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---ASLAN004 1b ´Á¤¤ AD ¸gÀٮįq57% Àu©óDupilumab 3´Á

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-----Eylea¸gÀٮįq35% Àu©ó Lucentis

¾P°â¥«³õÂX¥R¼Ò¦¡ ¡A

ASLAN004 ¥¼¨Ó¤W¥««e¥|¦~ ¾P°â¦ô­p¦p¤U

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¦ô­p2026¦~¤W¥«²Ä¤@¦~¾P°â 36»õ¬ü¤¸¬°dupilumab 30%(120*30%=36)

²Ä¤G¦~¾P°â 60»õ¬ü¤¸¬°dupilumab 50%(120*50%=60)

²Ä¤T¦~¾P°â 78»õ¬ü¤¸¬°dupilumab 65%(120*65%=78)

²Ä¥|¦~¾P°â115»õ¬ü¤¸¬°dupilumab 120%(96*120%=115),

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Dupilumab ¹w¦ô120»õ¬üª÷³Ì°ª¦~¾P°â(¬ü°êªÑ¥«¥«³õ»{µý),2020¾P40»õ¬ü¤¸, 2021¦ô¾P57»õ¬ü¤¸.

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1.ASLAN004 1b ´Á¤¤ADÁ{§É/QW*8¶g Àu¶Õ¼Æ¾Ú VS Dupilumab 3 ´Á AD /QW*16¶g ,

1.1

ASLAN004 1b´Á¤¤¸Ñª¼³ø§i 400mg /600mg EASI-75 (¤T´Á¥D­n«ü¼Ð¤§¤@)¹F67% ¹ï·Ó²Õ¬°0%,

Dupilumab 3 ´Á,¨C¶g¤@°w*16¶g EASI-75 =50% , ¹ï·Ó²Õ¬°13.5%

Aslan004 1b /Dupilumab p3/QW=67%/50%=134%. (°ò½u¼Æ­È¬Ûªñ)

¥D­nÀø®Ä«ü¼Ð Aslan004 1b Àu34% ©ó Dupilumab 3 ´Á,¨C¶g¤@°w*16¶g

1.2

ASLAN004 1b´Á¤¤¸Ñª¼³ø§i 400mg /600mg EASI-50(ªvÀø16¶g«á¥¼¹FEASI-50ªÌ,«OÀI¤½¥q¤£¦A¤ä¥I) ¹F89% ,¹ï·Ó²Õ¬°40%,

Dupilumab 3 ´Á,¨C¶g¤@°w*16¶g EASI-50 =61% , ¹ï·Ó²Õ¬°23.5%

Aslan004 1b /Dupilumab p3/QW=89%/61%=146%. (°ò½u¼Æ­È¬Ûªñ)

¦¸­nÀø®Ä«ü¼ÐEASI-50 ,

Aslan004 1b Àu46% ©ó Dupilumab 3 ´Á

ir.aslanpharma.com/static-files/5af23249-0b59-4bb1-95eb-199556171feb

1.3 ¸gÀٮįq®t²§

EASI-75 34% + EASI-50, +46%/2= 23%

=57%

Aslan004 1b ¸gÀٮįq Àu©ó Dupilumab 3 ´Á 57% ªº¼ç¤O(°²³]¥¼¨ÓÀøµ{¶O¬Û¦P)

( Dupilumab ¥D­nÀø®Ä«ü¼ÐIGA 0/1 °ª1.33~2­¿ ©ó¨ä¥L ¥u¯à§í¨îIL-13¡Ï³¡¤ÀIL-4/ ³æ§í¨îIL-13 ªº Lebrikiumab 75% of dupilumab /Tarlokinumab 50% of dupilumab)

2.¦w¥þ©Ê/°Æ§@¥Î :ASLAN004 µL Dupilumab ªº°ª¤ñ²vµ²½¤ª¢.(38%%¦³µ²¼Òª¢, ¹ê»Ú¨Ï¥Î241¤H¬ã¨s®×)

3.¥´°wÀW²v

ASLAN004 ¥|¶g¤@°w 600mg*4=2400mg ¹w´Á VS. Dupilumab*¤G¶g¤@°w/ 300mg*9=2700mg

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

Eylea ¥«³õ­°»ù66.6%,¥«³õ¾P°âÂX¥R76»õ¬ü¤¸¡AÂX¥R²v176%.

¥«Ô·º¯³z²v(¤H¼Æ)ÂX¥R265%,(176%/66.6%=265%)

2015 Lucentis ³Ì°ª¾P°â43»õ¬ü¤¸

2019¦~ ¨âÃľP°â¦X­p119»õ¬ü¤¸

¨ì2019¦~¥«³õ¼W¥[119-43=76»õ¬ü¤¸

76/43=176% ¼W¥[²v.-----(¥¼º¡¨¬¥«³õ,­°»ù¬O¦³¥Îªº)

2012: Eylea ¤W¥«²Ä¤@¦~¾P°â¬°Lucentis¤w¤W¥«6¦~ 36%.

2013: Eylea ¤W¥«²Ä¤G¦~¾P°â¬°Lucentis¤w¤W¥«7¦~ 51%.

2014: Eylea ¤W¥«²Ä¤T¦~¾P°â¬°Lucentis¤w¤W¥«8¦~ 65%.

2015: Eylea ¤W¥«²Ä¥|¦~¾P°â¬°Lucentis¤w¤W¥«9¦~ 120%.

2012 ¨âÃľP°â¦X­p32.7»õ¬ü¤¸

2013 ¨âÃľP°â¦X­p50.96»õ¬ü¤¸

2015 ¨âÃľP°â¦X­p74.8»õ¬ü¤¸

2016 ¨âÃľP°â¦X­p88.38»õ¬ü¤¸

2019 ¨âÃľP°â¦X­p119»õ¬ü¤¸

¥þ²y¾P°âª÷ÃB¡]»õ¬üª÷) PK

¡X- A:Lucentis) //B:(Eylea)**B/A**¦X­pA+B

2006(¤W¥«//)

2009¡V20.35//¡]Eylea 11¤ë FDA ®Ö­ã¤W¥«)

2012¡V24.00//8.70**B/A=36%**32.7

--------(Eylea²Ä¤@¦~¾P°â, ¦~«×¶O¥Î16,000¬ü¤¸¨C2­Ó¤ë¥´¤@°w vs Lu centis 24000¬ü¤¸/¨C¤ë¤@°w)

2013¡V39.53//20.43**B/A=51%**50.96

¡]2013/10¤ë¡A¤ÀªR®v¦ô2018/Eylea 47»õ¬ü¤¸)

2014¡V43.00//28.00**B/A=65%**71

2015¡V34.00//40.8.00**B/A=120%**74.8

(Lucentis ¡¥s ¥é¥ÍÃĦL«×¤W¥«//Eylea ¤W¥«²Ä¥|¦~,¦~¾P°â¶W¹LLucentis))

2016¡V33.00//55.38**B/A=161%**88.38

2017¡V33.00//62.82**B/A=190%**95.82

2018¡V37.00//67.00**B/A=181%**104

2019¡V41(¦ô)//78.52**B/A=191%**119

¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X-

AMD¡X¡X°w¾¯ Ävª§¥v¡]ªvÀø¡X²´·ú¶À¯Z³¡¯fÅÜ¡^

¤@¡BLucentis¡]Ranibizumab¡^¡X¡X2006¦~6¤ë¡AFDA®Ö­ã¤W¥«,ù¤ó(¬ü°ê¾P°â)/¿ÕµØ(¨ä¥L¦a°Ï¾P°â) ¡A¨C¤ë¤@°w¡A¨C¦~24,000¬ü¤¸Àøµ{¶O¥Î

¤G¡BEylea¡]aflibercept¡^¡X¡X-2011¦~11¤ë,FDA®Ö­ã¤W¥«¡ARegeneron Pharmaceuticals(¬ü°ê¾P°â)/«ô¦Õ(¨ä¥L¦a°Ï¾P°â,§Q¼í§¡¤À)¡A¨C2¤ë¤@°w¡A¨C¦~16,000¬ü¤¸Àøµ{¶O¥Î¡C

Lucentis¡]Ranibizumab¡^

©MEylea¡]aflibercept¡^

¬O¥Ø«e¼sªx¥Î©ó²´¬ì¯e¯fªºÀøªk¡AªvÀø¥]¬A·s¥Í¦åºÞ¡]Àã©Ê¡^¦~ÄÖ¬ÛÃö©Ê¶À´³ÅÜ©Ê¡Bµøºô½¤ÀR¯ßªý¶ë«á¶À´³¤ô¸~¡B¿}§¿¯f©Ê¶À´³¤ô¸~¡]DME¡^©MDME¦ñ¦³¿}§¿¯f©Êµøºô½¤¯fÅÜ¡C

¨âªÌ§¡¬°§Ü¦åºÞ¤º¥Ö¥Íªø¦]¤l¡]VEGF¡^Àøªk¡C2018¦~¡A³o¨â´ÚÃĪ«ªº¥þ²y¾P°âÃB±µªñ110»õ¬ü¤¸¡A¶È¦b¬ü°êªº¾P°âÃB´N¶W¹L¤F58»õ¬ü¤¸¡C

Lucentis¦b¬ü°êªº±M§Q±N©ó2020¦~¨ì´Á¡A¦ý¹w´ú2021¦~¾P°âÃB¤´±N¹F¨ì41»õ¬ü¤¸¡C

2015¦~²Ä¤@­Ó¥é¥ÍÃÄ¡A¦L«×¤W¥« 75%»ù®æ¡C

Eyleaªº¤@¶µÃöÁä±M§Q¦b¬ü°ê±N©ó2023¦~¨ì´Á¡A¦b¼Ú¬w¨ì2025¦~¤~¨ì´Á¡A¹w­p2021¦~¾P°âÃB±N¹F¨ì70»õ¬ü¤¸¡C

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2023¦~Q1°]³ø¥XÄl

Dupixent /Dupilumab ³æ¦ì:¦Ê¸U¬ü¤¸

USA(¬ü°ê)// ROW (¨ä¥L°Ï°ì)//¤p­p

2023

Q1 1,898.1//586.9//2,485.0

2022

Q1 1,325.6//484.8//1,810.4

Q2 1,582.1//509.7//2,091,8

Q3 1,824.0//506.1//2,330.1

Q4 1,936.3//512.6//2,448.9

¦X­p 6,668.8//2,013.2//8,681.1

2021

Q1 961.5 //301.4//1262.9

Q2 1140//352//1492

Q3 1256.7//406.2//1662.9

Q4 1348//426//1774

¦X­p 4712.8//1486//6198.8

2020

Q1 679.0 174.2 853.2

Q2 770.4 176.6 947.0

Q3 851.2 221.4 1072.6

Q4 925.6 246.4 1172.0

¤p­p3226.2 818.6 4044.8

2019

Q1 303.0 70.7 373.7

Q2 454.7 102.6 557.3

Q3 508.3 124.8 633.1

Q4 605.2 146.3 751.5

¤p­p 1,871.2 444.4 2,315.6

2018

Q1 117.2 14.2 131.4

Q2 180.9 28.3 209.2

Q3 219.6 43.0 262.6

Q4 258.6 60.2 318.8

¤p­p 776.3 145.7 922.0

2017

Q1 *******

Q2 *******

Q3 88.5 0.5 89.0

Q4 136.9 2.0 138.9

¤p­p 225.4 2.5 227.9

2017/03/28 FDA®Ö­ã¤W¥«

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2023¦~¦ôDupilumab ¦~¾P¤W¬Ý110»õ¬ü¤¸

2022¦~Q4°]³ø¥XÄl

Dupixent /Dupilumab ³æ¦ì:¦Ê¸U¬ü¤¸

USA(¬ü°ê)// ROW (¨ä¥L°Ï°ì)//¤p­p

2022

Q1 1,325.6//484.8//1,810.4

Q2 1,582.1//509.7//2,091,8

Q3 1,824.0//506.1//2,330.1

Q4 1,936.3//512.6//2,448.9

¦X­p 6,668.8//2,013.2//8,681.1

2021

Q1 961.5 //301.4//1262.9

Q2 1140//352//1492

Q3 1256.7//406.2//1662.9

Q4 1348//426//1774

¦X­p 4712.8//1486//6198.8

2020

Q1 679.0 174.2 853.2

Q2 770.4 176.6 947.0

Q3 851.2 221.4 1072.6

Q4 925.6 246.4 1172.0

¤p­p3226.2 818.6 4044.8

2019

Q1 303.0 70.7 373.7

Q2 454.7 102.6 557.3

Q3 508.3 124.8 633.1

Q4 605.2 146.3 751.5

¤p­p 1,871.2 444.4 2,315.6

2018

Q1 117.2 14.2 131.4

Q2 180.9 28.3 209.2

Q3 219.6 43.0 262.6

Q4 258.6 60.2 318.8

¤p­p 776.3 145.7 922.0

2017

Q1 *******

Q2 *******

Q3 88.5 0.5 89.0

Q4 136.9 2.0 138.9

¤p­p 225.4 2.5 227.9

2017/03/28 FDA®Ö­ã¤W¥«

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
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investor.regeneron.com/news-releases/news-release-details/regeneron-reports-third-quarter-2022-financial-and-operating

¤µ¦~À禬¦ôªñ87»õ¬ü¤¸¡C©ú¦~¦ô110»õ¬ü¤¸¡C

2022¦~Q3°]³ø¥XÄl

Dupixent /Dupilumab ³æ¦ì:¦Ê¸U¬ü¤¸

USA(¬ü°ê)// ROW (¨ä¥L°Ï°ì)//¤p­p

2022

Q1 1,325.6//484.8//1,810.4

Q2 1,582.1//509.7//2,091,8

Q3 1,824.0//506.1//2,330.1

2021

Q1 961.5 //301.4//1262.9

Q2 1140//352//1492

Q3 1256.7//406.2//1662.9

Q4 1348//426//1774

¦X­p 4712.8//1486//6198.8

2020

Q1 679.0 174.2 853.2

Q2 770.4 176.6 947.0

Q3 851.2 221.4 1072.6

Q4 925.6 246.4 1172.0

¤p­p3226.2 818.6 4044.8

2019

Q1 303.0 70.7 373.7

Q2 454.7 102.6 557.3

Q3 508.3 124.8 633.1

Q4 605.2 146.3 751.5

¤p­p 1,871.2 444.4 2,315.6

2018

Q1 117.2 14.2 131.4

Q2 180.9 28.3 209.2

Q3 219.6 43.0 262.6

Q4 258.6 60.2 318.8

¤p­p 776.3 145.7 922.0

2017

Q1 *******

Q2 *******

Q3 88.5 0.5 89.0

Q4 136.9 2.0 138.9

¤p­p 225.4 2.5 227.9

2017/03/28 FDA®Ö­ã¤W¥«

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¥»­¶ªº60»õ¬ü¤¸¬O2021¦~Dupilumab¦b¦U°Ïªº¾P°â¹êÁZ.

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P.39

Commercialization of eblasakimab has potential in different

regional markets

Eblasakimab(ASLAN004) ¦b¤£¦P»â°ì¨ã¦³¼ç¤O

°Ï°ì¥«³õªº°Ó·~¤Æ.

2021¦~Dupilumab ¾P°â¹êÁZ//2019¦~,AD±wªÌ¤H¼Æ

US $4,849M //41.4M(226¸U¤H)(¥¼¨ü±±¤¤-­««×¥Íª«»s¾¯¤H¤f¬ù¦û5.5%----REGN¸ê®Æ)

EU $793M//30.7M

JAPAN $322M//5.0M

CHINA $35M//535M

¦X­p $5,999M

¤G. P.38

Eblasakimab could be the favoured biologic, despite

dermatologists¡¦ long experience with dupilumab

Eblasakimab ¥i¯à¬O³Ì¨üÅwªïªº¥Íª«»s¾¯¡A¾¨ºÞ

¥Ö½§¬ìÂå¥Íªø´Á¨Ï¥Î dupilumab ªº¸gÅç

150¤H¥«½Õ

ASLAN004 VS DUPILUMAB ³ß¦nµ{«×

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Dupilumab 80»õ¬ü¤¸AD³Ì°ª¾P°â¥«³õ(REGN «Å¥¬Dupilumab 140»õ¬ü¤¸³Ì°ª¾P°â*56% AD/¥þ³¡«¬IIª¢¯g¥¼¨ü±±¬ü°ê¥«³õ)--

1.AD

°²³]DUPILUMAB AD ¤@½u¾P°â¦û2/3,¤G½u¦û1/3

Dupilumab ¨Ï¥Î52¶g«á¦³¤ÏÀ³ªº约50%(9¤ë15¤é CMO³ø§i资®Æ)

80*2/3¡Ñ50%=26.6(¤@½u)

+

80*1/3x50%=13.4(¤G½u)

=40»õ¬ü¤¸¡C

(¥H¤W­Ó¤H¨Ì¥«½Õµû¦ô³ß¦nµ{«×¤j¬ù¤ñ²v¦ô­p,¥¼¨Ó¨Ì2b¸Ñª¼¼Æ¾Ú¥i¯à·|¦A­×¥¿)

2.ASLN004 ¥þ³¡¾P°â¦ô¬ù70»õ¬ü¤¸

40/56%=¬ù70»õ¬ü¤¸ (¬ùDUPILUMAB 140»õ¬ü¤¸³Ì°ª¾P°âªº 50%)

¥|.©ú¦~4¤ë¸Ñª¼

EASI 75 = 73% (ASLAN004)VS 24%(¹ï·Ó²Õ)-----´Á±æ­È

IGA0,1 = 57% (ASLAN004)VS 15%(¹ï·Ó²Õ)-----´Á±æ­È

ASLAN004 2b VS Lebrikizumab 2b ---¦©°£¹ï·Ó²Õ¤zÂZ

°²³]°ò½u¦P¬°EASI25.5

EASI75 49%(73%-24%) /37%(61%-24%)=132%---(¹ï·Ó²Õ24%)

IGA0,1 42%(57%-15%) /30%(45%-15%)=140%---(¹ï·Ó²Õ15%)

­Y¯à¦p¥H¤W´Á±æ­È,

¨º±wªÌªº³ß¦n«×¥i¯à±q50%©Ô¨ì80%.

100~140»õ¬ü¤¸¾P°â¼ç¤O¤~¦³¥i¯à.

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ASLAN004 ¤¤-­««×AD谮¦b¥«¦û¥«Ô·¡A¤@&¤G½u¡A

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60/80 (dupilumab AD) ¡Ñ130(dupilumab ³Ì°ª¾P°â)=97.5»õ¬ü¤¸(¶×²v¬ü¤¸ 1¡G¼Ú¤¸ 1)

ASLAN004 ¯uªº¦³¦Ê»õ¬ü¤¸ªº¾P°â谮¤O¡C

¡K¡K¡K¡K¡K¡K¡K¡K¡K¡K¡K¡K¡K¡K¡K¡K¡K¡K

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ASLAN004 欧¬w°ÏAD±ÂÅv°ò¦

¥i¯à¬°Lebrikizumab(欧°Ï销°â5»õ¬ü¤¸)ªº1.6­¿Ã±约ª÷¡C

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ASLAN004 ¦b¤¤-­««×AD ¥þ²y¥«³õ ¦³ªñ60»õ¬ü¤¸¾P°â¼ç¤O(¤@½u¤Î¤G½u AD¥Íª«»s¾¯¥ÎÃÄ),

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US $4,849M //41.4M///¥¼¨ü±±AD约2.1M(REGN 资®Æ)

EU $793M//30.7M

JAPAN $322M//5.0M

CHINA $35M//35.6M(§ó¥¿资®Æ)

¦X­p $5,999M//113M(¥þ²y200M ±w-AD)

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¤HÃþ¦]¹Ú·Q¦Ó°¶¤j!!!!!

ASLN 2b ©ú¦~4¤ë¸Ñª¼

­Y¦pÀø®Ä¹w´Á

EASI 75=ASLAN004 73% VS ¹ï·Ó²Õ15%----(Dupilumab ¤T´Á 51% vs 15%) //Àø®Ä¤ñ(73%/51%=143%)

IGA 0,1=ASLAN004 58% VS ¹ï·Ó²Õ10%----(Dupilumab ¤T´Á 38% vs 10% )//Àø®Ä¤ñ(58%/38%=153%)

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

Two Phase 3 Trials of Dupilumab versus Placebo in Atopic Dermatitis

www.nejm.org/doi/full/10.1056/nejmoa1610020

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

­YªÑ»ù©Ô¤W20¬ü¤¸/ªÑ,

¥[¼Ú¬w±ÂÅvª÷¬°Lebrikizuamb 3­¿

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ASLN ¸ê¥»ÃB200,000¤dªÑADR

ASLN004 ³Ì°ª¾P°âª÷ÃB¦ô100~140»õ¬ü¤¸

³Q¨ÖÁʪ÷ÃB¤Î¤W¥««á¤T­Ó¤ë¤ºªÑ²¼¥«­È,

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150~210¬ü¤¸/ªÑ

------(¥i°µªº¤j¹Ú)----------------

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¤Ñ©R10141925  µoªí®É¶¡:2022/8/4 ¤U¤È 10:13:38²Ä 93 ½g¦^À³
investor.regeneron.com/news-releases/news-release-details/regeneron-reports-second-quarter-2022-financial-and-operating

2022¦~Q2°]³ø¥XÄl

Dupixent /Dupilumab ³æ¦ì:¦Ê¸U¬ü¤¸

USA(¬ü°ê)// ROW (¨ä¥L°Ï°ì)//¤p­p

2022

Q1 1,325.6//484.8//1,810.4

Q2 1,582.1//509.7//2,091,8

2021

Q1 961.5 //301.4//1262.9

Q2 1140//352//1492

Q3 1256.7//406.2//1662.9

Q4 1348//426//1774

¦X­p 4712.8//1486//6198.8

2020

Q1 679.0 174.2 853.2

Q2 770.4 176.6 947.0

Q3 851.2 221.4 1072.6

Q4 925.6 246.4 1172.0

¤p­p3226.2 818.6 4044.8

2019

Q1 303.0 70.7 373.7

Q2 454.7 102.6 557.3

Q3 508.3 124.8 633.1

Q4 605.2 146.3 751.5

¤p­p 1,871.2 444.4 2,315.6

2018

Q1 117.2 14.2 131.4

Q2 180.9 28.3 209.2

Q3 219.6 43.0 262.6

Q4 258.6 60.2 318.8

¤p­p 776.3 145.7 922.0

2017

Q1 *******

Q2 *******

Q3 88.5 0.5 89.0

Q4 136.9 2.0 138.9

¤p­p 225.4 2.5 227.9

2017/03/28 FDA®Ö­ã¤W¥«

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¤Ñ©R10141925  µoªí®É¶¡:2022/5/6 ¤U¤È 06:52:44²Ä 92 ½g¦^À³
investor.regeneron.com/news-releases/news-release-details/regeneron-reports-first-quarter-2022-financial-and-operating

2022¦~Q1°]³ø¥XÄl

Dupixent /Dupilumab ³æ¦ì:¦Ê¸U¬ü¤¸

USA(¬ü°ê)// ROW (¨ä¥L°Ï°ì)//¤p­p

2022

Q1 1,325.6//484.8//1,810.4

2021

Q1 961.5 //301.4//1262.9

Q2 1140//352//1492

Q3 1256.7//406.2//1662.9

Q4 1348//426//1774

¦X­p 4712.8//1486//6198.8

2020

Q1 679.0 174.2 853.2

Q2 770.4 176.6 947.0

Q3 851.2 221.4 1072.6

Q4 925.6 246.4 1172.0

¤p­p3226.2 818.6 4044.8

2019

Q1 303.0 70.7 373.7

Q2 454.7 102.6 557.3

Q3 508.3 124.8 633.1

Q4 605.2 146.3 751.5

¤p­p 1,871.2 444.4 2,315.6

2018

Q1 117.2 14.2 131.4

Q2 180.9 28.3 209.2

Q3 219.6 43.0 262.6

Q4 258.6 60.2 318.8

¤p­p 776.3 145.7 922.0

2017

Q1 *******

Q2 *******

Q3 88.5 0.5 89.0

Q4 136.9 2.0 138.9

¤p­p 225.4 2.5 227.9

2017/03/28 FDA®Ö­ã¤W¥«

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¤Ñ©R10141925  µoªí®É¶¡:2022/2/5 ¤U¤È 12:21:03²Ä 91 ½g¦^À³
2023¦~¦ô¥i¨úDupilumab·sÃĵý,¦p¤U

Eosinophilic Esophagitis (EOE), ¬ü¥Ø¼Ð¥«³õ48K

Chronic Spontaneous Urticaria(CSU),¬ü¥Ø¼Ð¥«³õ308K_

Prurigo Nodularis(PN),¬ü¥Ø¼Ð¥«³õ74K

¤p­p 430K(¥¼¨ü±±,¬ü°ê¥Íª«»s¾¯¼ç¦b¥«³õ)

2022¦~©³«e,¤w¨úDupilumabÃĵý,¦p¤U

1.AD 2300K

2.Asthma 975K

3.CRSwNP 90K

¤p­p 3465K(3,465,000¤H)(¥¼¨ü±±,¬ü°ê--¥Íª«»s¾¯¼ç¦b¥«³õ)

Dupilumab 2021/Q4°]³ø¥XÄl

investor.regeneron.com/static-files/2312afdd-0a3e-47cd-a8ed-d0ad3d9a83ad

Q4³æ©u½æ17.74»õ¬ü¤¸,2021¦~²Ö­p¦ÜQ4 ¾P°â62»õ¬ü¤¸

2020¦~¥þ¦~¾P°â½æ40.4»õ¬ü¤¸¡C2021¦~¦~¦¨ªø53%

¦ô­p2022¦~¥þ²y¾P°â 82~85 »õ¬ü¤¸

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

Dupixent /Dupilumab ³æ¦ì:¦Ê¸U¬ü¤¸

USA(¬ü°ê)// ROW (¨ä¥L°Ï°ì)//¤p­p

2021

Q1 961.5 //301.4//1262.9

Q2 1140//352//1492

Q3 1256.7//406.2//1662.9

Q4 1348//426//1774

¦X­p 4712.8//1486//6198.8

2020

Q1 679.0 174.2 853.2

Q2 770.4 176.6 947.0

Q3 851.2 221.4 1072.6

Q4 925.6 246.4 1172.0

¤p­p3226.2 818.6 4044.8

2019

Q1 303.0 70.7 373.7

Q2 454.7 102.6 557.3

Q3 508.3 124.8 633.1

Q4 605.2 146.3 751.5

¤p­p 1,871.2 444.4 2,315.6

2018

Q1 117.2 14.2 131.4

Q2 180.9 28.3 209.2

Q3 219.6 43.0 262.6

Q4 258.6 60.2 318.8

¤p­p 776.3 145.7 922.0

2017

Q1 *******

Q2 *******

Q3 88.5 0.5 89.0

Q4 136.9 2.0 138.9

¤p­p 225.4 2.5 227.9

2017/03/28 FDA®Ö­ã¤W¥«

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¤Ñ©R10141925  µoªí®É¶¡:2021/12/29 ¤U¤È 05:53:32²Ä 90 ½g¦^À³
www.novartis.com/sites/novartis_com/files/q3-2021-media-release-en.pdf

Lucentis ¾P°â

1.¼Ú°Ï

2021¦~«e¤T©u¾P°â16.5»õ¬ü¤¸,¦~¦¨ªø12%.

¦ô¤µ¦~¾P¦ô22»õ¬ü¤¸

2.¬ü°ê

2021¦~«e¤T©u¾P°â12»õ¬ü¤¸,¦~¦¨ªø-5%.

¦ô¤µ¦~¾P¦ô16 »õ¬ü¤¸

www.roche.com/dam/jcr:c976ca37-1e01-46b8-817c-7669586c6481/en/211020_IR_Q3_EN.pdf

3.¦X­p ¤µ¦~¾P°â¦ô38»õ¬ü¤¸

2006¦~¤W¥«,¤w¤W¥«²Ä15¦~

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

investor.regeneron.com/news-releases/news-release-details/regeneron-reports-third-quarter-2021-financial-and-operating

EYLEA

2021¦~«e¤T©u¾P°â67»õ¬ü¤¸,¦~¦¨ªø21%.

¦ô¤µ¦~¾P93~94»õ¬ü¤¸

2011¦~11¤ë¤W¥«,¤w¤W¥«²Ä10¦~.

2®a¤½¥q¦X­p¾P°â ¦ô 93+38=131»õ¬ü¤¸.------2021¦~

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

1¡BEylea»ù®æ¡]¥Ø«e»ù®æ¡^¡A¨C¤G¤ë¤@°w

40 mg/mL

Eylea intravitreal solution

from $1,940.90

for 0.05 milliliters

Quantity Per unit Price

0.05 milliliters $38,818.00 $1,940.

¦~1940¬ü¤¸X6¡×11640¬ü¤¸¡]¨C¦~¶O¥Î¡^

2¡BLucentis»ù®æ¡]¨C¤ë¤@°w¡^

6 mg/mL

Lucentis intravitreal solution

from $1,230.98

for 0.05 milliliters

Quantity Per unit Price

0.05 milliliters $24,619.60 $1,230.98

12x1230=14760¬ü¤¸¡A¨C¦~¶O¥Î

¤@¤@¤@¤@¤@¤@¤@¤@

Lucentis¶O¥Î¤ñEylea¶Q3000¬ü¤¸¡A¨C¦~¡A²´·ú¨C¦~¦h¥´6¦¸°w¡A³o¼ËÁÙ¯à¦~¾P4l»õ¬üª÷¡C

¥¼¨ÓAslan004¦~¾P°â¡A¥i¯à©MDupilumab ¬Û·íªº©w»ù¡A¦Óµ²½¤ª¢§C©ÎµL¡AÄvª§¤O¬Û¹ï°ª¡C

¾P°âÃB¦ôupilumab110»õ¬ü¤¸¤@¥b¡A¯uªº§C¦ô¤F¡C

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶

·|­û¡G¤Ñ©R10141925 µoªí®É¶¡:2021/12/29 ¤U¤È 02:34:47²Ä 5018 ½g¦^À³

¬Ý¤@¤UAMD¥«³õ²Ä¤G¦WªºLucentis¡]2006¦~¤W¥«¡^

¦b2019¦~¤´¦³²Ä¤@¦WEylea¡]2011¦~¤W¥«¡^ªº¬ù¤@¥b¾P°âª÷ÃB¡C

41»õ¬ü¤¸vs78»õ¬ü¤¸

¥«³õ°÷¤j¡A¤@ª½¦b¦¨ªø¡C´N«Ü¦³»ù»ù

AD¥¼¨Ó240»õ¬ü¤¸ªº¥Íª«»s¾¯¥«³õ¡A¥Ø«e¤~60»õ¬ü¤¸¡C

ASLAN004 vs dupilumab

±ø¥óÀu©óLucentis vs Eylea ¡A¤j®a©ñ¤ß¡I

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¤Ñ©R10141925  µoªí®É¶¡:2021/11/13 ¤W¤È 11:40:39²Ä 89 ½g¦^À³
2029¦~ªvÀø¤¤-­««×AD ,¥Íª«»s¾¯, ¦ô¾P240»õ¬ü¤¸ VS 2021¦~63»õ.

2030¦~ªvÀø¤¤-­««×­ý³Ý ,¥Íª«»s¾¯, ¦ô¾P200»õ¬ü¤¸ VS 2021¦~60~70»õ.(¤w¦³5ºØ¤W¥« IL5*33+ IL4 +IgE)

mops.twse.com.tw/nas/STR/474320211008M002.pdf

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

3.ªvÀø¤¤-­««×ADÀø®Ä¬ùDUPILUMAB 100%~130%, ASLAN004 ¦ô, 35~45»õ¬ü¤¸.

­ý³Ý¤Î¨ä¥L¾AÀ³¯g+ASLAN003 ¬ù¼W¤@­¿,

¦X­p ¦ô³Ì°ª¾P°â70~90»õ¬ü¤¸.

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

1.ªvÀø¤¤-­««×ADÀø®Ä¶È¬ùDUPILUMAB 75%, Lebrikizumab¦ô,°ª®p¦~¾P°â25»õ¬ü¤¸.

2019/02 ,Dermira ¦A±Â¥X¼Ú¬wLebrikizumab °Ó·~¤ÆÅv¤Oµ¹Almirall,¤½¥q.

Out-License and Other Agreements

\Almirall Agreement

·í®ÉAlmirall CEO ¦ô¼Ú¬w³Ì°ª¾P°â5»õ¬ü¤¸, (¦û¥þ²y¬ù20%)

5/20%=25»õ¬ü¤¸,---¦ô­p¥þ²y¾P°â°ª峄.

2.ªvÀø¤¤-­««×ADÀø®Ä¶È¬ùDUPILUMAB 50%, Adtralza (tralokinumab)¦ô,2027 ¦~¾P°â16»õ¬ü¤¸.

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GADAS10151414  µoªí®É¶¡:2021/11/5 ¤U¤È 05:09:33²Ä 88 ½g¦^À³
6497 ¤½¶}µo¦æ¤½¥q¤£Ä~Äò¤½¶}µo¦æ¡I

¬°¦ó¥i¥H¬Ý¨ì°]³ø

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¤Ñ©R10141925  µoªí®É¶¡:2021/11/4 ¤U¤È 10:04:15²Ä 87 ½g¦^À³
Dupilumab Q3°]³ø¥XÄl

Q3³æ©u½æ16.63»õ¬ü¤¸,¥»¦~²Ö­p¦ÜQ3 ¾P°â44.25»õ¬ü¤¸

¥h¦~¥þ¦~¾P°â½æ40.4»õ¬ü¤¸¡A¤µ¦~¦ô61~62»õ¬ü¤¸¡C

investor.regeneron.com/news-releases/news-release-details/regeneron-reports-third-quarter-2021-financial-and-operating

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

Dupixent /Dupilumab ³æ¦ì:¦Ê¸U¬ü¤¸

USA(¬ü°ê)// ROW (¨ä¥L°Ï°ì)//¤p­p

2021

Q1 961.5 //301.4//1262.9

Q2 1140//352//1492

Q3 1256.7//406.2//1662.9

Q4

¦X­p 3364.8//1060//4424.8

2020

Q1 679.0 174.2 853.2

Q2 770.4 176.6 947.0

Q3 851.2 221.4 1072.6

Q4 925.6 246.4 1172.0

¤p­p3226.2 818.6 4044.8

2019

Q1 303.0 70.7 373.7

Q2 454.7 102.6 557.3

Q3 508.3 124.8 633.1

Q4 605.2 146.3 751.5

¤p­p 1,871.2 444.4 2,315.6

2018

Q1 117.2 14.2 131.4

Q2 180.9 28.3 209.2

Q3 219.6 43.0 262.6

Q4 258.6 60.2 318.8

¤p­p 776.3 145.7 922.0

2017

Q1 *******

Q2 *******

Q3 88.5 0.5 89.0

Q4 136.9 2.0 138.9

¤p­p 225.4 2.5 227.9

2017/03/28 FDA®Ö­ã¤W¥«

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¤Ñ©R10141925  µoªí®É¶¡:2021/8/6 ¤W¤È 06:43:25²Ä 86 ½g¦^À³
Dupilumab Q2 °]³ø¥XÄl¡C

investor.regeneron.com/news-releases/news-release-details/regeneron-reports-second-quarter-2021-financial-and-operating

¥h¦~½æ40.4»õ¬ü¤¸¡A¤µ¦~¦ô58-60»õ¬ü¤¸¡C

Dupixent /Dupilumab ³æ¦ì:¦Ê¸U¬ü¤¸

USA(¬ü°ê)// ROW (¨ä¥L°Ï°ì)//¤p­p

2021

Q1 961.5 //301.4//1262.9

Q2 1140//352//1492

Q3

Q4

¦X­p 2101.5//653.4//2754.9

2020

Q1 679.0 174.2 853.2

Q2 770.4 176.6 947.0

Q3 851.2 221.4 1072.6

Q4 925.6 246.4 1172.0

¤p­p3226.2 818.6 4044.8

2019

Q1 303.0 70.7 373.7

Q2 454.7 102.6 557.3

Q3 508.3 124.8 633.1

Q4 605.2 146.3 751.5

¤p­p 1,871.2 444.4 2,315.6

2018

Q1 117.2 14.2 131.4

Q2 180.9 28.3 209.2

Q3 219.6 43.0 262.6

Q4 258.6 60.2 318.8

¤p­p 776.3 145.7 922.0

2017

Q1 *******

Q2 *******

Q3 88.5 0.5 89.0

Q4 136.9 2.0 138.9

¤p­p 225.4 2.5 227.9

2017/03/28 FDA®Ö­ã¤W¥«

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¤Ñ©R10141925  µoªí®É¶¡:2021/5/7 ¤U¤È 04:20:25²Ä 85 ½g¦^À³
2021¦~ Q1 Dupilumab À禬¥XÄl 12.6»õ¬ü¤¸,

¤ñ¥h¦~¦P´Á¼W¥[ 48%.

Dupilumaqb ¤µ¦~3¤ë1¤é¯Ç¤J¤¤°ê°ê«O¡C)

investor.regeneron.com/news-releases/news-release-details/regeneron-reports-first-quarter-2021-financial-and-operating

2020¦~²Ä¥|©u°]³ø¤½¥¬¡ADupilumab ¥þ¦~¾P°â¹F40.4»õ¬ü¤¸.

Dupixent /Dupilumab ³æ¦ì:¦Ê¸U¬ü¤¸

USA(¬ü°ê)// ROW (¨ä¥L°Ï°ì)//¤p­p

2020

Q1 961.5 //301.4//1262.9

Q2

Q3

Q4

¦X­p961.5//301.4//1262.9

2020

Q1 679.0 174.2 853.2

Q2 770.4 176.6 947.0

Q3 851.2 221.4 1072.6

Q4 925.6 246.4 1172.0

¤p­p3226.2 818.6 4044.8

2019

Q1 303.0 70.7 373.7

Q2 454.7 102.6 557.3

Q3 508.3 124.8 633.1

Q4 605.2 146.3 751.5

¤p­p 1,871.2 444.4 2,315.6

2018

Q1 117.2 14.2 131.4

Q2 180.9 28.3 209.2

Q3 219.6 43.0 262.6

Q4 258.6 60.2 318.8

¤p­p 776.3 145.7 922.0

2017

Q1 *******

Q2 *******

Q3 88.5 0.5 89.0

Q4 136.9 2.0 138.9

¤p­p 225.4 2.5 227.9

2017/03/28 FDA®Ö­ã¤W¥«

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¤Ñ©R10141925  µoªí®É¶¡:2021/3/20 ¤W¤È 09:50:25²Ä 84 ½g¦^À³
ASLAN Pharmaceuticals: A Next-Generation Dupixent And Potential 5x Return In A Year

Mar. 18, 2021 9:00 AM ETASLAN Pharmaceuticals Limited (ASLN)4 Comments1 Like

¤W­z³ø§i , ¦ô»ùªº°ò¦¡A³Ì°ª销°â40»õ¬ü¤¸¡C

ASLAN004¦X²z³Ì°ª¾P°â¡A°ê»Ú¦æ±¡¡A¦Ü¤Ö60»õ¬ü¤¸销°â

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20%§é现²v¡A¤U¤§ASLN¦U¦~¥Ø¼Ð»ù

2027 120/1.2=100¬ü¤¸

2026 100/1.2=83¬ü¤¸

2025 83/1.2=69 ¬ü¤¸

2024 69/1.2=58 ¬ü¤¸

2023 58/1.2=48 ¬ü¤¸

2022 48/1.2=40 ¬ü¤¸

2021 40/1.2=33 ¬ü¤¸¡C

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Dupilumab ¤wªá¶W¹L50»õ¬ü¤¸ªº¬ãµo费¡C

ASLAN004 AD¤Î­ý³Ý³Ì¨ÎÀøªk¼ç¤O

---ASLAN004 1b ´Á¤¤ AD ¸gÀٮįq57% Àu©óDupilumab 3´Á

¨Ì¾ÚEylea vs Lucentis ,

-----Eylea¸gÀٮįq35% Àu©ó Lucentis

¾P°â¥«³õÂX¥R¼Ò¦¡ ¡A

ASLAN004 ¥¼¨Ó¤W¥««e¥|¦~ ¾P°â¦ô­p¦p¤U

ASLAN004 ¾P°â¦ôdupilumab(2026-2029)

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²Ä¤T¦~¾P°â 78»õ¬ü¤¸¬°dupilumab 65%(120*65%=78)

²Ä¥|¦~¾P°â115»õ¬ü¤¸¬°dupilumab 120%(96*120%=115),

--------

Dupilumab ¹w¦ô120»õ¬üª÷³Ì°ª¦~¾P°â(¬ü°êªÑ¥«¥«³õ»{µý),2020¾P40»õ¬ü¤¸, 2021¦ô¾P57»õ¬ü¤¸.

--------

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1.1

ASLAN004 1b´Á¤¤¸Ñª¼³ø§i 400mg /600mg EASI-75 (¤T´Á¥D­n«ü¼Ð¤§¤@)¹F67% ¹ï·Ó²Õ¬°0%,

Dupilumab 3 ´Á,¨C¶g¤@°w*16¶g EASI-75 =50% , ¹ï·Ó²Õ¬°13.5%

Aslan004 1b /Dupilumab p3/QW=67%/50%=134%. (°ò½u¼Æ­È¬Ûªñ)

¥D­nÀø®Ä«ü¼Ð Aslan004 1b Àu34% ©ó Dupilumab 3 ´Á,¨C¶g¤@°w*16¶g

1.2

ASLAN004 1b´Á¤¤¸Ñª¼³ø§i 400mg /600mg EASI-50(ªvÀø16¶g«á¥¼¹FEASI-50ªÌ,«OÀI¤½¥q¤£¦A¤ä¥I) ¹F89% ,¹ï·Ó²Õ¬°40%,

Dupilumab 3 ´Á,¨C¶g¤@°w*16¶g EASI-50 =61% , ¹ï·Ó²Õ¬°23.5%

Aslan004 1b /Dupilumab p3/QW=89%/61%=146%. (°ò½u¼Æ­È¬Ûªñ)

¦¸­nÀø®Ä«ü¼ÐEASI-50 ,

Aslan004 1b Àu46% ©ó Dupilumab 3 ´Á

ir.aslanpharma.com/static-files/5af23249-0b59-4bb1-95eb-199556171feb

1.3 ¸gÀٮįq®t²§

EASI-75 34% + EASI-50, +46%/2= 23%

=57%

Aslan004 1b ¸gÀٮįq Àu©ó Dupilumab 3 ´Á 57% ªº¼ç¤O(°²³]¥¼¨ÓÀøµ{¶O¬Û¦P)

( Dupilumab ¥D­nÀø®Ä«ü¼ÐIGA 0/1 °ª1.33~2­¿ ©ó¨ä¥L ¥u¯à§í¨îIL-13¡Ï³¡¤ÀIL-4/ ³æ§í¨îIL-13 ªº Lebrikiumab 75% of dupilumab /Tarlokinumab 50% of dupilumab)

2.¦w¥þ©Ê/°Æ§@¥Î :ASLAN004 µL Dupilumab ªº°ª¤ñ²vµ²½¤ª¢.(38%%¦³µ²¼Òª¢, ¹ê»Ú¨Ï¥Î241¤H¬ã¨s®×)

3.¥´°wÀW²v

ASLAN004 ¥|¶g¤@°w 600mg*4=2400mg ¹w´Á VS. Dupilumab*¤G¶g¤@°w/ 300mg*9=2700mg

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

Eylea ¥«³õ­°»ù66.6%,¥«³õ¾P°âÂX¥R76»õ¬ü¤¸¡AÂX¥R²v176%.

¥«Ô·º¯³z²v(¤H¼Æ)ÂX¥R265%,(176%/66.6%=265%)

2015 Lucentis ³Ì°ª¾P°â43»õ¬ü¤¸

2019¦~ ¨âÃľP°â¦X­p119»õ¬ü¤¸

¨ì2019¦~¥«³õ¼W¥[119-43=76»õ¬ü¤¸

76/43=176% ¼W¥[²v.-----(¥¼º¡¨¬¥«³õ,­°»ù¬O¦³¥Îªº)

2012: Eylea ¤W¥«²Ä¤@¦~¾P°â¬°Lucentis¤w¤W¥«6¦~ 36%.

2013: Eylea ¤W¥«²Ä¤G¦~¾P°â¬°Lucentis¤w¤W¥«7¦~ 51%.

2014: Eylea ¤W¥«²Ä¤T¦~¾P°â¬°Lucentis¤w¤W¥«8¦~ 65%.

2015: Eylea ¤W¥«²Ä¥|¦~¾P°â¬°Lucentis¤w¤W¥«9¦~ 120%.

2012 ¨âÃľP°â¦X­p32.7»õ¬ü¤¸

2013 ¨âÃľP°â¦X­p50.96»õ¬ü¤¸

2015 ¨âÃľP°â¦X­p74.8»õ¬ü¤¸

2016 ¨âÃľP°â¦X­p88.38»õ¬ü¤¸

2019 ¨âÃľP°â¦X­p119»õ¬ü¤¸

¥þ²y¾P°âª÷ÃB¡]»õ¬üª÷) PK

¡X- A:Lucentis) //B:(Eylea)**B/A**¦X­pA+B

2006(¤W¥«//)

2009¡V20.35//¡]Eylea 11¤ë FDA ®Ö­ã¤W¥«)

2012¡V24.00//8.70**B/A=36%**32.7

--------(Eylea²Ä¤@¦~¾P°â, ¦~«×¶O¥Î16,000¬ü¤¸¨C2­Ó¤ë¥´¤@°w vs Lu centis 24000¬ü¤¸/¨C¤ë¤@°w)

2013¡V39.53//20.43**B/A=51%**50.96

¡]2013/10¤ë¡A¤ÀªR®v¦ô2018/Eylea 47»õ¬ü¤¸)

2014¡V43.00//28.00**B/A=65%**71

2015¡V34.00//40.8.00**B/A=120%**74.8

(Lucentis ¡¥s ¥é¥ÍÃĦL«×¤W¥«//Eylea ¤W¥«²Ä¥|¦~,¦~¾P°â¶W¹LLucentis))

2016¡V33.00//55.38**B/A=161%**88.38

2017¡V33.00//62.82**B/A=190%**95.82

2018¡V37.00//67.00**B/A=181%**104

2019¡V41(¦ô)//78.52**B/A=191%**119

¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X-

AMD¡X¡X°w¾¯ Ävª§¥v¡]ªvÀø¡X²´·ú¶À¯Z³¡¯fÅÜ¡^

¤@¡BLucentis¡]Ranibizumab¡^¡X¡X2006¦~6¤ë¡AFDA®Ö­ã¤W¥«,ù¤ó(¬ü°ê¾P°â)/¿ÕµØ(¨ä¥L¦a°Ï¾P°â) ¡A¨C¤ë¤@°w¡A¨C¦~24,000¬ü¤¸Àøµ{¶O¥Î

¤G¡BEylea¡]aflibercept¡^¡X¡X-2011¦~11¤ë,FDA®Ö­ã¤W¥«¡ARegeneron Pharmaceuticals(¬ü°ê¾P°â)/«ô¦Õ(¨ä¥L¦a°Ï¾P°â,§Q¼í§¡¤À)¡A¨C2¤ë¤@°w¡A¨C¦~16,000¬ü¤¸Àøµ{¶O¥Î¡C

Lucentis¡]Ranibizumab¡^

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Lucentis¦b¬ü°êªº±M§Q±N©ó2020¦~¨ì´Á¡A¦ý¹w´ú2021¦~¾P°âÃB¤´±N¹F¨ì41»õ¬ü¤¸¡C

2015¦~²Ä¤@­Ó¥é¥ÍÃÄ¡A¦L«×¤W¥« 75%»ù®æ¡C

Eyleaªº¤@¶µÃöÁä±M§Q¦b¬ü°ê±N©ó2023¦~¨ì´Á¡A¦b¼Ú¬w¨ì2025¦~¤~¨ì´Á¡A¹w­p2021¦~¾P°âÃB±N¹F¨ì70»õ¬ü¤¸¡C

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1.ASLAN004 1b Àu¶Õ ADÁ{§É¼Æ¾Ú VS Dupilumab 3 ´Á AD ,

1.1

ASLAN004 1b´Á¤¤¸Ñª¼³ø§i 400mg /600mg EASI-75 (¤T´Á¥D­n«ü¼Ð¤§¤@)¹F67% ¹ï·Ó²Õ¬°0%,

Dupilumab 3 ´Á,¨C¶g¤@°w*16¶g EASI-75 =50% , ¹ï·Ó²Õ¬°13.5%

Aslan004 1b /Dupilumab p3/QW=67%/50%=134%. (°ò½u¼Æ­È¬Ûªñ)

ir.aslanpharma.com/static-files/5af23249-0b59-4bb1-95eb-199556171feb

1.2

ASLAN004 1b´Á¤¤¸Ñª¼³ø§i 400mg /600mg EASI-50(ªvÀø16¶g«á¥¼¹FEASI-50ªÌ,«OÀI¤½¥q¤£¦A¤ä¥I) ¹F89% ,¹ï·Ó²Õ¬°40%,

Dupilumab 3 ´Á,¨C¶g¤@°w*16¶g EASI-50 =61% , ¹ï·Ó²Õ¬°23.5%

Aslan004 1b /Dupilumab p3/QW=89%/61%=146%. (°ò½u¼Æ­È¬Ûªñ)

1.3 ¸gÀٮįq®t²§

EASI-75= +34% +

EASI-50=+46%/2= 23%

=57%

Aslan004 1b ¸gÀٮįq Àu©ó Dupilumab 57% ªº¼ç¤O(°²³]¥¼¨ÓÀøµ{¶O¬Û¦P)

1.4 Dupilumab ¥D­nÀø®Ä«ü¼ÐIGA 0/1 °ª1.33~2­¿ ©ó¨ä¥L ¥u¯à§í¨îIL-13¡Ï³¡¤ÀIL-4/ ³æ§í¨îIL-13 ªº Lebrikiumab 75% of dupilumab /Tarlokinumab 50% of dupilumab

2.¦w¥þ©Ê/°Æ§@¥Î :ASLAN004 µL Dupilumab ªº°ª¤ñ²vµ²½¤ª¢.

3.¥´°wÀW²v

ASLAN004 ¥|¶g¤@°w 600mg*4=2400mg ¹w´Á VS. Dupilumab*¤G¶g¤@°w/ 300mg*9=2700mg

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ASLAN004ªº2b Á{§É³]­p¡A­Y¬°

0,2,4,8,12¡A¦@5°wx600mg¡Ñ16¶g¡A¦X­p3000mg,

vS Dupilumab 2¶g¤@°wx300mg¡A°_©l¶q600mg,

¦X­p2700mg,

¥¼¨ÓASLAN004 2b­Y¦¹³]­pªºÀø®Ä¡A¯à¦p1b¡A

ESAI-50 88% vs dupilumab 60%

EASI -75¹F67% vs dupilumab 50%

IGA¡A0/1 ©Ô¤W50% vs dupilumab 38%

¥D­nÀø®Ä«ü¼ÐÀu©ó¹ï¤â30%¤Q28%¥¼¹F¤ÏÀ³(EASI-50)/2-2%¦¨¥»®t²§=¦X­p42%

¤]´N¬O»¡¡AASLAN004ªº¸gÀٮįq¡A¶W¹LDupilumab ,·í¦~Àøµ{费¬Û¦P¤§¤U¡C

«OÀI¤½¥qµ´¹ï·|Àu¥ý¨Ï¥ÎASLAN004¡A«h¥¼¨Ó³Ì°ª¾P°â¹F100»õ¬ü¤¸¡A¤£¬O¹Ú¡C

«D±`¦nªº³Q¨ÖÁʼЪº¡C

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¸É¥R

Dupilumab MOA ¼v¤ù¥i»¡©ú¥H¤U¥|ÃÄ¡C

www.dupixenthcp.com/atopicdermatitis/about/mechanism-of-action

ªýÂ_«¬II½Æ¦X¨üÅ骺MOA ¤w¸g4ÃÄÅçÃÒ.

1.Dupilumab ¤W¥«¤v¾P°â»õ¬ü¤¸,¤T´Á¥D­n«üIGA,0/1©M¹ï·Ó¤ñ­È¬ù3.8~4.6­¿,

§@¥Î¦b¤¶¥Õ¯ÀIL-4R£\¨ü¾¹,¨Ï¤¶¥Õ¯ÀIL-4µLªkIL-4R£\µ²¦X,¦Ó©j断¤uL-4ªº°T®§¶Ç»¼¡C

¥t¥~¦P®ÉµLªk¨ÏIL-4R£\¥hµ²¦X©MIL-13+IL-13R£\1½Æ¦XÅé¡Aªý断IL¤@13°T®§¶Ç»¼¡C

2.Tralokinumab ¤w¤T´Á¹LÃö,¥Ó½ÐADÃĵý¤¤,¤T´Á¥D­n«üIGA,0/1©M¹ï·Ó¤ñ­È¬ù2­¿,

§@¥Î¦b¤¶¥Õ¯ÀIL-13ªºA,DÁ³±Û,¨ÏIL¤@13µLªk©MIL¤@13Ra1结¦X¡A¦Óªý断IL¤@13ªº°T®§¶Ç»¼¡C

¦ýµLªkªý断IL¤@4ªº°T®§¶Ç»¼¡C³o¥i¸ÑÄÀ¤T´ÁÁ{§ÉÀø®Ä¶ÈDupilumab ¤@¥b¡C

3.Lerikizumab ¤T´ÁÁ{§É¤¤, ¤G´Á¥D­n«üIGA,0/1©M¹ï·Ó¤ñ­È¬ù3­¿,

§@¥Î¦b¤¶¥Õ¯ÀIL-13ªºB,CÁ³±Û¡C¤uL-13©MIL13-Ra1¥i结¦X¡A¦ýµLªk©M¤uL-4Raµ²¦X¦¨«¬II½Æ¦XÅé¡Aªý断IL-13°T®§¶Ç»¼¡C¦^¦û¾Ú³¡¤ÀIL-13Ra1¡A¨Ï约¤@¥bªºIL4ªº°T®§¶Ç»¼³QªýÂ_¡C

4.ASLAN004 1a °µ§¹

§@¥Î¦b¤¶¥Õ¯ÀIL-13R£\1,¨Ï¤¶¥Õ¯ÀIL-13µLªkIL-13R£\1¨ü¾¹µ²¦X,ªý断IL-13°T®§¶Ç»¼¡C

¥t¥~¦P®ÉµLªk¨ÏIL-13R£\1¥hµ²©MIL-4+IL-4 R£\½Æ¦XÅé

ªý断IL-4°T®§¶Ç»¼¡C

Validated pathway:

(¤wÅçÃÒªº¸ô®|¡K¡KMOA§@¥Î¾÷Âà))

Targets the same pathway and receptor complex (Type II)

as dupilumab

(ASAN004¥Íª«»s¾¯¼Ð¹v¥Ø¼Ð©Mdupilumab¦³¬Û¦P¸ô®|¤Î«¬II½Æ¦X¨üÅé)

³Ì终结ªG¨Ï«¬II½Æ¦X¨üÅéµLªk组¦¨¡A¦Ó¦P®Éªý断¤¶¥Õ¯À4/13¸¹ªº°T®§¶Ç»¼¡A¦Óªý¤î«áÄòªº¹L±Óµoª¢¤ÏÀ³¡C

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ªýÂ_«¬II½Æ¦X¨üÅ骺MOA ¤w¸g4ÃÄÅçÃÒ.

1.Dupilumab ¤W¥«¤v¾P°â»õ¬ü¤¸,¤T´Á¥D­n«üIGA,0/1©M¹ï·Ó¤ñ­È¬ù3.8~4.6­¿,

§@¥Î¦b¤¶¥Õ¯ÀIL-4R£\¨ü¾¹,¨Ï¤¶¥Õ¯ÀIL-4µLªkIL-4R£\µ²¦X,¦Ó©j断¤uL-4ªº°T®§¶Ç»¼¡C

¥t¥~¦P®ÉµLªk¨ÏIL-4R£\¥hµ²¦X©MIL-13+IL-13R£\1½Æ¦XÅé¡Aªý断IL¤@13°T®§¶Ç»¼¡C

2.Tralokinumab ¤w¤T´Á¹LÃö,¥Ó½ÐADÃĵý¤¤,¤T´Á¥D­n«üIGA,0/1©M¹ï·Ó¤ñ­È¬ù2­¿,

§@¥Î¦b¤¶¥Õ¯ÀIL-13ªºA,DÁ³±Û,¨ÏIL¤@13µLªk©MIL¤@13Ra1结¦X¡A¦Óªý断IL¤@13ªº°T®§¶Ç»¼¡C

¦ýµLªkªý断IL¤@4ªº°T®§¶Ç»¼¡C³o¥i¸ÑÄÀ¤T´ÁÁ{§ÉÀø®Ä¶ÈDupilumab ¤@¥b¡C

3.Lerikizumab ¤T´ÁÁ{§É¤¤, ¤G´Á¥D­n«üIGA,0/1©M¹ï·Ó¤ñ­È¬ù3­¿,

§@¥Î¦b¤¶¥Õ¯ÀIL-13ªºB,CÁ³±Û¡C

4.ASLAN004 1a °µ§¹

§@¥Î¦b¤¶¥Õ¯ÀIL-13R£\1,¨Ï¤¶¥Õ¯ÀIL-13µLªkIL-13R£\1¨ü¾¹µ²¦X,

¥t¥~¦P®ÉµLªk¨ÏIL-13R£\1¥hµ²©MIL-4+IL-4 R£\½Æ¦XÅé

Validated pathway:

(¤wÅçÃÒªº¸ô®|¡K¡KMOA§@¥Î¾÷Âà))

Targets the same pathway and receptor complex (Type II)

as dupilumab

(ASAN004¥Íª«»s¾¯¼Ð¹v¥Ø¼Ð©Mdupilumab¦³¬Û¦P¸ô®|¤Î«¬II½Æ¦X¨üÅé)

³Ì终结ªG¨Ï«¬II½Æ¦X¨üÅéµLªk组¦¨¡A¦Ó¦P®Éªý断¤¶¥Õ¯À4/13¸¹ªº°T®§¶Ç»¼¡A¦Óªý¤î«áÄòªº¹L±Óµoª¢¤ÏÀ³¡C

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ROGER¤jªº¶K¤å

ºK¿ý¸ôÁ`±M³X¡C

°Ý¡G¦p¦ó¿Å¶q·sÃÄ»ù­Èªºµû¦ôÂI¡H

µª:

²Ä¤@¬O¥H°ê»Ú¥«³õ¬°¤ñ¸û°ò¦¡A§Aªº¹ï¤â´N¬O°ê»Ú¤jÃļt¡C

²Ä¤G¬O²Å¦XĹ®a³q¦Y­ì«h¡A­n°µ¥þ²y¦Ñ¤j¡C¡F

²Ä¤T¬O¦b¥«³õ¤G¤À¤§¤@ªk«h¤U¡A¦Ü¤Ö¦³10»õ¬ü¤¸¥H¤W¦~¹ê½è»Ý¨D¡A¤£­n½M¦£¡C

²Ä¥|¨ã¦³¥þ²y¿W¤@µL¤Gªº·sÃħ@¥Î¾÷¨î(MOA(¡A¦¨¥\¤~½æ±o±¼¡C

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

1.ASLAN004 ¹ï¤âdupilumab 100»õ¼Ú¤¸ªº³Ì°ª¦~¾P,¥h¦~¤w¾P40»õ¬ü¤¸,¹w¦ô¤W¥«§¹¦¨¾P°â²Ä7¦~(2024¦~)¥i¹F³Ì°ª¾P°â.

2.ASLAN004 ¦³¼ç¤O¦¨¬°AD&­ý³Ýªº³Ì¨ÎÀøªk

3.¦~¾P¼È¥Hdupilumab³Ì°ª¾P°â100»õ¼Ú¤¸ªº¤@¥b¦ô¤§¬ù60»õ¬ü¤¸

4.MOA ¬°¥þ²y°ß¤@§@¥Î¦bIL-13R£\1©Mdupilumab ¬Û¦P¥i¦P®É§é¨îIL-4/IL13°T®§¶Ç»¼ªº¥Íª«»s¾¯¼Ð¹v.

first-in-classs

ASLAN004 is a fully human monoclonal antibody that targets the IL-13 receptor £\1 subunit, or IL-13R£\1, with potential to be a best-in-class therapy

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2020¦~²Ä¥|©u°]³ø¤½¥¬¡ADupilumab ¥þ¦~¾P°â¹F40.4»õ¬ü¤¸.

investor.regeneron.com/news-releases/news-release-details/regeneron-reports-fourth-quarter-and-full-year-2020-financial

Dupixent /Dupilumab ³æ¦ì:¦Ê¸U¬ü¤¸

USA ROW ¤p­p

2020

Q1 679.0 174.2 853.2

Q2 770.4 176.6 947.0

Q3 851.2 221.4 1072.6

Q4 925.6 246.4 1172.0

¤p­p3226.2 818.6 4044.8

2019

Q1 303.0 70.7 373.7

Q2 454.7 102.6 557.3

Q3 508.3 124.8 633.1

Q4 605.2 146.3 751.5

¤p­p 1,871.2 444.4 2,315.6

2018

Q1 117.2 14.2 131.4

Q2 180.9 28.3 209.2

Q3 219.6 43.0 262.6

Q4 258.6 60.2 318.8

¤p­p 776.3 145.7 922.0

2017

Q1 *******

Q2 *******

Q3 88.5 0.5 89.0

Q4 136.9 2.0 138.9

¤p­p 225.4 2.5 227.9

2017/03/28 FDA®Ö­ã¤W¥«

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¬ü°ê¤½/¨p«O³W©w¡A¬Û¦PÃĮĤU¡A«K©yªºÃÄ¥ý¥Î¡C

ASLAN004¦³Àu©ó/µ¥©óDupilumabªºÀø®Ä¡C

¦~Àøµ{费¦³Dupilumab64%¡A¥H¤Uªº谮¤O¡C

µLDupilumab结½¤ª¢¤§°Æ§@¥Î¡C

»ù®æ¤j­°¡A¥«³õ¥²·|ÂX¤j¡A¥¼¨ÓASLAN004¾P°â¶W¯ÅDupilumab¬O¦³¾÷·|ªº¡C

100»õ¬ü¤¸ªº¾P°â¬OASLAN004¥i´Á¤§¹Ú¡C

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­Y¤¤³~³Q¨ÖÁÊ¡A¥H¥Ø«eªÑ»ù¥«­È¡Aªñ2»õ¬ü¤¸¦Ó¨¥(§t»{ªÑÅv¤Îªñ¤@¦~¼W资«áªÑ¥»)¡C

50¬ü¤¸/ªÑADR¡A¬O°ò¥»»ù­È¡C

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¡K¡K¡K¡K¡K¡K

ASLAN004¤§M0AÅçÃÒ

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¦bASLAN004IVª`®g¤@¤p®É«á¡A§Y³QªýÂ_¡A¥NªíM0A¦¨¥\¡C

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PRESS RELEASE

ASLAN PHARMACEUTICALS OPENS EXPANSION COHORT IN ASLAN004 ATOPIC DERMATITIS CLINICAL TRIAL

- ASLAN has completed recruitment of patients into the third, highest dose cohort of ASLAN004 in AD patients. ASLAN004 was found to be well tolerated at all dose levels

- Data Monitoring Committee approved proposal to open the expansion cohort based on blinded safety data, accelerating study completion timelines

Singapore, 11 January 2021 ¡V ASLAN Pharmaceuticals (Nasdaq:ASLN), a clinical-stage immunology focused biopharmaceutical company developing innovative treatments to transform the lives of patients, today announced that it has received approval from the Data Monitoring Committee (DMC) to initiate recruitment of patients into the final expansion cohort in its ongoing randomised, double-blind placebo-controlled multiple ascending dose (MAD) study of ASLAN004 for the treatment of moderate to severe atopic dermatitis (AD).

The approval was received following a review by the DMC of blinded safety data from all three dose cohorts of the MAD study. ASLAN004 was found to be well tolerated at all dose levels. There were no serious adverse events related to treatment and no clinically significant injection site reactions. The DMC approved the proposal to open the expansion cohort at the highest dose in advance of unblinding data from the first three cohorts of the study, which is expected to take place in early 2021. ASLAN plans to immediately commence recruitment of at least 18 patients into the expansion cohort, with at least 12 patients dosed weekly with 600mg ASLAN004 and the rest receiving placebo. Patients will be recruited from sites in the United States, Australia and Singapore.

Dr. Ken Kobayashi, CMO, ASLAN Pharmaceuticals, commented: ¡§The emerging safety profile of ASLAN004 has allowed us to move directly into the expansion cohort at the highest dose, 600mg weekly, based on blinded safety data, accelerating the completion of the study. Because ASLAN004 is the only clinical stage monoclonal antibody targeting IL-13R£\1, we believe it has the potential to be best-in-disease which may result in improved safety and efficacy over other biologics in the class. We look forward to presenting new, unblinded data from the first three dose cohorts as planned in early 2021, followed by data from the expansion cohort in mid-2021. Thereafter, we plan to initiate a global Phase 2b study in AD, in which we expect to evaluate biweekly and monthly dose regimens of ASLAN004.¡¨

The Phase 1 study is evaluating three doses of ASLAN004 (200mg, 400mg and 600mg) delivered subcutaneously and includes a fourth (expansion) cohort. Each of the first three dose cohorts contain up to six patients on ASLAN004 and two patients on placebo, and the expansion cohort will contain at least 12 patients on ASLAN004 and at least six patients on placebo. Patients are dosed weekly for eight weeks to determine safety and tolerability, as well as a number of secondary efficacy outcome measures.

ASLAN004 is a first-in-class monoclonal antibody that binds to the IL-13 receptor £\1 subunit (IL-13R£\1), blocking signalling of two pro-inflammatory cytokines, IL-4 and IL-13, which are central to triggering symptoms of AD, such as redness and itching of the skin

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¨Ì¨C©u©u¼W1.25»õ¬ü¤¸¦ôºâ

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Q3 dupilumab ¾P°â¹êÁZ10.7»õ¬ü¤¸¥XÄl

¦ô­p¤µ¦~²Ö­p±N¹F40»õ¬ü¤¸¡C

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Dupixent /Dupilumab ³æ¦ì:¦Ê¸U¬ü¤¸

USA ROW ¤p­p

2020

Q1 679.0 176.2 855.2

Q2 770.4 176.6 945.0

Q3 ??? ???? 1070.0

Q4

¤p­p149.4 352.8 2970.2

2019

Q1 303.0 70.7 373.7

Q2 454.7 102.6 557.3

Q3 508.3 124.8 633.1

Q4 605.2 146.3 751.5

¤p­p 1,871.2 444.4 2,315.6

2018

Q1 117.2 14.2 131.4

Q2 180.9 28.3 209.2

Q3 219.6 43.0 262.6

Q4 258.6 60.2 318.8

¤p­p 776.3 145.7 922.0

2017

Q1 *******

Q2 *******

Q3 88.5 0.5 89.0

Q4 136.9 2.0 138.9

¤p­p 225.4 2.5 227.9

2017/03/28 FDA®Ö­ã¤W¥«

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³Ì·s¤½¥q²¤¶¡X-11¤ë4¤é

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¥¼¨Ó11¦~(2019-2030) Atopic dermatitis (AD)& Asthma medication ¦X­p±N¼W¥[ 155+172=327»õ¬ü¤¸

¥þ²y¾P°â¶q.

Large and unmet market opportunity

The table below summarizes the estimated global market size for

our pipeline based on Frost & Sullivan.

Drug Market Global market size

(US$)

........................ Atopic dermatitis (AD) medication

2019: 7.9 Billion

2024E: 17.3 Billion

2030E: 23.4 Billion (¥¼¨Ó11¦~¤º±N¼W¥[155»õ¬ü¤¸)

CAGR(¦~½Æ¦X¦¨ªø²v)

2015-2019: 15.8%

2019-2024E: 17.0%

2024E-2030E: 5.1%

Asthma medication

2019: 32.8 Billion

2024E: 38.5 Billion

2030E: 50.0 Billion(¥¼¨Ó11¦~¤º±N¼W¥[172»õ¬ü¤¸)

CAGR(¦~½Æ¦X¦¨ªø²v)

2015-2019: 0.1%

2019-2024E: 3.2%

2024E-2030E: 4.4%

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ASLAN²{¦b¤w¶}©l©Û¶Ò¶i¤JÀH¾÷¡AÂùª¼¡A¦w¼¢¾¯¹ï·ÓªºMAD¬ã¨sªº²Ä¤T­Ó³Ì°ª¾¯¶q¡]600mg¡^¶¤¦C¡C±N±q·s¥[©Y¡A¬ü°ê©M¿D¤j§Q¨ÈªºÁ{§É¦aÂI©Û¶ÒÁ`¦@¤K¦W±wªÌ¡C ASLAN¹w­p±N¦b2021¦~ªì³ø§i©Ò¦³¤T­Ó¾¯¶q»¼¼W¶¤¦Cªº¤¤´Á¡A«Dª¼¥Ø¼Æ¾Ú¡C

ASLAN Pharmaceuticals­º®uÂå¾Ç©xKen Kobayashi³Õ¤hµû½×»¡¡G¡§­«­nªº¬O¡A¨´¤µ¬°¤î¡A¦b¬ã¨s¤¤±µ¨üªvÀøªº±wªÌ¹ïASLAN004ªº­@¨ü©Ê¤@ª½«Ü¦n¡A¨Ã¥B¥¼Æ[¹î¨ì»P¬ã¨sÃĪ«¬ÛÃöªºªvÀø¤¤Â_¡C¦b¸Ñ°£¤F¥ý«e´¿©µ¿ð¬ã¨sªº»PCOVID-19¬ÛÃöªº©Û¶Ò­­¨î¤§«á¡A§Ú­Ì°ª¿³¦aµù·N¨ì¡A²Ä¤G¾¯¬ã¨s²Õ¦b¤j¬ù¤T­Ó¬P´Á¤º¦b¨â­ÓÁ{§É¦aÂI©Û¶Ò¤F©Ò¦³¤K¦W±wªÌ¡C¹ï©ó²Ä¤T¾¯¬ã¨s¡A§Ú­Ì±N±q¦h¹F9­Ó¦aÂI©Û¶Ò±wªÌ¡A¨Ã¦b¿D¤j§Q¨È©M¬ü°ê±Ò¥Î¤F·s¦aÂI¡C§Ú­Ì¬Û«HASLAN004¦³¥i¯à¦¨¬°AD±wªÌªº³Ì¨Î¯e¯fªvÀø¤èªk¡A¨Ã´Á«Ý³ø§i§ó¦h¼Æ¾Ú¨Ã°í©w§Ú­Ì­p¹º¦b2021¦~±Ò°Ê2b´Á¬ã¨sªº­p¹º¡C¡¨

1´Á¬ã¨s¥¿¦bµû¦ô¥Ö¤U»¼°eªº¤T¾¯ASLAN004¡]200mg¡A400mg©M600mg¡^¡A¨Ã±N¥]¬A²Ä¥|²Õ¡]ÂX®i²Õ¡^¡C¨C­Ó¾¯¶q²Õ³Ì¦h¥]§t6¦ì¨Ï¥ÎASLAN004ªº±wªÌ©M2¦ì±wªÌ¨Ï¥Î¦w¼¢¾¯¡A¦ÓÂX®i²Õ±N¥]§t¦Ü¤Ö12¦ì¨Ï¥ÎASLAN004ªº±wªÌ©M¦Ü¤Ö6¦ì±µ¨ü¦w¼¢¾¯ªº±wªÌ¡C¨C¶g¹ï±wªÌµ¹ÃĤK¶g¡A¥H½T©w¦w¥þ©Ê©M­@¨ü©Ê¥H¤Î³\¦h¦¸­nÀø®Ä«ü¼Ð¡C

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ir.aslanpharma.com/news-releases/news-release-details/aslan-pharmaceuticals-initiates-third-dose-cohort-aslan004

Oct 22,2020

ASLAN Pharmaceuticals Initiates Third Dose Cohort of ASLAN004 in Atopic Dermatitis Clinical Trial

-- ASLAN has initiated recruitment of patients into third dose cohort at sites in the US, Australia and Singapore following successful safety review of second cohort

-- ASLAN004 found to be well tolerated at 400mg dose, third cohort will test 600mg dose

SINGAPORE, Oct. 22, 2020 (GLOBE NEWSWIRE) -- ASLAN Pharmaceuticals (Nasdaq:ASLN), a clinical-stage immunology focused biopharmaceutical company developing innovative treatments to transform the lives of patients, today announced that the Data Monitoring Committee (DMC) has completed its planned safety data review of the second dose cohort of its clinical trial of ASLAN004 in moderate to severe atopic dermatitis (AD) patients. ASLAN004 was found to be well tolerated at 400mg and the DMC has recommended that the multiple ascending dose (MAD) clinical study continue as planned.

ASLAN has now initiated recruitment into the third, highest dose (600mg) cohort of the randomised, double blind, placebo-controlled MAD study. A total of eight patients will be recruited from clinical sites in Singapore, the US and Australia. ASLAN expects to report interim, unblinded data from all three dose escalation cohorts in early 2021.

Dr Ken Kobayashi, Chief Medical Officer, ASLAN Pharmaceuticals, commented: ¡§Importantly, ASLAN004 continues to be well tolerated in the patients treated in the study to date and no discontinuations of treatment related to study drug have been observed. Following the lifting of recruitment restrictions associated with COVID-19 that had previously delayed the study, we were pleased to note that the second dose cohort enrolled all eight patients in around three weeks at two clinical sites. For the third dose cohort, we will be recruiting patients from up to nine sites, having activated new sites in Australia and the US. We believe that ASLAN004 has the potential to be a best-in-disease treatment for patients with AD and look forward to reporting further data and firming up our plans to initiate a Phase 2b study in 2021.¡¨

The Phase 1 study is evaluating three doses of ASLAN004 (200mg, 400mg and 600mg) delivered subcutaneously and will include a fourth (expansion) cohort. Each dose cohort contains up to six patients on ASLAN004 and two patients on placebo, and the expansion cohort will contain at least 12 patients on ASLAN004 and at least six patients on placebo. Patients are dosed weekly for eight weeks to determine safety and tolerability as well as a number of secondary efficacy outcome measures.

ASLAN004 is a first-in-class monoclonal antibody that binds to the IL-13 receptor £\1 subunit (IL-13R£\1), blocking signalling of two pro-inflammatory cytokines, IL-4 and IL-13, which are central to triggering symptoms of AD, such as redness and itching of the skin.

Media and IR contacts

Emma Thompson

Spurwing Communications

Tel: +65 6751 2021

Email: ASLAN@spurwingcomms.com

Robert Uhl

Westwicke Partners

Tel: +1 858 356 5932

Email: robert.uhl@westwicke.com

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THINGS YOU NEED TO KNOW ABOUT

TYPE 2 INFLAMMATORY DISEASES

WHAT IS TYPE 2 INFLAMMATION?

Recent scientific developments have shown that excessive

type 2 inflammation, an overactive immune system

response, underlies different inflammatory diseases

including AD, Asthma, and NP.1-

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WHAT ARE THE SYMPTOMS OF TYPE 2

INFLAMMATION?

Signs and symptoms vary by disease.

For instance, type 2 inflammation can contribute to

the debilitating itch of atopic dermatitis,4

unpredictable and sometimes lifethreatening

asthma attacks,5,6

and the loss of smell and taste associated

with chronic rhinosinusitis with nasal polyps.

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WHAT FACTORS PLAY A ROLE

IN TYPE 2 INFLAMMATION?

Genetic, environmental, and other

physiological factors play a role in

the presence of type 2 inflammation.

The genetics of type 2 inflammation

may explain why some people experience

more than one of these conditions throughout

the course of their life, and why these conditions

can run in families.

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CAN PEOPLE HAVE MORE THAN ONE

TYPE 2 INFLAMMATORY DISEASE?

It is not uncommon for people to have two or more type

2 inflammatory diseases, with different levels of severity.

When a person has multiple coexisting type 2 inflammatory

diseases, management is even more challenging.

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Up to 35% of people

with asthma also

have AD and up to

50% of those with

AD have

asthma

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About 17% of

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WHAT IS THE BURDEN OF

DISEASE ASSOCIATED WITH TYPE 2

INFLAMMATORY DISEASES?

Type 2 inflammatory diseases can affect both

physical and mental health, with the severity of disease

burden increasing when diseases are coexisting. People

with inadequately controlled, moderate-to-severe type 2

inflammatory diseases commonly experience frequent

and debilitating sleep disturbances and mental health

issues.4,6,9,10, 1

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About 46% of

adolescents with AD

have their school life

negatively impacted

by AD flares4

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Up to 50% of

people with

severe asthma

report symptoms

of depression

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More than 90%

of people with

CRSwNP report

sleep quality loss

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CRSwNP³ø§i

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Maximize patient benefits across several type 2 inflammatory diseases(p.37)

1.Type 2 inflammation is a maladapted immune response which leads to systemic barrier

dysfunction, driving multiple chronic diseases occurring at different stages of life

2.IL-4 and IL-13 play a critical role in Type 2 inflammation

3.By targeting IL-4 and IL-13 only, Dupixent® enables systemic inhibition with great specificity,

which we believe contributes to its efficacy and safety profile

4.First pediatric approval for Dupixent® in the U.S. and long-term extension study in adult AD

reconfirm strong safety and efficacy profile

5.Strong confidence in Dupixent® line extensions across Type 2 diseases based on clinical data

and real-world evidence

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

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www.sixthtone.com/news/1004811/for-chinese-patients%2C-new-drugs-offer-fresh-hope

Ni Dandan

Nov 08, 2019 5-min read

For Chinese Patients, New Drugs Offer Fresh Hope

Blanket media coverage of the China International Import Expo alerts patients to the availability of life-changing new drugs.

One of the drugs that Sanofi is promoting heavily at the expo is dupilumab, which the company claims is the world¡¦s first targeted drug for patients with moderate to severe atopic dermatitis ¡X a form of eczema affecting more than 100 million people in China, according Zhang Jianzhong, a senior dermatologist at the Peking University People¡¦s Hospital in Beijing.

Severe atopic dermatitis can cause patients to develop asthma and rhinitis, among other symptoms, making it difficult to lead a normal life. In China, the disease is currently treated using immunosuppressors, but the medication can cause liver problems and high blood pressure, requiring doctors to closely monitor patients.

—à

We view China as the most important market in the area of cancer.

- Ulrich Stefer, Bayer Group

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Sales of Enhertu in the US will be booked by Daiichi Sankyo with AZ claiming a share of gross profits.

AZ©MDaiichi SankyoÁÙ¦bHER2¶§©Ê¨Å¸¢Àù©M­GÀù¥H¤Î§CHER2ªí¹Fªº¸~½F¤¤¶i¦æ¤F¥t¥~¤T¶µ3´Á¸ÕÅç¡A³o¨ÇÃĪ«¥i¯à·|¤j¤jÂX®i¸ÓÃĪ«ªº¼ç¦b¥«³õ¡C ¤ÀªR¤H¤h»{¬°¡A³o¥i¯à·|ÄÀ©ñ¥X¶W¹L40»õ¬ü¤¸ªº¦~¾P°â®p­È¡C

AZ and Daiichi Sankyo are also conducting three additional phase 3 trials in HER2-positive breast and gastric cancer settings, as well as in low HER2-expressing tumours that could dramatically expand the potential market for the drug. Analysts think that could unlock peak sales in excess of $4bn a year.

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

AZ, Daiichi Sankyo get early okay for DS-8201, now named Enhertu

Early approval comes well ahead of schedule

AZ Daiichi logos

The FDA has given an early Christmas present to AstraZeneca and Daiichi Sankyo by approving their DS-8201 for HER2-positive breast cancer well ahead of schedule.

The US regulator has cleared the HER2 inhibitor drug ¡V now known as Enhertu (trastuzumab deruxtecan) ¡V for metastatic HER2-positive disease in patients who have previously been treated with two or more anti-HER2 based regimens.

Enhertu is one of a crop of new HER2-targeting drugs that aim to challenge Roche¡¦s long-dominant position in HER2-positive breast cancer with its triumvirate of Herceptin (trastuzumab), Perjeta (pertuzumab) and Kadcyla (trastuzumab emtansine).

Antibody-drug conjugate Enhertu is competing most closely rival with Kadcyla ¡V also an ADC ¡V in the third- and later-line therapy HER2 category, but AZ and Daiichi have made no secret of their intention to move their drug further up the treatment pathway.

This first regulatory approval is based on the DESTINY-Breast01 trial in patients who had previously been treated with Herceptin, Perjeta or Kadcyla. Enhertu achieved a 60% objective response rate, including just over 4% complete responses, with a median duration of response of 14.8 months.

AZ and Daiichi Sankyo are also conducting three additional phase 3 trials in HER2-positive breast and gastric cancer settings, as well as in low HER2-expressing tumours that could dramatically expand the potential market for the drug. Analysts think that could unlock peak sales in excess of $4bn a year.

The earlier-than-expected FDA approval is a big bonus for AZ, which wagered a whopping $1.35bn upfront to license the drug earlier this year in a deal that could eventually be worth up to $6.9bn if development and sales milestones are met.

The US approval sparks a $125m payment to Daiichi Sankyo from AZ ¡V the first milestone payment in the alliance. Sales of Enhertu in the US will be booked by Daiichi Sankyo with AZ claiming a share of gross profits.

Kadcyla is the smallest product in Roche¡¦s HER2 portfolio, but has started to enjoy an acceleration in sales thanks to approval for the of adults with HER2-positive early breast cancer, in addition to its established use as an adjuvant treatment in patients who fail Herceptin treatment.

In the meantime, further HER2 competition could be coming from Seattle Genetics¡¦ oral drug tucatinib, which recently cleared the phase 3 HER2CLIMB trial as an add-on to Herceptin plus Roche¡¦s chemotherapy Xeloda (capecitabine) in patients previously treated with Roche¡¦s trio of HER2 drugs.

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Seattle kills off $2B Immunomedics deal as biotech¡¦s CEO and founder axed

by Ben Adams | May 5, 2017 8:38am

Immunomedics saw its shares tick up early this morning on the news

Seattle Genetics has terminated a major drug tie-up with Immunomedics after intense legal battles, as Immunomedics revealed that it has axed its president and CEO Cynthia Sullivan.

This all goes back to February, when Immunomedics signed a potential $2 billion development and licensing deal with Seattle Genetics for IMMU-132, including a hefty $250 million upfront, only to have it placed on hold in March after a shareholder revolt.

Disgruntled investors¡Xled by activist investor venBio¡Xeventually forced through changes to the biotech¡¦s board of directors.

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The acrimonious battle centers on IMMU-132, a.k.a. sacituzumab govitecan, with venBio pushing to keep the drug in-house and calling the Seattle Genetics agreement ¡§a rushed deal that does not deliver fair value to shareholders.¡¨

¡§The Immunomedics transaction would have effectively utilized our substantial expertise in antibody-drug conjugate (ADC) development to advance IMMU-132 for patients in need,¡¨ Clay Siegall, Ph.D., president and CEO of Seattle Genetics, said this morning.

¡§However, due to significant delays and lack of progress towards closing the deal, we are turning our full attention and resources to our promising pipeline and the substantial opportunities in front of us, including the upcoming topline data readout from the ADCETRIS ECHELON-1 trial and ongoing or planned pivotal trials of vadastuximab talirine (SGN-CD33A) and enfortumab vedotin (ASG-22ME).¡¨

As part of this killing-off, Seattle Genetics will continue to hold 3 million shares of Immunomedics common stock, as well as a warrant to purchase an additional 8.7 million shares at $4.90 per share.

But then, about half an hour after the deal was cut, so too was Immunomedics¡¦ leader Sullivan, who according to a separate statement: ¡§will be stepping down from all director and officer positions with the company, including her role as president and chief executive officer.¡¨

Michael Garone, the current CFO of Immunomedics, becomes interim CEO as a search starts for a new full-time head.

The ax also swung on David Goldenberg, the biotech¡¦s founder, who is ¡§stepping down from all officer positions with the company, including as chief scientific officer and chief patent officer.¡¨ He will, however, continue to serve as a director on Immunomedics¡¦ board.

¡§It has been a pleasure to lead Immunomedics to this pivotal stage in its growth,¡¨ said Sullivan in a brief statement. ¡§I am confident that the board and leadership team will continue the work of bringing IMMU-132 to patients as soon as possible.¡¨

And there¡¦s more: After a board review, the company will now be delaying submission for its IMMU-132 BLA for approval in metastatic triple-negative breast cancer (mTNBC) between late fourth quarter 2017 and first quarter 2018, although details were not shared as to why.

It did say, however, that This review [from the board] has furthermore led to detailed filing and manufacturing plans. Alongside the immediate focus on preparations for a BLA filing, the company will proceed with the final selection of a CRO to launch the confirmatory phase 3 study with the expectation of first patient enrolled in late Q3 2017, as well as executing on a manufacturing plan to build commercial inventory in preparation for a potential launch in the U.S. in 2018.

The updates do not stop there, as the company has also made a $125 million private placement to ¡§support the development of IMMU-132, including the goal of filing a BLA for Accelerated Approval from the FDA.¡¨

As of March 31, 2017, cash and cash equivalents were $46 million for the biotech, but it says this, combined with its new capital, should see ¡§sufficient operating funds through the third quarter of 2018.¡¨

Under the original deal, Seattle said it would pay $250 million upfront for the rights to Immunomedics¡¦ solid tumor asset IMMU-132, although this could have grown to $2 billion, and would have put the biotech in charge of filing for accelerated FDA approval of IMMU-132 in metastatic triple-negative breast cancer, while also advancing the drug in other indications.

The med is an antibody-drug conjugate of SN-38¡Xthe active metabolite of the chemotherapy drug irinotecan¡Xand Immunomedics¡¦ anti-TROP2 asset hRS7. The ADC is designed to target the TROP-2 receptors that are found in certain tumors and hustle the payload into cells.

Immunomedics was up slightly premarket on the deal termination news, by 1.3%, but then jumped by 18% after the exec culling was announced.

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10 best-selling drugs in the world by 2026

Maia Anderson - Tuesday, July 28th, 2020 Print | Email

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In its annual World Preview 2020 report, EvaluatePharma, a pharmacy-focused data analytics firm, forecasted which prescription drugs will be best-sellers in 2026. Merck¡¦s oncology drug Keytruda is expected to top the list.

EvaluatePharma¡¦s 10 best-selling drugs in 2026 and their expected global sales:

1.Keytruda (Merck) ¡X $24.9 billion

2.Opdivo (Bristol Myers Squibb) ¡X $12.7 billion

3.Eliquis (Bristol Myers Squibb) ¡X $12.6 billion

4.Biktarvy (Gilead) ¡X $11.7 billion

5.Imbruvica (AbbVie + Johnson & Johnson) ¡X $10.7 billion

6.Ibrance (Pfizer) ¡X $9.7 billion

7.Tagrisso (AstraZeneca) ¡X $9.5 billion

8.Dupixent (Sanofi) ¡X $9.4 billion

9.Trikafta (Vertex Pharmaceuticals) ¡X$8.7 billion

10.Ozempic (Novo Nordisk) ¡X $8.3 billion

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PRESS RELEASE

ASLAN PHARMACEUTICALS COMPLETES ENROLMENT IN SECOND COHORT AND OPENS NEW SITES IN US AND AUSTRALIA IN ASLAN004 ATOPIC DERMATITIS STUDY

Singapore, 21 September 2020 ¡V ASLAN Pharmaceuticals (Nasdaq:ASLN), a clinical-stage immunology and oncology focused biopharmaceutical company developing innovative treatments to transform the lives of patients, today announced that clinical sites in the US and Australia are now open and ready to enrol patients into its multiple ascending dose (MAD) study testing the first-in-class therapeutic antibody ASLAN004 in moderate to severe atopic dermatitis (AD) patients. Patients will now be recruited from 4 sites in Australia, 3 sites in the US alongside 2 existing sites in Singapore.

ASLAN recently restarted recruitment into the second cohort of the randomised, double blind, placebo-controlled study in Singapore following the lifting of government restrictions in response to COVID-19. All 8 patients have now been fully recruited into the cohort and ASLAN plans to initiate recruitment into the third cohort following approval by the Data Monitoring Committee. A further 8 patients will be recruited in Singapore, the US and Australia. ASLAN expects to report interim, unblinded data from all 3 dose cohorts in 4Q 2020.

Dr Kenneth Kobayashi, Chief Medical Officer, ASLAN Pharmaceuticals, said: ¡§The speed at which we have been able to fully recruit the second cohort of the MAD study since restrictions lifted in Singapore last month reaffirms the scale of the demand by patients and the interest of physicians for innovative treatments for AD. We accelerated our plans to open new study sites in the US and Australia, and are pleased that the sites are now ready to recruit.¡¨

ASLAN004 is a first-in-class monoclonal antibody that binds to the IL-13 receptor £\1 subunit (IL-13R£\1), blocking signalling of two pro-inflammatory cytokines, IL-4 and IL-13, which are central to triggering symptoms of AD, such as redness and itching of the skin.

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ASLAN004 has the potential to be best-in-disease

1.IL-13R£\1 inhibitor : ASLAN004 is the only monoclonal antibody targeting IL-13R£\1, and has the potential to be best-in-disease for atopic dermatitis and asthma

2.Validated pathway : Targets the same pathway and receptor complex (Type II) as dupilumab

3.Targeting differentiated profile ¡G¡@

Potential for improved efficacy,

fewer adverse events,

monthly dosing

4.SAD completed : Phase 1 SAD in healthyvolunteerscompleted. No significant adverse events noted to date.

Profile may allow for monthly dosing.

5.MAD/PoCongoing :

Currently recruiting second cohort in MAD / PoC¡@study. Early efficacy data encouraging.

Expecting interim data 4Q 20, completion in 1H 21

¢µ¡DPhase 2b program¡G¡@Planning to initiate phase 2b program in 2021

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Potential to pursue development in other indications where dupilumabhas proven to be effective

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Seattle Genetics Announces U.S. FDA Approval of TUKYSA™ (tucatinib) for People with Advanced Unresectable or Metastatic HER2-Positive Breast Cancer

04/17/2020

-Approved for Patients with HER2-Positive Metastatic Breast Cancer Who Have Received One or More Prior Anti-HER2 Therapies in the Metastatic Setting-

-First HER-2 Tyrosine Kinase Inhibitor in Combination to Improve Overall and Progression-Free Survival in Patients with Metastatic HER2-Positive Breast Cancer With or Without Brain Metastases-

-Application Approved Four Months Prior to Action Date Under FDA¡¦s Real-Time Oncology Review (RTOR)-

-Investor Conference Call Today at 1:00 p.m. Pacific Time (PT); 4:00 p.m. Eastern Time (ET)-

BOTHELL, Wash.--(BUSINESS WIRE)-- Seattle Genetics, Inc. (Nasdaq:SGEN) today announced the U.S. Food and Drug Administration (FDA) granted approval to TUKYSA™ (tucatinib) tablets in combination with trastuzumab and capecitabine for adult patients with advanced unresectable (cannot be surgically removed) or metastatic HER2-positive breast cancer, including patients with brain metastases (disease that has spread to the brain), who have received one or more prior anti-HER2-based regimens in the metastatic setting. The FDA previously granted Breakthrough Therapy designation and Priority Review for TUKYSA and reviewed this application for approval under the Real-Time Oncology Review (RTOR) pilot program. The TUKYSA New Drug Application (NDA) is also part of Project Orbis, an initiative of the FDA Oncology Center of Excellence that provides a framework for concurrent submission and review of oncology drugs among participating international health authorities. TUKYSA is an oral, small molecule tyrosine kinase inhibitor (TKI) of HER2, a protein that contributes to cancer cell growth.1,2

(Photo: Business Wire)

(Photo: Business Wire)

¡§With highly significant and clinically important results for overall and progression-free survival, the addition of TUKYSA to trastuzumab and capecitabine has the potential to become a standard of care for people with HER2-positive metastatic breast cancer after having received one or more previous anti-HER2 therapies in the metastatic setting,¡¨ said Eric P. Winer, MD, Chief of the Division of Breast Oncology, Susan F. Smith Center for Women¡¦s Cancers at Dana-Farber. ¡§Cancer spreads to the brain in up to half of patients with HER2-positive metastatic breast cancer; and this approval is based on a unique clinical trial that included patients with active brain metastases, either untreated or progressing. TUKYSA is well tolerated by patients and is a valuable addition to the agents we have for HER2-positive metastatic breast cancer.¡¨

¡§We¡¦re pleased to have collaborated with the FDA on our second expedited real-time oncology review, enabling us to rapidly bring this new targeted medicine to patients,¡¨ said Clay Siegall, Ph.D., Chief Executive Officer at Seattle Genetics. ¡§TUKYSA has shown impressive results in people with HER2-positive metastatic breast cancer, including in patients with active brain metastases, and offers patients an effective medicine following previous treatment with other anti-HER2 agents in the metastatic setting.¡¨

TUKYSA, in combination with trastuzumab and capecitabine, was evaluated in the trial HER2CLIMB, a randomized (2:1), double-blind, placebo-controlled trial that enrolled 612 patients with HER2-positive unresectable locally advanced or metastatic breast cancer who had previously received, either separately or in combination, trastuzumab, pertuzumab, and ado-trastuzumab emtansine (T-DM1). Forty-eight percent of patients in the study had a presence or history of brain metastases. The primary efficacy outcome measure was progression-free survival (PFS) as assessed by blinded independent central review (BICR) in the first 480 randomized patients.1 Additional efficacy outcome measures were evaluated in all randomized patients and included overall survival (OS), PFS in patients with a history or presence of brain metastases, and confirmed objective response rate (ORR).

Patients who received TUKYSA in combination with trastuzumab and capecitabine had a 46 percent reduction in the risk of cancer progression or death (PFS) compared to patients who received trastuzumab and capecitabine alone (hazard ratio (HR)=0.54 [95% Confidence Interval (CI): 0.42, 0.71]; p<0.00001). The addition of TUKYSA reduced the risk of death (OS) by 34 percent compared to trastuzumab and capecitabine alone (HR=0.66 [95% CI: 0.50, 0.87]; p=0.0048). Nearly twice the number of patients who received TUKYSA in combination with trastuzumab and capecitabine had a confirmed objective response compared to those who received trastuzumab and capecitabine alone (40.6 percent (95% CI: 35.3, 46.0) vs. 22.8 percent (95% CI: 16.7, 29.8); p=0.00008). For patients with brain metastases, the addition of TUKYSA reduced the risk of cancer progression or death (PFS) by 52 percent compared to trastuzumab and capecitabine alone (HR=0.48 [95% CI: 0.34, 0.69]; p<0.00001).

Serious adverse reactions occurred in 26 percent of patients who received TUKYSA. Serious adverse reactions occurring in 2 percent or more of patients who received TUKYSA were diarrhea (4%), vomiting (2.5%), nausea, abdominal pain, and seizure (2% each). The most common adverse reactions occurring in 20 percent or more of patients who received TUKYSA were diarrhea, palmar-plantar erythrodysesthesia, nausea, fatigue, hepatotoxicity, vomiting, stomatitis, decreased appetite, abdominal pain, headache, anemia, and rash. Adverse reactions leading to treatment discontinuation occurred in 6 percent of patients who received TUKYSA; adverse reactions leading to treatment discontinuation of TUKYSA (in 1 percent or more of patients) were hepatotoxicity (1.5%) and diarrhea (1%).

The data were published in The New England Journal of Medicinein December 2019.

About TUKYSA (tucatinib)

TUKYSA is an oral medicine that is a tyrosine kinase inhibitor of the HER2 protein. In vitro (in lab studies), TUKYSA inhibited phosphorylation of HER2 and HER3, resulting in inhibition of downstream MAPK and AKT signaling and cell growth (proliferation), and showed anti-tumor activity in HER2-expressing tumor cells. In vivo (in living organisms), TUKYSA inhibited the growth of HER2-expressing tumors. The combination of TUKYSA and the anti-HER2 antibody trastuzumab showed increased anti-tumor activity in vitro and in vivo compared to either medicine alone.1

SeaGen Secure offers access and reimbursement support to help patients access TUKYSA. For more information, go to SeaGenSecure.com.

About HER2-Positive Breast Cancer

Patients with HER2-positive breast cancer have tumors with high levels of a protein called human epidermal growth factor receptor 2 (HER2), which promotes the growth of cancer cells. An estimated 279,100 new cases of breast cancer will be diagnosed in the U.S. in 2020.3 Between 15 and 20 percent of breast cancer cases are HER2-positive.3 Historically, HER2-positive breast cancer tends to be more aggressive and more likely to recur than HER2-negative breast cancer.4,5,6 Up to 50 percent of metastatic HER2-positive breast cancer patients develop brain metastases over time.7,8,9

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Merck¡¦s Partnership With Seattle Genetics Is a Bet on a New Anticancer Strategy

Published: Sept. 14, 2020 at 11:15 a.m. ET

Merck launched a $4.2 billion partnership with Seattle Genetics on Monday, for development of antibody-drug conjugates, a treatment that zeroes in on tumors.

Michael Vi/Dreamstime .

Merck unveiled a $4.2 billion partnership with Seattle Geneticson Monday, for development of a poison-tipped antibody treatment that zeroes in on tumors. The announcement comes a day after Gilead Science¡¦s $21 billion deal to acquire another antibody-drug developer, Immunomedics.Bidding for Immunomedics was fierce and reflects the excitement over so-called antibody-drug conjugates for treating tumors that defy existing therapies.

After Monday¡¦s announcement, the stock of Seattle Genetics (ticker: SGEN) was up 7% to $161, while Merck (MRK) was up 0.5% to $83.91. Gilead¡¦s $88-a-share deal for Immunomedics (IMMU) lifted Gilead stock (GILD) 2%, to $66.34.

Editor¡¦s Choice

.

Antibody-drug conjugates pair a toxin with an antibody designed to home-in on distinctive features of aggressive tumors. They¡¦ve proven effective, and relatively safe, in stubborn cancers that resisted other treatments. Other big drug companies developing antibody-drug conjugates include Japan¡¦s Daichi Sankyo (DSNKY),

Merck will pay Seattle Genetics $600 million up front and buy $1 billion worth of the biotech company¡¦s stock, with an additional $2.6 billion in potential payments down the road. The deal covers an investigational antibody-drug conjugate that will be tested against certain kinds of breast cancers and other solid tumors¡Xas a single treatment and in combination with Merck¡¦s blockbuster immuno-oncology treatment Keytruda.

Merck will also fund trials of another Seattle Genetics product called Tukysa, as a potential treatment for cancers of the breast, colon, and stomach.

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study, it is a 2 part study.

Study Design

Go to sections

Study Type ƒÊ : Interventional (Clinical Trial)

Estimated Enrollment ƒÊ : 278 participants

Allocation: Non-Randomized

Intervention Model: Single Group Assignment

Masking: None (Open Label)

Primary Purpose: Treatment

Official Title: Phase 1, Two-Part, Multicenter, Non-randomized, Open-label, Multiple Dose First-In-Human Study of DS-8201A, in Subjects With Advanced Solid Malignant Tumors

Study Start Date ƒÊ : August 2015

Estimated Primary Completion Date ƒÊ : March 2020

Estimated Study Completion Date ƒÊ : March 2020

FDA Approves Trastuzumab Deruxtecan for HER2-Positive Breast Cancer

December 20, 2019

Kristie L. Kahl

Relevant Topics

The FDA granted accelerated approval to trastuzumab deruxtecan for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer.

The FDA granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu; DS-8201) for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received 2 or more prior anti-HER2-based regimens in the metastatic setting.1

¡§There have been many advances in the development of drugs for HER2-positive breast cancer since the introduction of [Herceptin (trastuzumab)] in 1998. The approval of Enhertu represents the newest treatment option for patients who have progressed on available HER2-directed therapies,¡¨ Richard Pazdur, MD, director of the FDA¡¦s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA¡¦s Center for Drug Evaluation and Research, said in a press release issued by the agency. ¡§Drug development in the area of targeted therapies builds on our scientific understanding of malignant diseases not only in breast cancer, but in multiple other diseases.¡¨

The agency based its decision on findings from the global pivotal phase II single-arm DESTINY-Breast01 trial, designed to evaluate the HER2-targeting antibody drug conjugate in 194 patients with HER2-positive unresectable and/or metastatic breast cancer previously treated with trastuzumab emtansine.2

¡§These patients were heavily pretreated in the metastatic setting, receiving between two and 17 therapies prior to receiving Enhertu,¡¨ the FDA wrote in a release.

The trial consisted of part 1 to evaluate pharmacokinetics (n = 65) and to determine recommended dose (RP2D; n = 54) for part 2 (n = 134), which was 5.4 mg/kg trastuzumab deruxtecan. Patients received trastuzumab deruxtecan every 3 weeks in the trial, and tumor shrinkage was obtained every 6 weeks.

Confirmed objective response rate (ORR) per independent central review (ICR) served as the primary endpoint, while secondary endpoints included disease control rate (DCR), duration of response (DOR), and progression-free survival (PFS).

Trastuzumab deruxtecan induced an ORR of 60.3% per ICR (95% CI, 53.4-68.0), including 11 complete responses (CRs; 6.0%), 101 partial responses (PRs; 54.9%), 67 with stable disease (SD; 36.4%), and 3 with progressive disease (PD; 1.6%). Two patients were not evaluable.

Patients achieved a DCR of 97.3% with a median duration of response of 14.8 months and median PFS of 16.4 months.

Moreover, mxedian overall survival (OS) has not yet been reached, with an estimated survival rate of 86% at 1 year.

The safety and tolerability profile was consistent with that observed in the phase I trial. The most common grade 3 or higher treatment-emergent adverse events (TEAEs) were decreased neutrophil count (20.7%), anemia (8.7%), nausea (7.6%), decreased white cell count (6.5%), decreased lymphocyte count (6.5%) and fatigue (6.0%).

Overall, 13.6% of patients had confirmed interstitial lung disease (ILD) related to treatment; however, ILD was primarily grade 1 or 2 (10.9%) in severity, with 1 grade 3 (0.5%) and no grade 4 events. Four deaths (2.2%) were determined to be due to ILD.

¡§Trastuzumab deruxtecan has several distinct features,¡¨ Ian Krop MD, PhD, associate chief of the Division of Breast Oncology at Dana-Farber Cancer Institute, said during a press briefing held at the San Antonio Breast Cancer Symposium, where these study results were recently presented.

¡§One is the payload is a potent topoisomerase I inhibitor. This is a kind of chemotherapy that is not typically used in HER2-positive breast cancer so it is less likely that cancers will develop resistance to this agent. There are about 8 of these payload molecules per antibody, and this is a higher drug-antibody ratio than is typically seen in current antibody conjugates. Lastly, the payload is membrane permeable so in preclinical studies it allows it to diffuse out of the cell and kill neighboring tumor cells regardless of their HER2 expression.¡¨

References:

1. FDA approves new treatment option for patients with HER2-positive breast cancer who have progressed on available therapies. FDA. Published December 20, 2019. bit.ly/2tzcabv. Accessed December 20, 2019.

2. AstraZeneca and Daiichi Sankyo¡¦s trastuzumab deruxtecan demonstrated an impressive 14.8-month median duration of response and 16.4-month median progression-free survival. Published December 11, 2019. bit.ly/35L5RQr. Accessed December 20, 2019.

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Gilead Sciences is set to acquire Immunomedics in a $21 billion dollar deal, which is expected to close in the fourth quarter of 2020. Dr. Behzad Aghazadeh, Immunomedics Executive Chairman, joins Yahoo Finance¡¦s The First Trade with Alexis Christoforous and Brian Sozzi to discuss.

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The U.S. Food and Drug Administration today approved Trikafta (elexacaftor/ivacaftor/tezacaftor), the first triple combination therapy available to treat patients with the most common cystic fibrosis mutation. Trikafta is approved for patients 12 years and older with cystic fibrosis who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, which is estimated to represent 90% of the cystic fibrosis population.

¡§At the FDA, we¡¦re consistently looking for ways to help speed the development of new therapies for complex diseases, while maintaining our high standards of review. Today¡¦s landmark approval is a testament to these efforts, making a novel treatment available to most cystic fibrosis patients, including adolescents, who previously had no options and giving others in the cystic fibrosis community access to an additional effective therapy,¡¨ said acting FDA Commissioner Ned Sharpless, M.D. ¡§In the past few years, we have seen remarkable breakthroughs in therapies to treat cystic fibrosis and improve patients¡¦ quality of life, yet many subgroups of cystic fibrosis patients did not have approved treatment options. That¡¦s why we used all available programs, including Priority Review, Fast Track, Breakthrough Therapy, and orphan drug designation, to help advance today¡¦s approval in the most efficient manner possible, while also adhering to our high standards. The FDA remains committed to advancing novel treatment options for areas of unmet patient need, particularly for diseases affecting children.¡¨

Cystic fibrosis, a rare, progressive, life-threatening disease, results in the formation of thick mucus that builds up in the lungs, digestive tract, and other parts of the body. It leads to severe respiratory and digestive problems as well as other complications such as infections and diabetes. Cystic fibrosis is caused by a defective protein that results from mutations in the CFTR gene. While there are approximately 2,000 known mutations of the CFTR gene, the most common mutation is the F508del mutation.

Trikafta is a combination of three drugs that target the defective CFTR protein. It helps the protein made by the CFTR gene mutation function more effectively. Currently available therapies that target the defective protein are treatment options for some patients with cystic fibrosis, but many patients have mutations that are ineligible for treatment. Trikafta is the first approved treatment that is effective for cystic fibrosis patients 12 years and older with at least one F508del mutation, which affects 90% of the population with cystic fibrosis or roughly 27,000 people in the United States.

The efficacy of Trikafta in patients with cystic fibrosis aged 12 years and older was demonstrated in two trials. The first trial was a 24-week, randomized, double-blind, placebo-controlled trial in 403 patients who had an F508del mutation and a mutation on the second allele that results in either no CFTR protein or a CFTR protein that is not responsive to ivacaftor or tezacaftor/ivacaftor alone. The second trial was a four-week, randomized, double-blind, active-controlled trial in 107 patients who had two identical F508del mutations.

In each trial, the primary analysis looked at increases in the percent predicted forced expiratory volume in one second, known as ppFEV1, which is an established marker of cystic fibrosis lung disease progression. Trikafta increased the ppFEV1 in both trials. In the first trial, it increased mean ppFEV1 13.8% from baseline compared to placebo. In the second trial, it increased mean ppFEV1 10% from baseline compared to tezacaftor/ivacaftor. In the first trial, treatment with Trikafta also resulted in improvements in sweat chloride, number of pulmonary exacerbations (worsening respiratory symptoms and lung function), and body mass index (weight-to-height ratio) compared to placebo.

The safety profile of Trikafta is based on data from the 510 cystic fibrosis patients in the two trials. The safety profile was generally similar across all subgroups of patients. Serious adverse drug reactions that occurred more frequently in patients receiving Trikafta compared to placebo were rash and influenza (flu) events. The most common adverse drug reactions included headaches, upper respiratory tract infections, abdominal pains, diarrhea, rashes, increased liver enzymes (alanine aminotransferase and aspartate aminotransferase), nasal congestion, increased blood creatine phosphokinase (an enzyme that can be associated with muscle damage), rhinorrhea (mucus in the nasal cavity), rhinitis (swelling of the mucous membrane of the nose), influenza, sinusitis and increased blood bilirubin (may be caused by problems involving the liver, gallbladder or red blood cells).

The prescribing information for Trikafta includes warnings related to elevated liver function tests (transaminases and bilirubin), use at the same time with other products that are inducers or inhibitors of another liver enzyme called Cytochrome P450 3A4 (CYP3A), and the risk of cataracts. Patients and their caregivers should speak with a health care professional about these risks and any medicines they take before starting treatment.

Patients with cystic fibrosis should speak with a health care professional and have tests performed to understand which gene mutations they have. The presence of at least one F508del mutation should be confirmed using an FDA-cleared genotyping assay prior to treatment. The safety and effectiveness of Trikafta in patients with cystic fibrosis younger than 12 years of age have not been established.

The FDA granted this application Priority Review, in addition to Fast Track and Breakthrough Therapy Designation. Trikafta also received orphan drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases. Drugs approved under expedited programs are held to the same approval standards as other FDA approvals. Because of Trikafta¡¦s benefit to the cystic fibrosis community, the FDA reviewed and approved Trikafta in approximately three months, ahead of the March 19, 2020 review goal date. The approval of Trikafta was granted to Vertex Pharmaceuticals Incorporated, which will receive a Rare Pediatric Disease Priority Review Voucher for developing this therapy.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation¡¦s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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DOI: 10.1200/JCO.2020.38.15_suppl.9619 Journal of Clinical Oncology - published online before printMay 25, 2020

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­I´º¡GTROP2¬O«D¤p²Ó­MªÍÀù¤¤¹L«×ªí¹Fªº²Ó­M¤º¶t«H¸¹Âà¾É¤l¡A¹w¥Ü¥Í¦s²v§C¡C DS-1062¬O¹v¦VTROP2ªºADC¡A¨ã¦³·s«¬©Ý¼³²§ºc酶1§í»s¾¯¡]exatecan­l¥Íª«¡ADXd¡^©M¦³§Æ±æªºÁ{§É«e§Ü¸~½F¬¡©Ê¡C¾Ú³ø¾É¡A¨Ó¦Û¥¿¦b¶i¦æ¤¤ªºDS-1062¦b±ß´Á/Âಾ©ÊNSCLC¤¤ªº²Ä1´Á¬ã¨sªº§ó·sµ²ªG¥]¬A24­ÓÃB¥~ªº¾¯¶q»¼¼WÂI©M32­Ó¾¯¶qÂX®iÂI¡]NCT03401385 / J101¡^¡C¤èªk¡G¦~ÄÖ≥18¡]US¡^©Î≥20¡]¤é¥»¡^ªº¤£¥i¤Á°£NSCLC¹ï¥i´ú¶q¯e¯fªº¼Ð·ÇªvÀø¡]RECIST v1.1¡^µL®Ä/´_µo¥B¥i¥Î©ó¦^ÅU©ÊTROP2µû¦ôªº¸~½F²Å¦X±ø¥óªº±wªÌ¡C¥D­n¥Ø¼Ð¥]¬A³Ì¤j­@¨ü¾¯¶q¡]MTD¡^Ų©w¡A¦w¥þ©Ê©M­@¨ü©Ê¡A¦¸­n¥Ø¼Ð¥]¬A¥\®Ä¡AÃÄ¥N°Ê¤O¾Ç©M°w¹ïDS-1062ªº§ÜÃĪ«§ÜÅ骺µo¥Í²v¡C¤£½×TROP2ªºµ¥¯Å¦p¦ó¡A¿n¤À³£¬O¦X®æªº¡Cµ²ªG¡GºI¦Ü2019¦~11¤ë16¤é¡A95¨Ò±wªÌ±µ¨ü¤F≥1¾¯DS-1062ªºªvÀø¡C³v¨B¤É¯Å´Á¶¡ªvÀø63¤À¡A¤À§O¬°0.27¡]n = 4¡^¡A0.5¡]n = 5¡^¡A1.0¡]n = 7¡^¡A2.0¡]n = 6¡^¡A4.0¡]n = 6¡^¡A6.0¡]n = 19¡^¡A8.0 ¡]n = 8¡^©M10.0¡]n = 8¡^mg / kg©M32 pts¦bDS-1062ªºMTD¬°8 mg / kg®É¶i¦æ¤FÂX±i³B²z¡C°±¥Î59¤À¡]62¢H¡^¡]¥Ñ©óRECIST v1.1¾É­P¯e¯f¶i®i¡A¦û25 [42¢H]¡^¡C±NPt¼ÉÅS©ó3­ÓªvÀø¶g´Áªº¤¤¦ì¼Æ¡]½d³ò1-19¡^¡C 88¨Ò¥iµû¦ô¤ÏÀ³ªº±wªÌ¤¤¡A¦³22¨Ò¦³³¡¤À¤ÏÀ³¡]2.0 mg / kg®É1 PR / 6 pt¡A4.0 mg / kg®É2 PR / 6 pt¡A6.0 mg / kg®É5 PR / 18 pt¡A13 PR / 34 pt ¡]8.0²@§J/¤d§J¡^©M1­ÓPR / 8 pt¡]10.0²@§J/¤d§J¡^¡F½T»{¦³14­ÓPR¡A¦³8­ÓPR¥¿¦bµ¥«Ý½T»{¡C 95¨Ò±wªÌ¤¤¦³91¨Ò³ø§i¤F¦]¯f­ì¦]¦Ó¾É­PªºªvÀøºò«æ¤£¨}¨Æ¥ó¡]TEAE¡^¡]96¢H¡F¸g¾ú3¯Å¥H¤Wªº±wªÌ¬°44¨Ò[46¢H]¡AÄY­«¨Æ¥ó¬°30¨Ò[32¢H]¡^¡C¾Ú³ø¾É¡A»PªvÀø¦³ÃöªºTEAES¦³95¤À¤¤ªº76¤À¡]80¢H¡F¸g¾ú3¯Å¥H¤Wªº¦³17¤À[18¢H]¡A¦³8¤À[8¢H]¡^¦³ÄY­«¨Æ¥ó¡^¡C¼ç¦bªº¶¡½è©ÊªÍ¯e¯f¡]ILD¡^µo¥Í¦b8ÂI¡]8¢H¡F 6.0 mg / kg®Éµo¥Í2¦¸¡F 8.0 mg / kg®Éµo¥Í6¦¸¡^¡F 6/8ªº¼ç¦bILD³Q§P©w¬°»PªvÀø¦³Ãö¡]1­Ó¾¯¶q¬°6.0 mg / kg [2¯Å]¡A5­Ó¾¯¶q¬°8.0 mg / kg [1¯Å1¡B2¯Å2¡B1¯Å3©M1¯Å5]¡^¡C¤´¦³14­Ó¤É¯ÅÂI©M22­ÓÂX®iÂI¦b¸Õ¥Î¤¤¡C±NÅã¥Ü§ó·sªº¸ÕÅç¸Ô²Ó«H®§/µ²ªG¡Cµ²½×¡G¦b³o¶µDS-1062ªº­º¦¸¤HÅé¬ã¨s¤¤¡AªvÀø­@¨ü©Ê°ª¹F8 mg / kg¡A¦b¸g¹L¹w¥ýªvÀø¥B¸g¹L¹w¥ýªvÀøªºpts¤¤¡AÆ[¹î¨ì¹ï§Ü¸~½F¬¡©Êªº¾¯¶q®ÄÀ³¶W¹L2.0-10.0 mg / kg¡C¼Ð·ÇªvÀø¡CÁ{§É¸ÕÅç«H®§¡GNCT03401385¡C

Dose escalation and expansion from the phase I study of DS-1062, a trophoblast cell-surface antigen 2 (TROP2) antibody drug conjugate (ADC), in patients (pts) with advanced non-small cell lung cancer (NSCLC).

Background: TROP2 is an intracellular calcium signaling transducer overexpressed in NSCLC, portending poor survival. DS-1062 is a TROP2-targeting ADC with a novel topoisomerase 1 inhibitor (exatecan derivative, DXd) and promising preclinical antitumor activity. Updated results inclusive of 24 additional dose escalation pts and 32 dose expansion pts from an ongoing phase 1 study of DS-1062 in advanced/metastatic NSCLC are reported (NCT03401385/J101). Methods: Pts aged ≥18 (US) or ≥20 (Japan) with unresectable NSCLC refractory to/relapsed from standard treatment with measurable disease (RECIST v1.1) and available tumor for retrospective TROP2 evaluation were eligible. Primary objectives include maximum tolerated dose (MTD) identification, safety, and tolerability and secondary objectives include efficacy, pharmacokinetics, and incidence of anti-drug antibodies against DS-1062. Pts were eligible regardless of TROP2 level. Results: As of November 16, 2019, 95 pts were treated with ≥1 dose of DS-1062. 63 pts were treated during escalation at 0.27 (n = 4), 0.5 (n = 5), 1.0 (n = 7), 2.0 (n = 6), 4.0 (n = 6), 6.0 (n = 19), 8.0 (n = 8), and 10.0 (n = 8) mg/kg and 32 pts were treated in expansion at the MTD of DS-1062, 8 mg/kg. 59 pts (62%) discontinued (25 [42%] due to progressive disease per RECIST v1.1). Pts were exposed to a median of 3 treatment cycles (range, 1-19). In 88 response-evaluable pts, 22 had partial response (1 PR/6 pts at 2.0 mg/kg, 2 PR/6 pts at 4.0 mg/kg, 5 PR/18 pts at 6.0 mg/kg, 13 PR/34 pts at 8.0 mg/kg, and 1 PR/8 pts at 10.0 mg/kg; 14 PRs were confirmed and 8 PRs are awaiting confirmation). Treatment emergent adverse events (TEAEs) regardless of causality were reported in 91 of 95 pts (96%; 44 pts [46%] experienced ≥grade 3, 30 pts [32%] had serious events). Treatment-related TEAES were reported in 76 of 95 pts (80%; 17 pts [18%] experienced ≥grade 3, 8 pts [8%]) had serious events). Potential interstitial lung disease (ILD) occurred in 8 pts (8%; 2 at 6.0 mg/kg and 6 at 8.0 mg/kg); 6/8 with potential ILDs adjudicated as treatment-related (1 at 6.0 mg/kg [grade 2] and 5 at 8.0 mg/kg [1 grade 1, 2 grade 2, 1 grade 3, and 1 grade 5]). 14 escalation pts and 22 expansion pts remain on trial. Updated trial details/results will be presented. Conclusions: In this first-in-human study of DS-1062, treatment was well tolerated up to 8 mg/kg, and a dose effect on antitumor activity was observed over 2.0-10.0 mg/kg in heavily pretreated pts with prior progression on standard treatment. Clinical trial information: NCT03401385.

Daiichi Sankyo to Present New Research Data Across DXd ADC Portfolio at 2020 ASCO Annual Meeting

• Research data from the pivotal phase 2 DESTINY-Gastric01 trial of ENHERTU® to be presented along with phase 2 DESTINY-Lung01 and DESTINY-CRC01 research data

• Updated phase 1 data for DS-1062 in patients with unresectable advanced non-small cell lung cancer will be reported

• Investor conference calls to be hosted by Daiichi Sankyo to discuss ASCO presentations and provide oncology development updates

May 13, 2020 05:00 PM Eastern Daylight Time

BASKING RIDGE, N.J. & MUNICH--(BUSINESS WIRE)--Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that it will present new research data across its DXd antibody drug conjugate (ADC) portfolio at the 2020 American Society of Clinical Oncology (ASCO) Virtual Scientific Program to be held May 29 to May 31 (#ASCO20).

Highlights include research data presentations from four trials in the DESTINY program of ENHERTU® (fam-trastuzumab deruxtecan-nxki), a HER2 directed ADC, in several types of HER2 expressing cancers. Results will be reported from the pivotal phase 2 DESTINY-Gastric01 trial, which demonstrated a statistically significant and clinically meaningful improvement in objective response rate (ORR) and overall survival (OS) for patients with HER2 positive metastatic gastric cancer who progressed after two previous regimens treated with ENHERTU compared to investigator¡¦s choice of chemotherapy (irinotecan or paclitaxel monotherapy). ENHERTU was recently granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for patients in this setting.

Interim phase 2 data from the DESTINY-Lung01 trial in patients with HER2 mutant metastatic non-small cell lung cancer (NSCLC) and the DESTINY-CRC01 trial in patients with HER2 expressing advanced colorectal cancer will be presented during two oral presentations. Research data including objective response rate (ORR), duration of response (DOR), disease control rate (DCR), progression-free survival (PFS) as well as safety and tolerability from each of these trials will be reported. Findings from DESTINY-Breast01 evaluating clinical and molecular variables as possible predictors of efficacy also will be shared.

Updated phase 1 results with DS-1062, a TROP2 directed DXd ADC, will be presented in patients with advanced NSCLC who are refractory to or have relapsed following standard treatment or for whom no standard treatment is available, including research data for additional patients enrolled into both the dose escalation and dose expansion parts of the trial.

¡§We look forward to sharing updates from the DESTINY development program including pivotal data from DESTINY-Gastric01, which represent the first research data from a randomized controlled trial evaluating tumor response and overall survival for ENHERTU compared to investigator¡¦s choice of chemotherapy,¡¨ said Antoine Yver, MD, MSc, EVP and Global Head, Oncology Research and Development, Daiichi Sankyo. ¡§The body of research data to be presented at ASCO demonstrates significant development progress for two of our lead ADCs, as we remain committed to translating our DXd ADC technology into new treatment options for as many appropriate patients as possible.¡¨

The overall safety and tolerability profile of ENHERTU in DESTINY-Gastric01 was consistent with that seen in the phase 1 trial in which the most common adverse events (≥30 percent, any grade) were hematologic and gastrointestinal including neutrophil count decrease, anemia, nausea and decreased appetite. There were cases of drug-related interstitial lung disease (ILD) and pneumonitis, the majority of which were grade 1 and 2 with two grade 3 and one grade 4. No ILD-related deaths (grade 5) occurred in patients with gastric cancer in the phase 1 trial or in the DESTINY-Gastric01 trial.

Daiichi Sankyo will hold two ASCO conference calls for investors and analysts: on Sunday, May 31, 2020 from 6:30 PM-8:00 PM EDT (in Japanese/English) and on Tuesday, June 2, 2020 from 8:00 AM-9:30 AM EDT (in English). Company executives will provide an overview of the ASCO research data, updates for the oncology portfolio and address questions from investors and analysts.

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Tralokinumab ªº¤T´ÁÁ{§É¥D­n«ü¼Ð IGA,0/1 ¶È¬ù20%,¬°¹ï·Ó²Õ¬ù10%ªº2­¿.

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ASLAN044 ¦PDUPILUMAB MOA¸ô®|¡A¬GÀø®Ä±N¬Û·íDupilumab.

LEOºË·Ç2021¦~¬ü°ê±À¥XÀã¯l(²§¦ì©Ê¥Ö½§ª¢)AD ÃĪ«tralokinumab

Richard StainesRichard Staines 2020¦~7¤ë1¤é

LEO Pharma¦b¦VFDA´£¥æ¥Ó½Ð«á¡A¥¿·Ç³Æ¦b©ú¦~±À¥X¨äÀã¯lÃĪ«tralokinumab¡A¦]¬°¥¦¥¿·Ç³Æ»PÁɿյ᪺Ävª§¹ï¤âDupixentÄvª§¡C

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ÁÉ¿Õµá¦b³oºØ³QºÙ¬°¯SÀ³©Ê¥Öª¢ªº¯e¯f¤¤©~©ó»â¥ý¦a¦ì¡A¨äµù®gÃĪ«Dupixent¡]dupilumab¡^¤w¦¨¬°³o®aªk°ê¤½¥qªº¥D­n¦¬¤J¨Ó·½¡C

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¸Ó¤å¥ó°ò©óECZTRA 1¡B2©MECZTRA 3²Ä¤T¶¥¬q¬ã¨sªº¼Æ¾Ú¡A¼Ú·ùºÊºÞ¾÷ºc¦b¤W­Ó¤ë´£¥æ¤å¥ó«á¤]¤w¶}©l¹ï¨ä¶i¦æ¼f¬d¡C

ECZTRA 1©M2¦b¤¤­««×¯e¯fªº¦¨¦~¤H¤¤´ú¸Õ¤Ftriokinumab§@¬°¦w¼¢¾¯ªº³æ¤@Àøªk¡A¦ÓECZTRA 3¦b¤¤­««×¯e¯fªº¦¨¦~¤H¤¤µû¦ô¤F»P§½³¡¥Ö½èÃþ©T¾J¦X¥Îªº¦w¥þ©Ê©M¦³®Ä©Ê¡C

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pharmaphorum.com/news/leo-eyeing-2021-us-launch-for-eczema-drug-tralokinumab/

LEO eyeing 2021 US launch for eczema drug tralokinumab

Richard StainesRichard StainesJuly 10, 2020

LEO Pharma is gearing up to launch its eczema drug tralokinumab next year after submitting a filing to the FDA, as it bids to take on Sanofi¡¦s class rival Dupixent.

The Danish pharma said in a statement that the FDA has granted a standard ten-month review, setting a decision date in the second quarter of 2021.

Sanofi has taken a leadership position in the disease also known as atopic dermatitis with Dupixent (dupilumab), an injected drug which has become a major source of revenue for the French firm.

It brings in nearly half a million euros every quarter for the French firm and sales are still growing rapidly after a first FDA approval in eczema in 2017.

While it¡¦s not good form to directly compare different clinical trials, the consensus from the data available is that Dupixent is the better drug, and that Eli Lilly¡¦s phase 3 contender lebrikizumab may also provide stiff competition.

Pfizer is also developing abrocitinib, which looks like it may be effective, and can be taken as a patient-friendly pill, although there are concerns about its side-effects in trial data seen so far.

Like Dupixent tralokinumab is a fully human monoclonal antibody that neutralises the interleukin-13 (IL-13) cytokine that is a key driver of inflammation in atopic dermatitis.

The filing is based on data from ECZTRA 1, 2 and ECZTRA 3 phase 3 studies, and regulators in the EU have also begun their review following a filing last month.

ECZTRA 1 and 2 tested tralokinumab as a monotherapy against placebo in adults with moderate-to-severe disease, while ECZTRA 3 assessed safety and efficacy in combination with topical corticosteroid in adults with moderate-to-severe disease.

Tralokinumab was developed by AstraZeneca¡¦s MedImmune biologics division, and LEO paid $115 million for rights in dermatology indications in 2016 and could pay more than a billion dollars in milestones.

AZ retained rights to tralokinumab in asthma and respiratory indications, but the drug failed in three large asthma trials in 2017.

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¦b¬ü°ê¡Apegfilgrastim¡A¦±§´¯]³æ§Ü©M¨©¥ï³æ§Ü¥Íª«¥é»sÃĪº¥«³õ¥÷ÃB¥¿¦b¨³³tÃk¤É¡C¦b¼Ú¬w¡ANeulasta ®¥Íª«¥é»sÃĤw¸gÀò±o¤F¥«³õªº42¢H¡A¦Ó¬ü°ê¶È¬°29¢H¡A¦b¦Û±Ò°Êªº®É¶¡¤j­P¬Û¦Pªº®É¶¡¬q¡C¦³½ìªº¬O¡ANeulasta OnProªº¥«³õ¥÷ÃB®¦b¬ü°ê¬°54¢H¡A¤@ª½«O«ùí©w¡A©Ò¥H´X¥G©Ò¦³ªº¥Íª«¥é»sÃĪº¦¬¯q¦b³o¸Ì²×©ó¨Óªº¹w¥R¦¡ª`®g¾¹§Î¦¡ªº¶O¥Î¡CBernsteinªº³ø§i«ü¥X¡A¥Ñ©óCOVID-19¤j¬y¦æ¡AOnProªº¥«³õ¥÷ÃB¥i¯à·|¼W¥[¡A³o¬O¥Ñ©ó°ê®a«Øij¦b¾A·íªº¦a¤è´£¨Ñ§ÈÅ@¨Ã¾¨¥i¯à´î¤ÖÂå®v´N¶E¦¸¼Æ¡C¸Ó³ø§i°O¿ýªº³Ì¤pªº¥«³õ¥÷ÃB¬°¤s¼w¤hªºZiextenzo ®¡A¥¦­ì¥»¥u¦b¬ü°ê¦Û2019¦~11¤ë¤w¸g¤W¥«¾P°â¡C

¦b¨©¥ï³æ§Üªº±¡ªp¤U¡A¥D­nªºÃÄ«~±M§Q±N¤£·|¹L´Á¡Aª½¨ì2022¦b¼Ú¬w¡A¦b¬ü°ê¤Ï¹ï¦Ü2019¦~¡A¦]¦¹Mvasi ®©MZirabev ®¡AµL½×¬O¦b¼Ú·ù§å­ã¡AÁÙ¥¼¶}³q¨º¸Ì

TABLE: BIOSIMILAR UPTAKE IN THE EU* AND THE US (as of 1/2020)

Biosimilar Category /US Penetration(¬ü°êº¯³z²v) ///EU/US Trend

Filgrastim 72% Flat/Flat

Epoetin 29% Flat/Rising

Infliximab 14% Rising/Flat

Etanercept NA Rising/NA

Rituximab 5% Rising/Rising

Trastuzumab 17% Rising/Rising

Bevacizumab 25% NA/Rising

Adalimumab NA Rising/NA

Pegfilgrastim 29% Rising/Rising

Gal³Õ¤hªº¬ã¨s¤p²Õ»{¬°¡A­n§l¦¬³Ì·s¶i¤J¥«³õªº¤H¤@ª½¬O¤@­Ó¬D¾Ô¡C ¦pªG¬ü°êªü¹F¤ì³æ§Ü¥«³õ¦b2023¦~¶}©ñ¡A¥¦·|¹ï¨Ì¨º¦è´¶¥Íª«¥é»sÃIJ£¥Í­«¤jªº¼vÅT¡A¦pªG¨Ì¨º¦è´¶¥Íª«¥é»sÃīܧִN¥i¥H¤W¥«¡]®Ú¾Ú±M§Q¶D³^¡A¦b2029¦~¤£·|¤W¥«¡^¡C

³o¤@µo²{ªº¨Ò¥~¬OCoherus±À¥X¤FUdenyca®¡]pegfilgrastim¡^¡C ¹ê»Ú¤W¡A¦b¥»©P©óºÞ²zÅ@²zÃľǾǰ|¹q¤l¾Ç²ß¤éªº¤@­ÓºtÁ¿¤¤¡A¹D®æ¡P®Ô¡]Doug Long¡^±NCoherusªºµo¥¬µø¬°2019¦~¡§³Ì¦¨¥\¡¨¤§¤@¡C

*Does not consider uptake in individual member countries, but overall EU penetration. NA = Not available.

Data from IQVIA and Bernstein Research analysis.

An Interesting Comparison: The Latest Data on US and EU Biosimilar Uptake

biosimilarsrr.com/2020/04/23/an-interesting-comparison-the-latest-data-on-us-and-eu-biosimilar-uptake/

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April 23, 2020

Very little is comparable between the US and Europe in terms of biosimilar approval, launch, and market penetration, but the latest data from Ronny Gal, PhD and his team at Bernstein Research make it possible to do a snapshot review of the two major markets. The statistics paint an encouraging picture of increasing biosimilar penetration in most categories.

In Europe, biosimilar uptake of major reference products far outpaces that in the US. For example, filgrastim biosimilars have a 94% market penetration overall in Europe through January 2020, according to Bernstein¡¦s global report (compared with 72% in the US). That remains the top penetration of any biosimilar agent. In second place are the biosimilars of epoetin at 83%. These two leaders have been available the longest of the major biosimilar products (since 2008) in Europe.

There are stark differences between the EU and US, and these are not just for agents that have yet to launch in the US (e.g., etanercept and adalimumab biosimilars). Both infliximab and rituximab agents have done exceedingly well in the EU, capturing 71% shares, whereas the US share for infliximab biosimilars are still only at 15% since Inflectra®¡¦s introduction in late 2016. Rituximab biosimilars have only been available in the US since October 2019, and uptake has been slower. It should be noted that the market penetrations for both infliximab and rituximab in Europe are still rising.

In the US, marketshares of pegfilgrastim, trastuzumab, and bevacizumab biosimilars are climbing fast. In Europe, Neulasta® biosimilars have attained 42% of the market, compared with 29% in the US, in approximately the same period of time since launch. Interestingly, market share of Neulasta OnPro® in the US has remained steady at 54%, so nearly all of the biosimilar gains here have come at the expense of the prefilled syringe forms. Bernstein¡¦s report noted that because of the COVID-19 pandemic, OnPro¡¦s marketshare may increase, owing to the national recommendations to shelter in place and reduce physician office visits when possible. The report recorded minimal marketshare for Sandoz¡¦s Ziextenzo®, which had only been marketed in the US since November 2019.

In the case of bevacizumab, the principal drug patents won¡¦t expire until 2022 in Europe, as opposed to 2019 in the US, and so Mvasi® and Zirabev®, both approved in the EU, have not yet launched there.

TABLE: BIOSIMILAR UPTAKE IN THE EU* AND THE US (as of 1/2020)

Biosimilar Category US

Penetration EU/US

Trend

Filgrastim 72% Flat/Flat

Epoetin 29% Flat/Rising

Infliximab 14% Rising/Flat

Etanercept NA Rising/NA

Rituximab 5% Rising/Rising

Trastuzumab 17% Rising/Rising

Bevacizumab 25% NA/Rising

Adalimumab NA Rising/NA

Pegfilgrastim 29% Rising/Rising

*Does not consider uptake in individual member countries, but overall EU penetration. NA = Not available.

Data from IQVIA and Bernstein Research analysis.

According to the Dr. Gal¡¦s group, the uptake of late-to-market entrants is consistently challenging. This may have important implications for the US adalimumab marketplace once it opens in 2023 and for etanercept biosimilars, if they become available very soon (and not in 2029, per patent litigation).

The exception to this finding is Coherus¡¦ introduction of Udenyca® (pegfilgrastim). In fact, at a presentation this week at the Academy of Managed Care Pharmacy¡¦s E-Learning Days, Doug Long, characterized Coherus¡¦ launch as one of the ¡§most successful¡¨ of 2019.

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·|­û¡G¤Ñ©R10141925  µoªí®É¶¡:2020/8/31 ¤U¤È 04:10:46²Ä 15 ½g¦^À³
IQVIA Analyst Looks at Current Developments and the Decade Ahead for Biosimilars

www.centerforbiosimilars.com/conferences/smi-2019/iqvia-analyst-looks-at-current-developments-and-the-decade-ahead-for-biosimilars

September 25, 2019

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The global biosimilars market is beginning to take on a more defined shape as blockbuster therapies lose their exclusivities, the United States sees the entrance of the first anticancer biosimilars, and Europe gains experience and savings with adalimumab biosimilars. But what will the coming decade hold in terms of new development projects and global sustainability?

During the first day of the SMi 10th Annual Biosimilars Conference, being held in London, United Kingdom, Aurelio Arias, senior consultant, thought leadership, IQVIA, gave a look at the biosimilars landscape to date and offered insights into what may lie ahead in the coming decade.

Arias began with an overview of what commercial lessons have been garnered from experience with biosimilars so far; As of May 2019, IQVIA data demonstrate that biosimilar penetration has been the greatest in hospital settings, where healthcare systems may direct the choice of which agent can be given to patients. In the EU5 nations (the United Kingdom, Germany, France, Italy, and Spain), biosimilar infliximab has reached penetration levels of as high as 93%, biosimilar etanercept has risen to 83%, and biosimilar rituximab has reached 91% (all in the United Kingdom), while biosimilar trastuzumab has achieved 85% penetration (in France).

However, products that are traditionally dispensed in a retail setting have had far lower uptake; Biosimilar insulin glargine has reached a high of 23% penetration, and biosimilar insulin lispro has reached just 8% penetration, both in Italy. Adalimumab, which may be dispensed in a retail or hospital setting, has reached a high of 57% uptake in the EU5, once again in the UK setting.

These findings show, said Arias, that ¡§when you take the decision to prescribe away from the individual physician,¡¨ higher uptake is observable.

It is important to note, said Arias, that uptake in individual EU nations varies widely by region. In Germany, for example, some regions have achieved more than 70% uptake of biosimilar infliximab and adalimumab, while others have uptake levels under 60%. Indications, too, show wide variation. German prescribing of biosimilar infliximab is 56% in rheumatoid arthritis versus 75% in Crohn disease, for example, representing what Arias called a ¡§gradient of decisions to prescribe¡¨ within individual markets.

Europe also has a great variety of biosimilar discounts, ranging from just 10% to as much as 80% in some markets. Among anti¡Vtumor necrosis factor biosimilars, net price discounts, as opposed to list price discounts, have ranged from 10% to 55% in France, from 30% to 70% in Germany, from 40% to 50% in Italy, and from 30% to 80% in the United Kingdom. ¡§I would say that in general, adalimumab lies in the higher discount range, [about] 80% and 70%,¡¨ said Arias, adding that ¡§this is where the battle is won: at the net price level.¡¨

Looking to the future, Arias sees reference biologics ¡§on the cusp of being shaken up.¡¨ IQVIA¡¦s data show that the top 10 biologics by global sales, as of the second quarter of 2019, include those already competing with biosimilars or facing upcoming losses of exclusivity: adalimumab, insulin glargine, etanercept, infliximab, insulin aspart, bevacizumab, and trastuzumab.

The top 10 also includes 3 drugs that, while they face later losses of patent protection and exclusivity, currently comprise $25.3 billion of global sales: pembrolizumab, nivolumab, and ustekinumab. These drugs, said Arias, will represent large opportunities for biosimilars when they come off patent.

Those opportunities that hold hope for more than $1 billion in sales will be grasped primarily by the larger players in the biosimilars space, said Arias, and the market will likely see fierce competition and high price erosion for these drugs.

By contrast, products that can be expected to sell in the $100 million to $1 billion range will likely be targeted only by small and midsized biosimilar players and will see less competition and lower levels of price erosion. Arias foresees drug makers from China and India, who can operate at a lower cost base, playing a key role for these therapies. Among drugs that can expect to sell less than $100 million, such as some orphan drugs, Arias sees low levels of viability for these projects.

Notably, Arias said that, in order for biosimilars to deliver on their promise in the coming years, the US market must begin to open up to biosimilars. Non-EU and non-US markets, as of the second quarter of 2019, comprised approximately $800 million in biosimilar sales, compared with the approximately $10 billion global market. On their own, these markets, which already have low coverage of biologics and therefore low sales of these agents, are not large enough to justify biosimilar development programs. Therefore, if global biosimilar development projects are to be sustainable, the United States will need to succeed in its own biosimilar ambitions.

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SHAREHOLDER ALERT: Lowey Dannenberg Is Investigating Regeneron Pharmaceuticals, Inc. (REGN) for Potential Breaches of Fiduciary Duty by Its Board of Directors

GlobeNewswire

Lowey Dannenberg, P.C.

,GlobeNewswire¡EAugust 21, 2020

NEW YORK, Aug. 20, 2020 (GLOBE NEWSWIRE) -- Lowey Dannenberg P.C., a preeminent law firm in obtaining redress for consumers and investors, is investigating a potential breach of fiduciary duty claim involving the board of directors of Regeneron Pharmaceuticals, Inc. (¡§Regeneron¡¨ or the ¡§Company¡¨) (NASDAQ: REGN).

On June 24, 2020, U.S. Department of Justice filed a lawsuit alleging that the Company has violated the False Claim Act and actively engaged in a kickback scheme to bolster its sale of macular degeneration drug, Eylea.

Beginning in 2012, the Company began to pay Chronic Disease Fund to cover Medicare co-pays for Eylea patients so the doctors would prescribe them, and the Company would make an estimated 400% profit. The Company has also been accused of lying to the government about their contributions to Chronic Disease Fund during a 2013 audit.

If you are a shareholder of Regeneron and wish to participate, learn more, or discuss the issues surrounding the investigation, please contact our attorneys at (914) 733-7256 or via email at investigations@lowey.com.

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SANOFI AND REGENERON ANNOUNCE PUBLICATION OF POSITIVE PHASE 2A RESULTS OF DUPILUMAB IN ASTHMA IN THE NEW ENGLAND JOURNAL OF MEDICINE

PARIS and TARRYTOWN, N.Y., May 21, 2013 /PRNewswire/ -- Sanofi (EURONEXT: SAN and NYSE: SNY) and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the New England Journal of Medicinepublished online the positive Phase 2a study results of dupilumab (SAR231893/REGN668) in patients with moderate-to-severe allergic asthma. Dupilumab is an investigational monoclonal antibody targeting the alpha subunit of the interleukin 4 receptor (IL-4R alpha), which modulates signaling of both IL-4 and IL-13, drivers of Th2 (Type 2 helper T cell) immune response. The study results will also be presented today at a late-breaking clinical trials session at the American Thoracic Society 2013 International Conference.

The proof-of-concept study enrolled 104 patients with moderate-to-severe, persistent asthma that was not well controlled with inhaled glucocorticosteroids (ICS) and long-acting beta agonist (LABA) therapy, and who had elevated blood or sputum eosinophils (immune cells used as a marker of Th2 asthma in this study).

The primary objective of the trial was to assess the effect of dupilumab, dosed subcutaneously, weekly at 300 milligrams (mg) for twelve weeks. Patients were treated with dupilumab (N=52) or placebo (N=52) on top of ICS and LABA therapy for the first four weeks of the study. The LABA was withdrawn at week four and the ICS was tapered to withdrawal between weeks six and nine. Patients were treated for 12 weeks or until they experienced a protocol-defined asthma exacerbation, the primary endpoint of the study. 23 patients (44.2%) receiving placebo experienced an asthma exacerbation compared to three patients (5.8%) receiving dupilumab, resulting in an 87% reduction in the incidence of asthma exacerbations for the dupilumab arm compared to placebo (p < 0.0001).

Clinically meaningful and statistically significant improvements were observed for lung function and other asthma control parameters, such as forced expiratory volume over one second (FEV1) (difference from baseline to week 12 between dupilumab and placebo of 0.27 L, p < 0.001).

Treatment-emergent adverse events (AEs) were reported by a similar proportion of patients in both groups (76.9% placebo; 80.8% dupilumab). AEs were generally non-specific and of mild-to-moderate intensity. The most common AEs for placebo and dupilumab were injection-site reaction (9.6% and 28.8%), nasopharyngitis (3.8% and 13.5%), upper respiratory tract infection (17.3% and 13.5%), headache (5.8% and 11.5%) and nausea (1.9% and 7.7%).

Despite existing therapies, a significant number of patients with moderate-to-severe, persistent allergic asthma are not optimally controlled, which puts them at risk of poor clinical outcomes. These patients contribute to the significant economic burden of asthma, said Sally Wenzel, M.D., Professor of Medicine and Director of the Asthma Institute at the University of Pittsburgh and lead investigator of this trial. These encouraging data support the potential role of IL-4/IL-13 blockade in an important subset of asthma patients and warrant continued clinical investigation.

Through blockade of IL-4R alpha, dupilumab modulates signaling of both the IL-4 and IL-13 pathways, which have been implicated in the pathophysiology of Th2 mediated, or allergic, diseases such as asthma, said George D. Yancopoulos, M.D., Ph. D., Chief Scientific Officer of Regeneron and President of Regeneron Laboratories. These data, combined with our previously-reported positive proof-of-concept clinical results of dupilumab in atopic dermatitis, support the idea that blocking the IL-4/IL-13 pathway may be an effective mechanism to treat multiple allergic conditions. We look forward to initiating Phase 2b studies in both asthma and atopic dermatitis shortly.

These data will be presented by Dr. Sally Wenzel this morning at the American Thoracic Society 2013 International Conference in a presentation entitled, Efficacy and safety of SAR231893/REGN668 in patients with moderate-to-severe, persistent asthma and elevated eosinophil levels.

About IL-4R and the IL-4/IL-13 Pathway

Atopic dermatitis and some types of asthma are characterized by the induction of a specific type of an immune response that is driven by a subset of immune cells called Type 2 helper T cells, or Th2 cells. IL-4 and IL-13 are key cytokines that are required for the initiation and maintenance of this Th2 immune response. IL-4 and IL-13 signaling occurs through Type I and II IL-4 receptors (IL-4 through both receptors and IL-13 through Type II receptors), which both contain a common IL-4R alpha subunit.

About Dupilumab (SAR231893/REGN668)

Dupilumab is a fully human monoclonal antibody directed against IL-4R alpha and is administered via subcutaneous injection. By blocking IL-4R alpha dupilumab modulates signaling of both IL-4 and IL-13, drivers of a Th2 immune response. Dupilumab was created using Regeneron¡¦s pioneering VelocImmuneR technology and is being co-developed with Sanofi. Dupilumab is currently being studied in both atopic dermatitis and asthma.

About Asthma

Asthma is a chronic inflammatory disease of the airways characterized by airway sensitivity to environmental and biologic factors such as dust, chemicals, smoke, allergens, and viral infections leading to an acute and chronic narrowing of the airway and increased mucus production. Patients with asthma can experience wheezing, shortness of breath, cough and chest tightness, and in severe cases, these symptoms can be life-threatening. For most asthma patients, currently available treatments can control the disease. However, an estimated 10% to 20% of asthmatic patients are less than optimally controlled despite existing therapies. Moderate-to-severe asthma can negatively impact the lives of patients and is associated with a high burden to society both in terms of direct costs of medical care and prescription drugs, as well as loss of productivity. Moderate-to-severe asthma is recognized as a heterogeneous disease; the Th2 inflammation pathway is believed to play a role in disease pathogenesis in approximately 50% of these patients. It is estimated that approximately 25 million people in the United States are known to have asthma. The worldwide estimates are between 235-300 million people, with 180,000 deaths annually.

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NEWSNOVEMBER 5, 2015 / 7:32 PM / 5 YEARS AGO

UPDATE 2-Sanofi, Hanmi seal diabetes licence deal for up to $4.2 bln

3 MIN READ

* Hanmi gets 400 mln euros upfront, up to 3.5 bln milestones

* Sanofi wins exclusive licence to long-acting GLP-1 drugs

* Deal seen as negative for existing Sanofi partner Zealand (Adds analyst¡¦s comment, updates share price reaction)

By Matthias Blamont

PARIS, Nov 5 (Reuters) - Sanofi has signed a licence deal with Hanmi Pharmaceutical to develop experimental, long-acting diabetes treatments, the French drugmaker said on Thursday, in a move to revive its diabetes division.

South Korea-based Hanmi will receive an upfront payment of 400 million euros ($434 million) and is eligible for up to 3.5 billion euros in development, registration and sales milestones, as well as double-digit royalties on net sales.

In return Sanofi will get an exclusive worldwide licence to develop and commercialise Hanmi¡¦s so-called GLP-1 diabetes treatments. Hanmi will retain an exclusive option to co-commercialise the products in Korea and China.

The deal marks a sizeable bet by Sanofi on a new technology at a time when its all-important diabetes business is struggling.

www.reuters.com/article/sanofi-hanmi-diabetes/update-2-sanofi-hanmi-seal-diabetes-licence-deal-for-up-to-4-2-bln-idUSL8N1303GH20151105#zfxFkCQGu0cDA9Z7.97

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NEWSNOVEMBER 5, 2015 / 7:32 PM / 5 YEARS AGO

UPDATE 2-Sanofi, Hanmi seal diabetes licence deal for up to $4.2 bln

3 MIN READ

* Hanmi gets 400 mln euros upfront, up to 3.5 bln milestones

* Sanofi wins exclusive licence to long-acting GLP-1 drugs

* Deal seen as negative for existing Sanofi partner Zealand (Adds analyst¡¦s comment, updates share price reaction)

By Matthias Blamont

PARIS, Nov 5 (Reuters) - Sanofi has signed a licence deal with Hanmi Pharmaceutical to develop experimental, long-acting diabetes treatments, the French drugmaker said on Thursday, in a move to revive its diabetes division.

South Korea-based Hanmi will receive an upfront payment of 400 million euros ($434 million) and is eligible for up to 3.5 billion euros in development, registration and sales milestones, as well as double-digit royalties on net sales.

In return Sanofi will get an exclusive worldwide licence to develop and commercialise Hanmi¡¦s so-called GLP-1 diabetes treatments. Hanmi will retain an exclusive option to co-commercialise the products in Korea and China.

The deal marks a sizeable bet by Sanofi on a new technology at a time when its all-important diabetes business is struggling.

www.reuters.com/article/sanofi-hanmi-diabetes/update-2-sanofi-hanmi-seal-diabetes-licence-deal-for-up-to-4-2-bln-idUSL8N1303GH20151105#zfxFkCQGu0cDA9Z7.97

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