÁcµ¹ÃĪº«n¬ì¾ÇÃÒ¾Ú ASLAN004 Àu²§ªºÃĪ«¯S©Ê¥i¥H¬°²§¦ì©Ê¥Ö½§ª¢¯f±w´£¨Ñ¤@Ó¥ÎÃÄÀW²v¸û§CªºªvÀø¤è¦¡¡B¤ñ°_²{¦³ªvÀø¤è ¦¡§ó¬°«K§Qªºµ¹Ãij~®|¡AÂǦ¹´î»´²§¦ì©Ê¥Ö½§ª¢¯f±w»P¾ãÅéÂåÀøÅé¨tªºt¾á (°Ñ¦Ò6¤ë4¤é¤½§i ) ¥[¤W°Æ§@¥Î§C»PÀx¦sÄâ±a¤è«K ASLAN004 ¤@´Á¸ÕÅ窺³Ì«á¼Æªº½TÅý§Ú̹ï©ó¦¨¬°²§¦ì©Ê¥Ö½§ª¢¦P¯Å³Ì¨ÎÀøªkªº«H¤ß ¥H¤W¸ê°T¤À¨É ¶È¨Ñ°Ñ¦Ò |
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¤µ¦~¥þ²y¾P°âDupixent(¤¤««× ý³Ý/²§¦ì©Ê¥Ö½§ª¢),«e¥b¦~9.31»õ¬ü¤¸, ¥þ¦~¦ô¾P°â22~25»õ¬ü¤¸(¤W¥«¾P°â,2¦~) Mar 28, 2017 Approval FDA Approves Dupixent (dupilumab) for Eczema investor.regeneron.com/news-releases/news-release-details/regeneron-reports-second-quarter-2019-financial-and-operating TABLE 5 REGENERON PHARMACEUTICALS, INC. NET PRODUCT SALES OF REGENERON-DISCOVERED PRODUCTS (Unaudited) (In millions) Six Months Ended June 30,(2019,«e6¤ë¾P°â) --------------------------------- Net product sales recorded by Sanofi*: Dupixent $(¦Ê¸U¬ü¤¸) 757.7(¬ü°ê¾P°â)¦~¼W²v254% 173.3(¹Ò¥~¾P°â)¦~¼W²v408% 931.0(¥þ²y¾P°â) ¦~¼W²v273% ----------------------------- 2018¦~(«e6¤ë¾P°â) 298.1(¬ü°ê¾P°â) 42.5(¹Ò¥~¾P°â) 340.6(¥þ²y¾P°â) ------------------------------------------------- Three Months Ended June 30,(4-6¤ë¾P°â) Net product sales recorded by Sanofi*: Dupixent $ 454.7(¬ü°ê¾P°â) $ 102.6(¹Ò¥~¾P°â) $ 557.3(¥þ²y¾P°â), -------- 2018¦~4-6¤ë $ 180.9(¬ü°ê¾P°â) $ 28.3(¹Ò¥~¾P°â) $ 209.2(¥þ²y¾P°â) Development History and FDA Approval Process for Dupixent Date Article Jun 26, 2019 Approval FDA Approves Dupixent (dupilumab) for Chronic Rhinosinusitis with Nasal Polyposis Mar 11, 2019 Approval FDA Approves Dupixent (dupilumab) for Moderate-to-Severe Atopic Dermatitis in Adolescents Oct 19, 2018 Approval FDA Approves Dupixent (dupilumab) for Moderate-to-Severe Asthma Mar 28, 2017 Approval FDA Approves Dupixent (dupilumab) for Eczema 2019¦~6¤ë26¤éFDA§åãDupixent¡]dupilumab¡^ªvÀø»ó®§¦×¯fªººC©Ê»óÄuª¢ 2019¦~3¤ë11¤é§åãFDA§åãDupixent¡]dupilumab¡^ªvÀø«C¤Ö¦~¤¤«×¦Ü««×¯SÀ³©Ê¥Öª¢ 2018¦~10¤ë19¤é§åãFDA§åãDupixent¡]dupilumab¡^ªvÀø¤¤«×¦Ü««×ý³Ý 2017¦~3¤ë28¤é§åãFDA§åãDupixent¡]dupilumab¡^ªvÀø¤¤««×¯SÀ³©Ê¥Öª¢ |
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¤Ñ©R¤j ³o¬O´¼ÀºÂಾ©Ê¯Ø¸¢ÀùÃĪ«¦w¯à±o ¦s¬¡±¡ªp »P¤ÏÀ³²v mOS ¹êÅç²Õ 6.1 Ó¤ë «ÈÆ[¤ÏÀ³²v 7.7% (9/117) ¹ï·Ó²Õ 4.2Ó¤ë ¨â²Õ ®t1.9Ó¤ë P 0.014 ·ÀI¤ñ(95% CI) 0.68 (0.50, 0.93) mPFS ¹êÅç²Õ 3.1 Ó¤ë «ÈÆ[¤ÏÀ³²v 0.8% ( 1/119 ) ¹ï·Ó²Õ 1.5Ó¤ë ¨â²Õ®t1.6Ó¤ë ·ÀI¤ñ (95% CI) 0.55 (0.41, 0.75) www.ktgh.com.tw/Public/tbDrug/201808160842057055.pdf ·à¤l¤G½uÁx¹DÀù¥þ²y¼Ï¯Ã¬OÅç¸Ñª¼¨Ì¾ÚÁ{§É¸ÕÅç¹êÅç³]p±ø¥ó¦p¤U ( ³Ì«á¤@¦ì¦¬®×«á3Ó¤ë ©Î 70% ¨ü¸Õ PD ) ORR : Time Frame: the later of 3 months after last subject in or when 70% of the subjects (84 subjects) have experienced a PFS event in Part 1 PFS :Progression-free survival (PFS) - Time Frame: The later of 3 months after last subject in or when 70% of the subjects (84 subjects) have experienced a PFS event in Part 1 ] Ó¤H±À¦ô¹êÅç²Õ ¤§ mPFS ¤ñ¹ï·Ó²Õ mPFS ¦n ¤@ ¿´N¦³¹LÃö¾÷·| ²Î¤@§ëÅU¹ï¤U¥b¦~¥Í§Þ®i±æ ¹L¥h2-3¦~¸êª÷¹L«×¶°¤¤¦b¹q¤lªÑ ,¥Í§ÞªÑ¸¨«á¤Ï¬M°ò¥»±,ÄY«³Q§C¦ô,¥Í§ÞªÑ¤£¨ü¶T©ö¾Ô¼vÅT¬Æ¦Ü¨ü´f©óÂà³æ®ÄÀ³ ¨È·à±d±ÂÅv ®É¶¡¹w¦ô»Pª÷ÃB ....... ¥H¤W¸ê°T¤À¨É ¶È¨Ñ°Ñ¦Ò |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2019/7/30 ¤U¤È 11:22:59²Ä 1142 ½g¦^À³
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¥xÁÞ¤j¡A ¨È狮ASLAN001 ,¦¬®×18Ó¤ë+7Ó¤ë(³Ì«á¤@¦ì¦¬®×)=25¤ë §Æ±æHER®a±Ú¦b64¤H¡A¹êÅç组¦û70%,64¡Ñ70%=45¤H¡A 45¤Hx40%=18¤H,¬°IHC+3, «hORR¦³¾÷·|¹LÃö. HER®a±ÚªºPFS¦±½u¦³¾÷·|¬Û¦ü©óFIGHT-202,(¦¬®×14Ó¤ë+8Ó¤ë=22¤ë) FGHER2 47 ¤H¡A22¤HPD,25¤H¨ü¡AMPFS 9.2¤ë¡C ·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2019/7/11 ¤W¤È 09:42:59²Ä 1115 ½g¦^À³ Inctye (FIGHT-202) 87¤H¤G´ÁÁ{§É 2016/OCT²Ä¤@¦ì¦¬®×ªº¨ü¸Õ¨ì2018/JULY ¤w¸g¾ú22Ó¤ë ³Ì«á¤@¦ì¦¬®×¨ü¸Õ¨ì 2018/JULY (data cut as of July 24, 2018)¤w¸g¾ú8Ó¤ë¡C *************************** ¤@.Efficacy and Safety of Pemigatinib in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Who Failed Previous Therapy - (FIGHT-202) clinicaltrials.gov/ct2/show/NCT02924376 ****Study Start Date �� : October 2016 ¤G.Incyte Announces Positive Interim Data from Phase 2 Trial of Pemigatinib, Its Selective FGFR Inhibitor, in Patients with Cholangiocarcinoma investor.incyte.com/news-releases/news-release-details/incyte-announces-positive-interim-data-phase-2-trial-pemigatinib ******Key Findings from FIGHT-202 Updated, longer-term follow-up data from the interim analysis presentedtoday at ESMO (data cut as of July 24, 2018) ****** show that in patients withadvanced/metastatic or surgically unresectable iCCA with FGFR2translocations treated with pemigatinib who had at least eight months offollow up (Cohort A, n=47), ¡X¡X¡X¡X¡X¡X ***** Interim Results of fight-202, A Phase 2, Open-Label, Multicenter Study of INCB054828 in Patients With Previously Treated Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma (CCA) With/Without Fibroblast Growth Factor (FGF)/FGF Receptor (FGFR) Genetic Alterations Median PFS was 9.2 months in cohort A (Figure 5) ¡V¡V Median PFS in cohorts B and C were 2.1 and 1.7 months, respectively ¡´¡´ Median OS was 15.8 months in cohort A ¡V¡V Median OS in cohorts B and C were 6.8 and 4.0 months, respectively Figure 5. Kaplan-Meier Estimates of PFS (Assessed by Independent Reviewer) ESMO 2018: Incyte Posters ---October 22, 2018 investor.incyte.com/events-and-presentations/presentations?field_nir_tags_target_id=All&promote=All&field_nir_asset_type_target_id%5B26%5D=26&items_per_page=10&page=1 |
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·|û¡G¸¤H¥d¯S10145479 µoªí®É¶¡:2019/7/29 ¤W¤È 08:42:18²Ä 1141 ½g¦^À³
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To ©t¨àÃĤj, À³¸Ó¬O¨S¤H¥ýª¾¹D§a¡A§_«h¦¨¥æ¶q¤]¤Ó§C¤F³Ìªñ¡A«e°}¤l´N·Q°Ñ¥[¸Ñª¼¸ò¤£·Q°Ñ¥[¸Ñª¼ªº§ë¸ê¤H¦b¤¬¬Û¶R½æ§a¡A³Ìªñ¦]¬°¨SÔ£®ø®§¡A©Ò¥H¦¨¥æ¶q°ªº«Ü§C¡A¤j®aÀ³¸Ó³£ÁÙ¦bµ¥®ø®§§a¡A¦Ü©óCEO»¡¦~©³·|¦³µ²ªG¡A§Ú¤]¤£ª¾¹D¥L¬O±q¦ó§PÂ_ªº? ³oÓ¥i¯àn§ë¸ê¤H¥´¥h¤½¥q°Ý°Ý¤~¦³¥i¯à¤ñ¸û¤F¸Ñ§a! ÁÂÁÂ! |
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·|û¡G©t¨àÃÄ10140658 µoªí®É¶¡:2019/7/27 ¤U¤È 01:33:32²Ä 1140 ½g¦^À³
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Y¬O¯uªº¦~©³¤~¤½§G¡A¨º¹LÃö¾÷²v´N¤£¬O¥ý«e©Ò»¡ªº50-65%¡A¦Ó¬O80-90%¤F¡A®É¶¡©Ô¨º»òªø¡Aªí¥Ü¹êÅç²Õ¥¼PD ªº¤H¼Æ¤ñ·Q¹³ªº°ª¤Ó¦h¤F~ |
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·|û¡G©t¨àÃÄ10140658 µoªí®É¶¡:2019/7/27 ¤W¤È 07:53:04²Ä 1139 ½g¦^À³
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To:¸¤H¤j Carl°õ¦æªø»¡ªº¦~©³¼Æ¾Ú¥XÄl~~~²ö«D³o´N¬O¥ý«e©Ò´£ªº¡§¦³¤H¥ýª¾¹D¡¨~~~~ |
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·|û¡G¥xÁÞ10138776 µoªí®É¶¡:2019/7/26 ¤U¤È 06:24:02²Ä 1138 ½g¦^À³
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¬Ý°_¨Ó±À´ú¬O9¤ë¤~¯àData cut off¡A±q2017¦~6¤ë¨ì2019¦~1¤ë§¹¦¨¦¬®×¡A¦¬®×´Á¹F19Ó¤ë¡A¨ìData cut off®É¶¡±À´úªø¹F27Ó¤ë¡A¦nÀ¸¦b«áÀY¡I¥H¤W¤À¨É¶È¨Ñ°Ñ¦Ò |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2019/7/26 ¤U¤È 05:47:21²Ä 1137 ½g¦^À³
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Commenting on the appointment, Dr Carl Firth said: ¡§With the upcoming pivotal readout later this year for varlitinib and the continued advance of our other programs, Andrew¡¦s commercial experience will be invaluable in taking the company to the next stage. This decision to separate the roles of Chairman and CEO allows us to maintain the high standards of corporate governance we have set ourselves and I look forward to working closely with Andrew in the months and years ahead.¡¨ Media and IR contacts Emma Thompson Spurwing Communications Tel: +65 6571 2021 Email: ASLAN@spurwingcomms.com Robert Uhl Westwicke Partners Tel: +1 858 356 5932 Email: robert.uhl@westwicke.com About ASLAN Pharmaceuticals |
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·|û¡G¸¤H¥d¯S10145479 µoªí®É¶¡:2019/7/26 ¤U¤È 04:40:07²Ä 1136 ½g¦^À³
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¨È·à±d-KY ¥ô©R·~¬É¸ê²`¤§²{¥ô¸³¨Æ·|¦¨û ANDREW HOWDEN ¬°¸³¨Æªø 2019 ¦~ 7 ¤ë 26 ¤é,·s¥[©Y ¡V »EµJ©óÁ{§É¶¥¬q¸~½F¤Î§K¬Ì¾Ç¤§Á{§É¶¥¬q¥Íª«»sÃĤ½¥q¨È·à±d- KY(NASDAQ:ASLN, TPEx:6497)¤µ¤é«Å¥¬¿ï¥ô Andrew Howden ¬°¸³¨Æªø¡C¦Û¤½¥q 2010 ¦~³Ð¥ß¥H¨Ó¾á¥ô¸³¨Æªøº[ °õ¦æªøªº Carl Firth ³Õ¤h±N«ùÄò¾á¥ô¥»¤½¥q°õ¦æªø¤Î¸³¨Æ·|¦¨û¡C¬°¸¨¹ê¨}¦nªº¤½¥qªv²z¨î«×,¥»¤½¥q¸³¨Æªø ©M°õ¦æªøªºÂ¾°È±N¥Ñ¤£¦P¤H¿ï¤À¦Ó¥ô¤§¡C Andrew Howden ¦Û 2016 ¦~ 4 ¤ë°_§Y¾á¥ô¨È·à±d-KY ¸³¨Æ,©ó»sÃIJ£·~¾Ö¦³¶W¹L 35 ¦~¤§°Ó·~»P»â¾É¸gÅç¡C¥L ¥ý«e¾á¥ô iNova Pharmaceuticals °õ¦æªø¤@¾,ª½¨ì¸Ó¤½¥q¨Ö¤J Valeant Pharmaceuticals ¡CiNova ¬°¤@¾î¸ó¦hºØ ªvÀø»â°ì¤§¨È¤ÓÃĪ«¶}µo¤Î°Ó«~¤Æ»sÃĤ½¥q¡C¦b¦¹¤§«e,Andrew ´¿¥ô AstraZeneca¡BQuintiles »P IMS Health ¤§°Ï°ìt³d¤H¡C¥L¥ç¾á¥ô¹L¶W¹L 20 ¶¡»sÃÄ»PÂåÀø¤½¥q¤§¸³¨Æ·|¦¨û,²{¥ô¿D¬w»sÃĤ½¥q First Pharma ¸³¨Æ ªø,¨Ã´¿¥ô¥Dn¥«³õ¬°¤¤°ê»P¨È¬wªº¿D¬wÀ¦¨à°t¤è¨Å¤½¥q True Origins ¸³¨Æªø¡C Andrew Howden °w¹ï³o¶µ¿ï¥ô®×ªí¥Ü:¡u³Q±Â¤©³o¶µ³d¥ô§Ú·P¨ì«D±`ºa©¯,§Ú¤]´Á«Ý»P¸³¨Æ·|¤@¦P±a»â ASLAN «ùÄò¦V«eÁÚ¶i,«×¹L³o¬q¥O¤H¿³¾Äªº®É´Á¡C§Ú»P Carl ¤@¦P¦@¨Æ¦h¦~,§Ú̹綠¥qªºÄ@´º»P¥ø¹Ï¥ç¤£ ¿Ñ¦Ó¦X¡C§Ú«Ü¶}¤ß¯à¬Ý¨ì¥Lªº¹Î¶¤_§§,¨Ã´À§ÚÌ¿W¯Sªº¤À¤lÃĪ«²£«~²Õ¦X³Ð³y§ó¦h»ùÈ¡C¡v Carl Firth ³Õ¤h«hªí¥Ü:¡uÀHµÛ varlitinib ¼Ï¯Ã¸ÕÅç¼Æ¾Ú±N¦b¦~©³¥XÄl¤Î¨È·à±d¨ä¥L¸ÕÅ綵¥Ø«ùÄò¶i®i, Andrew ¤§°Ó·~¤Æ¸gÅç±N¯à¬°§Y±NÁÚ¦V¤U¤@¶¥¬qªº¨È·à±d±a¨ÓÄ_¶Qªº°^Äm¡C³o¶µ¸³¨Æªø»P°õ¦æªø¤À¥ô¤§¨M ©w±N½T«O¥»¤½¥q¯àºû«ù°ª¤ô·Çªº¤½¥qªv²z,§Ú«D±`´Á«Ý¥¼¨Ó¯à»P Andrew ±K¤Á¦X§@¥æ¬y¡C ¡v ³oÃ䦳´£¨ì±N¦b¦~©³¥XÄl¡A¤£ª¾¹D001¸Ñª¼µ²ªG¬O§_¯uªºn¦~©³¤~·|¥X¨Ó! |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2019/7/24 ¤U¤È 05:09:37²Ä 1135 ½g¦^À³
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Log-Rank Test www.real-statistics.com/survival-analysis/kaplan-meier-procedure/log-rank-test/ incyte fight 202 PFS K-M¹Ï 1¥þ³¡(87 ¤H) vs. other (40¤H) x^2 4.746000186 p 2.94% P<0.05 2.¥þ³¡(87 ¤H) vs. FGFER22 (47¤H) x^2 3.925298477 p 4.76% P<0.05 3. FGFER22 (47¤H) vs. other (40¤H) x^2 21.48105417 p 0.0004% P<0.05 ·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2019/7/23 ¤W¤È 11:17:40²Ä 1132 ½g¦^À³ incyte fight 202 PFS K-M¹Ï Time ¦s¬¡¤H¼Æ ¥þ³¡//FGFR//¨ä¥L 0¤ë 87¤H //47¤H//40¤H 1¤ë 81¤H//46¤H//35¤H 2¤ë 54¤H//40¤H//14¤H 3¤ë 46¤H//36¤H//10¤H 4¤ë 43¤H//34¤H//9¤H 5¤ë 37¤H//30¤H//7¤H 6¤ë 37¤H//30¤H//7¤H 7¤ë 26¤H//23¤H//3¤H 8¤ë 24¤H//23¤H//1¤H 9¤ë 18¤H//17¤H//1¤H 10¤ë10¤H//10¤H//0 11¤ë9¤H//9¤H//0 12¤ë5¤H//5¤H//0 13¤ë3¤H//3¤H//0 14¤ë3¤H//3¤H//0 15¤ë1¤H//1¤H//0 |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2019/7/23 ¤W¤È 11:53:31²Ä 1134 ½g¦^À³
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×¥¿ incyte fight 202 PFS K-M¹Ï 1.¥§¡¦s¬¡¤ë¼ÆAVG. PFS FGFR2 ¡X¡X 6.6¤ë(47¤H) , ¨ä¥L ¡X¡X2.2¤ë(40¤H) 2.MPFS ¤¤¦ì¦s¬¡¤ë¼Æ FGFR2¡X -9.2¤ë(47¤H) ¨ä¥L ¡X¡X1.68~2,1¤ë(40¤H) ESMO 2018: Incyte Posters ---October 22, 2018 investor.incyte.com/events-and-presentations/presentations?field_nir_tags_target_id=All&promote=All&field_nir_asset_type_target_id%5B26%5D=26&items_per_page=10&page=1 |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2019/7/23 ¤W¤È 11:33:24²Ä 1133 ½g¦^À³
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incyte fight 202 PFS K-M¹Ï 1.¥§¡¦s¬¡¤ë¼Æ FGFR2 ¡X¡X 6.6¤ë(47¤H) , ¨ä¥L ¡X¡X2.2¤ë(40¤H) 2.MOS ¤¤¦ì¦s¬¡¤ë¼Æ FGFR2¡X -9.2¤ë(47¤H) ¨ä¥L ¡X¡X1.68~2,1¤ë(40¤H) ESMO 2018: Incyte Posters ---October 22, 2018 investor.incyte.com/events-and-presentations/presentations?field_nir_tags_target_id=All&promote=All&field_nir_asset_type_target_id%5B26%5D=26&items_per_page=10&page=1 |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2019/7/23 ¤W¤È 11:17:40²Ä 1132 ½g¦^À³
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incyte fight 202 PFS K-M¹Ï Time ¦s¬¡¤H¼Æ ¥þ³¡//FGFR//¨ä¥L 0¤ë 87¤H //47¤H//40¤H 1¤ë 81¤H//46¤H//35¤H 2¤ë 54¤H//40¤H//14¤H 3¤ë 46¤H//36¤H//10¤H 4¤ë 43¤H//34¤H//9¤H 5¤ë 37¤H//30¤H//7¤H 6¤ë 37¤H//30¤H//7¤H 7¤ë 26¤H//23¤H//3¤H 8¤ë 24¤H//23¤H//1¤H 9¤ë 18¤H//17¤H//1¤H 10¤ë10¤H//10¤H//0 11¤ë9¤H//9¤H//0 12¤ë5¤H//5¤H//0 13¤ë3¤H//3¤H//0 14¤ë3¤H//3¤H//0 15¤ë1¤H//1¤H//0 |
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·|û¡G©t¨àÃÄ10140658 µoªí®É¶¡:2019/7/23 ¤W¤È 09:45:50²Ä 1131 ½g¦^À³
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To:¥xÁÞ¤j ¤èªk©Î³\¤£¦P,¦ýÁͶլO©¹¦¨¥\¾÷²v¶V¤jªº¤è¦V¨«¨S¿ù,¦ÓASLN001¤]¤£¬O¯«ÃÄ,©Ò¥H³Ì«á³o6Ó¤ë¥H¤W¹êÅç²ÕÁÙ¥¼PDªº´N¬OÃöÁä,¥B¤]¤£´±¦ô¦h,¥u¦ô¨â¤HÁÙ¥¼PD,¦Ó¹ï·Ó²Õ¬O¦ô¥þ³¡³£3Ó¤ë(¤]¦³¥i¯à3Ó¤ë¥H¤U©~¦h,¶W¹L3Ó¤ë¥H¤Wªº§Úı±o¬O¤Öªº),Y¥HEXCEL¤º«Ø¼Ò²Õ¨Ó»¡,²Îpªºµ²ªGÁö»PÁ{§É¥Îªº¤èªk¤£ºÉ¬Û¦P,¦ý¤´¬OÁͦV©ó®É¶¡¶V¤[¨S¤½§G,PȤp©ó0.05ªº¦¨¥\¾÷²v·U°ªªº¤è¦V¨«~~~ ±À¦ôªºµ²ªG..¶È¨Ñ°Ñ¦Ò,¤Å·í¶i¥X¨Ì¾Ú.... |
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·|û¡G¥xÁÞ10138776 µoªí®É¶¡:2019/7/22 ¤U¤È 11:52:57²Ä 1130 ½g¦^À³
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©t¨àÃĤj 1 §Ú¥H«e»¡¹LÂùª¼¸ÕÅç°£«D¶}ª¼§_«hµLªkª¾¨ìmPFS »P ORR ,¤£¹L¤j®a¥i¥H±q¤wª¾ªº¤ÆÀøÃÄmPFS ¤j¬ù2-3Ó¤ë¨Ó¬ù²¤±À¦ô¹ï·Ó²Õ PD ¨Æ¥ó¼Æ,¦A±qÁ{§É³]p³W©w¸Ñª¼®É¾÷¥h±À¦ô¹êÅç²Õ PD ¨Æ¥ó¼Æ §A´£¨ì3.9Ó¤ë¥H¤U¦³44¤H ¤]´N¬O§A¬O°²³]¹ï·Ó²ÕmPFS 3Ó¤ë ¹êÅç²Õ¬ù 3- 3.5Ó¤ë , ³oºØ®t²§§A¤S±À½×·|¹LÃö ¦³ÂI¤£¦XÅÞ¿è , ¦pªG§Aªº°²³]¬O¥¿½Tªº¸Ü Ó¤H±À½×¦¦b¥h¦~²Ä¤T¥½´NÀ³¤½§i¸Ñª¼¼Æ¾Ú , ¬°¦ó¨ì²{¦bÁÙ¨S¦³Å¥¨ì data cut off ªº¥ô¦ó¸ê°T ? (°²³]mPFS µo¥Í¦b ¦U²Õ¦¬®×¤H¼Æªº¬ù²¤¤¤¦ì¼Æ28-34¤§¶¡) ±q¤wª¾ªº¤ÆÀøÃÄÀø®ÄÓ¤H±À½×¹ï·Ó²Õ¥h¦~5-7¤ë¥ª¥k¼Æ¾Ú¤w¸g¦¨¼ô,¥Ø«e¥u¬O¦bµ¥¹êÅç²ÕPD ¼Æ¹F¨ì³W©wªº¸Ñª¼±ø¥ó¦Ó¤w ( incyte fight 202 ¹êÅç²Õµ¥±±¨î²Õ¬ùµ¥7Ó¤ë¼Æ¾Ú¤~¦¨¼ô ) 2 §A¼ÒÀÀªº²Îp¤èªk¦n¹³»P¨È·à±d¥þ²y¼Ï¯Ã¸ÕÅç²Îp¤èªk¤£¦P,¨È·à±d¥þ²y¼Ï¯Ã¸ÕÅç²Îp¤èªk¬O¨Ï¥ÎHochberg procedure §A¥Îªº²Îp¤èªk¬O¿ùªº, ¬°¦ó¤S´£¥X¨Ó ? 3 ¶V±ß¤½§i¼Æ¾Ú¦¨¥\¾÷·|¶V¤j ºCºC¦w¤ßÀR«Ý ! §ÚÁÙ¬On¦A»¡¤@¦¸ Âùª¼¸ÕÅç°£«D¶}ª¼§_«hµLªkª¾¨ìmPFS »P ORR ¤@¤Áªº±À½×³£¬O°²³]©ÊªºÁr´ú ¥H¤W¤À¨É ¶È¨Ñ°Ñ¦Ò |
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·|û¡G©t¨àÃÄ10140658 µoªí®É¶¡:2019/7/22 ¤W¤È 10:12:54²Ä 1129 ½g¦^À³
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¤S¹L¤F¥bÓ¤ë¤F~~~¦A°²³]¤@¨Ç¸ÕÅçµ²ªG¦Aºâºâ¬Ý¦p¤U:: ¤G½uÁx¹DÀùÁ{§É¶i«×±À¦ô~~~~¥H¥Ø«e®Éµ{°²³]¹êÅç²ÕPFS±ø¥ó¦p¤U(¹ï·Ó²Õ¬Ò3Ó¤ë): 3Ó¤ë¥H¤U16¤H 3-3.9Ó¤ë28¤H 4-4.9Ó¤ë13¤H 5-5.9Ó¤ë4¤H 6-7Ó¤ë2¤H ¥H¤W¦@¹êÅç²Õ63¤H~~~PÈpºâµ²ªG¦p¤U: t ÀË©w¡G¨âÓ¥ÀÅ饧¡¼Æ®tªºÀË©w¡A°²³]Åܲ§¼Æ¬Ûµ¥ 3 3.2 ¥§¡¼Æ 3 3.343548387 Åܲ§¼Æ 0 1.828072448 Æ[¹îÈÓ¼Æ 62 62 Pooled Åܲ§¼Æ 0.914036224 °²³]ªº§¡¼Æ®t 0 ¦Û¥Ñ«× 122 t ²Îp -2.000723425 «n¼ÒÀÀµ²ªG: P(T<=t) ³æ§À 0.023821108 ¤W¦¸6Ó¤ë¬O¨â¤H(P(T<=t) ³æ§À 0.026843567),¥»¦¸6Ó¤ë¥H¤W¤]¬O¨â¤H ¥H¤W¨Ñ°Ñ¦Ò.... |
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·|û¡G¥xÁÞ10138776 µoªí®É¶¡:2019/7/19 ¤U¤È 11:28:01²Ä 1128 ½g¦^À³
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·PÁ©t¨àÃĤj ¤Ñ©R¤jªº¤À¨É pºâmPFS ¬O¥Î Kaplan-Meier¦s¬¡¤ÀªR Kaplan-Meier¦s¬¡¦±½u©w¸q¬°¦bµ¹©w®É¶¡¤º¦s¬¡ªº·§²v ¦b¸Ó¤ÀªR¤¤¨Ï¥Î¤F¤TÓ°²³]¡C A º¥ý°²³]¦b¥ô¦ó®ÉÔ³Q³]¸ê®Æ Censored Data ªº±wªÌ »P Ä~Äò³Q°l踪ªº±wªÌ¦³¬Û¦Pªº¦s¬¡¾÷²v ³]¸ê®Æ : 1 ¬¡µÛ°h¥X¬ã¨s 2 ¦b¬ã¨s¤¤PD (¥]¬A¦º¤` ) 3 ¬ã¨sµ²§ô®É¤´µM¬¡µÛ B °²³]¬ã¨s¦´Á©M±ß´Á©Û¶Òªº¨ü¸ÕªÌªº¥Í¦s·§²v¬Û¦P¡C C °²³]¨Æ¥óµo¥Í¦b«ü©wªº®É¶¡¡C www.ncbi.nlm.nih.gov/pmc/articles/PMC3059453/ 2017/06 ²Ä¤@¦ì¦¬®×ªº¨ü¸Õ ¨ì2019/07 ¤w¸g¾ú25Ó¤ë ( ²Ä¤@¦ì¦¬®×ªº¨ü¸Õ¬O2017 / 06 ¨Ì¾Ú 2018 ASCO ) ±q³Ì«á¤@¦ì¦¬®×ªº¨ü¸Õ(2019 01 02) ¨ì 2019 07 19 ¤w¸g¶W¹L 6.5Ó¤ë ....... Data cut off ¯uªº¤£ª¾¦ó®É·|µo¥Í ? ¤j®a@¤ßÀRÀRªºµ¥§a ¨Ì¾Ú 2018 ASCO part 1 primary objectives : ORR PFS secondary objectives : OS DCR DOR ¥H¤W¤À¨É ¶È¨Ñ°Ñ¦Ò |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2019/7/19 ¤U¤È 07:27:30²Ä 1127 ½g¦^À³
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¥xÁÞ¤j, ¨S§ä¨ìInctye (FIGHT-202) ¤G´ÁÁ{§É mOS¦s¬¡¦±½u¹Ï. ASAN001 ªºÁ{§É¸ê®Æ¥»©uÀ³¸Ónµo§G¤F¡A´Nµ¥§a¡I |
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Inctye (FIGHT-202) 87¤H¤G´ÁÁ{§É 2016/OCT²Ä¤@¦ì¦¬®×ªº¨ü¸Õ¨ì2018/JULY ¤w¸g¾ú22Ó¤ë ³Ì«á¤@¦ì¦¬®×¨ü¸Õ¨ì 2018/JULY (data cut as of July 24, 2018)¤w¸g¾ú8Ó¤ë¡C *************************** ¤@.Efficacy and Safety of Pemigatinib in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Who Failed Previous Therapy - (FIGHT-202) clinicaltrials.gov/ct2/show/NCT02924376 ****Study Start Date ƒÊ : October 2016 ¤G.Incyte Announces Positive Interim Data from Phase 2 Trial of Pemigatinib, Its Selective FGFR Inhibitor, in Patients with Cholangiocarcinoma investor.incyte.com/news-releases/news-release-details/incyte-announces-positive-interim-data-phase-2-trial-pemigatinib ******Key Findings from FIGHT-202 Updated, longer-term follow-up data from the interim analysis presentedtoday at ESMO (data cut as of July 24, 2018) ****** show that in patients withadvanced/metastatic or surgically unresectable iCCA with FGFR2translocations treated with pemigatinib who had at least eight months offollow up (Cohort A, n=47), ¡X¡X¡X¡X¡X¡X ***** Interim Results of fight-202, A Phase 2, Open-Label, Multicenter Study of INCB054828 in Patients With Previously Treated Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma (CCA) With/Without Fibroblast Growth Factor (FGF)/FGF Receptor (FGFR) Genetic Alterations Median PFS was 9.2 months in cohort A (Figure 5) ¡V¡V Median PFS in cohorts B and C were 2.1 and 1.7 months, respectively ¡´¡´ Median OS was 15.8 months in cohort A ¡V¡V Median OS in cohorts B and C were 6.8 and 4.0 months, respectively Figure 5. Kaplan-Meier Estimates of PFS (Assessed by Independent Reviewer) ESMO 2018: Incyte Posters ---October 22, 2018 investor.incyte.com/events-and-presentations/presentations?field_nir_tags_target_id=All&promote=All&field_nir_asset_type_target_id%5B26%5D=26&items_per_page=10&page=1 |
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Varlitinib in Combination With Capecitabine for Advanced or Metastatic Biliary Tract Cancer (TreeTopp) clinicaltrials.gov/ct2/show/NCT03093870?term=aslan001&rank=9 Actual Study Start Date : July 4, 2017 Estimated Primary Completion Date : July 2019 ¨Ì¾Ú¨È·à¤µ¦~¤¸¤ëPosted ¡A¦ôp7¤ë(¥»¤ë) ,§¹¦¨ªì¨B¼Æ¾Ú(7¤ë¸Ñ¨w). |
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¥xÁÞ¤j, Ó¤H¹w´ú: ASLAN001 ¤G缐Áx¹DÀù127¤H¡A ¦³50%~60%ªº¾÷·|¡A ¤@¡BASLAN001ªºPFS K-M ¦±½u¡A±µªñINCYTE FIGHT-202 ªºK¤@M缐¡C ¨ä§Ü·½¤ñ¨Ò¡A¹êÅç²Õ64¤H (1)HER1&HER2 §Ü·½¦û60%~70%, (2)HER3&HER4 ¦û15%~20%¤Î NON- HER®a±Ú§Ü·½,¦û15%~20%, ¦@¦û30%~40% (3)¦X¨ÖK¤@M½u MPFS ,¦p FIGHT-202 , ¤T½u¦X¨Ö¦b 5~6Ӥ붡¡C¦X¨ÖORR 20% (13/64)¬O¦³¾÷·|¡C ¤G¡B¦Ó¹ï·Ó²Õ¦b³æ¤@¤ÆÀø¤UMPFS ¤£·|°ª©ó2Ó¤ë¡AORR =1.56%(1/64) ¦p www.ncbi.nlm.nih.gov/pmc/articles/PMC5344285/ ¹Ï¤@¡AFlu ³æ¤@¤ÆÀøªºK-M¹Ï. ¤T¡C¹êÅç²Õªº MPFS 5~6¤ë¡A°ª©ó¹ï·Ó²Õ2Ó¤ë¡A¬° 2.5~3 ¿¡AP²Õ< 0.01 , ¹LÃö¡C ¥H¤W¾÷²v§Ü·½ªº¾÷²v50~60% ,°Ñ¦Ò ¦p¤U , ·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2019/4/8 ¤W¤È 11:05:19²Ä 924 ½g¦^À³ www.cancerjournal.net/article.asp?issn=0973-1482;year=2018;volume=14;issue=8;spage=28;epage=35;aulast=Zhou ¥»¬ã¨sªºªþ¿ý¡A¦³¦U¬ã¨sªº¸Ô¤å. ¤å¤¤°ªªí²{²v=IHC+2 ¤ÎIHC+3 ¬Ý¹L´XÓ¬ã¨s IHC +2 : IHC +3 = 3 : 2 . ©Ò¥HY¥»¬ã¨s IHC +2 &IHC+3 > 50%, ¥§¡¨C67% .¡X-7Ó¬ã¨s. ¨ä¤¤IHC +3, 67%x2/5=27.2% IHC+3V , >ORR 20%ªº ¾÷²v°ª. . ¡X¡X¡X¡X IHC+3 & IHC +2 ,>50% , ¡X-67% MPFS = ±N¸¨¦bIHC +2 , SD .¤W, MPFS ¦³¾÷·|4~5Ó¤ë.¡X¡X¡XÓ¤H²q´ú¡C ¹ï·Ó²Õ ¥i¯à 2~3Ó ¤ë. ¹LÃö¾÷²v°ª. ¡X¡X¡X- µ²½× : Y¯à¨Ì·Ó¤j¼Æ¾Ú 58% ªº¾÷²v¡A¸¨¦bIHC ¡Ï2/IHC+3 >50% (67%), ¾÷¥G¹LÃö, P <0.05 .ªº¥i¯à¡C ¡X¡X¡X¡X¡X¡X Interim Results of fight-202, A Phase 2, Open-Label, Multicenter Study of INCB054828 in Patients With Previously Treated Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma (CCA) With/Without Fibroblast Growth Factor (FGF)/FGF Receptor (FGFR) Genetic Alterations Median PFS was 9.2 months in cohort A (Figure 5) ¡V¡V Median PFS in cohorts B and C were 2.1 and 1.7 months, respectively ¡´¡´ Median OS was 15.8 months in cohort A ¡V¡V Median OS in cohorts B and C were 6.8 and 4.0 months, respectively Figure 5. Kaplan-Meier Estimates of PFS (Assessed by Independent Reviewer) ESMO 2018: Incyte Posters ---October 22, 2018 investor.incyte.com/events-and-presentations/presentations?field_nir_tags_target_id=All&promote=All&field_nir_asset_type_target_id%5B26%5D=26&items_per_page=10&page=1 |
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¦Ñ·àÄw½XÅܤÆ~~¥Ñ¥H¤U¬Ý¨Ó¤£©ãª`ªº¤d±i¤j¤á«Ü¦h,¦ý¯d¤U¨Ó¬Ýµ²ªGªº¤j¤á¤]¦³....³Ì¦nªºµ²ªG´N¬O¶]±¼ªº¤d±i¤j¤á¥h¤j¶RADRÅý¥xªÑ¦Ñ·à¯à¤Ñ¤Ñº¦°±~~~~~ 2019403-50±i¥H¤W¤j¤á«ùªÑ-137,605,265 2019705-50±i¥H¤W¤j¤á«ùªÑ-137,042,660 ¤Ö¤Fªñ563±i 2019403-¤d±i¥H¤W¤j¤á«ùªÑ-119,607,391 2019705-¤d±i¥H¤W¤j¤á«ùªÑ-113,701,071 ¤Öªñ5996±i ¥H¤W¨Ñ°Ñ¦Ò,¤Å·í¶i¥X¨Ì¾Ú..... |
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Interim Results of fight-202, A Phase 2, Open-Label, Multicenter Study of INCB054828 in Patients With Previously Treated Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma (CCA) With/Without Fibroblast Growth Factor (FGF)/FGF Receptor (FGFR) Genetic Alterations ESMO 2018: Incyte Posters ---October 22, 2018 investor.incyte.com/events-and-presentations/presentations?field_nir_tags_target_id=All&promote=All&field_nir_asset_type_target_id%5B26%5D=26&items_per_page=10&page=1 ¡´ Median PFS was 9.2 months in cohort A (Figure 5) ¡V¡V Median PFS in cohorts B and C were 2.1 and 1.7 months, respectively ¡´¡´ Median OS was 15.8 months in cohort A ¡V¡V Median OS in cohorts B and C were 6.8 and 4.0 months, respectively Figure 5. Kaplan-Meier Estimates of PFS (Assessed by Independent Reviewer) |
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PFE - Pfizer Inc. NYSE - Nasdaq Real Time Price. Currency in USD 42.67 ¥«È237B USD ¶R¥«È11 B USD ARRAY bio. |
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Pfizer to buy Array BioPharma, strike $10.6B deal Yahoo Finance Video Yahoo Finance VideoJune 17, 2019, 9:13 PM GMT+8 Pfizer is buying Array BioPharma in a deal valued at $10.6 billion. Yahoo Finance¡¦s Alexis Christoforous and Brian Sozzi discuss the deal and how it will impact pharmaceutical stocks. |
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¨CºØÀù¯g¤£¦P´Á§O»Ýn¤£¦PªºÃĪ«¥Hº¡¨¬¤£¦P¥ÎÃıø¥ó, Áx¹DÀù¬ü°ê¬ù12000¤H ¼Ú¬w13000¤H ¤é¥»20000¤H Á`¼Æ45000¤H ( 2017 12 ªk»¡Â²³ø17¶) ¤¤°ê170000¤H ³o¤TÓ¦a°Ï»P°ê®a ¦³ FGFR2°ò¦]¤U¤G½uÁx¹DÀù ¬ü¡B¼Ú¡B¤é¬ù2000¤H~3000¤H( ¨Ì¤Ñ©R¤j´£¨Ñ¸ê°T) 2000-3000/45000 ±À¦ô¦³FGFR2°ò¦]¤ñ²v¬ù4.4% -- 6.6% ( Ó¤H²Ê¦ô ¦³¥i¯à¤£«Ü¥¿½T) ¨S¦³FGFR2°ò¦]ªº¯f±w¦û¤j¦h¼Æ¥u¯à¨Ï¥Î¤ÆÀøÃÄ, ¨È·à±d¤G½uÁx¹DÀù ¨Ì¾Ú106¦~«×¦~³ø43¶´£¨ì: ÅX°ÊÁx¹DÀùªº¯S©w¶Ç»¼¸ô®|©|¥¼³QÃÒ¹ê, ¤£¹L¤é¥»»P¤¤°ê¼Æ¾ÚÅã¥Ü¬ù70%Áx¹DÀù¯f±w¸~½F¦³HER®a±Ú¹L«×ªí²{ªº±¡§Î(HER1 HER2 HER3 HER4 ) varlitinib ¬OªxHER§í¨î¾¯,¯à«ÊÂêÂ꦳ªºHER¨ü¾¹ ,Ãö³¬¦hºØ¸~½F¥Íªø¸ô®|, ¾A¥Î¤H¤f¼Æ»·¤j©óIncyte Pemigatinib ¤µ¤Ñ¤À¨Éªº¸ê°T ¶È¨Ñ°Ñ¦Ò |
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·|û¡G¥ß§»10147985 µoªí®É¶¡:2019/6/12 ¤U¤È 05:17:01²Ä 1044 ½g¦^À³
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¦ô ·sÃĦbFGFR2 °ò¦]¤U, ¤G½uÁx¹DÀù ¬ü¡B¼Ú¡B¤é¥«³õ ,2000¤H~3000¤H,¬ù1.8»õ¬ü¤¸~2.4»õ¬ü¤¸ªº¥«³õ. --------- ·sÃĦb¤G½uÁx¹DÀùMOS 15.8-6.8=9 ,¼W¥[9Ӥ몺¦s¬¡ ¥Ø«e°ê»Ú·sÃĨC¼W¤@¤ë¦s¬¡,¥iÈ10,000¬ü¤¸. 9*10,000=90,000 ¬ü¤¸ªºq»ù. MPFS=9.2¤ë, ¨C¤ëÃÄ»ù¬ù 10,000 ¬ü¤¸ 90,000*2000¤H~3000¤H(¬ü¡B¼Ú¡B¤é) 1.8»õ¬ü¤¸~2.4»õ¬ü¤¸ªº¥«³õ The incidence of cholangiocarcinoma with FGFR2 rearrangements is increasing and is currently estimated at 2,000-3,000 patients in the U.S., Europe and Japan. finance.yahoo.com/news/incyte-announces-first-patient-treated-113000907.html Cohort A FGFR2 Translocations (N=47) Best OR, n (%) 0 CR (0.0) 19 PR (40) 21 SD (45) Median PFS, Months (95% CI) 9.2 (6.44-NE) Median OS, Months (95% CI) 15.8 Cohort B Other FGF/FGFR Genetic Alterations (N=22) 0 CR (0.0) 0 PR (0.0) 10 SD (46) Median PFS, Months (95% CI) 2.1 (1.18-6.8) Median OS, Months (95% CI) 6.8 |
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·|û¡G¥xÁÞ10138776 µoªí®É¶¡:2019/6/12 ¤W¤È 11:01:20²Ä 1042 ½g¦^À³
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2019/6/12 ¤W¤È 10:26:18²Ä 1041 ½g¦^À³
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Cholangiocarcinoma is a cancer that arises from the cells within the bile ducts. It is often diagnosed late (stages III and IV) and the prognosis is poor. It is most common in those over 70 years old and is more common in men than women. FGFR2 fusion genes are drivers of the disease ¡V occurring almost exclusively in patients with intrahepatic cholangiocarcinoma (iCCA), a subset of the disease. The incidence of cholangiocarcinoma with FGFR2 rearrangements is increasing and is currently estimated at 2,000-3,000 patients in the U.S., Europe and Japan. finance.yahoo.com/news/incyte-announces-first-patient-treated-113000907.html ---------------------- |
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·|û¡G¥xÁÞ10138776 µoªí®É¶¡:2019/6/12 ¤W¤È 10:03:38²Ä 1040 ½g¦^À³
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¤Ñ©R¤j Áx¹DÀù¯f±w¨ã¦³FGFR2°ò¦]¤ñ²v¬O¦h¤Ö ? ¦pªG¤ñ²v§C´N¤£¥Î¾á¤ß«Â¯Ù¨È·à±dÁx¹DÀù¥«³õ ¨Ì¾Ú106¦~«×¦~³ø43¶´£¨ì: ÅX°ÊÁx¹DÀùªº¯S©w¶Ç»¼¸ô®|©|¥¼³QÃÒ¹ê, ¤£¹L¤é¥»»P¤¤°ê¼Æ¾ÚÅã¥Ü¬ù70% Áx¹DÀù¯f±w¸~½F¦³HER ®a±Ú¹L«×ªí²{ªº±¡§Î |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2019/6/11 ¤U¤È 08:34:37²Ä 1039 ½g¦^À³
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In patients with FGFR2 translocations who were followed for at least eight months Incyte ªº¤G½u¤G´ÁÁx¹DÀùÁ{§É¦Ü¤Ö8Ӥ몺followed , interim study results demonstrated an overall response rate (ORR) of 40 percent, the primary endpoint, and a median progression free survival (PFS) of 9.2 months °ò¦]FGFR2ªº, ORR 40%, M(PFS) of 9.2 months.MOS,15.8months ---------------------------------------------- ©Ò¥HASLAN001 ¤]¬O¦Ü¤Ö8Ó¤ë«á¦A¸Ñª¼,´N®e©ö³Q¸ÑÄÀ¤F. ¦pªGASLAN001 ¥¼¨Ó¦PIncyte¤@¼Ë ª½±µ¶} ¤@½u¤T´ÁÁx¹DÀùÁ{§É¤]¬O¦³¥i¯à. -------- Incyte Announces Positive Interim Data from Phase 2 Trial of Pemigatinib, Its Selective FGFR Inhibitor, in Patients with Cholangiocarcinoma investor.incyte.com/news-releases/news-release-details/incyte-announces-positive-interim-data-phase-2-trial-pemigatinib Cohort A FGFR2 Translocations (N=47) Best OR, n (%) 0 CR (0.0) 19 PR (40) 21 SD (45) Median PFS, Months (95% CI) 9.2 (6.44-NE) Median OS, Months (95% CI) 15.8 |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2019/6/11 ¤U¤È 05:02:38²Ä 1038 ½g¦^À³
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finance.yahoo.com/news/incyte-announces-first-patient-treated-113000907.html ¤@缐Áx¹DÀù¡A¤T´ÁÁ{§É¡A¦¬®×²Ä¤@¤H¡C Incyte , ¤G缐Áx¹DÀù¤G´ÁÁ{§É¡A¥h¦~°µ§¹¡Aª½±µ°µ¤@½u¤T´ÁÁ{§É Study Design Go to sections Study Type : Interventional (Clinical Trial) Estimated Enrollment : 432 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: A Phase 3, Open-Label, Randomized, Active-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Gemcitabine Plus Cisplatin Chemotherapy in First-Line Treatment of Participants With Unresectable or Metastatic Cholangiocarcinoma With FGFR2 Rearrangement (FIGHT-302) Actual Study Start Date : December 13, 2018 Estimated Primary Completion Date : March 2022 Estimated Study Completion Date : March 2023 clinicaltrials.gov/ct2/show/NCT03656536?term=Pemigatinib&rank=7 Incyte Announces First Patient Treated in Phase 3 Clinical Trial of Pemigatinib as a First-Line Therapy for Cholangiocarcinoma Business Wire Business WireJune 4, 2019 WILMINGTON, Del.--(BUSINESS WIRE)-- Incyte (INCY) today announced that the first patient has been treated in FIGHT-302, an open-label Phase 3 study evaluating pemigatinib (INCB54828), its selective fibroblast growth factor receptor (FGFR) inhibitor, compared to gemcitabine with cisplatin chemotherapy, the current standard of care, as a first-line therapy for patients with metastatic or surgically unresectable cholangiocarcinoma (bile duct cancer) and activating FGFR2 rearrangements. ¡§We are pleased to initiate FIGHT-302 ¡V the first Phase 3 study of pemigatinib ¡V which we hope will add to the growing body of evidence demonstrating its potential as a safe and effective treatment for patients with cholangiocarcinoma with known FGFR2 rearrangements, a rare and potentially life-threatening form of cancer,¡¨ said Steven Stein, M.D., Chief Medical Officer, Incyte. ¡§Most patients that present with cholangiocarcinoma, like those patients to be enrolled in the FIGHT-302 study, have an advanced form of the disease that cannot be surgically removed, and the majority do not respond to the current standard of care, demonstrating the significant need for new treatment options.¡¨ Cholangiocarcinoma is a cancer that arises from the cells within the bile ducts. It is often diagnosed late (stages III and IV) and the prognosis is poor. It is most common in those over 70 years old and is more common in men than women. FGFR2 fusion genes are drivers of the disease ¡V occurring almost exclusively in patients with intrahepatic cholangiocarcinoma (iCCA), a subset of the disease. The incidence of cholangiocarcinoma with FGFR2 rearrangements is increasing and is currently estimated at 2,000-3,000 patients in the U.S., Europe and Japan. About FIGHT and FIGHT-302 The FIGHT (FIbroblast Growth factor receptor in oncology and Hematology Trials) clinical trial program includes several ongoing studies investigating the safety and efficacy of pemigatinib monotherapy across several FGFR-driven malignancies. Currently, the program is comprised of the recently initiated FIGHT-302 study, and three Phase 2 studies: FIGHT-201 in patients with metastatic or surgically unresectable bladder cancer, including with activating FGFR3 alterations; FIGHT-202 in patients with metastatic or surgically unresectable cholangiocarcinoma who have failed previous therapy, including with activating FGFR2 translocations; FIGHT-203 in patients with myeloproliferative neoplasms with activating FGFR1 translocations; and FIGHT-207 in patients with previously-treated, locally-advanced/metastatic or surgically unresectable solid tumor malignancies harboring activating FGFR mutations or translocations, irrespective of tumor type. FIGHT-302 (NCT03656536) is an open-label, randomized, active-controlled Phase 3 trial evaluating the safety and efficacy of pemigatinib (INCB54828), Incyte¡¦s selective oral fibroblast growth factor receptor (FGFR) inhibitor compared to the current standard of care ¡V gemcitabine plus cisplatin chemotherapy ¡V as a first-line treatment for adult (age ≥ 18 years) patients with metastatic or surgically unresectable cholangiocarcinoma with a known FGFR receptor 2 (FGFR2) rearrangements. The study will enroll approximately 432 participants 1:1 into one of two treatment groups ¡V Group A will receive pemigatinib (13.5 mg once daily [QD]) administered as continuous therapy schedule (a cycle is three weeks), and Group B will receive gemcitabine (1000 mg/m2) plus cisplatin (25 mg/m2) administered on Days 1 and 8 of every three-week cycle for up to eight cycles. The primary endpoint of FIGHT-302 is progression free survival (PFS) across both groups, assessed by independent review per RECIST v1.1. Secondary endpoints include overall response rate (ORR), overall survival (OS), duration of response (DOR), disease control rate (DCR), safety and quality of life impact. FIGHT-302 is currently recruiting participants; for more information about the study, please visit clinicaltrials.gov/ct2/show/NCT03656536. |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2019/6/11 ¤U¤È 04:50:29²Ä 1037 ½g¦^À³
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Incyte Pemigatinib ¤G´ÁÁ{§ÉªvÀø¤G½uÁx¹DÀù, ¹êÅç¼Æ¾Ú¡A2018.10¤ë¤½¥¬ ¨ä¤¤±aµÛ°ò¦] FGFR2 ORR ¹F40%. (19/47),MPFS 9.2 ¤ë¡AMOS15.8¤ë ¨ä¥L¤G²Õ«DFGFR2°ò¦]ORR¬Ò0% , MPFS 2.1/1.68¡A MOS6.8 ¤ë/4.0¤ë ¡X¡X¡X ARQ087 ¤]¬OFGFR2ªº§í¨î剤,¤G´ÁÁ{§É¹êÅ礤 ¡X¡X¡X¡X ¿zÀË°ò¦]¬O¥²nªº¡C ASLAN001 ¤U¥b¦~¸Ñª¼«áªºµ²ªG¡A¥i¯à¦³¾÷·|¦p¤Wz¡A¦³EGFR ªºORR¡APFS¡B0S¬Ò·|°ª¼Ð¡C ¦Ü©ó·|¤£·|p 𡿨0.05 ¡A N=19 N=87(47¤H¡A47/87=54%, ±a¦³FGFR2) ORR=19/87=21.83% Y¦p¤W©ÒzIncyte, ORR 21.83 %(¹êÅç²Õ) vs. 0%(¹ï·Ó²Õ) ,p¡Õ0.01 ¡A¥²¹LÃö. PFS¹LÃö¾÷·|¥ç«D±`°ª ¡X¡X¡X¡X¡X¡X¡X¡X Incyte Announces Positive Interim Data from Phase 2 Trial of Pemigatinib, Its Selective FGFR Inhibitor, in Patients with Cholangiocarcinoma investor.incyte.com/news-releases/news-release-details/incyte-announces-positive-interim-data-phase-2-trial-pemigatinib WILMINGTON, Del.--(BUSINESS WIRE)--Oct. 21, 2018-- Incyte Corporation (Nasdaq:INCY) announces updated data from its ongoing Phase 2 FIGHT-202 trial evaluating pemigatinib (INCB54828), its selective fibroblast growth factor receptor (FGFR) inhibitor, in patients with advanced/metastatic or surgically unresectable cholangiocarcinoma (bile duct cancer) who failed at least one previous treatment. In patients with FGFR2 translocations who were followed for at least eight months, interim study results demonstrated an overall response rate (ORR) of 40 percent, the primary endpoint, and a median progression free survival (PFS) of 9.2 months, a key secondary endpoint. FIGHT-202 Overall Response Rates (ORR), Disease Control Rates (DCR), Durability of Response (DOR), Progression-Free Survival (PFS) and Overall Survival (OS) by Patient Cohort Cohort A FGFR2 Translocations (N=47) Best OR, n (%) 0 CR (0.0) 19 PR (40) 21 SD (45) Median PFS, Months (95% CI) 9.2 (6.44-NE) Median OS, Months (95% CI) 15.8 Cohort B Other FGF/FGFR Genetic Alterations (N=22) 0 CR (0.0) 0 PR (0.0) 10 SD (46) Median PFS, Months (95% CI) 2.1 (1.18-6.8) Median OS, Months (95% CI) 6.8 Cohort C No FGF/FGFR Genetic Alterations (N=18) 0 CR (0.0) 0 PR (0.0) 4 SD (22) Median PFS, Months (95% CI) 1.68 (1.38-1.84) Median OS, Months (95% CI) 4.0 |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2019/6/6 ¤U¤È 05:15:25²Ä 1032 ½g¦^À³
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www.genetinfo.com/investment/featured/item/27225.html OS ¹ï¥Ó½ÐÃĵý«D±`«n. |
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·|û¡G¥xÁÞ10138776 µoªí®É¶¡:2019/6/6 ¤U¤È 03:38:24²Ä 1031 ½g¦^À³
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2019/4/29 ¤U¤È 02:21:15²Ä 968 ½g¦^À³ ¥xÁÞ¤j¡A Ó¤H¬Ýªk: ¥Ñ©ó¤T´Á¥Dn«ü¼Ð¬OOS¡A¤U¥b¦~¸Ñª¼ªº¼Æ¾Ú¤ñ¸û¦³¦¨¼ôªºOS¼Æ¾Ú¡C ¨ä¥¦¼Ë¥»ÅܼƤ¤§Ü·½IHC¡Ï3/¡Ï2ªº¤ñ²v¦h¹è¥ç¥i¯à¼vÅT¼Ð¹vÃĪ«ªºÁ{§Éµ²ªG¡A¥»¦¸±N°µ±´¯Á¬ã¨s¡C aslanpharma.com/app/uploads/2018/06/2018-ASCO-ASLAN001-009.pdf Exploratory objectives: ¡E Part1 1. To explore the role of HER family status as a predictor of benefit to varlitinib 2. To explore possible relationships between HER family and downstream signaling protein and phospho-protein expression levels and clinical outcomes 3. To explore possible relationships between gene mutational status and clinical outcomes ¡E Part2 If a relationship is found between biomarker(s) expression and clinical outcomes in Part 1 of the study, the biomarker(s) could be prospectively evaluated in Part 2 of the study. ±´¯Á¥Ø¼Ð¡G ¡E ²Ä1³¡¤À 1.±´°QHER®a®xª¬ºA§@¬°¹w´ú¦]¤lªº§@¥Î ¹ïvarlitinib¦³¯q 2.±´°QHER®a®x»P®a®x¤§¶¡¥i¯à¦s¦bªºÃö«Y ¤U´å«H¸¹³J¥Õ©MÁC»Ä¤Æ³J¥Õ ªí¹F¤ô¥©MÁ{§Éµ²ªG 3.±´¯Á°ò¦]¤§¶¡ªº¥i¯àÃö«Y ¬ðÅܪ¬ºA©MÁ{§Éµ²ªG ¡E ²Ä2³¡¤À ¦pªG¦b¬ã¨sªº²Ä1³¡¤À¤¤µo²{¥Íª«¼Ð»xª«ªí¹F»PÁ{§Éµ²ªG¤§¶¡ªºÃö«Y¡A«h¥i¥H¦b¸Ó¬ã¨sªº²Ä2³¡¤À¤¤«e¤©Ê¦aµû¦ô¥Íª«¼Ð»xª«¡C |
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ÁÂÁ¤ѩR¤j´£¨Ñªº¤À¨É A Ó¤H¬ã§P¤G½uÁx¹DÀù¼Æ¾Ú·|¦bADRµo¦æ«e¤½§i , ¶¶¤ô±À¦à §¹¦¨¶Ò¸ê , ADRµo¦æ¥[¤W¥¼¨Ó Varlitinib »P ASLAN 003 °Ï°ì±ÂÅv³o¨Ç¦¬¤J¨¬¥HÀ³¥I Varlitinib »P ASLAN 004 Àò±o¥þ²y°Ó«~¤ÆÅv§Q©Ò»Ý¤ä¥Iªº´Ú¶µ B Varlitinib »P ASLAN 003 ¤w±ÂÅv«nÁú ¥¼¨Ó¤]¦³¶¥¬q©Ê¦¬¤J C ³Ì«nªº¦¬¤JÓ¤H»{¬°¬OéwªºRoyalty¦¬¤J,¤]´N¬O °£¤F Varlitinib , ASLAN 003 ,ASLAN 004 °Ï°ì±ÂÅv©Ò¦³ ¦¬¤J¦©°£Àò±o¥þ²y°Ó«~¤ÆÅv§Q©Ò»Ý¤ä¥Iªº´Ú¶µ¥~ , ¨C¦~±q¾P°âª÷ÃB©ÒÀò±oªºÅv§Qª÷ ( Royalty ) D ³¡¤À¦a°Ï¦Û¦æ¾P°â§Q¼í³Ì°ª,·íµM«e´£¬OÃÄn¦w¥þ¦³®Ä¼Æ¾Ú¯à¹F¼Ð¨Ã¦b®³¨ìÃÄÃÒ«e¯à¶¶§Q±ÂÅv¥X¥h , ¨È·à±d¥H¤p¦¨¥» ¤Þ¶i¬ãµoÃĪ«¶i¦Ó¦ø¾÷Àò±o¥þ²y°Ó«~¤ÆÅv§Q, ³oºØ¥H¤p·i¤jªºµ¦²¤«D±`¥¿½T,𷪺¸}¨B,¸`¬Ùªº¶}¤ä,ÃĪ«¬ãµo¥æ¤e ±»Å@(¦p¤@½uÁx¹DÀù ±»Å@¤G½uÁx¹DÀù )ÅýªÑªF·ÀI°§C ,¥t¥~¨È·à±d¦A±ÂÅv½Í§P¤è±¸gÅç¤Q¨¬¬O¨ä¯SÂI ¥H¤WÓ¤H¤À¨É ¶È¨Ñ°Ñ¦Ò |
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Dupixent(dupilumab) ±q¤@´Á¨ì¨ú±oÃĵý¦@5¦~. 31¤Hªº¤G´ÁÁ{§É¶}©l¨ìµ²§ô7Ó¤ë 671 ¤Hªº¤T´ÁÁ{§É¡A¶Èªá14Ó¤ë´N§¹¦¨¡A¥Dn«ü¼ÐªvÀø´µ4Ó¤ë¡C2014,oct~ 2015.nov ¤T´ÁÁ{§É§¹¦¨¤é´Á¨ìÃĵý¨ú±o¡A¦@p16Ó¤ë,. 2015 ,dec ~ 2017, mar clinicaltrials.gov/ct2/show/NCT02277743 Study of Dupilumab Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis (SOLO 1) ASLAN004 ¨Ì¤Wz¸ô®| , 1b©M¤G´ÁÁ{§É ¦b¥¼¨Ó17Ӥ맹¦¨¡C ¤T´ÁÁ{§É ¸Ñª¼ ¦b¥¼¨Ó18~32¤ë¥ª¥k§¹¦¨¡C ¥Ó½ÐÃĵý¡C33~48 ¤ë¥ª¥k§¹¦¨. |
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clinicaltrials.gov/ct2/show/NCT03721263 Study of ASLAN004 in Healthy Subjects Study Design Go to sections Study Type : Interventional (Clinical Trial) Actual Enrollment : 44 participants Intervention Model: Single Group Assignment Intervention Model Description: Single Ascending Dose Masking: None (Open Label) Primary Purpose: Treatment Official Title: A Phase 1, Open-Label, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of ASLAN004 in Healthy Subjects Actual Study Start Date : October 15, 2018 Estimated Primary Completion Date : May 20, 2019 Estimated Study Completion Date : September 30, 2019 |
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