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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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[..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. ]

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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

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In 2015, 3.2 million people died from COPD worldwide, an increase of 11.6 percent compared with 1990. During that same time period,

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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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¤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........

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
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ÁÂÁ¦U¦ì¤j¤jªº»¡©ú¡A¦ý¬OªÑ»ù¤@ª½¯}§C¡AÁ`­n½Ð¤½¥q»¡©ú¤@¤U§a¡I
¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
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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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¥Íª«»s¾¯Àøªk¦b¬ü°ê¤w¸g¹ê¦æ¤@¨â¦~¡A¥xÆW¬O¤µ¦~7¤ë©³¤~®Ö­ã¤W¥«¡A¥x¤jÂå°|¥Ø«e¦³7¦W¤¤­««×²§¦ì©Ê¥Ö½§ª¢±wªÌ¥¿¦b±µ¨ü¥Íª«»s¾¯ªvÀø¡A¦³6¦W±wªÌ¤ÏÀ³¬Û·í¦n¡A¤W­z¬G¨Æ¤¤ªº­J¥ý¥Í´N¬O¨ä¤¤¤@¦ì¡A±q¤K¤ë¶}©l¶i¦æªvÀø¡C

¡u¥Íª«»s¾¯¬O¥L±q¤p¨ì¤j±µÄ²ªºªvÀø¤¤®ÄªG³Ì¦nªº¡AÁöµM«e­±¨â¶g®ÄªG¤£©úÅã¡A¦ý±q²Ä¤T¶g¶}©l´N·|©úÅã·P¨ü¨ì¯gª¬¦nÂà¡A´X¥G¨S¦³µoª¢¯gª¬¡C¡v­J¥ý¥Íªí¥Ü¡A¥H«e¦YÃþ©T¾J¡BÀ¿Ãþ©T¾JªºÃij£¥u¯àÅý¯gª¬¼È®É±o¨ì±±¨î¡Aª½¨ì±µ¨ü¥Íª«»s¾¯ªvÀø«á¡A¥L·Pı¦Û¤v¯à¹³¥¿±`¤H¤@¼Ë¡A¥i¥H¹B°Ê¡B¦Y¬µª«¡A¤£¦AÄo¨ìºÎ¤£µÛı¡A¥Í¬¡©MºÎ¯v«~½è³£©úÅã´£¤É¡A¡u¸g¹Lµuµu¤T­Ó¤ëªvÀø«á¡A²×©ó·P¨ü¨ì¥Ö½§¦b©I§l¡A¶}©lı±o¤H¥ÍÅܱo¦³§Æ±æ¡I¡v

¤£¹L¥Íª«»s¾¯¨Ã¤£¬O§¹¥þ¨S¦³°Æ§@¥Î¡A¦¶®a·ì«ü¥X¡A¥´°w®É¡A¦³¨Ç±wªÌ·|¥X²{¥´°w³¡¦ì¬õ¸~¡Bµh·P¡A¦ý¤ñ¨Ò¤£°ª¡A¥t¥~8~10%ªº±wªÌ¥X²{µ²½¤ª¢ª¬ªp¡C­J¥ý¥Íªí¥Ü¡A¨Ï¥Î¥Íª«»s¾¯«á¡AÁöµM¥þ¨­¥Ö½§ª¬ªp¦nÂà¡A¦ý¦³¥X²{²´©P¡B²´·úÄoªºª¬ªp¡A¥i¾aÂI²´ÃĤô¡BÀ¿ÃÄ»I§ïµ½¡C

¶À·¶´fªí¥Ü¡A¡u­Y¬O±w³¡­±¿n¶W¹L10%ªº±wªÌ¡A´NÄݩ󤤭««×±wªÌ¡A¥i¦Ò¼{¨Ï¥Î¥Íª«»s¾¯¡C¡v¥Íª«»s¾¯ÁöµM®ÄªG¨Î¥B°Æ§@¥Î¤Ö¡A¦ý¥O±wªÌ³Ì«o¨Bªº´N¬O¶O¥Î°ª©ù¡A¤@°w­n»ù¤j¬ù2¸U8¤d¤¸¡A°·«O¥Ø«e©|¥¼µ¹¥I¡C¦¶®a·ì«Øij¡A¤¤­««×±wªÌ¥i¥H¥ý¨Ï¥Î²{¦³°·«Oµ¹¥IªºªvÀø¡A­Y¬O¨S¦³¦¨®Ä¦A¦Ò¼{¨Ï¥Î¥Íª«»s¾¯¡A¡u¤@¯ë¨Ó»¡¡AÄY­«¨ì»Ý­n¨Ï¥Î¥Íª«»s¾¯ªvÀøªº±wªÌ¤ñ¨Ò¤£°ª¡A¤j·§¦û¦¨¤H±wªÌªº10%¡C¡v

¶À·¶´f«Øij¡A­Y¥Á²³·Q¨Ï¥Î¥Íª«»s¾¯Àøªk¡AÀ³«ùÄò¥|­Ó¤ë¡A±N¯f±¡±±¨î¨ì¤@©wµ{«×«á¡A¦A©MÂå®v°Q½×·f°t¨ä¥LÀøªk¡C¦¶®a·ì«h±j½Õ¡A¡u¥|­Ó¤ë«á±wªÌ§¹¥þ¤£¥´°w¡A¤@¦~¤º´_µo¾÷²v¤j¬ù20%¡A¥B´Nºâ´_µo«á¦A¥´°w¤]¤@¼Ë¦³Àø®Ä¡C¡v

----¥Íª«»s¾¯©M¶Ç²ÎÀøªk¤£¦P¡A¬O°w¹ï²Ä¤G«¬²Ó­M©ÒÄÀ©ñªºIL-4¤ÎIL-13¶i¦æ§@¥Î¡A¤£·|¯}Ãa²Ä¤@«¬²Ó­M¡AÅý¨­Åé¨Ì¯à©è¿m¥~¨Ó¯f¬r¡B²Óµß¡A´î¤Ö¶Ç²ÎÀøªkªº°Æ§@¥Î¡A¹³¬O¥Õ¦å²y¤U­°¡B§K¬Ì¤O§C¤U¡A©Î¬O¥i¯àµo¥ÍªºµÇ¡B¨x¥\¯à¨ü·lµ¥¡C

¡u¥Íª«»s¾¯¬O±Ä¨ú°wµ©ª`®g¡A²Ä¤@¦¸¬I¥´¥²¶·¥´¨â°w¡A±µµÛ¹j¨â¶g´N¥²¶·¥´¤@°w¡A³q±`¤@­Ó¤ë´N¦³©úÅãÀø®Äªº¤ñ¨Ò°ª¹F¤@¥b¡A¥|­Ó¤ë§ïµ½75%ªº¤ñ¨Ò¦û¤T¤À¤§¤G¡C¡v¦¶®a·ì»¡¡C

(¸`¿ý)

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°Ó¾÷«Ü¤j,ºÝ¬ÝÃĪ«¦³®Ä§_!

²§¦ì©Ê¥Ö½§ª¢¶Ç²Î¤T½uªvÀø 8¦¨±wªÌ¤£º¡·N¡A¥|¦¨±wªÌ§ä¹L5­Ó¥H¤WªºÂå®v´M¨DªvÀø¡C

www.commonhealth.com.tw/article/article.action?nid=78471

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²§¦ì©Ê¥Ö½§ª¢¶Ç²Î¤T½uªvÀø 8¦¨±wªÌ¤£º¡·N¡A¥|¦¨±wªÌ§ä¹L5­Ó¥H¤WªºÂå®v´M¨DªvÀø¡C

www.commonhealth.com.tw/article/article.action?nid=78471

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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

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
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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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·|­û¡G¥xÁÞ10138776  µoªí®É¶¡:2019/8/11 ¤U¤È 10:15:29²Ä 1174 ½g¦^À³
¤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¶

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¤Ñ©R10141925  µoªí®É¶¡:2019/8/11 ¤W¤È 09:30:28²Ä 1173 ½g¦^À³
¥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§Ú­Ì¹ï©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¨â­Ó¼Æ¶q¯Å¤§¶¡¤ñ¬° 10¡C¨Ò¦p»¡¨â¼Æ¬Û®t¤T­Ó¼Æ¶q¯Å¡A¨ä¹ê´N¬O»¡¤@­Ó¼Æ¤ñ¥t¤@­Ó¤j 1000 ­¿¡C

¦p»¡¨â¼Æ¬Û®t¤G­Ó¼Æ¶q¯Å¡A¨ä¹ê´N¬O»¡¤@­Ó¼Æ¤ñ¥t¤@­Ó¤j 100 ­¿

¦p»¡¨â¼Æ¬Û®t¤@­Ó¼Æ¶q¯Å¡A¨ä¹ê´N¬O»¡¤@­Ó¼Æ¤ñ¥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¤@­Ó¼Æ¶q¯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§Ú­Ì¹ï©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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·|­û¡G¤Ñ©R10141925  µoªí®É¶¡:2019/8/7 ¤U¤È 12:28:48²Ä 1171 ½g¦^À³

¤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

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(5)°²³] ORR , ¹ï·Ó²Õ 0¤H(0/63=0%)¡A¹êÅç²Õ6¤H (6/64=9.4%)

¦]¹ï·Ó²Õ³æ¤ÆÀø ORR <=1.6%ªº¾÷²v«D±`°ª.(¬Ý¹L¼Æ­Ó¨Æ«á¤ÀªR­Ó®×¡A¦bµL§Ü·½¿zÀˤU,ORR ¬Û¹ï§C)

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·|­û¡G¥xÁÞ10138776  µoªí®É¶¡:2019/7/31 ¤W¤È 10:37:11²Ä 1146 ½g¦^À³
1143«h¸ê°T¤À¨É§@¼o §ó¥¿¸É¥R­«¶K¦p¤U

¤Ñ©R¤j

³o¬O´¼ÀºÂಾ©Ê¯Ø¸¢ÀùÃĪ«¦w¯à±o mOS mPFS »P¤ÏÀ³²v±¡ªp

A mOS : ¹êÅç²Õ 6.1 ­Ó¤ë ¹ï·Ó²Õ 4.2­Ó¤ë ¨â²Õ®t1.9­Ó¤ë P 0.014 ­·ÀI¤ñ(95% CI) 0.68 (0.50, 0.93)

B mPFS: ¹êÅç²Õ 3.1 ­Ó¤ë ¹ï·Ó²Õ 1.5­Ó¤ë ¨â²Õ®t1.6­Ó¤ë ­·ÀI¤ñ (95% CI) 0.55 (0.41, 0.75)

C «ÈÆ[¤ÏÀ³²v: ¹êÅç²Õ 7.7% (9/117) ¹ï·Ó²Õ 0.8% (1/119)

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 ]

¨Ì¾Ú¦w¯à±o¨â²ÕmPFS ±¡ªp±À´ú ,¹êÅç²Õ ¤§ mPFS ¤ñ¹ï·Ó²Õ mPFS ¦n ¤@ ­¿´N¦³¹LÃö¾÷·|

mPFS¥¼¤½§ip­È, ±qmPFS ­·ÀI¤ñ 0.55 ¨Ó¬Ý¤ñ mOS ­·ÀI¤ñ 0.68 ¨Ó±o¦n p­ÈÀ³¦³¹LÃö

²Î¤@§ëÅU¹ï¤U¥b¦~¥Í§Þ§ë¸ê®i±æ²³æ±Ô­z¦p¤U

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

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ASLAN 001 Áú°êQ1±ÂÅv¤w¸g¤½§i, ²Î¤@§ëÅUµû¦ô ASLAN 001 ¤é¥» Q4 ±ÂÅv ¬ù 1 »õ ¬ü¤¸

ASLAN 003 ¼Ú¬ü Q3 ±ÂÅv¬ù1»õ¬ü¤¸

­Ó¤H¤À¨É :

A ¤j®a¥i¥H±q¤é¥»Àù¯gÃĪ«¦û¤ñ °²³]¥i¥H±ÂÅvª÷1»õ¬ü¤¸ , ¦A¥h±À¦ô¤¤°ê ¼Ú¬w ¬ü°êÀù¯gÃĪ«¦û¤ñ

¤§±ÂÅvª÷. ­Ó¤H»{¬°ASLAN 003 ±ÂÅvª÷ »P ASLAN 001 ±µªñ( ³£¬OÀù¯gÃĪ«) , ASLAN 003 ¼Ú¬ü±ÂÅv¦ô1»õ¬ü¤¸¬O«O¦u¤@ÂI ( ¥i°Ñ¦Ò¨È·à±d2017¦~¦~³ø73­¶¥þ²y±ÂÅv±¡ªp)

B ¨Ì¾Ú 2017 1¤ë Global Data ñ¬ùª÷§¡­È ¤@´Á±ÂÅvñ¬ùª÷3100¸U¬ü¤¸ ¤G´Á±ÂÅvñ¬ùª÷4200¸U¬ü¤¸

¤T´Á±ÂÅvñ¬ùª÷ 4500¸U¬ü¤¸

¤@´Á±ÂÅv¨½µ{ª÷§¡­È 4.61»õ¬ü¤¸ ¤G´Á±ÂÅv¨½µ{ª÷§¡­È 2.76»õ¬ü¤¸ ¤T´Á±ÂÅv¨½µ{ª÷§¡­È 2.02»õ¬ü¤¸

C ¨Ì¾ÚBMI ¤ÀªR2017¦~¥þ²y¤Q¤jÃÄ«~¥«³õ ¬ü ¤¤ ¤é ¼w ­^ ªk ·N ¦è ¤Ú ¥[ ¦@8745.7»õ¬ü¤¸

¬ü°ê¥[®³¤j¦û¤ñ33.4 ¤¤°ê11.9 ¤é¥» 8.7 ¼w­^ªk¸q¦è 18.2 ¤Ú¦è 2.1 ( °Ñ¦Ò¯E¹©107¦~«×¦~³ø)

¥H¤W¸ê°T¤À¨É ¶È¨Ñ°Ñ¦Ò

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To:­¸¤H¤j

¾Ú§Ú©Òª¾, ¥«³õ¨S¤H¦A°Q½×¨È·à±d,¦n¹³­n¬Ý¨È·à±dªºªº°Q½×¸ò¤ÀªR,´N¬O³o¤@ª©¤F...«¢«¢

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To ¥xÁÞ¤j,

¥i¥H½Ð§A¤À¨É²Î¤@§ëÅU¹ï¤U¥b¦~¥Í§Þ®i±æªº¤å³¹¤º®e¶Ü? §Ú·Q¤F¸Ñ¤@¤U°ê¤º§ëÅU¹ï¨È·à±dªº¬Ýªk¡A¦A³Ò·Ð§A¦³ªÅ¥i¥H¤À¨É!

Thanks,

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
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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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¥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

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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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Carl°õ¦æªø»¡ªº¦~©³¼Æ¾Ú¥XÄl~~~²ö«D³o´N¬O¥ý«e©Ò´£ªº¡§¦³¤H¥ýª¾¹D¡¨~~~~

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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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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
¨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

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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

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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¦~,§Ú­Ì¹ï¤½¥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
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

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incyte fight 202 PFS K-M¹Ï

1.¥­§¡¦s¬¡¤ë¼ÆAVG. PFS

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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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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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***************************

¤@.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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rate for Part 1 at the 10% level (one-sided).

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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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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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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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In patients with FGFR2 translocations who were followed for at least eight months

Incyte ªº¤G½u¤G´ÁÁx¹DÀùÁ{§É¦Ü¤Ö8­Ó¤ëªºfollowed ,

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

----------------------------------------------

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--------

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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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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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.

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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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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

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C ³Ì­«­nªº¦¬¤J­Ó¤H»{¬°¬Oí©wªºRoyalty¦¬¤J,¤]´N¬O °£¤F Varlitinib , ASLAN 003 ,ASLAN 004 °Ï°ì±ÂÅv©Ò¦³

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clinicaltrials.gov/ct2/show/NCT02277743

Study of Dupilumab Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis (SOLO 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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1 Nutten, S. 2015. Atopic dermatitis: global epidemiology and risk factors

2 Atopic Dermatitis in America, accessed 17 October 2018

3 Decision Resources, 2017

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