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C ITT EASI 16- 66 ¦@289¤H(100%) EASI score mean 27.9 IGA3/4 58.8%/41.2%
600mg Q4W ( 59¤H) -73.0% /--51.1%) p=0.001 400mg Q4W ( 59¤H) -61.9% /--51.1%) p=0.1054 ( ªí²{¤í¨Î²Õ ) 400mg Q2W( 56¤H) -65.8% /--51.1%) p=0.029 300mg Q2W( 58¤H) -69.8 % /--51.1%) p=0.005 ¦w¼¢¾¯²ÕQ2W( 57¤H) --51.1%
D EASI 18- 66¦¬®×231¤H (80%) EASI score mean 30.7 IGA3/4 51.5%/48.5% ¦b¹ï°ò½uEASI µû¤À¦Ü¤Ö¬°18 ªº±wªÌ ( 231¤H) ¨È²Õªº¤ÀªR¤¤¡Aeblasakimab ªvÀø²Õ»P¦w¼¢¾¯²Õ¤§¶¡²Ä16 ¶g®ÉEASI ¦Ê¤À¤ñÅܤƬ۹ï©ó°ò½uªº®t²§§ó¤j¡G 600mg Q4W ( 47¤H) -75% /-42.3 %¡]p<0.0001¡^ 400mg Q4W ( 49¤H) -60.4% /-42.3 %¡]p<0.0098¡^ 400mg Q2W( 46¤H) -73.5%/ -42.3 %¡]p<0.0001¡^ 300mg Q2W( 44¤H) -71.8%/-42.3 %¡]p< 0.0001¡^ ¦w¼¢¾¯²ÕQ2W( 45¤H) -42.3 %
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1¬ü°êFDA 2023¦~10¤ë2¤é§_¨MLebrikizumabÃÄÃҥӽР(»s³y¤è±¥X°ÝÃD) Eblasakimab ¤Ö¤F¤@ÓÄvª§¹ï¤â, 2b ´Á¬ã¨sªº¶i¤@¨B¼Æ¾Ú¡A¥]¬A±wªÌ³ø§iªºµ²ªG©M¥Íª«¼Ð°O¼Æ¾Ú¡A¹wp±N©ó 2023 ¦~²Ä¥|©u«×´£¨Ñ (¥Íª«¼Ð°O¼Æ¾Ú±À´ú°µ¬°¤T´ÁÁ{§É¥l¶Ò¨ü¸Õ°Ñ¦Ò¼Ð·Ç, AD¥«³õªñ240»õ¬ü¤¸,¤£¥²¥þ®³ ,¥un®³¤U²Å¦X¥Íª«¼Ð°O»P¤£¾A¦X¨Ï¥Îdupilumabªº¯f±w, ¥«³õ´N°÷Åå¤H¤F ) ¥Ø«e§e²{Eblasakimab»Pdupilumab Ävª§ºA¶Õ Tralokinumab ¼Æ¾ÚÁö®t (FDA 2021¦~12¤ë ®Öãtralokinumab ÃÄÃÒ)
2 ¤GB Á{§É¬O¦b§ä³Ì¨Î¾¯¶q Eblasakimab§ä¨ì600mg4¶g¤@°w , dupilumab§ä¨ì300mg2¶g¤@°w , lebrikizumab §ä¨ì250mg2¶g¤@°w ·í¦~dupilumab ¤T´ÁÁ{§É¨Ï¥Î¾¯¶q¬°300mg ¤@¬P´Á¤@°w »P 300mg ¤G¬P´Á¤@°w («á¨ÓÃĪ«¤W¥« ¨Ï¥Î300mg¤G¬P´Á¤@°w) Eblasakimab¤Gb´ÁÁ{§ÉÃĪ«¦w¥þ©Ê¦n «Øij¤½¥q¤T´ÁÁ{§É¨Ï¥Î600mg¤G¬P´Á¤@°w»P¥|¬P´Á¤@°w ( ¨C¤ë¤@°w) ¥H¥Íª«¼Ð°O¼Æ°µ¬°¤T´ÁÁ{§É¥l¶Ò¨ü¸Õªº°Ñ¦Ò¼Ð·Ç, ÅýÀø®Ä¤j´T´£¤É °t¦X°ª¦w¥þ©Ê»PÀu¨}»s³y( ¤w©e°UThermo Fisher Scientific ¶}©l»s³y3´ÁÁ{§É¥ÎÃÄ »P¥¼¨Ó°Ó·~¤Æ¤§ÃĪ«»s³y)¥H¤À¹2029¦~¥þ²y240»õ¬ü¤¸AD ¥«³õ (Eblasakimab³W¹º¹L±Ó®ð³Ý ,ëC·ò¯lCSU »P COPD )
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A IGA 0/1 Eblasakimab 2b 600mg (n=59) Q4W 31.2%/ 15.1% p=0.0502 ( 4¶g1°w) 2.01¿ (59¤HPȦ³¹F¼Ð) (80¤HPÈ·|§ó§C)
B EASI-75% eblasakimab 2b 600mg (n=59) Q4W 52.%/ 24.4% p value 0.0040 ( 4¶g1°w) 2.13¿
C EASI-90% Eblasakimab 2b 600mg (n=59) Q4W 27.6%/ 7.9% p value 0.0080( 4¶g1°w) 3.49¿
Àø®Ä«ü¼Ð ¤G (2¶g1°w) A IGA 0/1 eblasakimab 2b 400mg (n=56) Q2W 32.6 %/15.1% P value 0.0380 ( 2¶g1°w) eblasakimab 2b 300mg (n=58) Q2W 33.1%/15.1% P value 0.0327 ( 2¶g1°w) dupilumab 2b 300mg (n=64) /(n=61)Q2W 30 %/ 2 % P value 0.001 ( 2¶g1°w)
dupilumab phase 3 Solo1 300mg (n=224) /(n=224 )Q2W 37.4%/ 10 .2% P value 0.001 ( 2¶g1°w) dupilumab phase 3 Solo2 300mg (n=233) /(n=236 )Q2W 36%/ 8% P value 0.001 ( 2¶g1°w)
tralokinumab ECZTRA 1 15.8% /7.1 % P=0.002 (300mg 2¶g1°w16¶g) ( 601¤H/ 197¤H) tralokinumab ECZTRA 2 22.2 % /10.9 % P< 0.001 (300mg 2¶g1°w16¶g) ( 591¤H/ 201¤H) (FDA 2021¦~12¤ë ®Öãtralokinumab ÃÄÃÒ)
B EASI-75%
eblasakimab 2b 400mg Q2W (n=56) 43.6/24.4% P value 0.0360 ( 2¶g1°w) eblasakimab 2b 300mg (n=58) Q2W 51.2/24.4% P value 0.0050 ( 2¶g1°w)
dupilumab 2b 300mg (n=64) / (n=61 ) Q2W 53.1%/11.5% p value 0.001 ( 2¶g1°w)
dupilumab phase 3 solo1 300mg (n=224) /(n=224 )Q2W 50.3%/ 15.2 % P value 0.001 ( 2¶g1°w) dupilumab phase 3 solo2 300mg (n=233) /(n=236 )Q2W 44%/ 12% P value 0.001 ( 2¶g1°w)
tralokinumab ECZTRA1 25% /12.7% P < 0•001 (300mg 2¶g1°w16¶g) ( 601¤H/ 197¤H) tralokinumab ECZTRA2 33.2% / 11.4% P < 0•001 (300mg 2¶g1°w16¶g) ( 591¤H/ 201¤H) (FDA 2021¦~12¤ë ®Öãtralokinumab ÃÄÃÒ) C EASI-90% eblasakimab 2b 400mg (n=56) Q2W 25.3%/7.9% p value 0.0177 ( 2¶g1°w) eblasakimab 2b 300mg (n=58) Q2W 30.8%/7.9% p value 0.0028( 2¶g1°w) dupilumab 2b 300mg( n=64)/ n=61) 29.7 %/3.3 % p value 0.001 ( 2¶g1°w)
dupilumab phase 3 solo1 300mg (n=224) /(n=224 )Q2W 32.8%/ 7.4 % P value 0.001 ( 2¶g1°w) dupilumab phase 3 solo2 300mg (n=233) /(n=236 )Q2W 30%/ 7% P value 0.001 ( 2¶g1°w)
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eblasakimab昰¤£¬Oª÷µP±o¥D¤£¬Oª©±¤W¥ô¦ó¤H»¡¤Fºâ¡A¦Ó¬O¥Ñ¥Ö½§¯f»â°ì±M®a»¡¤Fºâ¡A¨S¦³¬Ý¨ì¼Æ¾Ú«e§Ú«Ü«O¦u¡A¬Ý¨ì¼Æ¾Ú«á§Ú¤£±o¤£¼ÖÆ[¡Aª§°õµL¯q¡A®É¶¡¬O³Ì¦nªºÃÒ©ú¡A½Ð@¤ßµ¥«Ý¡A¥t¥~n¤ñÀø®Ä¥ý¬Ý昰¨â¶g¤@°wÁÙ¬O¥|¶g£¸°w,¦w¥þ©Ê¦p¦ó,¨Ï¥Î¤è«K©Ê,»ù®æ¦p¦ó,¥ÎDupilumab¨â¶g¤@°w»Peblasakimab¥|¶g£¸°w¨Ó¤ñ¤]¤£Û¤£Ãþ¡A«Øij¤½¥q¥Î600mg¥|¶g£¸°w °µ¬°¤T´ÁÁ{§É¸ÕÅ羯¡A¿n·¥¶i¨ú¡A¦pªGn«O¦u¦]À³¤]¥i¦A¥[¤J300mg¨â¶g¤@°w¡A ¥Î¨âºØ¾¯¶q¡A¨ì®É¬Ý¬Ý¼Æ¾Ú¦p¦ó¦A¨M©wªvÀø¾¯¶q»PÀW²v¡C
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This is the first time we¡¦ve seen a once-a-month treatment option deliver competitive efficacy data, which would be a game-changer for patients with AD,¡¨ said Eric L. Simpson, M.D., Frances J. Storrs Professor of Medical Dermatology at the Oregon Health and Science University and Lead Investigator in the TREK-AD study. ¡§We haven¡¦t seen much in the way of advancement since the launch of dupilumab, and there remains a huge unmet burden of disease experienced by patients. These results support eblasakimab¡¦s potential to be a leading therapy for the treatment of AD, if approved |
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ASLAN PHARMACEUTICALS REPORTS SECOND QUARTER 2023 FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE
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tralokinumab ¤T´Á¼Æ¾Ú ¥DnÀø®Ä«ü¼Ð IGA 0/1 ( 300mg ¨â¶g¤@°w 16¶g )
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tralokinumab ECZTRA 2 IGA 0/1 22.2 % /10.9 % P< 0.001 (300mg 2¶g1°w16¶g) ( 591¤H/ 201¤H)
Eblasakimab 2b 600mg (n=59) Q4W 31.2%/ 15.1% p=0.0502 ( 4¶g1°w16¶g) eblasakimab 2b 400mg (n=56) Q2W 32.6 %/15.1% P value 0.0380 ( 2¶g1°w16¶g) eblasakimab 2b 300mg (n=58) Q2W 33.1%/15.1% P value 0.0327 ( 2¶g1°w16¶g)
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¤£n§Ñ¤F Eblasakimab ¬O¥|¶g¤@°w»P dupilumab¨â¶g¤@°w¤ñ¸û¤@ÂI¤]¤£®t , Dupilumab Á{§É¸ÕÅç®É¹ï·Ó²Õ¤£¥i¯à¨Ï¥ÎDupilumab ¨S¦³ÃĪ«¬~²æ°ÝÃD ¨ì¤FLebrikizumab »PEblasakimabÁ{§É¸ÕÅç®É´N·|¹J¨ìÃĪ«¬~²æ°ÝÃD ¦b¤H¼Æ¶V¦h±¡ªp¤U¤~¯àÁקK°¾®t , ÃĪ«¬~²æ¥R¨¬¤~¯à¹w¨¾¹ï·Ó²Õ¼Æ¾Ú¤£¦X²z ÄY®æºÞ±±¹ï·Ó²Õ¦]¥Ö½§Äo¬ÝÂå¥Í¥ÎÃÄ( ·|¦³´NÂå¬ö¿ý ) ( ç°£¦³´NÂ媺¹ï·Ó²Õ¨ü¸Õ ¤~¯à¤½¥ªº¤ñ¸û ) dupilumab ¦]¨C²Õ¤H¼Æ¹F224-233¤H ·íÃĪ«¦³®Ä P value < 0.0001 «Ü¥¿±` ªÑ²¼º¦¥i¥H¨S¦³²z¥Ñ , ¼Æ¾Ú¦³¼ç¤OªÑ»ù¤]¥i¯à¶^ ( Äw½XÁÙ¨S¦¬°÷) (·íÄw½X¸¨¤J¤j¤á§ë¸ê¾÷ºcªÑ»ù¥i¥H§ä²z¥Ñº¦¤£°±ªº®×¨Ò ¹ð¨£¤£ÂA)
TREK-AD ¬ã¨s¤¤¨C¥|©P¤@¦¸ªº600mg eblasakimab¹F¨ì ¤F¨ã¦³²Îp¾Ç·N¸qªº¥Dn²×ÂI¡A62.7% ªº±wªÌ¹F¨ì EASI-75¡A34.1% ¹F¨ì EASI-90¡A31.2% ¹F¨ì vIGA-AD 0 ©Î 1 ¡C
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A¥DnÀø®Ä«ü¼ÐPrimary endpoint percent change in EASI from baseline at 16 week
Eblasakimab phase1 600mg (n= 16/13) -61%/-32% P value 0.023 ( ¨C¶g1°w 8¶g) Eblasakimab 2b 600mg (n=59) Q4W -73%/-51.1% P value 0.001 ( 4¶g1°w16¶g) Lebrikizumab 2b 250mg ( n=80) Q4W -69.2% /-41.1 % p value 0.002 ( 4¶g1°w16¶g)
Eblasakimab 2b 400mg (n=56) Q2W ¡V65.8%/-51.1 P value 0.0294 ( 2¶g1°w16¶g) Eblasakimab 2b 300mg (n=58) Q2W -69.8%/-51.1% P value 0.0050 ( 2¶g1°w16¶g)
Eblasakimab 2b 400mg (n=56) Q2W ¡V65.8%/-51.1 P value 0.0294 ( 2¶g1°w16¶g) Eblasakimab 2b 300mg (n=58) Q2W -69.8%/-51.1% P value 0.0050 ( 2¶g1°w16¶g) Lebrikizumab 2b 250mg ( n=75) Q2W -72.1% /-41 % p value 0.001 ( 2¶g1°w16¶g) dupilumab 2b 300mg( n=64)/ (n=61) Q2W -70.8%/-26.3% P value 0.0001 ( 2¶g1°w16¶g)
B ¦¸nÀø®Ä«ü¼Ðsecondary endpoint
A vIGA-AD 0 ©Î 1 Eblasakimab phase1 600mg (n= 16/13) 32%/19 % P value > 0.05 ( ¨C¶g1°w 8¶g) Eblasakimab 2b 600mg (n=59) Q4W 31.2%/ 15.1% p=0.0502 ( 4¶g1°w16¶g)
Lebrikizumab 2b 250mg ( n=80) Q4W 33.7% /15.3% p value 0.006 ( 4¶g1°w16¶g)
eblasakimab 2b 400mg (n=56) Q2W 32.6 %/15.1% P value 0.0380 ( 2¶g1°w16¶g) eblasakimab 2b 300mg (n=58) Q2W 33.1%/15.1% P value 0.0327 ( 2¶g1°w16¶g) dupilumab 2b 300mg (n=64) /(n=61)Q2W 30 %/ 2 % P value 0.0001 ( 2¶g1°w16¶g) Lebrikizumab 2b 250mg ( n=75) Q2W 44.6% /15.3% p value 0.0001 ( 2¶g1°w16¶g)
B EASI-75
Eblasakimab phase1 600mg (n= 16/13) 50%/13% P value 0.018 ( ¨C¶g1°w 8¶g) eblasakimab 2b 600mg (n=59) Q4W 62.7%/ 30.7% p value 0.0041 ( 4¶g1°w16¶g)
Lebrikizumab 2b 250mg ( n=80) Q4W 56.1% /24.3 % p value 0.002 ( 4¶g1°w16¶g) Lebrikizumab 2b 125mg ( n=73) Q4W 44.3% /23.3 % p value 0.06 ( 4¶g1°w16¶g)
eblasakimab 2b 400mg Q2W (n=56) 54.5 /30.7% P value 0.0322 ( 2¶g1°w16¶g) eblasakimab 2b 300mg (n=58) Q2W 60.7/30.7% P value 0.0064 ( 2¶g1°w16¶g) Lebrikizumab 2b 250mg ( n=75) Q2W 60.6% /24.3 % p value 0.001 ( 2¶g1°w16¶g) dupilumab 2b 300mg (n=64) / (n=61 ) Q2W 54.7%/13.1% p value 0.0001 ( 2¶g1°w16¶g)
C EASI-90 Eblasakimab phase1 600mg (n= 16/13) 27%/13% P value 0.018 ( ¨C¶g1°w 8¶g) Eblasakimab 2b 600mg (n=59) Q4W 34.1%/ 10.1% p value 0.0088 ( 4¶g1°w16¶g) Lebrikizumab 2b 250mg ( n=80) Q4W 36.1% /11.4 % p value 0.006 ( 4¶g1°w16¶g) Lebrikizumab 2b 125mg ( n=73) Q4W 26.1% /11.4 % p value 0.08 ( 4¶g1°w16¶g)
eblasakimab 2b 400mg (n=56) Q2W 32.6 %/10.1% p value 0.0194 ( 2¶g1°w16¶g) eblasakimab 2b 300mg (n=58) Q2W 37.7%/10.1% p value 0.0033 ( 2¶g1°w16¶g) dupilumab 2b 300mg( n=64)/ n=61) 29.7 %/3.3 % p value 0.001 ( 2¶g1°w16¶g) Lebrikizumab2b 250mg ( n=75) Q2W 44% /11.4 % p value 0.001 ( 2¶g1°w16¶g)
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ASLAN Pharmaceuticals receives US$12,000,000 from Zenyaku Kogyo On July 20, 2023, ASLAN Pharmaceuticals Limited (the ¡§Company¡¨) announced that it had received the sum of US$12,000,000 (twelve million US dollars) from Zenyaku Kogyo Co., Ltd (¡§Zenyaku¡¨), a subsidiary of privately held Zenyaku Holdings Co., Ltd, being the upfront payment pursuant to the strategic licensing agreement granting Zenyaku rights to develop and commercialize eblasakimab in atopic dermatitis and all other indications in Japan (the ¡§Strategic Licensing Agreement¡¨) , as previously disclosed in the Form 6-K filed with the SEC on June 22, 2023.
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2 ¤@¯ë¦Ê¦ÌÁɨú«e¤T¦W Æ[²³¥Ø¥ú³£·|§ëª`¦b ª÷µP »ÈµP »ÉµP±o¥D, ³o¦¸TREK-AD ¤G´Á¬ã¨s§ë¸ê¤H¥Ø¥ú¤Ï¦Ó§ëª`¦b²Ä¥|¦W ( ¹ï·Ó²Õ)¤W, §Ñ¤FTREK-AD ¥|¶g¤@°w¤~¬O EASI-90ªºª÷µPÁɱo¥D, ³o¬OÃø«×³Ì°ªªº¤ñÁÉ, ¹êÅç²Õ»P¹ï·Ó²Õ®t¶Z´N©úÅã©Ô¥X¨Ó (ÃÒ©úÃĪ«ªº¦³®Ä©Ê) ( ¨â¶g¤@°w¤]¬O¤@ ¼Ë±j)
3¤£n§Ñ¤F Eblasakimab ¬O¥|¶g¤@°w»P dupilumab¨â¶g¤@°w¤ñ¸û¤@ÂI¤]¤£®t , ¦P¼ËªºEASI-75%»ÈµPÁÉ »P IGA 0/1»ÉµPÁÉ ¦b¤H¼Æ¤£¦h»PÃĪ«¬~²æ¤£¨¬±¡ªp¤U ©ÎªÌ¦³¨Ç©â¨ì¹ï·Ó²Õªº¨ü¸Õ¤]¥i¯à¥Ö½§Äo¬ÝÂå¥Í¥ÎÃÄ,¦b³o¨Ç¼vÅTÅܼƤ§¤UEblasakimab ¼Æ¾Ú¤@ÂI¤]¤£®t ( dupilumab ¦]¨C²Õ¤H¼Æ¹F224-233¤H P value < 0.0001 )
4 TREK-AD ¬ã¨s¤¤¨C¥|©P¤@¦¸ªº600mg eblasakimab¹F¨ì ¤F¨ã¦³²Îp¾Ç·N¸qªº¥Dn²×ÂI¡A62.7% ªº±wªÌ¹F¨ì EASI-75¡A34.1% ¹F¨ì EASI-90¡A31.2% ¹F¨ì vIGA-AD 0 ©Î 1 ¡C •EASI-90ª÷µPÁÉ Eblasakimab 2b 600mg (n=59) Q4W 34.1%/ 10.1% p value 0.0088 ( 4¶g1°w) dupilumab 2b 300mg 29.7 %/3.3 % ( 2¶g1°w) dupilumab phase3 300mg (SOLO 1 224¤H) 36%/8% ( 2¶g1°w) dupilumab phase3 300mg (SOLO 2 233¤H) 30.%/7% ( 2¶g1°w)
EASI-75%»ÈµPÁÉ eblasakimab 2b 600mg (n=59) Q4W 62.7%/ 30.7% p value 0.0041 ( 4¶g1°w) dupilumab 2b 300mg (n=58) 53.1%/11.5% ( 2¶g1°w) dupilumab phase3 300mg (SOLO 1 224¤H) 51%/15% ( 2¶g1°w) dupilumab phase3 300mg (SOLO 2 233¤H) 44.%/12% ( 2¶g1°w)
IGA 0/1»ÉµPÁÉ Eblasakimab 2b 600mg (n=59) Q4W 31.2%/ 15.1% p=0.0088 ( 4¶g1°w) dupilumab 2b 300mg Q2W 29.7 %/3.3 % ( 2¶g1°w) dupilumab phase3 SOLO 1( 224¤H) /SOLO 2 (233¤H) 38%/10% 36% /9% ( 2¶g1°w)
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