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¬ü°ê 1b ¤¤««× AD Á{§É ªÑ²¼, §ë¸ê´A¤O! ---------------------------------------------------- ASLAN004 24¦W,¤¤««× AD ·§©À©ÊÁ{§É¼Æ¾Úªº±N¤½¥¬¡C(²Ä¥|©u) ¦P¯e¯f³Ì¨ÎASLAN004, ¬O§_¦³ AnaptysBio ,4-5Ó¤ë¡A ¤jº¦ 24»õ¬ü¤¸ªº¾÷·|? ¤@¦¸¤ÏÀ³ ? ----------------------------- AnaptysBio ,IL33 ªvÀø¤¤««×AD ²§¦ì©Ê¥Ö½§ª¢¼Ð¹vµo¥¬12¦W·§©À©ÊÁ{§É¥¿¦V¼Æ¾Ú¡C ªÑ»ù2017¦~10¤ë«Å¥¬«e32¬ü¤¸¡A³sº¦4-5Ó¤ë¡Aº¦¥|¿¡A³Ì°ª128¬ü¤¸¡A±q¥«È8»õ¬ü¤¸¡Aº¦¨ì32»õ¬ü¤¸¡C ------------------------------------ ¥i±¤«e2Ó¤ë¡A2019¦~11¤ë8¤é¤½¥¬2b/300¤HADÁ{§É¸Ñª¼¥¼¹LÃö¡C ªÑ»ù¦^15¬ü¤¸¡A³Ñ¥|»õ¬ü¤¸¡C www.marketwatch.com/investing/stock/anab www.google.com.tw/amp/s/www.fool.com/amp/investing/2017/10/10/heres-why-anaptysbio-inc-is-rocketing-higher-today.aspx ³o´N¬OAnaptysBio Inc.¤µ¤Ñ¸³tµo®iªºì¦] ¤¤¶¡¶¥¬qªº·§©ÀÅçÃҼƾڹ蘆¤ÑªºAnaptysBioªÑ²¼²£¥Í¤F²§±`±j¯Pªº¼vÅT¡C Cory Renauer¡]TMFang4apples¡^ 2017¦~10¤ë10¤é¡A¤W¤È11:38 µo¥Í¤F¤°»ò AnaptysBio Inc.¡]¯Ç´µ¹F§JªÑ²¼¥N½X¡GANAB¡^¬O¤@®aÁ{§É¶¥¬qªº¥Íª«§Þ³N¤½¥q¡A¥¿¦b¶}µo·s«¬§Üª¢ÃÄ¡A¸Ó¤½¥q³ø§i¤F¨äÀã¯lÔ¿ïÃĪ«ªºÁ{§É¸ÕÅçÀò±o¤F¿n·¥ªº¼Æ¾Ú«á¡A¡C¾¨ºÞ³o¥u¬O¤@¶µ¦³12¦W±wªÌªº·§©ÀÅçÃÒ¬ã¨s¡A¦ýºI¦Ü¶g¤G¬üªF®É¶¡¤W¤È10:15¡A¸ÓªÑ¤Wº¦¤F¬ù70.7¢H¡C ©Ò¥H©O ¤µ¤Ñªº¿³¾Ä¨Ó¦Û©ó¤@ӫܤjªº·t¥Ü¡A§Y¸Ó¤½¥q¤@¬yªºIL-33§í»s¾¯¦³±æ¦¨¬°¹L±Ó©Ê¥Öª¢¡]³Ì±`¨£ªºÀã¯lÃþ«¬¡^±wªÌªº¶W«K±¶ªvÀø¿ï¾Ü¡C¦b±µ¨ü³æ¾¯ANB020«áªº57¤Ñ¶¡¹j¤¤¡A 12¦W±wªÌ¤¤¦³10¦WÀò±o¤F50¢H©Î§ó°ªªº§ïµ½¡C¤ÏÀ³¦ü¥G¤]«Ü§Ö¡A¦b15¤Ñªºµû¦ô¤¤¡A12¨Ò±wªÌ¤¤¦³9¨Ò§ïµ½¤F50¢H¡C ¼y¯¬¦b¹êÅç«Ç¸Ìªº¤T¦ì¬ì¾Ç®a¡C ¹Ï¹³¨Ó·½¡GGETTY¹Ï¹³¡C ¦b²Ä¤G¶¥¬qªº·§©ÀÅçÃҼƾڪº¤ä«ù¤U¡A³q±`±z¤£·|¦b¤@©]¤§¶¡¬Ý¨ì¤½¥qªº¥«È¼Wªø¶W¹L5»õ¬ü¤¸¡C Celgene©MTesaro¤w±qAnaptysBioÀò±o¤F§ÜPD1Ô¿ïÃĪ«ªº³\¥i¡A¦ý³o¬O¸Ó¤½¥q¥þ¸ê¾Ö¦³ªº·sÔ¿ïÃĪ«¤¤ªº²Ä¤@Ó¡Aªí©ú¥¦½T¹ê¦b«n®É¨è¦³¥X¤â¡C¾Ú¦ôp¡A¬ü°ê¦¨¦~¤H¤f¤¤¦³3¢H±w¦³¬YºØ§Î¦¡ªºÀã¯l¡A³o·N¨ýµÛ¦pªGÄ~Äòµ¹¤H¯d¤U²`¨èªº¦L¶H¡AANB020¾Ö¦³¥¨¤jªºµo®i¼ç¤O¡C ¦b±µ¨ü³æ¾¯ANB020µ¹Ãī᪺140¤Ñ¤º¡AAnaptysBio±NÄ~Äòµû¦ô³o12¦W±wªÌ¡C¦b2018¦~¤W¥b¦~¡A§Ú̧Ʊæ¦Ü¤Ö¦³200¦WÀã¯l±wªÌ±µ¨ü¦h¾¯ªvÀø¥H±Ò°Ê¤@¶µ§ó¤jªº¬ã¨s¡C ¸Ó¤½¥qÁÙ¥¿¦b¬°±w¦³ÄY«ªá¥Í¹L±Ó¯gªº¦¨¦~¤H¶}µoANB020¡A¥t¤@®a¥þ¸ê»È®h¯fÔ¿ïÃĪ«ANB019À³¸Ó¦b¦~©³¤§«e§¹¦¨¨äºÓÁ{§É¶¥¬q¸ÕÅç¡C Here¡¦s Why AnaptysBio Inc. Is Rocketing Higher Today Mid-stage proof-of-concept data is having an unusually strong effect on AnaptysBio stock today. Cory Renauer (TMFang4apples) Oct 10, 2017 at 11:38AM What happened Shares of AnaptysBio Inc. (NASDAQ:ANAB), a clinical-stage biotech developing novel anti-inflammatory drugs, took flight after the company reported positive data from a clinical trial with its eczema candidate. Although it was just a 12-patient proof-of-concept study, the stock soared about 70.7% higher as of 10:15 a.m. EDT on Tuesday. So what Today¡¦s excitement is due to a big hint that the company¡¦s first-in-class IL-33 inhibitor has a shot at becoming an ultra-convenient treatment option for people with atopic dermatitis, the most common type of eczema. At an interval of 57 days after receiving a single dose of ANB020, 10 of 12 patients achieved a 50% or greater improvement. Responses also appear rapid, nine of the 12 patients had achieved a 50% improvement at the 15-day assessment. Three scientists celebrating in a laboratory. IMAGE SOURCE: GETTY IMAGES. You don¡¦t normally see a company¡¦s market cap rise more than $500 million overnight on the back of phase 2 proof-of-concept data. Celgene and Tesaro have licensed anti-PD1 candidates from AnaptysBio, but this is the first of the company¡¦s wholly owned new drug candidates to show it really has a shot at the big time. An estimated 3% of America¡¦s adult population has some form of eczema, which means ANB020 has blockbuster potential if it continues to impress. Now what AnaptysBio will continue assessing these 12 patients up to 140 days after they were given a single dose of ANB020. In the first half of 2018, look for the initiation of a larger study with at least 200 eczema patients receiving multiple doses. The company is also developing ANB020 for adults with severe peanut allergies, and another wholly owned psoriasis candidate, ANB019, should wrap up its first clinical-stage trial before the end of the year. |
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clinicaltrials.gov/ct2/history/NCT04090229?A=1&B=3&C=merged#StudyPageTop History of Changes for Study: NCT04090229 A Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Subcutaneously Delivered ASLAN004 in Adults With Moderate-Severe Atopic Dermatitis ¨È·à±d ASLN004 AD «nÁ{§Éקï: 1.¤w³q¹L¬ü°êÁ{§É¥Ó½Ð¡C 2.¼W¥[¬ü°ê¡B¿D¬w¦U3ÓÁ{§ÉÂå°|¡C 3.§¹¦¨®É¶¡2021¦~3¤ë31¤é¡C Study Design Go to sections Study Type : Interventional (Clinical Trial) Estimated Enrollment : 50 participants Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Double Blind, Placebo-controlled, Randomized Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment Official Title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Subcutaneously Delivered ASLAN004 in Adults With Moderate-Severe Atopic Dermatitis Actual Study Start Date : September 9, 2019 Estimated Primary Completion Date : March 31, 2021¡]©ú¦~¤T¤ë31¤é§¹¦¨¡^ Estimated Study Completion Date : March 31, 2021 Locations ( ¼W¥[¬ü°ê3ÓÁ{§ÉÂå°|) United States, California Center for Dermatology Clinical Research, INC Not yet recruiting Fremont, California, United States, 94538 Contact: Clinical Trial Unit Principal Investigator: Sunil Dhawan United States, Pennsylvania Paddington Testing Co, INC Not yet recruiting Philadelphia, Pennsylvania, United States, 19103 Contact: Clinical Trial Unit Principal Investigator: Jennifer Parish United States, Texas Dermatology Treatment and Research Cancer Not yet recruiting Dallas, Texas, United States, 75230 Contact: Clinical Trial Research Unit Principal Investigator: William Abramovitis ¡]¼W¥[¿D¬w¤TÓÁ{§ÉÂå°|) Australia, New South Wales Premier Specialists Pty Ltd Not yet recruiting Kogarah, New South Wales, Australia, 2217 Contact: Clinical Trials Unit Principal Investigator: Deidre (Dedee) Frances Murrell Australia, Queensland Veracity Clinical Research Pty Ltd Not yet recruiting Woolloongabba, Queensland, Australia, 4102 Contact: Veracity Clinical Research Principal Investigator: Lynda Spelman Australia, Victoria Skin Health Institute, Inc. Not yet recruiting Carlton, Victoria, Australia, 3053 Contact: Clinical Trials Department Principal Investigator: Peter Foley Australia, Western Australia Fremantle Dermatology Not yet recruiting Fremantle, Western Australia, Australia, 6160 Contact: Clinical Trials Department Principal Investigator: Kurt Gebauer Singapore National Skin Centre Recruiting Singapore, Singapore, 308205 Contact: Clinical Trials Unit Principal Investigator: Steven Thng Changi General Hospital Recruiting Singapore, Singapore, 529889 Contact: Changi General Hospital Principal Investigator: Shanna Ng Studies a U.S. FDA-regulated Drug Product: Yes ( ³q¹L¬ü°ê Á{§É¥Ó½Ð) |
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MOA¾÷Âà¤wÀòÃҹ꦳¦h¥i¶Q? ¥H¤Udupilumab ADÁ{§É¸ê®Æ¬Ò¥i°Ñ¦Ò,¦]¬°¦b¬Û¦P¥´°wÀW²v,§¹¥þ§í¨î¶q¤U,¹w«á«ü¼ÐªºÀø®Ä²z½×¤W«Ü±µªñ. ¸gÀç¤è¦V : ¤½¥q¦A±ÂÅv/³Q¨ÖÁÊ »ùȦôºâ. ¥i¹w¦ô¥¼¨Ó¾P°âÃB(¤è¯à±ÂÅv), q©w¦æ¾Pµ¦²¤:²£«~/q»ù/³q¸ô/«P¾P! ¤@.Dupilumab ¦U´ÁAD Á{§É¼Æ¾Ú¡C 1. Dupilumab ¦´Á¥|Ó AD Á{§É 4¶g/12¶g , 2014/07/10 Dupilumab Treatment in Adults with Moderate-to-Severe Atopic Dermatitis www.nejm.org/doi/10.1056/NEJMoa1314768 2. Dupilumab 2a/2b Á{§É ,2018/SEP journals.lww.com/jaanp/Fulltext/2018/09000/Efficacy_and_safety_of_dupilumab_for_the_treatment.10.aspx 3.Dupilumab AD 2Ó¤T´ÁÁ{§É, 300mg/¨C¶g¤@°w/300mg/¨C¤G¶g¤@°w 2016/12/15 Two Phase 3 Trials of Dupilumab versus Placebo in Atopic Dermatitis www.nejm.org/doi/full/10.1056/nejmoa1610020 ------------------------------------- ¤@¡B¨È·à±d¤½¥q³Ìªñ²¤¶ 2020,05,26 ¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X ASLAN004¦³¼ç¤O¦¨¬°¦P¯e¯f³Ì¨ÎÀøªk 1. IL-13R£\1 §í¨î¾¯: ASLAN004¬O°ß¤@Âê©wIL-13R£\1ªº³æ®è§ÜÅé¡A¦³¼ç¤O¦¨¬°ªvÀø²§¦ì©Ê ¥Ö½§ª¢»P®ð³Ý¤§³Ì¨ÎÀøªk 2.¾÷Âà¤wÀòÃÒ¹ê :»PdupilumabÂê©w¬Û¦Pªº¸ô®|»P¨üÅé½Æ¦XÅé(·¥Àø®ÄÀ³¬Û·í) |
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5 Aug 2020 ASLAN CEO Dr Carl Firth and Chief Business Officer Stephen Doyle to present at H.C. Wainwright 22nd Annual Global Investment Conference at 2020, 14-16 September 5 Aug 2020 ASLAN CEO Dr Carl Firth and Chief Business Officer Stephen Doyle to present at BTIG Virtual Biotechnology Conference 2020, 10-11 August aslanpharma.com/news/ |
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ASLAN004 MOA -¼v¤ù aslanpharma.com/drug/aslan004/ 2.Dupilumab MOA -¼v¤ù www.dupixenthcp.com/atopicdermatitis/about/mechanism-of-action MOA www.tsim.org.tw/journal/jour29-6/02.PDF?fbclid=IwAR2B85aLqBUAt5agx6K7u0NkCGTGpr7w6HDCagHhLuu54ZH7FEqHMAdXG3M ASLAN004 ¦Pdupilumab MOA ¥i¦P®Éªý¤îIL-4/IL13 °T¸¹¶Ç»¼, ¤w¸g20¸U¤HÅçµý¹LªºMOA. |
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ASLAN004 ¤w½T»{MOA, 2019/05/31, ¸g2.8¥üªÑ»ù¥«ÈCSL °ê»Ú±ÂÅv¤@¦¸! ¦p¦ó¤ñOBI822 MOA ¥¼½T©w ?, 2/3´ÁÁ{§É, ¥¼¸Ñª¼«eª¬ªp? ¥¼±ÂÅv¹L! ¤@¡B¨È·à±d¤½¥q³Ìªñ²¤¶ 2020,05,26 ¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X ASLAN004¦³¼ç¤O¦¨¬°¦P¯e¯f³Ì¨ÎÀøªk 1. IL-13R£\1 §í¨î¾¯: ASLAN004¬O°ß¤@Âê©wIL-13R£\1ªº³æ®è§ÜÅé¡A¦³¼ç¤O¦¨¬°ªvÀø²§¦ì©Ê ¥Ö½§ª¢»P®ð³Ý¤§³Ì¨ÎÀøªk 2.¾÷Âà¤wÀòÃÒ¹ê :»PdupilumabÂê©w¬Û¦Pªº¸ô®|»P¨üÅé½Æ¦XÅé(·¥Àø®ÄÀ³¬Û·í) 3.Âê©w¥«³õ°Ï¹j®ÄªG:¨ãÀø®Ä¼W¶i¤§¼ç¤O¡B´î¤Ö¤£¨}¤ÏÀ³(µ²½¤ª¢) ¡B¨C¤ëµ¹ÃĤ@¦¸(«¤jªºÄvª§Àu¶Õ) §¹¦¨³æ¤@¾¯¶q»¼¼W¸ÕÅç. 4.¤w§¹¦¨°·±d¨ü¸ÕªÌªº¤@´Á³æ¤@¾¯¶q»¼¼W¸ÕÅç¡C¦Ü¤µ©|¥¼µo²{©ú Å㤣¨}¤ÏÀ³¡C¥ÎÃÄÀW²v¥i±æ¬°¨C¤ë¤@¦¸¡C ¦h¾¯¶q»¼¼W¸ÕÅç/·§©À ©ÊÅçÃÒ¶i¦æ¤¤ 5.¦h¾¯¶q»¼¼W¸ÕÅç/·§©À©ÊÅçÃÒªº²Ä¤G¾¯¶q±Ú¸s²{¥¿¦¬®×¤¤¡C ªì´ÁÀø®Ä¥O¤H®¶¾Ä¡C aslanpharma.com/app/uploads/2020/05/20-05-19-ASLAN-CN.pdf ¤G¡BDupilumab ¾P°â¹w´Á110»õ¬ü¤¸/¦~°ªÂI¡C 2019/12 REGNªº CEO «Å¥¬Dupilumab ¥¼¨Ó¾P°â°ªÂI110»õ¬ü¤¸¡A¶W¥X¥«³õ¹w´Á50»õ¬ü¤¸¡Cªñ¥b¦~ªÑ»ù¥«È¤jº¦300»õ¬ü¤¸. 2017/Q3¤W¥« 2018¾P°â8»õ¬ü¤¸ 2019¾P°â23»õ¬ü¤¸ 2020¦ô ¾P°â40»õ¬ü¤¸ 2021¦ô ¾P°â60»õ¬ü¤¸ 2022¦ô ¾P°â80»õ¬ü¤¸ 2023¦ô ¾P°â100»õ¬ü¤¸ |
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˼Æ13¤Ñ¡A¤½¶}»OÆWÂd¥x¥æ©ö Shares of Regeneron Pharmaceuticals climbed Wednesday morning after the company reported non-GAAP diluted earnings per share of $7.16, beating Wall Street expectations by a hefty margin. The company also beat revenue estimates, reporting second-quarter sales of $2 billion, up 24% from the same quarter last year, and well above the S&P Capital IQ Consensus estimate of $1.7 billion. The consensus estimate for Regeneron¡¦s (ticker: REGN) earnings was $5.96 a share. ¡§Regeneron¡¦s business continues to be resilient during these times, delivering double digit top- and bottom-line growth in the second quarter,¡¨ Regeneron¡¦s chief financial officer, Robert Landry, said in a statement. Shares of Regeneron were up 3% in premarket trading. The stock has climbed 112.4% so far this year, driven largely by excitement over its antibody cocktail designed to prevent and treat Covid-19. On Monday, Regeneron announced promising data on an animal trial of the drug, which is currently undergoing human testing. Regeneron trades at 21.4 times earnings expected over the next 12 months, below its 5-year average of 22.8 times. Of the 27 analysts tracked by FactSet who cover the stock, 15 rate it a Buy, 11 rate it a Hold, and one rates it a Sell. In a note Wednesday morning, Piper Sandler analyst Christopher Raymond wrote that he had expected Regeneron to beat consensus expectations, but not by this much. He noted that U.S. sales of the company¡¦s wet age-related macular degeneration drug Eylea were higher than the Wall Street consensus view by $50 million, and worldwide sales of the cancer drug Libtyaho beat consensus by $11 million. The biggest reason for the surprisingly strong result was $211 million of ¡§Other revenue¡¨ the company recorded as it received U.S. federal government funding for its Covid-19 antibody and an Ebola drug, he noted. ¡§Given that this was a solid beat, we could see REGN shares continue to move up as the day progresses,¡¨ Citi Research analyst Mohit Bansal wrote early Wednesday. The company scheduled a call for investors at 8:30 a.m. Eastern time on Wednesday morning. Regeneron PharmaceuticalsªºªÑ²¼¦b©P¤T¦¤W¤Wº¦¡A¦¹«e¸Ó¤½¥q«Å¥¬«ö·Ó«D¤½»{·|p·Ç«h¡]non-GAAP¡^¡AÅuÁ¡«á¨CªÑ¦¬¯q¬°7.16¬ü¤¸¡A»·¶WµØº¸µó¹w´Á¡C ¸Ó¤½¥qÁÙ¶W¹L¤F¦¬¤J¹w´Á¡A³ø§i²Ä¤G©u«×¾P°âÃB¬°20»õ¬ü¤¸¡A¤ñ¥h¦~¦P´Á¼Wªø24¢H¡A¨Ã¥B¤j¤j¶W¹L¤F¡m¼Ð·Ç´¶º¸¸ê¥»´¼°Ó¦@ÃÑ¡n¡]S¡®P Capital IQ Consensus¡^ªº17»õ¬ü¤¸¡C RegeneronªºªÑ²¼¥«³õ´¶¹M¹w´Á¬°¨CªÑ¦¬¯q5.96¬ü¤¸¡C Regeneronªºº®u°]°È©xù§B¯S¡PÄõ¼w¨½¡]Robert Landry¡^¦b¤@¥÷Án©ú¤¤»¡¡G¡§¦b³o¬q®É¶¡¸Ì¡A¦A¥Í¤¸ªº·~°ÈÄ~Äò«O«ù¼u©Ê¡A²Ä¤G©u«×¹ê²{¤F¨â¦ì¼Æªº³»½u©M©³½u¼Wªø¡C¡¨ ½L«e¥æ©ö¤¤¡A¦A¥Í¤¸ªÑ»ù¤Wº¦¤F3¢H¡C¤µ¦~¨´¤µ¬°¤î¡A¸ÓªÑ¤w¸g¤Wº¦¤F112.4¢H¡A³o¥Dn¬O¥Ñ©ó¨ä¥Î©ó¹w¨¾©MªvÀøCovid-19ªº§ÜÅé²V¦Xª«ªº¿³¾Ä¡C¶g¤@¡ARegeneron«Å¥¬¤F¦³Ãö¸ÓÃĪ«ªº°Êª«¸ÕÅ窺¦³§Æ±æªº¼Æ¾Ú¡A¸Ó¸ÕÅç¥Ø«e¥¿¦b±µ¨ü¤HÅé´ú¸Õ¡C Regeneronªº¥«¬Õ²v¬O¥¼¨Ó12Ó¤ë¹w´Áªº21.4¿¡A§C©ó¨ä5¦~¥§¡È22.8¿¡C FactSet°l踪ªº27¦ì¤ÀªR®v²[»\¤FªÑ²¼¡A¨ä¤¤15¦ì±N¨äµû¬°¶R¤J¡A11¦ì±N¨äµø¬°«ù¦³¡A±N¨äµû¬°½æ¥X¡C ¬£¬Ä¡E®á¼w°Ç¡]Piper Sandler¡^¤ÀªR®v§J¨½´µ¦«¥±¡E¹p»X¼w¡]Christopher Raymond¡^¦b©P¤T¦¤Wªº¤@¥÷³ø§i¤¤¼g¹D¡A¥L´¿´Á±æ¦A¥Í¤¸¯à¶W¹L¦@Ãѹw´Á¡A¦ý´T«×¤£¤j¡C¥L«ü¥X¡A¸Ó¤½¥q¦b¬ü°ê»PÀã©Ê°I¦Ñ¬ÛÃöªº¶À´³ÅÜ©ÊÃĪ«Eylea¦b¬ü°êªº¾P°âÃB¤ñµØº¸µóªº¦@ÃÑ°ª¥X5,000¸U¬ü¤¸¡A¦Ó¦b¥þ²y½d³ò¤º¡A§ÜÀùÃĪ«Libtyahoªº¾P°âÃB«h¶W¥X¤F¦@ÃÑ1,100¸U¬ü¤¸¡C ¥L«ü¥X¡A¨ú±o¥O¤HÅå³Yªº±j«l·~ÁZªº³Ì¤jì¦]¬O¸Ó¤½¥q¿ý±o¡§¨ä¥L¦¬¤J¡¨ 2.11»õ¬ü¤¸¡A¦]¬°¸Ó¤½¥qÀò±o¤F¬ü°êÁp¨¹¬F©²¬°¨äCovid-19§ÜÅé©M®J³Õ©ÔÃĪ«´£¨Ñªº¸êª÷¡C ªáºX»È¦æ¡]Citi Research¡^¤ÀªR®v¿p§Æ¯S¡P¯ZÂĺ¸¡]Mohit Bansal¡^¶g¤T¦¨Ç®ÉÔ¼g¹D¡G¡§Å²©ó³o¬O¤@¦¸Ã°·ªºªí²{¡A§ÚÌ¥i¥H¬Ý¨ìREGNªºªÑ²¼ÀHµÛ¤éÁ͵o®i¦ÓÄ~Äò¤Wº¦¡C¡¨ |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2020/8/5 ¤W¤È 09:06:32²Ä 3250 ½g¦^À³
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www.tspccm.org.tw/download/5303/08ed73829a0b1ad4dbbe6fb30f0b6d6f/®ð³Ýªº¶EÂ_»PÁ{§ÉºÊ´ú.pdf ®ð³Ýªº¶EÂ_»PÁ{§ÉºÊ´ú |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2020/8/5 ¤W¤È 06:09:06²Ä 3249 ½g¦^À³
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Dupilumab ¤TÓ¤T´Áý³ÝÁ{§É www.accessdata.fda.gov/drugsatfda_docs/label/2018/761055s007lbl.pdf AS¸Õ¥Î1 AS¸ÕÅç1¬O¤@¶µ¬°´Á24¶gªº¾¯¶q½d³ò¬ã¨s¡A¨ä¤¤¥]¬A776¦W¨ü¸ÕªÌ¡]18·³¤Î¥H¤W¡^¡C¦b¤¤«×¦Ü««×ý³Ýªº¦¨¦~¨ü¸ÕªÌ¤¤¡A¨Ï¥Î¤¤µ¥©Î¤j¾¯¶q§l¤J¥Ö½èÃþ©T¾J©Mªø®Ä£]¿E°Ê¾¯µû¦ô¤FDUPIXENT»P¦w¼¢¾¯ªº¤ñ¸û¡C¨ü¸ÕªÌ³QÀH¾÷¤À°t¬°¨C¨â¶g¤@¦¸¡]Q2W¡^±µ¨ü200 mg¡]N = 150¡^©Î300 mg¡]N = 157¡^DUPIXENT¡A©Î¦b¨C4¶g±µ¨ü200 mg¡]N = 154¡^©Î300 mg¡]N = 157¡^DUPIXENT¡Cªì©l¾¯¶q¤À§O¬°400 mg¡A600 mg©Î¦w¼¢¾¯¡]N = 158¡^¡C¥Dn²×ÂI¬O°ò½u¦å²G¶Ý»Ä©Ê²É²ÓM≥300²ÓM/ mcLªº¨ü¸ÕªÌ±q°ò½u¨ì²Ä12¶gFEV1¡]L¡^ªº¥§¡ÅܤơC¨ä¥L²×ÂI¥]¬A¦b24©P¦w¼¢¾¯¹ï·ÓªvÀø´Á¶¡FEV1¬Û¹ï©ó°ò½uªºÅܤƦʤÀ¤ñ¥H¤ÎÄY«ý³Ý«æ©Êµo§@¨Æ¥óªº¦~¤Æ²v¡C®Ú¾Ú°ò½u¦å¶Ý»Ä©Ê²É²ÓMp¼Æ¡]≥300²ÓM/ mcL©M<300²ÓM/ mcL¡^¦bÁ`¤H¸s©M¨È²Õ¤¤µû¦ôµ²ªG¡C¨ä¥L¦¸n²×ÂI¥]¬A±wªÌ³ø§iªºý³Ý±±¨î°Ý¨÷¡]ACQ-5¡^©Mý³Ý¥Í¬¡½è¶q°Ý¨÷¼Ð·Çª©¡]AQLQ¡]S¡^¡^µû¤À¤¤ªº½w¸Ñ²v¡C AS¸Õ¥Î2 AS¸ÕÅç2¬O¤@¶µ¬°´Á52¶gªº¬ã¨s¡A¨ä¤¤¥]¬A1902¦W¨ü¸ÕªÌ¡]12·³¥H¤W¡^¡C¦b¤¤«×¦Ü««×ý³Ýªº107¦W«C¤Ö¦~©M1795¦W¦¨¦~¨ü¸ÕªÌ¤¤¡A¹ïDUPIXENT»P¦w¼¢¾¯¶i¦æ¤F¤ñ¸û¡A¬ã¨s¹ï¶H¨Ï¥Î¤¤«×©Î°ª¾¯¶q§l¤J©Ê¿}¥Ö½è¿E¯À¡]ICS¡^¥H¤Î¦Ü¤Ö¤@ºØ©M¨âºØ¥H¤Wªº¨ä¥L±±»sÃĪ«¡C¨ü¸ÕªÌÀH¾÷±µ¨ü200 mg¡]N = 631¡^©Î300 mg¡]N = 633¡^DUPIXENT Q2W¡]©Î»P¤§¤Ç°tªº¦w¼¢¾¯¡^ °Ñ¦ÒID¡G4337903 ²Ä17¶¡A¦@25¶ ªì©l¾¯¶q¤À§O¬°400 mg¡A600 mg©Î¦w¼¢¾¯«á200 mg [N = 317]©Î300 mg [N = 321] Q2W¡^¡C¥Dn²×ÂI¬O¦b52©P¦w¼¢¾¯¹ï·Ó´Á¶¡ªºÄY««æ©Êµo§@¨Æ¥óªº¦~¤Æ²v¡A¥H¤ÎÁ`¤H¸s¤¤²Ä12¶g®É¤ä®ðºÞÂX±i¾¯«eFEV1ªº°ò½uÅܤơ]¤£¨ü³Ì§C°ò½u¦å²G¶Ý»Ä©Ê²É²ÓMp¼Æªº¨î¡^¡C¨ä¥L¦¸n²×ÂI¥]¬A¦å²G¤¤¶Ý»Ä©Ê²É²ÓM°ò½u¤ô¥¤£¦Pªº±wªÌªº¦~ÄY«¥[«²v©MFEV1¡A¥H¤ÎACQ-5©MAQLQ¡]S¡^µû¤Àªº½w¸Ñ²v¡C AS¸Õ¥Î3 AS¸ÕÅç3¬O¤@¶µ°w¹ï210¦Wý³Ý±wªÌªº¬°´Á24¶gªº¤fªA¿}¥Ö½è¿E¯À´î¤Ö¸ÕÅç¡A¬ã¨s¹ï¶H°£¤F¨C¤Ñ©w´Á¨Ï¥Î¤j¾¯¶q§l¤J¿}¥Ö½è¿E¯À¥~¡AÁÙ»Ýn¨C¤é¤fªA¿}¥Ö½è¿E¯À¡A¥t¥~ÁÙ»ÝnÃB¥~ªº±±¨î¾¹¡C¦b¿z¿ï´Á¶¡Àu¤ÆOCS¾¯¶q«á¡A¨ü¸ÕªÌ¦b600²@§J©Î¦w¼¢¾¯ªºªì©l¾¯¶q«áQ2W±µ¨ü¤@¦¸300 mg DUPIXENT¡]N = 103¡^©Î¦w¼¢¾¯¡]N = 107¡^24¶g¡C¦b¬ã¨s´Á¶¡¡A¨ü¸ÕªÌÄ~Äò±µ¨ü¥L̲{¦³ªºý³ÝÃĪ«¡C¦ý¬O¡A¥un«O«ùý³Ý±±¨î¡A¥L̪ºOCS¾¯¶q¦bOCS´î¤Ö¶¥¬q¡]²Ä4-20¶g¡^±N¨C4¶g´î¤Ö¤@¦¸¡C¥Dn²×ÂI¬O»P°ò½u¾¯¶q¬Û¤ñ¦b²Ä20¦Ü24¶g®É¤fªA¥Ö½èÃþ©T¾J¾¯¶q´î¤Öªº¦Ê¤À¤ñ¡A¦P®É¦bÁ`Åé¤H¸s¤¤«O«ùý³Ý±±¨î¡]¤£¨ü³Ì§C°ò½u¦å²G¶Ý»Ä©Ê²É²ÓMp¼Æªº¨î¡^¡C¨ä¥L¦¸n²×ÂI¥]¬AªvÀø´Á¶¡ªºÄY««æ©Êµo§@¨Æ¥óªº¦~¤Æ²v¥H¤ÎACQ-5©MAQLQ¡]S¡^µû¤À¤¤ªº½w¸Ñ²v¡C AS Trial 1 AS Trial 1 was a 24-week dose-ranging study which included 776 subjects (18 years of age and older). DUPIXENT compared with placebo was evaluated in adult subjects with moderate to severe asthma on a medium or high-dose inhaled corticosteroid and a long acting beta agonist. Subjects were randomized to receive either 200 mg (N=150) or 300 mg (N=157) DUPIXENT every other week (Q2W) or 200 mg (N=154) or 300 mg (N=157) DUPIXENT every 4 weeks following an initial dose of 400 mg, 600 mg or placebo (N=158), respectively. The primary endpoint was mean change from baseline to Week 12 in FEV1 (L) in subjects with baseline blood eosinophils ≥300 cells/mcL. Other endpoints included percent change from baseline in FEV1 and annualized rate of severe asthma exacerbation events during the 24-week placebo controlled treatment period. Results were evaluated in the overall population and subgroups based on baseline blood eosinophil count (≥300 cells/mcL and <300 cells/mcL). Additional secondary endpoints included responder rates in the patient reported Asthma Control Questionnaire (ACQ- 5) and Asthma Quality of Life Questionnaire, Standardized Version (AQLQ(S)) scores. AS Trial 2 AS Trial 2 was a 52-week study which included 1902 subjects (12 years of age and older). DUPIXENT compared with placebo was evaluated in 107 adolescent and 1795 adult subjects with moderate-to-severe asthma on a medium or high-dose inhaled corticosteroid (ICS) and a minimum of one and up to two additional controller medications. Subjects were randomized to receive either 200 mg (N=631) or 300 mg (N=633) DUPIXENT Q2W (or matching placebo for Reference ID: 4337903 Page 17 of 25 either 200 mg [N=317] or 300 mg [N=321] Q2W) following an initial dose of 400 mg, 600 mg or placebo respectively. The primary endpoints were the annualized rate of severe exacerbation events during the 52-week placebo controlled period and change from baseline in pre- bronchodilator FEV1 at Week 12 in the overall population (unrestricted by minimum baseline blood eosinophils count). Additional secondary endpoints included annualized severe exacerbation rates and FEV1 in patients with different baseline levels of blood eosinophils as well as responder rates in the ACQ-5 and AQLQ(S) scores. AS Trial 3 AS Trial 3 was a 24-week oral corticosteroid-reduction study in 210 subjects with asthma who required daily oral corticosteroids in addition to regular use of high dose inhaled corticosteroids plus an additional controller. After optimizing the OCS dose during the screening period, subjects received 300 mg DUPIXENT (N=103) or placebo (N=107) once Q2W for 24 weeks following an initial dose of 600 mg or placebo. Subjects continued to receive their existing asthma medicine during the study; however their OCS dose was reduced every 4 weeks during the OCS reduction phase (Week 4-20), as long as asthma control was maintained. The primary endpoint was the percent reduction of oral corticosteroid dose at Weeks 20 to 24 compared with the baseline dose, while maintaining asthma control in the overall population (unrestricted by minimum baseline blood eosinophils count). Additional secondary endpoints included the annualized rate of severe exacerbation events during treatment period and responder rate in the ACQ-5 and AQLQ(S) scores. |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2020/8/5 ¤W¤È 05:41:09²Ä 3248 ½g¦^À³
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˼Æ14¤Ñ! dupilumab ý³Ý 200mg/¤G¶g¤@°wx24¶g¡A°_©l¶q400mg,¦@2600mg. ¦ôp ASLAN004 ý³Ý ,2a Á{§É 120mg/¤G¶g¤@°wX24¶g¡A°_©l¶q120mg/240mg,¦@1440/1560 mg ¡X¡X¡X¡X¡X¡X¡X¡X¡X Lerikizumab ý³Ý (ROCHE) 125mg/¥|¶g¤@°w¡Ax52¶g¡A°_©l¶q250mg,¦@3375mg 2Ó¤T´ÁÁ{§É¸Ñª¼¥¢±Ñ¡I pubmed.ncbi.nlm.nih.gov/27616196 Efficacy and safety of lebrikizumab in patients with uncontrolled asthma (LAVOLTA I and LAVOLTA II): replicate, phase 3, randomised, double-blind, placebo-controlled trials ¨Ó¤ñ¯]³æ§Ü¦b¥¼±±¨îý³Ý¡]LAVOLTA I©MLAVOLTA II¡^±wªÌ¤¤ªºÀø®Ä©M¦w¥þ©Ê¡G«½Æ¡A3´Á¡AÀH¾÷¡AÂùª¼¡A¦w¼¢¾¯¹ï·Ó¸ÕÅç I´º¡G ¦b2´ÁÁ{§É¸ÕÅ礤¡A§Ü¥Õ²ÓM¤¶¯À13³æ§J¶©§ÜÅélebrikizumab°§C¤Fý³Ý¤£¨ü±±¨îªº±wªÌªº¯f±¡´c¤Æ²v¡A¨Ã§ïµ½¤FFEV 1¡A¯S§O¬O¦b2«¬¥Íª«¼Ð»xª«¿@«×¸û°ªªº±wªÌ¡]¨Ò¦p°©½¤¯À©Î¦å²G¶Ý»Ä©Ê²É²ÓM¡^¤¤¡C§Ú̶i¦æ¤F«½Æªº3´Á¬ã¨s¡A¥Hµû¦ô¨Ó¥²§J¯]³æ§Ü¦b¾¨ºÞ§l¤J¥Ö½èÃþ©T¾J©M¦Ü¤Ö¤@ºØ²Ä¤GºØ±±»sÃĪ«ªº±¡ªp¤U¥¼±±¨îªºý³Ý±wªÌªºÀø®Ä©M¦w¥þ©Ê¡C ¤èªk¡G±N ¦¨¦~¤ä®ðºÞý³Ý¡A¹w´úªº¤ä®ðºÞÂX±i¾¯FEV 1¬° 40-80¢H¡AI´ºÃ©wªº¦¨¤H±wªÌ¡A±Ä¥Î°ò©ó»yµºôµ¸ªº¥æ¤¬¦¡¤ÏÀ³¨t²ÎÀH¾÷¤À°t¡]1¡G1¡G1¡^¡A¥H±µ¨ülebrikizumab 37¡P5 mg¨C4¶g¤@¦¸¡A©Î125²@§J©Î¥Ö¤Uª`®g¦w¼¢¾¯¡C³q¹L¿z¬d¦å²M°©½¤¯À¿@«×¡A³Ìªñ12Ӥ뤺ý³Ý«æ©Êµo§@¥v¡A°ò½uý³ÝÃĪ«©M°ê®a¨Ó¹ïÀH¾÷¤À²Õ¶i¦æ¤À¼h¡C¥DnÀø®Ä²×ÂI¬O°ª¥Íª«¼Ð»xª«±wªÌ¡]periostin≥50ng / mL©Î¦å²G¶Ý»Ä©Ê²É²ÓM≥300²ÓM/£gL¡^¶W¹L52¶gªºý³Ý«æ©Êµo§@²v¡A¨Ã³q¹L¥ÎPearson£q®Õ¥¿¹L¤À´²ªºPoisson¦^Âk¼Ò«¬¶i¦æ¤F¤ÀªR¡C 2¨ä¤¤¥]¬AªvÀø²Õªº±ø´Ú¡A¶i¤J¬ã¨s«e12Ӥ뤺ý³Ýµo§@ªº¦¸¼Æ¡A°ò½uý³Ý¥ÎÃÄ¡A¦a²z°Ï°ì¡A¿z¬d°©½¤¯À¿@«×©M¦å²G¶Ý»Ä©Ê²É²ÓMp¼Æ§@¬°¨óÅܶq¡C³o¨â¶µ¸ÕÅç¬O¦bClinicalTrials.gov¡ALAVOLTA§Ú¡A¸¹½Xµù¥UNCT01867125¡A©MLAVOLTA II¡A¼Æ¶qNCT01868061¡C µo²{¡G LAVOLTA IªvÀø1081¨Ò¡ALAVOLTA IIªvÀø1067¨Ò¡C¦b52¶g¤º¡Alebrikizumab°§C¤F37¡P5 mg¾¯¶q²Õ¤¤°ª¥Íª«¼Ð»xª«±wªÌªº´c¤Æ²v¡]¤ñ²v[RR] 0¡P49 [95¢HCI 0¡P34-0¡P69]¡Ap <0¡P0001¡^©M¦b125 mg¾¯¶q²Õ¤¤¡]RR 0¡P70 [0¡P51-0¡P95]¡Ap = 0¡P0232¡^»PLAVOLTA I¤¤ªº¦w¼¢¾¯¬Û¤ñ¡C¦b¨âӥͪ«¾¯¶q¸û°ªªº±wªÌ¤¤¡A»P¦w¼¢¾¯¬Û¤ñ¡A¨âºØ¾¯¶q²Õ¤¤¥[«¥Íª«¼Ð»xª«ªº±wªÌªº¯f±¡´c¤Æ²v¤]¦³©Ò°§CLAVOLTA II¡]37¡P5 mg¡GRR 0¡P74 [95¢HCI 0¡P54-1¡P01]¡Ap = 0¡P0609; 125 mg¡GRR 0¡P74 [0¡P54-1¡P02]¡Ap = 0¡P0626¡^¡Cºî¦X³o¨â¶µ¬ã¨s¡Aµo¥Í«æ©ÊªvÀø¤£¨}¨Æ¥óªº±wªÌ¤ñ¨Ò¡]¨âºØ¨Ó¥¬¦C¯]³æ§Ü¤À§O¬°79¢H[1432¦W±wªÌ¤¤ªº1125¦W]»P¦w¼¢¾¯ªº80¢H[716¦W±wªÌ¤¤ªº576¦W]¡^¡AÄY«¤£¨}¨Æ¥ó¡]8¢H[115¦W±wªÌ] ]¨âºØ¹p¥¬¦C¯]³æ§Ü¾¯¶q¬Û¤ñ¡A¦w¼¢¾¯¬°9¢H[65¨Ò±wªÌ]¡ALebrikizumab©M¦w¼¢¾¯¤§¶¡ªº¤£¨}¤ÏÀ³©M¾ÉP¬ã¨sÃĪ«²×¤îªº¤£¨}¨Æ¥ó¡]¨âºØ¾¯¶qªºlebrikizumab¦û3¢H[49¨Ò±wªÌ¡A¦w¼¢¾¯¦û4¢H[31¨Ò]¡^¡C¾Ú³ø¾É¡A¦b¦w¼¢¾¯¹ï·Ó´Á¤º¥X²{¥H¤UÄY«¤£¨}¨Æ¥ó¡G¦b±µ¨ü¨Ó¥¬¦C¯]³æ§ÜªvÀøªº±wªÌ¤¤¡A¦A¥Í»Ùê©Ê³h¦å¨Æ¥ó1¦¸©M¶Ý»Ä©Ê²É²ÓM¿@«×¤É°ª¬ÛÃöªº5¦¸ÄY«¤£¨}¨Æ¥ó¡A¦w¼¢¾¯²Õ¤¤µo¥Í1¦¸¶Ý»Ä©Ê²É²ÓM©ÊªÍª¢¡C¨Ó¦±Ðü³æ§ÜªvÀøªº±wªÌ¦³1¨Ò¦A¥Í»Ùê©Ê³h¦å©M5¨Ò»P¶Ý»Ä©Ê²É²ÓM¿@«×¤É°ª¦³ÃöªºÄY«¤£¨}¨Æ¥ó¡A¦Ó¦w¼¢¾¯²Õ¦³1¨Ò¶Ý»Ä©Ê²É²ÓM©ÊªÍª¢¡C¨Ó¦±Ðü³æ§ÜªvÀøªº±wªÌ¦³1¨Ò¦A¥Í»Ùê©Ê³h¦å©M5¨Ò»P¶Ý»Ä©Ê²É²ÓM¿@«×¤É°ª¦³ÃöªºÄY«¤£¨}¨Æ¥ó¡A¦Ó¦w¼¢¾¯²Õ¦³1¨Ò¶Ý»Ä©Ê²É²ÓM©ÊªÍª¢¡C |
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·|û¡G¸Ø±i10133098 µoªí®É¶¡:2020/8/4 ¤U¤È 03:21:56²Ä 3247 ½g¦^À³
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Dr Carl Firth, Chief Executive Officer, ASLAN Pharmaceuticals, said: ¡§We are pleased to welcome Ken to our team and look forward to working with him as we plan for the late stage development of ASLAN004 in atopic dermatitis. He brings strong industry expertise and relationships from working on other novel biologics being developed for AD as well as his insights as a trained dermatologist. Ken¡¦s appointment is an important step for ASLAN as we build our presence in the US in order to execute our global Phase 2b program in 2021.¡¨ Dr Ken Kobayashi, Chief Medical Officer, ASLAN Pharmaceuticals, commented: ¡§I am very excited to join ASLAN and lead the global development of ASLAN004, a program I believe has the potential to be best-in-disease for atopic dermatitis and other indications. I am looking forward to working closely with the team as we prepare for important clinical data readouts later this year from the ongoing multiple ascending dose study in AD and plan our move into additional indications.¡¨ Dr Kobayashi completed his residency in Dermatology at the University of British Columbia and was a Chief Resident at the National Defence Medical Centre, Ottawa. He is an Adjunct Professor, Department of Medicine, at the University of Ottawa, and a fellow of the Royal College of Physicians and Surgeons of Canada and the American Academy of Dermatology. |
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·|û¡G¸Ø±i10133098 µoªí®É¶¡:2020/8/4 ¤U¤È 03:16:12²Ä 3246 ½g¦^À³
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SINGAPORE, Aug. 03, 2020 (GLOBE NEWSWIRE) -- ASLAN Pharmaceuticals (Nasdaq: ASLN, TPEx:6497), a clinical-stage immunology and oncology focused biopharmaceutical company developing innovative treatments to transform the lives of patients, today announced that Dr Kenneth Kobayashi has been appointed Chief Medical Officer. Dr Kobayashi will be based in California and will be responsible for the global clinical development of ASLAN¡¦s pipeline, including the lead program, ASLAN004, an antibody that blocks the IL-13 receptor, which is being developed for atopic dermatitis (AD). Dr Kobayashi has more than 25 years of experience in drug development, clinical practice and regulatory affairs as a Dermatology expert. He most recently served as Senior Medical Director at Dermira, a subsidiary of Eli Lilly, where he was responsible for the development of lebrikizumab, a monoclonal antibody for atopic dermatitis, and supported five Phase 3 registration studies together with preclinical and early clinical development for two novel compounds. Prior to joining Dermira, Dr Kobayashi was Clinical Development Medical Director at Novartis, in the Immunology, Hepatology and Dermatology Global Development Unit, where he supported the development programs for anti-IL-17C and anti-IgE monoclonal antibodies. He has also held senior and global leadership positions at LEO Pharma and was an Associate Professor, and Chair and Chief of the Division of Dermatology at the University of Ottawa and The Ottawa Hospital. |
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¨È·à±d-KY¡]6497¡^¤µ¡]3¡^¤é¤½§i¥ÑKenneth KobayashiÂå¾Ç³Õ¤h¾á¥ôÂå¾Çªø¡A±N¬°©ú¦~¥þ²y2b´ÁÁ{§É¸ÕÅç°µ·Ç³Æ¡C ³o¼Ë¬O§_¥Nªí¤½¥q¦³§â´¤1bÁ{§É¹LÃö¡A¤½¥q¦³¯à¤O½Ð¨ì°ê»Úªº±M®a¥Nªí¤½¥q¤jªÑªFªº¤H¯ß¹ê¤O¡A¤]¥Nªí004½T¹ê¦³¾÷·|ÅD¤WÂi±ªº |
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˼Æ15¤Ñ¡C ¥þ¬ü°ê³Ì±M·~¤§¤@ªºADÂå¾Çªø¤w¤W¥ô¡C «n²Ä¤G®a¥~资¨é°Ó«¦^¶R¶W¦æ¦C¡C(¬üªL/³Í°ò) 200mg§C¾¯¶q6+2¤H 1b¥¼¸Ñª¼AD¼Æ¾Ú¡A¤â¤W¤w¦³¡C ASLAN004 «e¤T¤H¡A¥§¡²Ä¤¶g1000mg´N¼È®É¶W¶VDupilumab ¤G´Á¥Dn«ü¼Ð16¶g2700mg组¡AESAI¥§¡°´T: ASLAN004/1000mg,ESAI° 71%>Dupilumab 2700mg ESAI °70.5%¡C¡C |
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·|û¡G¥xÁÞ10138776 µoªí®É¶¡:2020/8/3 ¤U¤È 10:21:12²Ä 3242 ½g¦^À³
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¨È·à±d «õ¨¤¦¨¥\ Aslan Pharmaceuticals¥ô©RKenneth Kobayashi¬° chief medical officer (Âå¾Çªø) Kobayashi¤@¦~«e¥[¤J¤FDermira¡A°Ñ»Plebrikizumabªº3´ÁÁ{§É¬ã¨sp¹º¡A³o¬O¤@ºØ§ÜIL-13¡A±q¤G´ÁÁ{§É¼Æ¾Ú¬Ý°_¨Ó¹³¬OÁÉ¿Õµá©M Regeneron¡¦s «½SÃĪ« Dupixent ªº¼ç¦b¬D¾ÔªÌ¡C Dermira ¤G´ÁÁ{§É¼Æ¾Ú§l¤Þ¤F§¨Ó¤½¥q¤µ¦~µy¦¥H11»õ¬ü¤¸ªº»ù®æ§¹¦¨¤F¹ïDermiraªº¦¬ÁÊ¡C ¸Ô±¡½Ð¾\Ū www.fiercebiotech.com/biotech/aslan-hires-kobayashi-to-add-il-13-clinical-trial-expertise |
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°±¤îMOR106Á{§ÉªvÀø¯SÀ³©Ê¥Öª¢®{³Ò ¬ü°êªF³¡®É¶¡2019¦~10¤ë28¤é16:45 |¸ê®Æ¨Ó·½¡G¥[©Ô©¬¤à´µ¤º 20.15 CET¡F¨üºÞ¨îªº«H®§-MorphoSys AG¡]FSE¡GMOR¡F Prime Standard Segment¡ATecDAX¡F NASDAQ¡GMOR¡^©MGalapagos NV¡]Euronext¡®NASDAQ¡GGLPG¡^¤µ¤Ñ«Å¥¬¡AMOR106¦b¯SÀ³©Ê¥Öª¢¤¤ªºÁ{§É¶}µop¹º¤wµ²§ô¡C¥[©Ô©¬¤à´µNV¡AMorphoSys AG©MNovartis Pharma AG³o¤TÓ°Ñ»P¤èªº¦@¦P¨M©w§¡°ò©ó¦bIGUANA 2´Á¸ÕÅ礤¶i¦æªºµL®Ä©ÊÁ{®É¤ÀªR¡C¸Ó¤ÀªRÀË´ú¨ì¹F¨ì¬ã¨s¥Dn²×ÂIªº¥i¯à©Ê«Ü¤p¡A¸Ó²×ÂI©w¸q¬°Àã¯l±¿n©MÄY«©Ê«ü¼Æ¡]EASI¡^±o¤Àªº¦Ê¤À¤ñÅܤơC¸Ó¨M©w¬O°ò©ó¯Ê¥F®Ä¤O¦Ó¤£¬O¥X©ó¦w¥þ¦Ò¼{¡C MOR106¦b¯SÀ³©Ê¥Öª¢¤¤ªºÁ{§É¶}µop¹º¥]¬A¨â¶µIGUANA©MGECKOªº2´Á¬ã¨s¡A¥H¤Î¥Ö¤U»s¾¯ªº1´Á¾ô±µ¬ã¨s©M¤@¶µ¤é¥»ªº¥Á±Ú¾ô±µ¬ã¨s¡CÃö©ó¯SÀ³©Ê¥Öª¢ªº©Ò¦³¬ã¨s³£±Nµ²§ô¡C¦U¤è±N¨Ï¥ÎMOR106±´¯Á¥¼¨Óªº¾Ô²¤¡C MOR106¥Ñ¥[©Ô©¬¤à´µ©MMorphoSys¦@¦Pµo²{¡C¦b2019¦~7¤ë¡A¥[©Ô©¬¤à´µ©MMorphoSys´NNov 106»P¿ÕµØ¹F¦¨¤F¿W®aªº¥þ²y¶}µo©M°Ó·~¤Æ¦X§@¡C ¡§ÅãµM¡AMOR106¹ï¯SÀ³©Ê¥Öª¢ªº³o¤@µ²ªG¥O§ÚÌ·P¨ì¥¢±æ¡C¥[©Ô©¬¤à´µ¸s®qº®u¬ì¾Ç©xPiet Wigerinck³Õ¤h»¡¡G¡§§Ú̱N»P§Ú̪º¦X§@¹Ù¦ñ¤@¹D¡A³q¹LMOR106±´¯Á¥¼¨Ó¾Ô²¤¡C¡¨ MorphoSysº®u¬ì¾Ç©xMarkus Enzelberger³Õ¤h»¡¡G¡§¤£©¯ªº¬O¡A¹ïµL®Ä©Êªº¤¤´Á¤ÀªRµ²ªG¨Ã¤£¤ä«ùMOR106¦b¯SÀ³©Ê¥Öª¢¤è±ªº³Ì·sÁ{§É¶i®i¡C¡¨ ¡§¾¨ºÞ§ÚÌÅãµM·P¨ì¥¢±æ¡A¦ý§Ṳ́´µMP¤O©ó¶}µoMorphoSys±M¦³ªº¦´Á©M±ß´ÁÔ¿ïÃĪ«¡A¨Ò¦pMOR202¡A¤×¨ä¬Otafasitamab¡C¡¨ Ãö©óMOR106 MOR106¬O¨Ï¥ÎMorphoSysªºYlanthia§ÜÅ饥x¥Í¦¨ªº¡A¨Ã¥B°ò©ó¥[©Ô©¬¤à´µµo²{ªº¥Ø¼Ð¡C IL-17C¬O¤@ºØÀu¥ý¦b¥Ö½§¤¤ªí¹Fªº²ÓM¦]¤l¡A»P¥Ö½§ª¢¯g¦³Ãö¡A¨Ã¥B»PIL-17²ÓM¦]¤l®a±Úªº¨ä¥L¦¨û¤£¦P¡C MOR106¬O¥@¬É¤W²Ä¤@Ó°w¹ïIL-17Cªº¤½¶}¤wª¾ªº¤HÃþ³æ§J¶©§ÜÅé¡C MOR106¬O¬ã¨sÃĪ«¡A©|¥¼½T©w¨ä¦w¥þ©Ê©M¦³®Ä©Ê¡C®Ú¾Ú»PMorphoSys©MGalapagos¹F¦¨ªº¨óij¡A¿ÕµØ»sÃĪѥ÷¤½¥q¾Ö¦³MOR106¶}µo©M°Ó·~¤Æªº¥þ²y¿W®a³\¥i¡A¸Ó¨óij©ó2018¦~9¤ë10¤é¥Í®Ä MOR106 clinical development in atopic dermatitis stopped for futility October 28, 2019 16:45 ET | Source: Galapagos NV 20.15 CET; regulated information - MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; NASDAQ: MOR) and Galapagos NV (Euronext & NASDAQ: GLPG) today announced the end of the clinical development program of MOR106 in atopic dermatitis. The joint decision of all three involved parties, Galapagos NV, MorphoSys AG and Novartis Pharma AG, was based on an interim analysis for futility that was performed in the Phase 2 IGUANA trial. The analysis detected a low probability to meet the primary endpoint of the study, defined as the percentage change in the eczema area and severity index (EASI) score. The decision was based on a lack of efficacy and not on safety concerns. The clinical development program of MOR106 in atopic dermatitis included the two Phase 2 studies IGUANA and GECKO, as well as a Phase 1 bridging study for subcutaneous formulation and a Japanese ethno-bridging study. All studies in atopic dermatitis will be ended. Parties will explore the future strategy with MOR106. MOR106 was jointly discovered by Galapagos and MorphoSys. In July 2019, Galapagos and MorphoSys entered into an exclusive worldwide development and commercialization collaboration with Novartis with respect to MOR106. ¡§We are obviously disappointed with this result with MOR106 in atopic dermatitis. Together with our collaboration partners, we will explore the future strategy with MOR106,¡¨ said Dr Piet Wigerinck, Chief Scientific Officer of Galapagos. ¡§Unfortunately, the results from the interim analysis for futility do not support the continuation of the current clinical development of MOR106 in atopic dermatitis¡¨ said Dr. Markus Enzelberger, Chief Scientific Officer of MorphoSys. ¡§While we are clearly disappointed, we remain committed to the development of MorphoSys¡¦ proprietary early and late-stage drug candidates, such as MOR202 and especially tafasitamab.¡¨ About MOR106 MOR106 was generated using MorphoSys¡¦s Ylanthia antibody platform and is based on a target discovered by Galapagos. IL-17C is a cytokine expressed preferentially in the skin and which has been implicated in dermal inflammation and shown to be distinct from other members of the IL-17 cytokine family. MOR106 is the first publicly known human monoclonal antibody directed against IL-17C in clinical development worldwide. MOR106 is an investigational drug and its safety and efficacy have not yet been established. Novartis Pharma AG owns the worldwide, exclusive license for the development and commercialization of MOR106 under an agreement with MorphoSys and Galapagos which became effective on September 10, 2018. |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2020/8/3 ¤U¤È 03:46:58²Ä 3237 ½g¦^À³
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¡uÃį«¡v©é¤F 10»õ¬ü¤¸¶R¤UÀã¯l¯S®Ä·sÃıM§QÅv 2018/07/19 18:12 ¹d¦ëºô½sĶ³¯¥@³Ç ¦]¤j³°·s¤ù¡u§Ú¤£¬OÃį«¡v§ó¥[Án¦W¤j¾¸ªº·ç¤hÃļt¿ÕµØ (Novartis)¡A¥H 10 »õ¬ü¤¸¦V Galapagos NV ©M MorphoSys AG ÁʶR¤@ºØ¥Ö½§¯fÃĪ«ªº±M§QÅv¡A¸Ó¤½¥q°õ¦æªø Vas Narasimhan ±N¥þ¤O¶}µo³o¶µ³Ð·s³B¤èÃÄ¡A¥H©M¹ï¤âÁÉ¿Õµá (Sanofi) ¬Û§Ü¿Å¡C ¦¹¶µ¥æ©ö¤¤¡A¿ÕµØ¥ý¤ä¥I MorphoSys ©M Galapagos ¦@ 9500 ¸U¼Ú¤¸ (1.11 »õ¬ü¤¸) ªº¹w¥I´Ú¡A¤ä¥IºÊºÞ¡B°Ó·~©M¾P°â¨½µ{¸Oª÷ÃB¥i¯à°ª¹F¬ù 8.5 »õ¼Ú¤¸ (¬ù 10 »õ¬ü¤¸)¡A¦¹¥~¡AÁÙ¶·¤ä¥I¤À¼h¯S³\Åv¨Ï¥Î¶O¡C ®Ú¾Ú¤T¤è¨óij±ø´Ú¡AGalapagos ©M MorphoSys ±N¥§¡¤À±o¿ÕµØ¤ä¥Iªº©Ò¦³´Ú¶µ¡C ¦Ó Narasimhan ¤]»Ýn³o´ÚªvÀøÀã¯l¥Ö½§¯fªº·sÃÄ¡A¥H©è®ø¸û«K©yªº¥é»s«~¹ï²£«~ªº¼vÅT¡C ³o´ÚªvÀø¥Ö½§¯fªº·sÃħÜÅé³QºÙ¬° MOR106¡A°£¤F°w¹ïÄY«ªºÀã¯lªvÀø¥~¡A¨Ã±N¥[¤JªvÀø¹x±jªº¤û¥ÖÅ~ (Cosentyx)¡A¥H¤Î¬°ºC©ÊëC³Â¯l¶}¥ßªºý³ÝÃĪ« (Xolair)¡A¥H¥[±j¿ÕµØ¤½¥qªº¥Ö½§¬ì·~°È¡C ¨ü¨ì¦¹¶µ¥æ©öªº¿EÀy¡AMorphoSys ªÑ»ùötº¦ 5.3%¡A¨Ó¨ì 18 ¦~¨Ó·s°ª¡FGalapagos ¤]ªÑ»ù¤]¤Wº¦¤F 3.9%¡F¦Ü©ó¿ÕµØªºªÑ»ù«hºû«ù¦b 81.04 ·ç¤hªk¦ªþªñ¡C MOR106 ±Mªvªº²§¦ì©Ê¥Öª¢ (atopic dermatitis) ¬O¤@ºØÄY«Àã¯l¡A·|¾ÉP¥Ö½§µoÄo¡B鸨¡Bº¯¥X©Î¥X¦å¡C¿ÕµØ¤½¥qªí¥Ü¡A¦¹¯g¼vÅT¥þ²y¬ù 8% ªº¦¨¦~¤H©M 14% ªº¨àµ£¡A¥LÌ¥i¿ï¾ÜªºªvÀø¨Ã¤£¦h¡C Áɿյ᤽¥q¬ãµoªº³æ§ÜÃĪ« Dupixent ¥h¦~¤¤¤W¥«¡A¥Î©óªvÀø²§¦ì©Ê¥Öª¢¡A¿ÕµØ¶R¤U MOR106 ªº±M§QÅv¡A·N¨ý¦b¦¹»â°ì¤¤±N¬D¾ÔÁÉ¿Õµá©M Regeneron ÃĪ«¤½¥q¡C |
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¯u¥¿ªºAD ±M·~Âå¾Çªø ³Õ¤h¬O¤@¦ì¥Ö½§¬ì±M®a¡A¦b·sÃĬãµo¡BÁ{§É¹ê°È¤Îªk³W¨Æ°Èµ¥»â°ì¤w¦³¶W¹L25¦~¸gÅç¡C 2020¦~/¤¸¤ë15¤é§¨Ó(Eli Lilly) ¨ÑÁÊDermira¤½¥q ----------------------------- lebrikizumab (2019/10 ¶i¤J AD¤T´ÁÁ{§É, 2Ó400¤Hªº¤T´ÁÁ{§É,250mg/2¶g¤@°w*16 ¶g,Á`¶q2250mg/¥Dn«ü¼ÐIGA,0/1 ºû«ùªvÀø 16~52 ¶g. «e16¶gESAI-50 ¦³¤ÏÀ³,¥|¶g¤@°w,没¤ÏÀ³ªÌ,2¶g¤@°w. ----------------------------------------- ¾á¥ô¸ê²`Âå¾ÇÁ`ºÊ(Senior Medical Director)¡At³d¶}µoªvÀø²§¦ì©Ê¥Ö½§ª¢ªº³æ®è§ÜÅélebrikizumab¡A´Á¶¡Á٤䴩5¶µ²Ä¤T´Á¬dÅçµn°O¸ÕÅç¡A¥H¤Î¨âºØ·s¤Æ¦Xª«ªºÁ{§É«e»P¦´ÁÁ{§É¶}µo¡C ¦b¥[¤JDermira¤§«e¡A Kenneth Kobayashi³Õ¤h´¿©ó¿ÕµØ(Novartis)ªº§K¬Ì¡B¨xŦ»P¥Ö½§¬ÛÃö¥þ²y¶}µo³¡ªù¾á¥ôÁ{§É¶}µoÂå¾ÇÁ`ºÊ(Clinical Development Medical Director)¡A¨ó§Uanti-IL-17C©Manti-IgE³æ®è§ÜÅ骺¶}µopµe¡C-- ------------------------------ anti-IL-17C--AD ,2b ,´Á¤¤¤ÀªR«á2019¦~,¤w¦]¥¼¹F¹w´ÁÀø®Ä¦Ó¤¤¤îÁ{§É,·l¥¢1.1»õ¬üª÷ªº±ÂÅvª÷(2018¦~±ÂÅv¤W´å**¤½¥q,1b AD §¹¦¨,IV *12¶g,----10»õ¬üª÷±ÂÅvª÷+¾P°â¤À¼í=20»õ¬ü¤¸Áô§t¾P°â. ----------------------------------- ¥L¤]´¿¦bLEO Pharma¾ú¥ô¦h¶µ¸ê²`»P´xºÞ¥þ²y¨Æ°Èªº¥DºÞ¾°È¡A¨Ã©ó´ì¤ÓµØ¤j¾Ç(University of Ottawa)¤Î´ì¤ÓµØÂå°|(Ottawa Hospital)¥Ö½§¬ì¾á¥ô°Æ±Ð±Â¡B¨t¥D¥ô¤Î¬ì¥D¥ô¡C ______________ LEO Tralokinumab 300mg/2¶g¤@°w(2019/12 ¤T´ÁÁ{§É¹LÃö,¦ýIGA 0/1 »P¹ï·Ó²Õ¤ñÈ2,¶Èdupilumab ¤@¥b) FB825/¦X¤@ªº³Q±ÂÅvªÌ. |
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·s»D½Z ¨È·à±d-KY¥ô©RÂå¾Ç³Õ¤hKENNETH KOBAYASHI¬°¤½¥qÂå¾Çªø 2020¦~8¤ë3¤é¡A·s¥[©Y ¡V »EµJ©óÁ{§É¶¥¬q¸~½F¤Î§K¬Ì¾Ç¨ÃP¤O©ó¶}µo³Ð·sÀøªk¨Ó§ïÅܱwªÌ¥Í¬¡¤§Á{§É¶¥¬q¥Íª«»sÃĤ½¥q¨È·à±d-KY (NASDAQ:ASLN, TPEx:6497)¤µ¤é«Å¥¬¥ô©RKenneth Kobayashi³Õ¤h¬°Âå¾Çªø(Chief Medical Officer)¡CKobayashi³Õ¤h±N¦b¥[¦{¥D¾É¨È·à±d¦b¥þ²y¦U¦aªº²£«~Á{§É¬ãµo¶µ¥Ø¡A¥]¬A¬ãµo¤¤ªº¥D¤O²£«~ASLAN004¡AASLAN004¬O¤@ºØ°w¹ï²§¦ì©Ê¥Ö½§ª¢(AD)ªº§ÜÅé¡A¥i¥HªýÂ_IL-13¨üÅé¡C Kenneth Kobayashi³Õ¤h¬O¤@¦ì¥Ö½§¬ì±M®a¡A¦b·sÃĬãµo¡BÁ{§É¹ê°È¤Îªk³W¨Æ°Èµ¥»â°ì¤w¦³¶W¹L25¦~¸gÅç¡C¦¹«e¥L´¿©ó§¨Ó(Eli Lilly)¤l¤½¥qDermira¾á¥ô¸ê²`Âå¾ÇÁ`ºÊ(Senior Medical Director)¡At³d¶}µoªvÀø²§¦ì©Ê¥Ö½§ª¢ªº³æ®è§ÜÅélebrikizumab¡A´Á¶¡Á٤䴩5¶µ²Ä¤T´Á¬dÅçµn°O¸ÕÅç¡A¥H¤Î¨âºØ·s¤Æ¦Xª«ªºÁ{§É«e»P¦´ÁÁ{§É¶}µo¡C ¦b¥[¤JDermira¤§«e¡AKenneth Kobayashi³Õ¤h´¿©ó¿ÕµØ(Novartis)ªº§K¬Ì¡B¨xŦ»P¥Ö½§¬ÛÃö¥þ²y¶}µo³¡ªù¾á¥ôÁ{§É¶}µoÂå¾ÇÁ`ºÊ(Clinical Development Medical Director)¡A¨ó§Uanti-IL-17C©Manti-IgE³æ®è§ÜÅ骺¶}µopµe¡C¥L¤]´¿¦bLEO Pharma¾ú¥ô¦h¶µ¸ê²`»P´xºÞ¥þ²y¨Æ°Èªº¥DºÞ¾°È¡A¨Ã©ó´ì¤ÓµØ¤j¾Ç(University of Ottawa)¤Î´ì¤ÓµØÂå°|(Ottawa Hospital)¥Ö½§¬ì¾á¥ô°Æ±Ð±Â¡B¨t¥D¥ô¤Î¬ì¥D¥ô¡C ¨È·à±d-KY °õ¦æªø³Å«i³Õ¤hªí¥Ü:¡u§ÚÌ«Ü°ª¿³¦aÅwªïKenneth Kobayashi³Õ¤h¥[¤J¹Î¶¤¡A¤]´Á«Ý»P¥L¦X§@¶i¦æASLAN004°w¹ï²§¦ì©Ê¥Ö½§ª¢ªº±ß´ÁÁ{§É¸ÕÅç¡C¥L´¿°Ñ»P¶}µo¨ä¥LªvÀø²§¦ì©Ê¥Ö½§ª¢ªº³Ð·s¥Íª«»s¾¯¡A¥i¬°§Ú̱a¨Ó±j¤jªº²£·~§Þ³N»P¤H¯ß¡AÁÙ¦³¥L¨¬°¥Ö½§¬ì±M®aªº¿W¯S¬}¨£¡C¥ô©RKenneth Kobayashi³Õ¤h¹ï¨È·à±d¨Ó»¡¬O«¤jªº¤@¨B¡A§Ú̱N³v¨B´£°ª¦b¬ü°ê¥«³õªº¯à¨£«×¡A¥H«K©ó2021¦~±Ò°Ê¥þ²y2b´ÁÁ{§É¸ÕÅç¡C¡v ¨È·à±d-KY Âå¾ÇªøKenneth Kobayashi³Õ¤h«ü¥X:¡u«Ü°ª¿³¯à¥[¤J¨È·à±d¨Ã»â¾ÉASLAN004ªº¥þ²y¶}µopµe¡A§Ú¬Û«H³oÓpµe¦³¼ç¤O¦¨¬°ªvÀø²§¦ì©Ê¥Ö½§ª¢©M¨ä¥L¾AÀ³¯gªº³Ì¨ÎÀøªk¡C§Ú´Á¬ß¯à»P¹Î¶¤±K¤Á¦X§@¡A¬°¤µ¦~¤U¥b¦~¨ú±o²§¦ì©Ê¥Ö½§ª¢¦h¾¯¶q»¼¼WÃĪ«¸ÕÅ窺«nÁ{§É¼Æ¾Ú°µ¦n·Ç³Æ¡A¨Ã³W¹º¨ä¥L¾AÀ³¯gªº¬ã¨s¡C¡v Kenneth Kobayashi³Õ¤h©ó^ÄÝôÛ¤ñ¨È¤j¾Ç(University of British Columbia)§¹¦¨¥Ö½§¬ì¦í°|Âå®v°V½m¡A¨Ã´¿¦b´ì¤ÓµØ°ê¨¾Âå¾Ç¤¤¤ß(National Defence Medical Centre)¾á¥ôÁ`¦í°|Âå®v¡C²{¬°´ì¤ÓµØ¤j¾ÇÂå¾Ç¨tÝ¥ô±Ð±Â¡A¤]¬O¥[®³¤j¬Ó®a¤º¬ìÂå®v©M¥~¬ìÂå®v¾Ç°|(Royal College of Physicians and Surgeons of Canada)»P¬ü°ê¥Ö½§¯f¾Ç·|(American Academy of Dermatology)ªº°|¤h¡C ¥»¤åµ²§ô |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2020/8/3 ¤W¤È 11:35:44²Ä 3234 ½g¦^À³
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2020/8/3 ¤W¤È 10:30:08²Ä 3233 ½g¦^À³
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DUPILUMAB AD ¤G´ÁÁ{§É ¤²Õ P<0.001, ,°£¤w¤W¥««e¤G²Õ,¨ä¥L¤T²Õ,¬Ò¦³¸ê®æ®³Ãĵý. ¦ÓASLAN004 ¤§³]p¦³¾÷·|1000mg~1600mgªvÀø(8~16¶g),¥i¾Ö¦³¶W¹Ldupilumab 2700mg¤W¥«¼Ð·Ç¥Î¶qªº¹w«áÀø®Ä. ----------------- ASLAN004 ,1b , 200mg/¨C¶g¤@°w¡A3¤H¡A¡]4-6¶g/¥§¡5¶g¡^,5x200mg=1000mg ,ESAI¥§¡°´T71%.¡A ±µªñ©ó DUPILUMAB 300mg/¨C¤G¶g¤@°w¡A¦@2700mg ESAI¥§¡°70.5%¡]16¶g¤W¥«¼Ð·Ç¥Î¶q¡^ ------------------------------------------------------------ ASLAN004/dupilumab ¥i¯à¥ÎÃľ¯¤ñ 37%~59% 1000/2700=37% 1600/2700=59% ----------------------- ¤G´ÁAD Á{§É dupilumab ¤À¤²Õ¡Ï¹ï·Ó²Õ¦@¤»²Õ¡AN=380¤H¡A16¶gªvÀø ¥Dn«ü¼Ð 5²Õ PȬҤp©ó0.001 ¡A ¥Dn«ü¼ÐESAI ¥§¡°´T©M¹ï·Ó²Õ ¤ñ ¿¼Æ 2.3~3.7¿¡A DUPILUMAB 300mg/¨C¶g¤@°w ,¦@5100mg ,ESAI¥§¡°75.5%//IGA,0/1 33.3% 300mg/¨C¤G¶g¤@°w¡A¦@2700mg ESAI¥§¡°70.5%//IGA,0/1 29.7%¡]¤W¥«¼Ð·Ç¥Î¶q¡^ 200mg/¨C¤G¶g¤@°w¡A¦@1800mg ESAI¥§¡°67.4%//IGA,0/1 27.9% 300mg/¨C¥|¶g¤@°w¡A¦@1500mg ESAI¥§¡°64.9%//IGA,0/1 21.5% 100mg/¨C¥|¶g¤@°w¡A¦@700mg ESAI¥§¡°46.7%//IGA,0/1 12.3% ¹ï·Ó²Õ ESAI¥§¡°20.2%//IGA,0/1 1.6% clinicaltrials.gov/ct2/show/results/NCT01859988?view=results |
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¦Ü¤Ö2007¦~¤w¬ü°ê/¼Ú·ù ¥Ó½Ð±M§Q.2008¦~¶}©l¤G´ÁÁ{§É. ¼Ú¬ü¤T´ÁÁ{§É©|¥¼¶}©l ¦ý20¦~ªº±M§QÅv³Ñ´X¦~? ¥i¥H¥h°Ý¤½¥q --------------------§ë¸êªÌ¥²¶·°µªº¥\½Ò clinicaltrials.gov/ct2/show/NCT00709514 Clinical Evaluation of DCB-WH1 in Healing of Chronic Diabetic Foot Ulcers------¤G´ÁÁ{§É Study Design Study Type ƒÊ : Interventional (Clinical Trial) Actual Enrollment ƒÊ : 41 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment Official Title: A Phase II, Double-blind, Placebo-controlled Clinical Evaluation of DCB-WH1 in Healing of Chronic Diabetic Foot Ulcers Study Start Date ƒÊ : December 2008 Actual Primary Completion Date ƒÊ : April 2011 Actual Study Completion Date ƒÊ : March 2012 Evaluate the Efficacy and Safety of ON101 Cream for the Treatment of Chronic Diabetic Foot Ulcers (ON101 (WH-1))-----¤T´ÁÁ{§É Study Design Study Type ƒÊ : Interventional (Clinical Trial) Estimated Enrollment ƒÊ : 236 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment Official Title: Randomized Controlled Study to Evaluate the Efficacy and Safety of ON101 Cream for the Treatment of Chronic Diabetic Foot Ulcers Study Start Date ƒÊ : September 2012 Estimated Primary Completion Date ƒÊ : June 2020 Estimated Study Completion Date ƒÊ : September 2020 clinicaltrials.gov/ct2/show/NCT01898923?term=ON101%28WH-1%29&draw=2&rank=1 ¥Í§Þ¤¤¤ß¿}§¿¯f¶Ë¤f¡¦XÃÄ(DCB-WH1)§ÞÂत¤Ñ¥Í§Þ µo§G¤é´Á: 2007-08-30 . ¥Í§Þ¤¤¤ß¿}§¿¯f¶Ë¤f¡¦XÃÄ(DCB-WH1)§ÞÂत¤Ñ¥Í§Þ µo§G¤é´Á:96/08/30 °]¹Îªk¤H¥Íª«§Þ³N¶}µo¤¤¤ß¡]DCB¡^8¤ë29¤é»P¤¤¤Ñ¥Íª«¬ì§ÞªÑ¥÷¦³¤½¥qÁ|¦æ¥¿¦¡Ã±¬ù¨å§¡A¥Í§Þ¤¤¤ß¡]DCB¡^±N¤@¶µ¾ú®É¶W¹L¤T¦~¬ãµo¥Xªº¿}§¿¯f¶Ë¤f¡¦XÃÄ»sÃħ޳NDCB-WH1¥¿¦¡²¾Â൹¤¤¤Ñ¥Í§Þ¡A¹wpªñ´Á¤º±N¦V¬ü°ê¹«~ÃĪ«ºÞ²z§½¡]FDA¡^¥Ó½ÐPhase£L/£L£L·sÃĤHÅéÁ{§É¹êÅç¡A¥»¶µ·sÃĤw¸g¥Ó½Ð¤¤µØ¥Á°ê¡B¬ü°ê¡B¼Ú·ù¡Kµ¥¦h°ê¥Ó½Ð±M§Q¡C ñ¬ù»ö¦¡¬O¦b¥Í§Þ¤¤¤ß¡]DCB¡^ªº°ê»Ú·|ijÆUÁ|¦æ¡A¥Ñ¥Í§Þ¤¤¤ß¡]DCB¡^¸³¨Æªø§d¾ð¥Á¾á¥ô¨£ÃÒ¤H¡A¤¤¤Ñ¥Í§Þ¸³¨Æªø¸ô¤Õ©ú»P¥Í§Þ¤¤¤ß¡]DCB¡^°õ¦æªø§d©ú°ò³Õ¤h¤À§O¥NªíÂù¤è½l¬ù¡CÂù¤è¦bñ¬ù¨å§«áÁ|ªM¼y¯¬³o¶µ¤¤¯óÃħ޳N¥H¤Î¶Ë¤f¡¦XÂåÀø»â°ìªº«¤j¬ð¯}¡C ¥Í§Þ¤¤¤ß¸³¨Æªø§d¾ð¥Áªí¥Ü¡A³o¬O¥Í§Þ¤¤¤ß¹L¥h¤KÓ¤ë¨Ó¡A¾ú¸g¤@³s¦ê¿¦±Kªº²Õ´§ï³y«á¡Aº«×¦¨¥\»P·~¬É¦X§@½l¬ùªº§Þ³N²¾Âà®×¨Ò¡A¤£¶È¥i¥H´£¤É¥Í§Þ¤¤¤ß¬ãµo¹Î¶¤ªº¤h®ð¡A§ó«nªº¬O¡A¥¦ÃÒ©ú¤F¥Í§Þ¤¤¤ß¤w±q«¾ãªº¸ÀÅܤ¤¦¨¥\¦A¥Xµo¡C¥Í§Þ¤¤¤ß³z¹Lºë¨}ªº¬ãµo¹Î¶¤¡A³Ð³y¥X¤¤¯óÃIJ£«~¶}µoªº®Ö¤ß§Þ³N¡A¨Ã¦¨¥\³z¹L§Þ³N¥[È¡A´£¨ÑªA°È©ó²£·~¬É¡A¨ó§U°ê¤º¼t°Ó´£¤É²£·~Ävª§¤O¡A¶}©Ý·s¥«³õ¡C³o»¡©ú¤FDCB¸ÀÅܪº¦¨¥\¯à¶q¡A§Y±N²¾Âন¬°¥xÆW¥Í§Þ²£·~µo®iªº°Ê¤O¡C §d¾ð¥Áªí¥Ü¡A¥¼¨ÓDCB¤]±N«ùÄò±À°Ê¤¤¯óÃħ޳Nªº¬ãµo»P·sÃĶ}µo¡A®i²{¥xÆW·sÃĶ}µo¯à¶q¡A¨Ã±NÅýDCBP¤O§êºt¥xÆW¤¤¯óÃIJ£·~«e¾ÉªÌªº¨¤¦â¡A´£¤É¥xÆW¤¤¯óÃIJ£«~¹F¨ì°ê»Ú¤ô·Ç¡B©Ý®i°ê»Ú¤Æ¥«³õ¡A¶i¦Ó¦b¥þ²y¥«³õ¤W¦û¦³¤@®u¤§¦a¡C ¥Í§Þ¤¤¤ß°õ¦æªø§d©ú°ò«hªí¥Ü¡A³o¦¸¦¨¥\ñ¬ùªº®Ö¤ß¹Î¶¤¡A¬O¥»¤¤¤ßªº¤¤¯óÃĶ}µopµe¥þÅé¬ã¨s¤Hû¡A¦b¸gÀÙ³¡§Þ³N³B¤ä«ù¤U¡A¾ú¸g¶W¹L¤T¦~§V¤O¬ã¨sªº¦¨ªG¡C§ó«nªº¬O¡ADCB-WH1ÁٯǤJ¤F¤@ºØ¬Ã¶Qªº¥xÆW¥»¤g´Óª«¡A°ò©ó°Ó·~¾÷±K§ÚÌ©h¥BºÙ¤§¬°PA¡A¸g¥ÑPA¦³®Ä²Õ¦¨¤Àªº¤ÀªR¼Æ¾Ú¡A°t¦XPA¥Ð¶¡ºØ´Ó¦b¤£¦P®É¶¡Éç´¡¡B±Ä¦¬¡B¬IªÎ¡B¨Ñ¤ô©M®ðԤΰ«B¶qµ¥°Ñ¼Æªº¾ã¦X¡A¥i«ØºcPA´Óª«GAPºØ´Ó¥¥x§Þ³N¡A¦¹¶µ¥¥x§Þ³Nªº«Ø¥ß±N¨Ó¥i±À®iÀ³¥Î©ó¨ä¥LÃħ÷ªºGAPºØ´Ó¡A¹ï«p´Ó¥xÆWµo®i°ª¶QÃħ÷ªºGAPºØ´Ó²£·~¦³«Ü¤jªºÀ°§U¡C ¥¼¨ÓDCBªº¤¤¯óÃÄpµe±N§óµÛ«©ó¥xÆWì¥ÍºØÃĥδӪ«ªº¬ã¨s»Pµo®i¡A¥H®i²{¥xÆW¦b°ê»Ú·sÃĬãµo¬ÉªºÃÄ·½¿W¯S©Ê¡CDCB¤]±NP¤O§êºt¥xÆW¤¤¯óÃIJ£·~ªº«e¾ÉªÌ¡A´£¤É¥xÆWÃĥδӪ«ªºÂåÀøª««~¹F¨ì°ê»Ú¤ô·Ç¡B©Ý®i°ê»Ú¤Æ¥«³õ¡A¨Ã¦b¥þ²y¥«³õ¤W¦û¦³¤@®u¤§¦a¡C t³d¬ãµoDCB-WH1ªº¥Í§Þ¤¤¤ß¤¤¯óÃÄpµet³d¤H§d·çà±³Õ¤h«hªí¥Ü¡A¶Ë¤f¡¦X§xÃøªº°ÝÃD¦V¨ÓÄY«§xÂZ¿}§¿¯f±wªÌ¡B§K¬Ì¥\¯à§í¨îªÌ¥H¤ÎµLªk¦æ°Êªº¯f±w¡C¤£¶È»Ýnªá¶O³\¦hªº®É¶¡»Pª÷¿ú©óÂåÀø·ÓÅU¤W¡A§óÄY«¼vÅT±wªÌ¥Í¬¡«~½è¡C ²{¦æ¬ü°ê°ß¤@®Ö¥iªvÀø¿}§¿¯f¶Ë¤f¡¦Xªº¤W¥«ÃĪ«¥s°µ Regranex ¡A§d·çà±³Õ¤hªí¥Ü¡ADCB-WH1¤£¦ý¨ã¦³»PRegranex¬Û¦ü®Ä¥Îªº¶Ë¤f¡¦X¯à¤O¡A§ó«nªº¬ODCB-WH1¬O¥Ñ´Óª«¨Ó·½²Õ¦¨¡A¨ã¦³¸û§Cªº¥ÎÃĦ¨¥»¡A¨ã¦³²£«~¦w©w©Ê¨Î¡B¥i¦b«Ç·Å¤U«O¦s¡B¨Ï¥Î¤è«K¡B¨ã¦³¦hºØ½Æ¦X¦¨¥÷¡]multiple components¡^¡A°£¤F«P¶i²ÓM¼W¥Í¥~¡AÁÙ¦³§Üµß¡B§Üµoª¢¡B¶Ë¤f¡¦X¨}¦n¾ã»ôµ¥¦h«¦n³B¡A³ôºÙ¹ï¿}§¿¯f±w¡B¿N¿S¶Ë¤Î¿È½H©Ê¼ìºÅµ¥¶Ë¤f¡¦X§xÃø±wªÌªº¤@¤jºÖµ¡C ®Ú¾Ú¥Í²£RegranexªºÃÄ«~¤½¥q½Õ¬d¡A¥þ²y¦b³B²zºC©Ê¶Ë¤f¡¦Xªºªá¶O¨C¦~¬ù°ª¹F50¨ì70»õ¬üª÷¡A¨Ã¦³µÛéwªº¥«³õ¦¨ªø²v¡A¥H¿}§¿¯f¯f¨¬¼ìºÅ¬°¨Ò¡A¨ä¥§¡¦~¦¨ªø²v¬°8.3%¡C ¥Í§Þ¤¤¤ß(DCB)¦P®É¤]»P¤¤¤Ñ¥Í§Þñq¡uªvÀøÃþ·Àã©ÊÃö¸`ª¢¤§´Óª«µÑ¨úª«¡vªº§Þ³N²¾Âà¦X§@®×¡A¸Ó®×¥]¬A¦b¥»¦¸Ã±q¤§§Þ³N²¾Âà®×¤º¡A¥ÑÂù¤è¦@¦P¶}µoªvÀøÃþ·Àã©ÊÃö¸`ª¢·sÃÄ¡C |
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50±i¥H¤U«ùªÑ¤H¼Æ¡A¦b®ø°h¤¤¡C ¸ê°T¤£¹ïºÙ»ùÈ ¡X-¬ü¡B¥xªÑ¥«©|¥¼¤ÏÀ³ 1.¨È狮»PCSL¦@¦P¶}µoASLAN004¨ì1aÁ{§É§¹¦¨ªº¿W±o¼ç¦b§Q¯q10»õ¬ü¤¸¡C 2019/05/31¤w¸g°ê»Ú±ÂÅv¡A¨È·à©Ò±o§Q¯q¦ô§é现È10»õ¬ü¤¸¡C¥tCSL¥ç±o10»õ¬ü¤¸ªº¼ç¦b§Q¯q¡A¦@20»õ¬ü¤¸¡C ñ约°ò¦¡A°Ñ¦Ò°ê»Ú¦P级¦X¬ù¡A¤Î·í®ÉDupilumab ¥«³õ»{¦P¥¼¨Ó³Ì°ª¥i销50»õ¬ü¤¸ ¦ôpaslan004 ³Ì°ª销°â30»õ¬ü¤¸¡C ¡X¡X.2020¦~¤¸¤ë Dermira/Lebrikizumab AD ªº¨ÖÁʧé²{»ùÈ 29»õ¬ü¤¸. 2020/01 §¨Ó¨ÖÁÊDermira ¤½¥q 11»õ¬ü¤¸²{ª÷+ ¤ä¥Iù¤óROCHE Lebrikizumab¥þ²yAD¶}µoÅv,°Ó·~¾P°â¨ã¦³¨½µ{¸O·N¸q®É¤ä¥I2.1»õ¬ü¤¸¡A°£¶¡½è©ÊªÍ¯f¥H¥~ªº¾AÀ³¯gªº²b¾P°âÃB¹F¬Y¨Ç»ùȳ̰ª¹F¨ì10.25»õ¬ü¤¸,¦Xp¬ù12.35»õ¬ü¤¸,¥[¾P°â¤À¼í<= 10%. §é²{Ȧô 11»õ¬ü¤¸+18»õ¬ü¤¸=29»õ¬ü¤¸, 2.2020/8/1 a.¦]Dupilumab ¥«³õ»{¦P°ª¾P°âÃB´£¤É¨ì110»õ¬ü¤¸¡C ASLAN004ÀH¥«³õÂX¤j¡A¥¼¨Ó·s°ê»Ú±ÂÅvÈ¨Ì¾Ú ³Ì°ª¾P°â¦ô¥i¹F50~70»õ¬ü¤¸ ¡X¡XDermiraªº§é现»ùLebriKiulmab¥u¦³ AD ¾AÀ³¯g¡A¤w¹F29»õ¬ü¤¸ ASLAN004 ¦P Dupilumab Àø®Ä¥i¬° LebriKiulmab 1/0.75=1.33¿ 29*1.33=38.7 »õ¬ü¤¸ ¡X¡X¨È·à ý³Ý/ªÍ³¡COPD¨â¤j¾AÀ³¯g¦¨¥\¦Pdupilumab¾÷·|¡C ¦ôp ¾P°â°ªÂI¦³20»õ¬ü¤¸ªº¾P°â»ùÈ.(µ¥¨È·à±À1aý³ÝÁ{§É¦A¦ô) ¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X ¥¼¨ÓªºASLAN004 ±ÂÅv¦X约±ø¥ó: ¦ôp ±ÂÅvª÷25»õ¬ü¤¸+销°â¤À¼í¡]隠§tAD 50»õ¬ü¤¸³Ì°ª¾P°â¡A©|¥¼¦ôý³Ý/COPD 20»õ¬ü¤¸ ¡^ §é²{È40»õ¬ü¤¸¡C ¨È狮¥i¤À21»õ¬ü¤¸+2bÁ{§É»ùÈ4»õ¬ü¤¸¦@25e¬ü¤¸¡C CSL¥i¤À15»õ¬ü¤¸ Y¥¼¨Ó¨ÖÁʵo¥Í,¥i¯à¦X¬ù: 1. ¡X¡X¥Ø«e¤ä¥I¨È·à²{ª÷»ù21e¬ü¤¸¡þ¡X¡X¡XÀH®É¯àµo¥Í ¡X¡X©ÎY¦b2022 °µ§¹2b ADÁ{§É ¡Ï4e =25e ¬ü¤¸¡X¡X2022¦~¤U¥b¦~ 2. ¡Ï©Ó¾á¤ä¥ICSL 2019¦~5¤ë31¤é±ÂÅv¦X¬ù±ø¥ó: ±ÂÅvª÷7.8»õ¬ü¤¸¡Ï5~10% ¾P°â¤À¼í |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2020/8/1 ¤W¤È 08:55:22²Ä 3226 ½g¦^À³
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ªÑªF¤H¼Æ 7¤ë17¤é 5221¤H 7¤ë24¤é 4263¤H(©M¤W¶g¤ñ´î¤Ö958¤H) 7¤ë31¤é 3947¤H(©M¤W¶g¤ñ´î¤Ö316¤H) ¥§¡«ùªÑ48.13±i/¤H¡A³Ð2017¦~0603¤W¥«¥H¨Ó³Ì°ª¡C norway.twsthr.info/StockHolders.aspx?stock=6497 ÃÒ¨é¥N¸¹¡G6497 ÃÒ¨é¦WºÙ¡G¨È·à±d-KY ¸ê®Æ¤é´Á¡G109¦~07¤ë31¤é §Ç «ùªÑ/³æ¦ì¼Æ¤À¯Å ¤H¡@¡@¼Æ ªÑ¡@¡@¼Æ/³æ¦ì¼Æ ¥e¶°«O®w¦s¼Æ¤ñ¨Ò (%) 1 1-999 106 11,668 0.00 2 1,000-5,000 2,734 5,529,017 2.91 3 5,001-10,000 455 3,737,517 1.96 4 10,001-15,000 163 2,113,816 1.11 5 15,001-20,000 137 2,593,000 1.36 6 20,001-30,000 107 2,796,549 1.47 7 30,001-40,000 40 1,472,952 0.77 8 40,001-50,000 32 1,491,000 0.78 9 50,001-100,000 68 5,005,368 2.63 10 100,001-200,000 36 5,394,483 2.83 11 200,001-400,000 22 5,833,849 3.07 12 400,001-600,000 13 6,402,967 3.37 13 600,001-800,000 3 2,210,000 1.16 14 800,001-1,000,000 6 5,323,155 2.80 15 1,000,001¥H¤W 25 140,039,629 73.72 ¦X¡@p 3,947 189,954,970 100.00 »¡©ú¡G 1. ¿Ä¸ê¿Ä¨é±M¤á¡BÃÒ¥æ©Òɨ鹺¼·±M¤á¡Bɨé¾á«O«~±M¤á¡A»P´Á¥æ©Ò¼ÐªºÃÒ¨éú¥æ½æ¥X¶RÅv«OÃÒª÷±M¤á¡B¼ÐªºÃÒ¨é¼i¬ù¥æ³Î±M¤áµ¥¦U±M¤á³¡¤À¡A¥H¸Óµ¥±M¤á©Ò¸üªÑ¼Æpºâ¡C 2. ¦XpªÑ¼Æ¥]§t¹sªÑ«Ý»â¦^©ÎÃÒ¨é¤ä¥I¾Ì³æ¤§ªÑ¼Æ¡C 3. ¥»¾ú¥vÀɮ׸ê®Æ¦Û97¦~7¤ë¥÷°_«Ø¸m¡A¸ê®Æ«O¦s´Á¶¡¬°¤@¦~¡C ÃÒ¨é¥N¸¹¡G6497 ÃÒ¨é¦WºÙ¡G¨È·à±d-KY ¸ê®Æ¤é´Á¡G109¦~07¤ë24¤é §Ç «ùªÑ/³æ¦ì¼Æ¤À¯Å ¤H¡@¡@¼Æ ªÑ¡@¡@¼Æ/³æ¦ì¼Æ ¥e¶°«O®w¦s¼Æ¤ñ¨Ò (%) 1 1-999 104 13,007 0.00 2 1,000-5,000 2,973 5,995,151 3.15 3 5,001-10,000 502 4,108,087 2.16 4 10,001-15,000 167 2,171,773 1.14 5 15,001-20,000 154 2,907,000 1.53 6 20,001-30,000 112 2,932,549 1.54 7 30,001-40,000 49 1,814,952 0.95 8 40,001-50,000 34 1,572,000 0.82 9 50,001-100,000 67 4,934,368 2.59 10 100,001-200,000 33 5,050,483 2.65 11 200,001-400,000 23 6,365,849 3.35 12 400,001-600,000 13 6,233,967 3.28 13 600,001-800,000 3 2,235,000 1.17 14 800,001-1,000,000 4 3,587,155 1.88 15 1,000,001¥H¤W 25 140,033,629 73.71 ¦X¡@p 4,263 189,954,970 100.00 |
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·|û¡G·¤p¶³10150138 µoªí®É¶¡:2020/7/30 ¤W¤È 09:09:07²Ä 3225 ½g¦^À³
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½Ð°Ý¤j¤j ¦³¤HÀ´±o«ç»ò¶ñ¼gADRÂà´«±ÂÅv®Ñ¶Ü ¬Ý¤£¤ÓÀ´«ç»ò¶ñ¼g ÁöµM¦³¤j¤j½Ķ¥X¨Ó¤F «Ü¦hÁÙ¬O¤£ª¾¹D¦p¦ó¶ñ¼g |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2020/7/30 ¤W¤È 08:15:24²Ä 3224 ½g¦^À³
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www.ktgh.com.tw/Public/tbDrug/201905241612517055.pdf §ùÁת¢ª`®g¾¯300²@§J DUPIXENT solution for injection 300mg ½Ã³¡µß¬Ì¿é¦r²Ä001082¸¹ ¥»ÃÄ¥ÑÂå®v¨Ï¥Î dupilumab (dupixent)¤¤¤å¥é³æ |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2020/7/29 ¤W¤È 10:42:11²Ä 3223 ½g¦^À³
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dupilumab 2013/03 µo¥¬ dupilumab 1b ¥¿¦V¼Æ¾Ú 2014/07 µo¥¬ dupilumab 2b ¥¿¦V¼Æ¾Ú 2014/11 dupilumab Àò BTD in ¤¤-««×AD 2015/11 §¹¦¨ dupilumab AD 3´Á ¤GÓÁ{§Ésolo1&2 n=671/ solo2 n=708 ¨ú±oªì¨B¼Æ¾Ú(2014/10¶}©l) 2016/9 FDA ±µ¨ü ¥Ó½ÐÃĵý. 2017/03 ,FDA ®Ö²a ¤¤-««×ADÃĵý 1.¥«³õ¬ã¨smarketresearch, 2012¦~ ¹w´ú,dupilumab,2016¤W¥«, 2022¦~¾P°â°ªÂI 7 »õ¬ü¤¸. Sanofi/Regeneron¡¦s dupilumab is expected to reshape the moderate-to-severe treatment paradigm, and serve as an alternative therapeutic option for patients that are typically prescribed the gold-standard systemic agent cyclosporine, and for those that have become refractory to all available treatments. Its 2016 launch across the major healthcare markets will be the most pertinent event in the atopic dermatitis market space in the nearterm. With optimism over the drug¡¦s future prospects from key opinion leaders, GlobalData expects strong uptake and forecasts the biologic to garner sales of $746.2m by 2022. Overall, dupilumab¡¦s uptake across the 7MM will be fueled by its potential to address the high unmet need for a systemic agent for patients that fall into the severe recalcitrant category, and its potential to displace cyclosporine, www.marketresearch.com/product/sample-8042296.pdf 2.2016¦~ ¤¸¤ë ¬ü°ê¬ã¨s³ø§i: dupilumab 2023¦~±N¾P50»õ¬ü¤¸ research-doc.credit-suisse.com/docView?language=ENG&format=PDF&document_id=1056847681&source_id=em&serialid=RVmLiVis3Gs%2FI4n%2FY5NRIBrwLqAKdjQcrgmTu6Bh8bM%3D 19 January 2016 Americas/United States Equity Research Biotechnology We are initiating coverage of Regeneron with a Neutral rating and a $552 target price. We are still positive on the grandfather of all platform stories in the long term, but at these levels, we think the market is too. Our Dupilumab sales estimate is $5B adjusted in 2023, 3.2019/12 REGN CEO ¹w¦ôdupilumab ¾P°â°ªÂI¨ì110»õ¬ü¤¸ 2017/Q3 ¤W¥« 2018/¦~¾P8»õ¬ü¤¸ 2019/¦~¾P23»õ¬ü¤¸ 2020¦~¦ô¾P40»õ¬ü¤¸ 2021¦~¦ô¾P60»õ¬ü¤¸ 2022¦~¦ô¾P80»õ¬ü¤¸ 2023¦~¦ô¾P100»õ¬ü¤¸ |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2020/7/29 ¤W¤È 09:22:50²Ä 3222 ½g¦^À³
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REGEN 2013/03/02 µo¥¬ Dupilumab/ 1b AD¥¿¦V¼Æ¾Ú «á2Ӥ뤺,ªÑ»ù¤jº¦95¬ü¤¸/ªÑ, ¤jº¦55% ¥«È. ¤µ¦~Q4±Nµo¥¬ ASLAN004 1b ´Á¤¤³ø§i,§Æ±æ¥«³õ¯à¥ý¤ÏÀ³1bªº»ùÈ/¦@¦P¶}µoªÌ. REGN ªÑ»ù 2013/03/02µo¥¬Dupilumab/ 1b AD¥¿¦V¼Æ¾Ú -----2013/03/01 ªÑ»ù171¬ü¤¸ 2013/04/29 ªÑ»ù266¬ü¤¸(2Ó¤ë¤jº¦95¬ü¤¸,¤jº¦55%,¥«È¤jº¦ªñ¦Ê»õ¬ü¤¸) finance.yahoo.com/chart/REGN 2017/03 FDA ®Öã¤W¥«(Â÷1b¼Æ¾Ú µo¥¬4¦~/2014 ,ÀòBTD) SANOFI©MREGENRON³ø§i¶§©Ê¥Öª¢¤¤IL-4Rªüº¸ªk§ÜÅéDUPILUMABªº·§©ÀÅçÃÒ¼Æ¾Ú ¤Ú¾¤©M¯Ã¬ù¦{¶ð¨½´°¡A2013¦~3¤ë2¤é/¬ü³qªÀ/-ÁÉ¿Õµá¡]ªx¼ÚÃÒ¨é¥æ©ö©Ò¡GSAN¡A¯Ã¬ùÃÒ¨é¥æ©ö©Ò¡GSNY¡^©M¦A¥Í¤¸»sÃĤ½¥q¡]¯Ç´µ¹F§JªÑ²¼¥N½X¡GREGN¡^¤µ¤Ñ«Å¥¬¡A¶×Á`¤F¨â¶µ¨Ï¥Îdupilumab¡]REGN668¡^ªº1b´Á¸ÕÅ窺¼Æ¾Ú/ SAR231893¡^¡A³o¬O¤@ºØ°w¹ï¥Õ¤¶¯À4¨üÅé¡]IL-4R alpha¡^ªº°ª¿Ë©M¤O¡A¸g¥Ö¤Uµ¹ÃĪº¥þ¤HÃþ§ÜÅé¡A¤w¦b¬ü°ê¥Ö½§¯f¾Ç·|¡]AAD¡^²Ä71©¡¦~·|¤W´£¥X¦bÁÚªü±K¡C 1b´Á¬ã¨sªº¥Dn¥Øªº¬Oµû¦ôdupilumabªº¦w¥þ©Ê¡C¨ä¥L±´¯Á©Ê²×ÂI¥]¬AÃÄ¥N°Ê¤O¾Ç¡A¥Íª«¼Ð»xª«©M¥\®Ä°Ñ¼Æ¡C¥\®Ä¼Æ¾Úªí©ú¡A¨C¶g¥|¦¸¥Ö¤Uª`®gdupilumab¨C¶g150²@§J¡]mg¡^©Î300mg¶i¦æªvÀø¡A¥iÅãµÛ§ïµ½¯e¯f©M¯gª¬±o¨ì¾A·í±±¨îªº¤¤«×¦Ü««×¯SÀ³©Ê¥Öª¢¡]AD¡^±wªÌªºÅé¼x©M¯gª¬§½³¡¥ÎÃÄ¡C¨ãÅé¦Ó¨¥¡A»P¦w¼¢¾¯¬Û¤ñ¡A±q°ò½u¨ì²Ä4¶g¡A±µ¨üdupilumabªvÀøªº±wªÌªºÅéªí±¿n¡]BSA¡^µû¤À¡A¬ã¨sªÌÁ`Åéµû¦ô¡]IGA¡^µû¤À©MÀã¯l±¿nÄY«©Ê«ü¼Æ¡]EASI¡^§¡¦³ÅãµÛ§ïµ½¡]p <0.05 vs.¦w¼¢¾¯©Ò¦³±¹¬I©M¾¯¶q¡^¡C 300mg¾¯¶q²ÕªºBSA¡AIGA©MEASIµû¤À¦b²Ä8©P«O«ù¤FÅãµÛ§ïµ½¡]»P¦w¼¢¾¯¬Û¤ñ¡Ap <0.05¡^¡C¤@¶µÅTÀ³ªÌ¤ÀªRÅã¥Ü¡A¦b²Ä4¶g¡A±µ¨ü150mg¾¯¶qªvÀøªº±wªÌ¤¤¦³54.5¢Hªº±wªÌ©M±µ¨ü300mg¾¯¶qªvÀøªº±wªÌ¤¤¦³71.4¢HªºEASI±o¤À°§C¤F50¢H©Î§ó°ª¡A¦Ó¦w¼¢¾¯¬°18.8¢H¡]p <0.05¡^ ¡C³Ì±`¨£ªº¤£¨}¨Æ¥ó¬O»ó«|ª¢¡]19.6¢Hvs¦w¼¢¾¯12.5¢H¡^©MÀYµh¡]11.8¢Hvs 6.3¢H¦w¼¢¾¯¡^¡C «X°Ç©£¦{Á{§É¬ã¨s°Æ±Ð±Â®J¨½§J¡P¨¯´¶´Ë¡]Eric Simpson¡^³Õ¤h»¡¡A¾¨ºÞ¤w¦³ªvÀø¤èªk¡A¦ý¤¤««×¯SÀ³©Ê¥Öª¢±wªÌ¤¤¤´¦³«Ü¤j¤@³¡¤ÀÄ~Äò¾D¨ü¥Ö½§µoª¢©M¹x©T©Êæ±Äoªº§xÂZ¡A³oÄY«¼vÅT¤F¥L̪º¥Í¬¡½è¶q¡C¬ü°ê«X°Ç©£¦{ªi¯SÄõ¥«½Ã¥Í¬ì§Þ¤j¾Ç¡A¸Ó¬ã¨sªºº®u¬ã¨sû¡C³oºØ¨ã¦³·s¿o§@¥Î¾÷¨îªº¥Íª«Àøªkªº¦´Áµ²ªG¹ï¨º¨ÇªvÀø³o¨Ç±wªÌ¨Ãȱo¶i¤@¨BÁ{§É¬ã¨sªº¤H¨Ó»¡¬O¥O¤H¹ª»Rªº¡C Âå¾Ç³Õ¤hGeorge D. Yancopoulos³Õ¤h»¡¡A³q¹LªýÂ_IL-4R£\¡A§ù¤Ç³æ§Ü¥i½Õ¸`IL-4©MIL-13³q¸ôªº«H¸¹¶Ç¾É¡A³o»P¹L±Ó©Ê¯e¯fªº¯f²z¥Í²z¾Ç¦³Ãö¡C Regeneron¤½¥qÁ`µôÝRegeneron¹êÅç«ÇÁ`µô¡C§ÚÌ´Á«Ý¤µ¦~±ß¨Ç®ÉÔ±q¤@¶µ¬°´Á12¶gªº¯SÀ³©Ê¥Öª¢ªº2a´ÁÁ{§É¸ÕÅ礤´£¨Ñ§ó¦h¼Æ¾Ú¡A¥H¤Î¦b±w¦³¯SÀ³©Ê¥Öª¢ªº±wªÌ¤¤¶i¦ædupilumab§ó¤jªº2b´ÁÁ{§É¸ÕÅç¡C ¤µ¤Ñ¦bAAD·|ijªº³Ì·sÁ{§É¸ÕÅç·|ij¤W¤¶²Ðªº1b´Á¸ÕÅç¥]¬A67¦ì±wªÌ¡AÀH¾÷¤À°t¤TºØ¤£¦P¾¯¶qªºdupilumab¡]75mg¡An = 8¡F 150mg¡An = 22¡F 300mg¡An = 21¡^©M¦w¼¢¾¯¡]n = 16¡^¡C 1b´Á¬ã¨sªº¥Dn¥Øªº¬Oµû¦ôdupilumabªº¦w¥þ©Ê¡C¨ä¥L²×ÂI¥]¬AÃÄ¥N°Ê¤O¾Ç¡A¥Íª«¼Ð»xª«©M¥\®Ä°Ñ¼Æ¡C¦b¬°´Á4¶gªºªvÀø´Á«á¡A¹ï¬ã¨s¤¤ªº±wªÌ¦AÀH³X4¶g¡A¦@p8¶g¡C SANOFI AND REGENERON REPORT POSITIVE PROOF-OF-CONCEPT DATA FOR DUPILUMAB, AN IL-4R ALPHA ANTIBODY, IN ATOPIC DERMATITIS PARIS and TARRYTOWN, N.Y., March 2, 2013 /PRNewswire/ -- Sanofi (EURONEXT: SAN and NYSE: SNY) and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that pooled data from two Phase 1b trials with dupilumab (REGN668/SAR231893), an investigational, high-affinity, subcutaneously administered, fully-human antibody targeting the alpha subunit of the interleukin 4 receptor (IL-4R alpha), were presented at the 71st Annual Meeting of the American Academy of Dermatology (AAD) in Miami. The primary objective of the Phase 1b studies was to assess the safety profile of dupilumab. Other exploratory endpoints included pharmacokinetic, biomarker, and efficacy parameters. The efficacy data showed that treatment with four weekly subcutaneous injections of dupilumab at either 150 milligrams (mg) or 300mg per week, significantly improved the signs and symptoms of patients with moderate-to-severe atopic dermatitis (AD) whose disease was not adequately controlled with topical medications. Specifically, patients treated with dupilumab had significant improvements in body surface area (BSA) score, Investigator Global Assessment (IGA) score, and Eczema Area Severity Index (EASI) from baseline to week 4 compared to placebo (p < 0.05 vs. placebo for all measures and doses). The significant improvements in BSA, IGA, and EASI scores were maintained at week 8 in the 300mg dose group (p < 0.05 vs. placebo). A responder analysis demonstrated that at week 4, 54.5% of patients treated with the 150mg dose and 71.4% of patients treated with the 300mg dose achieved a reduction in EASI score of 50% or greater compared to 18.8% with placebo (p < 0.05). The most common adverse events (AEs) were nasopharyngitis (19.6% vs 12.5% for placebo) and headache (11.8% vs 6.3% for placebo). Despite existing therapies, a significant proportion of patients with moderate-to-severe atopic dermatitis continue to suffer from inflamed skin and intractable itch, which significantly impacts their quality of life, said Dr. Eric Simpson, Associate Professor, Director of Clinical Studies, Oregon Health and Science University, Portland, Oregon, USA, and Principal Investigator of the study. The early phase results with this biologic therapy, which has a novel mechanism of action, are encouraging to those of us who treat these patients and warrant further clinical investigation. Through blockade of IL-4R alpha, dupilumab modulates signaling of both the IL-4 and IL-13 pathway, which have been implicated in the pathophysiology of allergic disease, said George D. Yancopoulos, M.D., Ph.D., Chief Scientific Officer of Regeneron and President of Regeneron Laboratories. We look forward to presenting additional data from a 12-week, Phase 2a trial in atopic dermatitis, as well as starting a larger Phase 2b trial with dupilumab in patients with atopic dermatitis, later this year. Presented today in a late-breaking clinical trials session at the AAD meeting, the Phase 1b trials included 67 patients randomized to three different doses of dupilumab (75mg, n=8; 150mg, n=22; 300mg, n=21) and placebo (n=16). The primary objective of the Phase 1b studies was to assess the safety profile of dupilumab. Other endpoints included pharmacokinetic, biomarker, and efficacy parameters. Following the 4-week treatment period, patients in the studies were followed for an additional 4 weeks for a total of 8 weeks. |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2020/7/29 ¤W¤È 07:07:31²Ä 3221 ½g¦^À³
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¨ÅÀù¦Ê»õ¬ü¤¸¤jÃÄ贺Àù¥¤W¥«20¦~¥é¥ÍÃÄ ¤~¦b¬ü¤W¥«¡A±M§QÅv«OÅ@ªº¬Û·í¦n¡C Development History and FDA Approval Process for Herceptin Date Article Nov 16, 2006 FDA Approves Herceptin for the Adjuvant Treatment of HER2-Positive Node-Positive Breast Cancer Sep 25, 1998 Herceptin: Biotechnology Breakthrough In Breast Cancer Wins FDA Approva |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2020/7/28 ¤W¤È 10:37:12²Ä 3220 ½g¦^À³
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×¥¿-1 ASLAN004 VS DUPILUMAB ²z½×¾¯¶qPK ¤@¡B¦³§O©ódupilumab¡AASLAN004¤£·|ªýÂ_I«¬¨üÅé(Type I Recepter) (1) Dupilumab ±µ¦X IL4R£\¦ÓªýÂ_»Py chain ²Õ¦¨ ±ÂÅé½Æ¦XÅé(IL-4¡ÏIL-4R£\¡Ïy china)¤§¸ô®|¡A (¸Ô¨£Dupilumab MOA),¦ÓµLªk²Õ¦¨I«¬¨üÅé(Type I Recepter) (2) ¥i¯à¸ÑÄÀdupilumab ¼W¥[µ²½¤ ª¢ªº25%~50%·ÀIªºì¦] ¤G¡BII«¬¨üÅé(Type II Recepter)ÂX´²¼sªx¥B·|IJµo¹L ±Ó¡A¦]¦¹Àø®Ä±N¥ÑII«¬¨üÅ餩¥H ÅX°Ê 1.ASLAN004 IV 10mg/kg ,¥i§¹¥þ§í¨î29¤Ñ¥H¤W¡ApSTAT6 ¤U´å¤¶½èµL³Q¬¡¤Æ¡A ¥BÀø®Ä(2019/12/03 3¦ì (4-6¶g)ESAI ¥§¡°´T71% ±µªñdupilumab 2a ²Ä¤¶gESAI°´T67% . ¬G¥i説©úIL-4 »P IL4R£\»Py chain ²Õ¦¨ ±ÂÅé½Æ¦XÅé(IL-4¡ÏIL-4R£\¡Ïy china),±µ¦X¦¨I«¬¨üÅé(Type I Recepter) ,¤Þµoªº¹L±Óµoª¢¤ÏÀ³©Î³\¤£¤j¡C 2.Tralokinumab ±µ¦XIL-13 A¡BDÁ³±Û¡A¨ÏIL-13 µLªk»P IL-13R £\±µ¦X¡A¦Ó¼vÅT¤@¥bªº¤T´ÁÁ{§É¹w«á ¥Dn«ü¼ÐIGA,0/1Àø®Ä¡C ¦¹¥i¯à説©ú IL-4 ¡A IL-13 ¦bType II Recepter °T¸¹¶Ç»¼¶q¼vÅT Àø®Ä¬Û·í¡C IL-4 R £\, IL-13 £\1 ¦b Type II Recepter ¼Æ¶q¥i¯à±µªñ¤§±À½× ¤T¡BDupilumab VS ASLAN004 ±µ¦X¶q¤§¤ñ¸û 1.¦bType II Recepter ¤W ¥Ñ¤W±À½× Dupilumab ±µ¦XIL-4R£\ »P ASLAN004 ±µ¦XIL-13 £\1 ,¨âªÌ±µ¦X¼Æ¶q±µªñªº¾÷·|¤j¡C ESAI¥§¡°´T·¥¤j¦b75%¥ª¥k¡C ¥ÑªýÂ_IL-4R£\¤ÎIL-13 £\1 ¨âªÌ¨ü¾¹§¡¤À¡A¦U¨ÑÄm37.5% 2. ²Õ¦¨ Type I recepter , Dupilumab ±µ¦X IL-4R£\ , ²£¥Í 25%~50% ,¥§¡ 37.5% ·|¦³µ²½¤ª¢ªº·ÀI 3. dupilumab ¥i¯à±µ¦X¶q: IL-4R£\ ¼Æ¶q¦ôp = 丅ype II Recepter :37.5% ¡ÏType I Recepter:37.5%(25%~50%) = 75% (62.5%~87.5%)¡X¡X¡X¡XA ASLAN004 ¥i¯à±µ¦X¶q IL-13R£\1 ¼Æ¶q¦ôp = 丅ype II Recepter :37.5% ¡ÏType I Recepter 0% =37.5%¡X¡X¡X¡XB B/A = 37.5%/75%= 50% (60%~43%)¡C 结½×; ASLAN004 ±µ¦X©óIL-13R£\1 ¼Æ¶q ¥i¯à¶È50% (43%~60%)©ódupilumab ±µ¦X©óIL-4R£\¤§¼Æ¶q ¥¼¨ÓASLAN004 ³]pªº°w¾¯¶q¦b¦P¬I°wÀW²v¤U¡A¦³50%(43%~60%) ¤Ö©óDupilumab ¥i¯à¡C ¦p 1b aslan004 , 200mgX5¶g=1000mg.¡X¡XESAI 71% 2a Dupilumab x 5¶g=1800mg ¡X¡XESAI 67% 1000mg/1800mg=55% 1.Dupilumab MOA -¼v¤ù www.dupixenthcp.com/atopicdermatitis/about/mechanism-of-action 2.¨È·à¤½¥q²³ø ,p10 aslanpharma.com/app/uploads/2020/05/20-05-19-ASLAN-CN.pdf p.10 |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2020/7/28 ¤W¤È 10:19:29²Ä 3219 ½g¦^À³
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±`¨£ªº£^Ãì¡]£^c¡^£^chain ¡]©ÎCD132¡^¡A ¤]ºÙ¬°¥Õ¤¶¯À2¨üÅé¨È°ò£^©ÎIL-2RG¡A¬O²ÓM¦]¤l¨üÅé¨È°ò¡A¹ï©ó¦Ü¤Ö¤»Ó¤£¦Pªº¥Õ¤¶¯À¨üÅé¡A¥¦Ìªº¨üÅé½Æ¦Xª«¦@¦³¸Ó²ÓM¦]¤l¨üÅé¨È°ò¡GIL- 2¡AIL-4¡A[5] IL-7¡A[6] IL-9¡AIL-15 [7]©M¥Õ¤¶¯À21¨üÅé¡C £^c¿}³J¥Õ¬O¤j¦h¼Æ²O¤Ú²ÓM¡]¥Õ²ÓM¡^ºØ¸s¤¤ªí¹FªºI«¬²ÓM¦]¤l¨üÅé®a±Úªº¦¨û¡A¨ä°ò¦]¦s¦b©ó÷¨Å°Êª«ªºX¬V¦âÅé¤W¡C ¸Ó³J¥Õ¦ì©ó°©Å褤¥¼¦¨¼ôªº³y¦å²ÓMªí±¡C³J¥Õ½èªº¤@ºÝ¦ì©ó²ÓM¥~¡A»P²ÓM¦]¤lµ²¦X¡A³J¥Õ½èªº¥t¤@ºÝ¦ì©ó²ÓM¤º¡A±N«H¸¹¶Ç»¼¦Ü²ÓM®Ö¡C±`¨£ªº£^Ãì»P¨ä¥L³J¥Õ½èµ²¦X¡A«ü¾É³y¦å²ÓM§Î¦¨²O¤Ú²ÓM¡]¤@ºØ¥Õ²ÓM¡^¡C¸Ó¨üÅéÁÙ«ü¾É²O¤Ú²ÓM¨È«¬ªº¥Íªø©M¦¨¼ô¡GT²ÓM¡AB²ÓM©M¦ÛµM±þ¶Ë²ÓM¡C³o¨Ç²ÓM±þ¦º¯f¬r¡A»s³y§ÜÅé¨ÃÀ°§U½Õ¸`¾ãÓ§K¬Ì¨t²Î¡C en.wikipedia.org/wiki/Common_gamma_chain The common gamma chain (£^c) (or CD132), also known as interleukin-2 receptor subunit gamma or IL-2RG, is a cytokine receptor sub-unit that is common to the receptor complexes for at least six different interleukin receptors: IL-2, IL-4,[5] IL-7,[6] IL-9, IL-15[7] and interleukin-21 receptor. The £^c glycoprotein is a member of the type I cytokine receptor family expressed on most lymphocyte (white blood cell) populations, and its gene is found on the X-chromosome of mammals. This protein is located on the surface of immature blood-forming cells in bone marrow. One end of the protein resides outside the cell where it binds to cytokines and the other end of the protein resides in the interior of the cell where it transmits signals to the cell¡¦s nucleus. The common gamma chain partners with other proteins to direct blood-forming cells to form lymphocytes (a type of white blood cell). The receptor also directs the growth and maturation of lymphocyte subtypes: T cells, B cells, and natural killer cells. These cells kill viruses, make antibodies, and help regulate the entire immune system. |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2020/7/28 ¤W¤È 08:30:55²Ä 3218 ½g¦^À³
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³Ì°ª¾P°â=DUPILUMAB 110»õ¬ü¤¸x64%(q»ùµ¦²¤)=70»õ¬ü¤¸ AD: 50»õ¬ü¤¸ ý³Ý/COPD/¨ä¥L: 20»õ¬ü¤¸ ASLAN004 §é²{¼çÈ =¨È·àÀò§Q 32»õ¬ü¤¸¡ÏCSLÀò§Q 18»õ¬ü¤¸ = 50»õ¬ü¤¸§é ¦X²z¨ÖÁʼç¦b§é²{È : (1) ¥Ø«e21»õ¬ü¤¸§é²{È¡X-AD¡Ï (2)7»õ¡X¡Xý³Ý/COPD/¨ä¥L¡Ï (3)4»õ 2B Á{§É§Q¯q(2022¦~°µ§¹¤~ºâ) ¶RªÌ¥t¥~¶·¨Ì¦X¬ù¤ä¥ICSL (4)±ÂÅvª÷7.8»õ¬ü¤¸¡Ï(5)5%~10%¾P°â¤À¼í⋯⋯CSL¼ç¦b§é²{AD15»õ¬ü¤¸¡Ïý³Ý/COPD/¨ä¥L 3»õ¬ü¤¸§é²{È ¶W¹Lºâ¾ß¨ì¡I ¬ü°ê¥«³õ«Ü²z©Ê¡A¬Ýªº¬O§é²{È¡I ------------------------------------------------ ¨Ì¾Ú¥¼¨Ódupilumab ³Ì°ª¾P°â110»õ¬ü¤¸*80%*80%=70»õ¬ü¤¸ ¤§¾P°âµ¦²¤,¨Ó¦ÛMOA , ¨Ï¥ÎÃĶq¦³50%(43%~60%) §C©ódupilumab ªº¾÷·|,Ävª§¤O¤Q¨¬. |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2020/7/28 ¤W¤È 07:36:52²Ä 3217 ½g¦^À³
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dupilumab 300mg/¤G¶g¤@°w(°_©l¶q600mg) ,16¶g ,¦Xp2700mg¡X¡X¡XA ASLAN004 200mg/¤G¶g¤@°w(°_©l¶q200mg),16 ¶g¡A¦Xp1600mg¡X¡X¡XB B/A =1600mg/2700mg =60% ¨È·àªº¨â¶g¤@°w¡A¦ôp2b ·|¦s¦b¡C Dupilumab ¥|¶g¤@°wªº¥i¯à³]p 600mg/600mg/600mg/600mg=2400mg ¡X¡X¡X¶]¤£±¼ ì¦]: 1.¦]爲¨ä200mg/¨C¨â¶g¤@°w, ¡]°_©l¶q400mg),¦Xp 1800mg , Àø®Ä¤´µM¤£¤Î 300mg/¦A¶g¤@°w¡C 2.dupilumab 600mg/300mg/300mg/300mg ¤§2b Àø®Ä¡A®t¤Wz¨âªÌ§ó»·¡AIGA,0/1 ¥u¦³21% ¬G±À½×YDUPILUAMB ¥¼¨Ón±À¥X¥|¶g¤@°w 600mg/600mg/600mg/600mg=2400mg ¡X¡X¡X¶]¤£±¼ ¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X- ¦ÓASLAN004 2400x60%=1440mg ¤§°w¶q³]p¨¬¥H¡A¨ÏÀø®Ä±µªñDupilumab ¥|¶g¤@°w¤§¬D¾Ô 600mg/600mg/200mg/200mg=1600mg 600mg/400mg/200mg/200mg=1400mg 400mg/400mg/400mg/200mg=1400mg ¥H¤W¬Ò¦³¥i¯à¦b2b ¤¤¥X²{¡C |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2020/7/28 ¤W¤È 07:16:32²Ä 3216 ½g¦^À³
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结½×; ASLAN004 ±µ¦X©óIL-13R£\1 ¼Æ¶q ¥i¯à¶È50% (43%~60%)©ódupilumab ±µ¦X©óIL-4R£\¤§¼Æ¶q ¥¼¨ÓASLAN004 ³]pªº°w¾¯¶q¦b¦P¬I°wÀW²v¤U¡A¦³50%(43%~60%) ¤Ö©óDupilumab ¥i¯à¡C ASLAN004 VS DUPILUMAB ²z½×¾¯¶qPK ¤@¡B¦³§O©ódupilumab¡AASLAN004¤£·|ªýÂ_I«¬¨üÅé(Type I Recepter) (1) Dupilumab ±µ¦X I«¬¨üÅé(Type I Recepter) ¤W IL4R£\¦ÓªýÂ_»Py chain ²Õ¦¨ ±ÂÅé½Æ¦XÅé(IL-4¡ÏIL-4R£\¡Ïy china)¤§¸ô®|¡A (¸Ô¨£Dupilumab MOA) (2) ¥i¯à¸ÑÄÀdupilumab ¼W¥[µ²½¤ ª¢ªº25%~50%·ÀIªºì¦] ¤G¡BII«¬¨üÅé(Type II Recepter)ÂX´²¼sªx¥B·|IJµo¹L ±Ó¡A¦]¦¹Àø®Ä±N¥ÑII«¬¨üÅ餩¥H ÅX°Ê 1.ASLAN004 IV 10mg/kg ,¥i§¹¥þ§í¨î29¤Ñ¥H¤W¡ApSTAT6 ¤U´å¤¶½èµL³Q¬¡¤Æ¡A ¥BÀø®Ä(2019/12/03 3¦ì (4-6¶g)ESAI ¥§¡°´T71% ±µªñdupilumab 2a ²Ä¤¶gESAI°´T67% . ¬G¥i説©úIL-4 ±µ¦XI«¬¨üÅé(Type I Recepter) ¤W IL4R£\»Py chain ²Õ¦¨ ±ÂÅé½Æ¦XÅé(IL-4¡ÏIL-4R£\¡Ïy china) ¤Þµoªº¹L±Óµoª¢¤ÏÀ³©Î³\¤£¤j¡C 2.Tralokinumab ±µ¦XIL-13 A¡BDÁ³±Û¡A¨ÏIL-13 µLªk»P IL-13R £\±µ¦X¡A¦Ó¼vÅT¤@¥bªº¤T´ÁÁ{§É¹w«á ¥Dn«ü¼ÐIGA,0/1Àø®Ä¡C ¦¹¥i¯à説©ú IL-4 ¡A IL-13 ¦bType II Recepter °T¸¹¶Ç»¼¶q¼vÅT Àø®Ä¬Û·í¡C IL-4 R £\, IL-13 £\1 ¦b Type II Recepter ¼Æ¶q¥i¯à±µªñ¤§±À½× ¤T¡BDupilumab VS ASLAN004 ±µ¦X¶q¤§¤ñ¸û 1.¦bType II Recepter ¤W ¥Ñ¤W±À½× Dupilumab ±µ¦XIL-4R£\ »P ASLAN004 ±µ¦XIL-13 £\1 ¨âªÌ±µ¦X¼Æ¶q±µªñªº¾÷·|¤j¡C ESAI¥§¡°´T·¥¤j¦b75%¥ª¥k¡C ¥ÑªýÂ_IL-4R£\¤ÎIL-13 £\1 ¨âªÌ¨ü¾¹§¡¤À¡A¦U¨ÑÄm37.5% 2.©ó Type I recepter ,Dupilumab ±µ¦X IL-4R£\ , ²£¥Í 25%~50% ,¥§¡ 37.5% ·|¦³µ²½¤ª¢ªº·ÀI 3. dupilumab ¥i¯à±µ¦X¶q: IL-4R£\ ¼Æ¶q¦ôp = 丅ype II Recepter :37.5% ¡ÏType I Recepter:37.5%(25%~50%) = 75% (62.5%~87.5%)¡X¡X¡X¡XA ASLAN004 ¥i¯à±µ¦X¶q IL-13R£\1 ¼Æ¶q¦ôp = 丅ype II Recepter :37.5% ¡ÏType I Recepter 0% =37.5%¡X¡X¡X¡XB B/A = 37.5%/75%= 50% (60%~43%)¡C 结½×; ASLAN004 ±µ¦X©óIL-13R£\1 ¼Æ¶q ¥i¯à¶È50% (43%~60%)©ódupilumab ±µ¦X©óIL-4R£\¤§¼Æ¶q ¥¼¨ÓASLAN004 ³]pªº°w¾¯¶q¦b¦P¬I°wÀW²v¤U¡A¦³50%(43%~60%) ¤Ö©óDupilumab ¥i¯à¡C ¦p 1b aslan004 , 200mgX5¶g=1000mg.¡X¡XESAI 71% 2a Dupilumab x 5¶g=1800mg ¡X¡XESAI 67% 1000mg/1800mg=55% 1.Dupilumab MOA -¼v¤ù www.dupixenthcp.com/atopicdermatitis/about/mechanism-of-action 2.¨È·à¤½¥q²³ø ,p10 aslanpharma.com/app/uploads/2020/05/20-05-19-ASLAN-CN.pdf p.10 |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2020/7/27 ¤U¤È 04:42:20²Ä 3215 ½g¦^À³
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2019¦~10¤ë22¤é¡A¤½¥q«Å¥¬©Û¦¬²Ä¤@¦ìASLAN004 ¤¤-««× AD ¯f±w¡C 2019¦~12¤ë3¤é¡A¤½¥¬ 3¤H ESAI (4-6)¶g, ¥§¡°´T71% 2019¦~ 12¤ë 6¤é ¡A増¸ê§¹²¦. ¤µ¦~8¤ëÄ~Äò ²Ä¤G²Õ400mgÁ{§É¡A¼W¥[¿D¬w/¬ü°êÁ{§É¡C ¹w´Á²Ä¥|©u¤½¥¬ 200mg/400mg/600mg ¨C¶g¤@°wx 8¶g ¡A¦U6¤H ,¦Xp18¤H¡A¥[ 6¤H¹ï·Ó²Õ. ¥¿±`¦Ó¨¥ 3²Õ¹w«á«ü¼Ð ESAI ¥§¡°´T À³±µªñ 75%~80%. ¤~²Å¦XMOA ¤w½T»{¡A¦PDUPILUMAB ¸ô®| ¤§¤ô·Ç¡C ¦~©³¤jÀ¸±N¶}³õ¡C |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2020/7/27 ¤U¤È 02:56:46²Ä 3214 ½g¦^À³
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Àq§JÃļt ARQ531 ¨ÖÁʨƥó: 1.²Ä¤@¦¸«Å¥¬ ARQ531 1b CLL ¦åÀù¤G缐 , ¥ÎÃÄ 6¤H¤¤¦³4¤HORR . Arqul 2019/06/14 «Å§G ARQ531 ·§©À©ÊÁ{§É CLL¦åÀù¤G缐 ORR = ORR of 66%¡]4/6) (4 responses in 6 evaluable patients) was observed in heavily pretreated R/R CLL patients, all with the BTK-C481S mutation, from cohort 7 www.biospace.com/article/releases/arqule-announces-clinical-proof-of-concept-data-from-ongoing-phase-1-study-of-reversible-btk-inhibitor-arq-531-in-patients-with-relapsed-refractory-hematologic-malignancies-at-the-2019-eha-annual-meeting/ 2. ArQule 2019¤¸ 12¤ë 9¤é¡A²Ä¤G¦¸«Å¥¬ ARQ531 ªvÀø ¤G½u¦åÀù 1b , ORR 8/9=89%.¡A9¤H¤¤¦³8¤H¬OORR. Àq§JÃļt¦P¤é «Å¥¬27»õ¬ü¤¸¡A¨CªÑ20¬ü¤¸¡A¨ÖÁÊArQule , ¡]¤§«e¨â®a¤½¥q´N¤w¨ó°Ó¬ù6Ó¤ë) ·í¤éªÑ»ù°¨¤W¤@»ù¨ì20¬ü¤¸¡C ArQule 2020¦~¤¸¤ë16¤é¤U¥«¡C finance.yahoo.com/quote/ARQL/ ArQule Announces Final Phase 1 Clinical Data for Its Reversible BTK Inhibitor, ARQ 531, at the American Society of Hematology 2019 Annual Meeting Published: Dec 09, 2019 Logo Dec. 9, 2019 13:05 UTC ARQ 531 demonstrates substantial anti-tumor activity and manageable safety profile Eight of nine evaluable CLL patients initially dosed at ≥65 mg experienced a Partial Response (PR) Five of five CLL patients that were evaluable at the third scan (cycle 9) are durable PRs and continue on therapy Three of six evaluable Richter¡¦s patients dosed at 65 mg experienced a PR Call with management scheduled for today, December 9, at 8:15 am EST to discuss these results BURLINGTON, Mass.--(BUSINESS WIRE)-- ArQule, Inc. (Nasdaq: ARQL) today announced final results from the phase 1 study for ARQ 531, an orally bioavailable, potent and reversible dual inhibitor of both wild type and C481S-mutant Bruton¡¦s tyrosine kinase (BTK) in patients with relapsed or refractory hematologic malignancies at the American Society of Hematology (ASH) 2019 Annual Meeting & Exposition in Orlando, Florida. ¡§The final phase 1 data set confirms the potential utility of ARQ 531 for the treatment of these heavily pretreated CLL patients. We were excited to observe such deep and durable responses at a well-tolerated dose in this highly refractory population,¡¨ commented Dr. Brian Schwartz, Chief Medical Officer of ArQule. ¡§In addition, the three responses we observed in Richter¡¦s Transformation patients were a welcome outcome and allowed several patients to transition to potentially curative therapies.¡¨ ¡§ARQ 531 was selected and extensively tested preclinically to address the emerging therapeutic needs of patients who have become resistant to covalent BTK inhibitors in a broad set of hematologic malignancies,¡¨ commented Dr. Jennifer Woyach, Associate Professor of Medicine at The Ohio State University and the Principal Investigator of the study. ¡§It is tremendously gratifying to witness the emergence of a potential therapeutic for patients with such a high degree of unmet need, such as C481S-mutant CLL and Richter¡¦s Transformation, and beyond. The data presented in this poster provide compelling proof-of-concept for this novel class of reversible BTK inhibitors.¡¨ The reported data are from the phase 1, open label, single arm dose escalation study and include patients (n=47) initially dosed at levels of 5, 10, 15, 20, 30, 45, 65 and 75 mg once a day with relapsed or refractory chronic lymphocytic leukemia (CLL), small lymphocytic leukemia (SLL), Richter¡¦s Transformation, Waldenstrom macroglobulinemia and other B-cell Non-Hodgkin lymphomas. Key Findings: 65 mg QD was selected as the Recommended Phase 2 Dose (RP2D) for further studies |
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·|û¡G«Ó°¶10144972 µoªí®É¶¡:2020/7/27 ¤W¤È 11:57:05²Ä 3213 ½g¦^À³
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ÃÙ¦¨§ë¸ê¬ö«ß¤j §Úı±o´Nºâ¬OÀ´^¤åªº¤]ı±o¤£¦n¶ñ ¹³§Ú¦³¨Ç®æ¤l¤]¬O¤£ª¾¶ñ¤°»ò ¤½¥qÀ³¸ÓÀ°¥xÆW§ë¸ê¤H·Q·Q¡A©ñÓ½d¨Ò |
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·|û¡G§ë¸ê¬ö«ß10145266 µoªí®É¶¡:2020/7/27 ¤W¤È 10:13:40²Ä 3212 ½g¦^À³
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¤½¥qÀ³¸Ó¥i¥H²³æ¥Î¤@Ó½d¨Ò¨Ó¨ó§U§ë¸ê¤H¤@¦¸´N¶ñ§´©Ò»Ýªº¸ê®Æ §Ú¬Û«HÁÙ¬O¦³¤@¨Ç¤H¬Ý¨ìº¡º¡ªº^¤å·|¤£ª¾¦p¦ó¬O¦n °µÓ½d¨Ò¤]¥i¥H¬Ù¤U«Ü¦h³Â·Ð.. |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2020/7/27 ¤W¤È 09:51:11²Ä 3211 ½g¦^À³
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clinicaltrials.gov/ct2/show/results/NCT01859988?view=results dupilumab 2b 380 ¤Hªº¹êÅç¼Æ¾Ú¡A¦p¤W. |
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TRANSFER I/We, (the Transferor) Account Number: _________________________________ DO HEREBY transfer to JPMorgan Chase Bank, N.A. (the Transferee) Shareholder Number: 00001 the ordinary shares at par value of NT$10.00, equivalent to ___________________ ADSs (ordinary share: ADS = 5:1) standing in my/our name in the undertaking called ASLAN Pharmaceuticals Limited to hold the same unto the Transferee Dated: __________________, 2020 Signed by the Transferor _______________________________ _______________________________ Signature/Authorized Signature Chop/Seal (if available) N.B. The same authorized signature/chop with Stock Service Agent specimen card is required. CONVERSION DOCUMENT 2 LETTER OF TRANSMITTAL Dated: ___________________, 2020 To: CAPITAL Securities Co. Ltd. B2 No. 97, Sec. 2, Dunhua S. Rd., Da¡¦an Dist., Taipei City 106, Taiwan (R.O.C.) +886 2 2702-3999 1. Name of Issuer: ASLAN Pharmaceuticals Limited (the ¡§Company¡¨) 2. Number of Ordinary Shares to be deposited: _____________________________ (the ¡§Deposited Securities¡¨)1 3. Number of ADSs to be Issued (Each ADS Representing Five Ordinary Shares): ________________________ 4. Name of U.S. Broker Where the Undersigned Has an Account: _____________________________________2 5. U.S. Brokerage Account Number: ____________________________________________________________ 6. DTC Participant Account Number for such U.S. Broker: __________________________________________ 7. Sub-Brokerage Account Name (if any): ________________________________________________________ 8. Sub-Brokerage Account Number (if different from the U.S. Brokerage Account Number): ___________________ 3 9. Share Extract Date: ________________________________________________________________________4 10. Share Certificate Number: ___________________________________________________________________ 11. Shareholder Registration Number: ____________________________________________________________ 1 Items 2 - 4: shareholder to provide. 2 Items 5 - 8: shareholder to get this information from broker. 3 If there is no Sub-Brokerage Account, please either leave blank or insert N/A. 4 Items 9 - 11: shareholder can leave this blank. Local Administrator/Cayman Registrar will complete. Dear Sirs: We refer to the Instrument of Transfer, executed by the undersigned (the ¡§Transferor¡¨), pursuant to which the Transferor has transferred the Deposited Securities of the Company into the name of JPMorgan Chase Bank, N.A. in its capacity as depositary for the benefit of holders of ADRs (the ¡§Depositary¡¨). Capitalized terms used but not defined herein have the meanings assigned to such terms in the Deposit Agreement. In connection with the transfer of the Deposited Securities, the Transferor hereby confirms that (a) it has opened the above-referenced account with the U.S. broker named above and that such U.S. broker is a participant within, or otherwise has access to The Depository Trust Company (¡§DTC¡¨), (b) such U.S. broker has informed the Transferor of such Transferor¡¦s U.S. Brokerage Account Number and Sub-Brokerage Account Number (if any) at such U.S. broker, (c) it has instructed such U.S. broker to initiate a DWAC (Deposit/withdrawal at custodian) request within DTC containing the US. Brokerage Account Number and Sub-Brokerage Account Number (if any) set forth above and (d) it authorizes the addressee of this Letter of Transmittal, in its capacity as conversion agent for the Company (the ¡§Conversion Agent¡¨) to (i) receive the Deposited Securities from the Transferor and deposit such Deposited Securities, for and on behalf of the Transferor, with the Depositary under the Deposit Agreement dated as of May 8, 2018 among the Company, the Depositary and all holders from time to time of American Depositary Receipts issued thereunder (as the same may be amended and restated and/or amended from time to time, the ¡§Deposit Agreement¡¨), (ii) in connection with such deposit, provide a written order to the Depositary (each a ¡§Global Letter of Transmittal¡¨) directing the Depositary to accept the U.S. broker initiated DWAC referencing the U.S. Brokerage Account Number and Sub-Brokerage Account Number (if any), and to issue American Depositary Shares representing the Deposited Securities (the ¡§ADSs¡¨) in book entry form in accordance with the issuance information/delivery instructions set forth above, against payment by the Transferor of any amounts owing under the Deposit Agreement, and (iii) provide the issuance information/delivery instructions set forth above to the Depositary as part of a master list which we understand shall be attached to a Global Letter of Transmittal so as to enable the Depositary to issue the ADSs after the Transferor¡¦s U.S. broker has requested a DWAC (which shall include the U.S. Brokerage Account Number and Sub-Brokerage Account Number (if any) set forth above) for the ADSs to which the Transferor might be entitled. The Transferor acknowledges and agrees that all amounts owing under the Deposit Agreement will be collected by the Conversion Agent for forwarding to the Depositary. The Transferor also acknowledges and agrees that should its U.S. broker fail to properly request a DWAC containing the U.S. Brokerage Account Number and Sub-Brokerage Account Number (if any) set forth above within five U.S. trading days of the submission of a Global Letter of Transmittal, the Depositary may return the Deposited Securities to the Conversion Agent for return to the Transferor and any and all fees under the Deposit Agreement related to the deposit of such Deposited Securities shall be retained by the Depositary to cover processing costs related to the same. In connection with the deposit of the Deposited Securities, the Transferor certifies, confirms, represents, warrants, agrees and covenants to the Conversion Agent that (1) the Transferor has read all of the representations and warranties applicable to it that are set forth in the Deposit Agreement pursuant to which the Deposited Securities will be deposited including, without limitation, those set forth in paragraph (1) of the form of ADR attached to the Deposit Agreement, (2) all of such representations and warranties set forth in the Deposit Agreement are incorporated herein by this reference, and are deemed to be a part hereof as if directly set forth herein, (3) the deposit to be made in accordance with this Letter of Transmittal and pursuant to such Deposit Agreement will be in compliance with the representations, warranties and provisions of such Deposit Agreement and all applicable laws, rules and regulations, and (4) by causing such Deposited Securities to be deposited, the Transferor will be bound by the provisions of the Deposit Agreement. The Transferor hereby further certifies, confirms, represents and warrants that the Deposited Securities have either been registered under the U.S. Securities Act of 1933, as amended (the Securities Act), or the deposit, sale and transfer of such Deposited Securities is exempt from the registration requirements thereof. The Transferor hereby further certifies, confirms, represents, warrants, agrees and covenants that: (A) (1) the Transferor is not an ¡§issuer¡¨ of the Deposited Securities and is not directly or indirectly acting for such ¡§issuer,¡¨ is not an ¡§affiliate¡¨ (as defined in Rule 144(a)(1) promulgated under the Securities Act) of such issuer, and has not been an affiliate of such ¡§issuer¡¨ during the preceding three (3) months, (2) the Transferor has not purchased any of such Deposited Securities directly or indirectly from an ¡§issuer¡¨ or an ¡§affiliate¡¨ of an ¡§issuer¡¨ in a transaction or chain of transactions not involving any public offering, and the Deposited Securities are not otherwise ¡§restricted securities¡¨ (as defined in Rule 144(a)(3) promulgated under the Securities Act), (3) the Transferor has not purchased any of such Deposited Securities from an ¡§issuer¡¨ with a view to distribution, is not proposing to offer or sell any of such Deposited Securities for an ¡§issuer¡¨ in connection with the distribution of such Deposited Securities, and is not participating, and does not have a direct or indirect participation, in any such undertaking or in the direct or indirect underwriting of any such undertaking, and (4) such Deposited Securities do not constitute the whole or a part of an unsold allotment to or subscription by a ¡§dealer¡¨, as a participant in the distribution of such Deposited Securities by the Company issuing the same or by or through an ¡§underwriter¡¨; or (B) to the extent (1) the Transferor is an issuer of such Deposited Securities or is directly or indirectly acting for such ¡§issuer¡¨ or is an ¡§affiliate¡¨ of such ¡§issuer¡¨, or has been an affiliate of such ¡§issuer¡¨ during the preceding three (3) months, or (2) the Deposited Securities were acquired directly or indirectly from an ¡§issuer¡¨ or an ¡§affiliate¡¨ of an ¡§issuer¡¨ in a transaction or chain of transactions not involving any public offering, or the Deposited Securities are ¡§restricted securities¡¨, the Transferor (a) is currently able to sell all of the ADSs issuable on the deposit of such Deposited Securities in a single transaction pursuant to (i) an effective registration statement under the Securities Act or (ii) Rule 144 promulgated under the Securities Act, and in the case of each of sub-clause (i) and (ii), any purchaser of such ADSs and/or the Deposited Securities represented thereby will not receive ¡§restricted securities¡¨, (b) in the case of a sale made or to be made in reliance on Rule 144 promulgated under the Securities Act, the Transferor and its broker, if any, have complied with all of the requirements of Rule 144 with respect to the ADSs to be issued on deposit of such Deposited Securities, or it and its broker, if any, represent and covenant that all such requirements of Rule 144 will be on the sale of such ADSs fully complied with, (c) in the case of a sale made or to be made in reliance on Rule 144 promulgated under the Securities Act, has placed an order to sell, or represents and covenants that it has a bona fide intention to sell, the ADSs issuable upon deposit of such Deposited Securities within a reasonable time after the issuance thereof, in the manner required by Rule 144, or, at the time of deposit, the requirements of paragraphs (c), (e), (f) and (h) of Rule 144 shall not then apply so that such Deposited Securities may be freely transferred and may otherwise be offered and sold freely in the United States, and (d) has notified the Depositary and the ¡§issuer¡¨ of such Deposited Securities that such Deposited Securities are being deposited in accordance with this clause (B), and has provided each of the Depositary and such ¡§issuer¡¨ with legal opinions, representation letters and such other information as and to the extent requested by the Depositary and/or such ¡§issuer¡¨ prior to requesting such ¡§issuer¡¨ or its transfer agent and/or share registrar to re-registrar the Deposited Securities to be deposited in the name of JPMorgan Chase Bank, N.A. as depositary for the benefit of holders of ADRs (or as otherwise directed by JPMorgan Chase Bank, N.A.). For the purposes of this certification the term ¡§issuer¡¨ includes not only the Company but also any person directly or indirectly controlling, controlled by or under direct or indirect common control with the Company; the term ¡§dealer¡¨ means any person who engages either for all or part of his time, directly or indirectly, as agent, broker, or principal, in the business of offering, buying, selling, or otherwise dealing or trading in securities issued by another person; the term ¡§underwriter¡¨ means any person who has purchased from the ¡§issuer¡¨ the securities presented for deposit with a view to, or offers or sells for the ¡§issuer¡¨ in connection with, the distribution of any such securities, or participates or has a direct or indirect participation in any such undertaking, or participates or has a participation in the direct or indirect underwriting of any such undertaking; but the term ¡§underwriter¡¨ does not include a person whose interest is limited to a commission from an underwriter or dealer not in excess of the usual and customary distributors¡¦ or seller¡¦ commission. The Transferor hereby further certifies, confirms, represents, warrants, agrees, covenants and guarantees that: (1) the Deposited Securities are not subject to any pre-emptive or similar rights; (2) the Deposited Securities are duly authorized, validly issued, fully paid and non-assessable, and were legally obtained by the Transferor; (3) all pre- emptive (and similar) rights with respect to the Deposited Securities have been validly waived or exercised; (4) the Transferor is duly authorized to cause the Deposited Securities to be deposited and has fulfilled all requirements of applicable law or regulation with respect to the Deposited Securities or the deposit thereof against the issuance of ADSs; (5) the Deposited Securities are free and clear of any lien, encumbrance, security interest, charge, mortgage or adverse claim; (6) the Deposited Securities have not been stripped of any rights or entitlements; (7) the Deposited Securities are not subject to any unfulfilled requirements of applicable law or regulation; (8) the deposit of the Deposited Securities with JPMorgan Chase Bank, N.A., the entry in the register of members of the Company of JPMorgan Chase Bank, N.A. as the registered holder of the Deposited Securities, the issuance of ADSs representing the Deposited Securities, and any offer, transfer, sale, pledge or other disposition of the ADSs or the Deposited Securities represented thereby do not conflict with or result in a breach of any terms or provisions of the Company¡¦s governing charter documents or any law, rule or regulation, and do not require any order, consent, permit, license, validation, exemption, authorization or approval of or registration with any governmental authority or agency or other official body; and (9) there are no restrictions under law on the transfer of any of the Deposited Securities or the rights of the holder of the Deposited Securities to hold or vote such Deposited Securities. The Transferor does hereby unconditionally guarantee that the Deposited Securities are genuine and that the Transferor has good title to them, and that there are no stops or restraints against the same on the books of the above Company or otherwise, and the Transferor agrees that at all times hereafter, if for any reason the Depositary, the Custodian or any other party or parties should make claim on said Deposited Securities or declare said Deposited Securities to be invalid, if for any reason JPMorgan Chase Bank, N.A. is not recognized or at any time fails to continue to be recognized as the holder or the certification made above was not true when made, the Transferor will, upon request, substitute other valid securities. The Transferor authorizes the Conversion Agent to rely upon the certifications, confirmations, representations, warranties, agreements, covenants and guarantees made by the Transferor hereunder for purposes of issuing a Global Letter of Transmittal to the Depositary and providing corresponding certifications, confirmations, representations, warranties, agreements, covenants and guarantees to the Depositary pursuant to a Global Letter of Transmittal. The Transferor also authorizes the Depositary and its agents to rely upon the certifications, confirmations, representations, warranties, agreements, covenants and guarantees made by the Transferor hereunder for purposes of confirming the Global Letter of Transmittal(s) to be submitted to the Depositary by the Conversion Agent. The Transferor acknowledges and agrees that its indemnities, acknowledgements, certifications, confirmations, representations, warranties, agreements, covenants and guarantees herein shall survive the deposit of the Deposited Securities under the Deposit Agreement, the issuance of ADSs representing the Deposited Securities, any offer, transfer, sale, pledge or other disposition of the ADSs or the Deposited Securities represented thereby, any surrender and cancellation of ADSs, and any withdrawal of Deposited Securities represented by ADSs. Certified and Agreed to as of the date first above written: _________________________________________________ (Firm name for institutional holders) By: _________________________________________________ (Signature) Name in full: _________________________________ Title (if any): _________________________________ Contact Phone Number: _________________________ N.B. The same authorized signature/chop with Stock Service Agent specimen card is required. |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2020/7/25 ¤W¤È 09:20:41²Ä 3203 ½g¦^À³
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·|û¡G§_¨ì©³°Õ10148994 µoªí®É¶¡:2020/7/24 ¤U¤È 05:16:25²Ä 3202 ½g¦^À³
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2020/7/24 ¤U¤È 03:21:12²Ä 3201 ½g¦^À³
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ADÃĤýDupilumab ¥¼¨Ó±N¾P110»õ¬ü¤¸. ---------------------------------------------------------- ¯SÀ³©Ê¥Öª¢--¬ð¯}Àøªk(Breakthrough Therapy Designation in Atopic Dermatitis) ----Dupilumab , 2014/07/10 Dupilumab ¦U´ÁÁ{§É¼Æ¾Ú¡C ¦]¬°2a/2b dupilumab ¼Ð¹vªvÀøAD Àø®Ä(ESAI ¥§¡°´T)Àu²{¦³Àøªk3.2¿! P< 0.001 ©Ò¥H2014/07/10 ÀòFDA BTD--in AD ¯SÀ³©Ê¥Öª¢--¬ð¯}Àøªk(Breakthrough Therapy Designation in Atopic Dermatitis) ³Ì«á¤T´ÁÁ{§É dupilumab /¹ï·Ó²Õ ESAI ¥§¡°´T :1.9~2.2 ¿ ®t²§ (1)2a/12 ¶gªº§¹¥þ§í¨îÀø®Ä(300mg/¨C¶g¤@°w) 3900mg ESAI ¥§¡°´T 73.6% ¹ï·Ó²Õ:ESAI ¥§¡°´T 23.2% 73.6%/23.2%=3.2¿ (2)2b/12 ¶gªº§¹¥þ§í¨îÀø®Ä(300mg/¤G¶g¤@°w) 2100mg ESAI ¥§¡°´T 66.7% ¹ï·Ó²Õ :ESAI ¥§¡°´T 20.4% 66.7%/20.4%=3.3¿ --------------------------------------------------------------- (3) ¤T´Á /16 ¶gªº§í¨îÀø®Ä(300mg/¤@¶g¤@°w) ,5100mg,ESAI ¥§¡°´T 72%/69.1% ¹ï·Ó²Õ :ESAI ¥§¡°´T 37.6%/30.9% 72%/37.6%=1.9¿ 69.1%/30.9%=2.2¿ (4) ¤T´Á /16 ¶gªº§í¨îÀø®Ä(300mg/¤G¶g¤@°w) ,2700mg,ESAI ¥§¡°´T 72.3%/67.1% ¹ï·Ó²Õ :ESAI ¥§¡°´T 37.6%/30.9% 72.3%/37.6%=1.9¿ 67.1%/30.9%=2.2¿ 1. Dupilumab ¦´Á¥|Ó AD Á{§É 4¶g/12¶g , 2014/07/10 Dupilumab Treatment in Adults with Moderate-to-Severe Atopic Dermatitis www.nejm.org/doi/10.1056/NEJMoa1314768 2. Dupilumab 2a/2b Á{§É ,2018/SEP journals.lww.com/jaanp/Fulltext/2018/09000/Efficacy_and_safety_of_dupilumab_for_the_treatment.10.aspx 3.Dupilumab AD 2Ó¤T´ÁÁ{§É, 300mg/¨C¶g¤@°w/300mg/¨C¤G¶g¤@°w 2016/12/15 Two Phase 3 Trials of Dupilumab versus Placebo in Atopic Dermatitis investor.regeneron.com/news-releases/news-release-details/regeneron-and-sanofi-announce-dupilumab-has-received-fda/ 2014¦~11¤ë20¤é Regeneron©MSanofi«Å¥¬Dupilumab¤wÀò±oFDA¯SÀ³©Ê¥Öª¢¬ð¯}ÀøªkªººÙ¸¹ ¯Ã¬ù¦{¶ð¨½´°©M¤Ú¾¤¡A2014¦~11¤ë20¤é¡A¬ü³qªÀ/-Regeneron Pharmaceuticals¡AInc.¡]NASDAQ¡GREGN¡^©MÁÉ¿Õµá¡]Sanofi¡^¤µ¤Ñ«Å¥¬¡A¬ü°ê¹«~ÃÄ«~ºÊ·þºÞ²z§½¡]FDA¡^¤w±Â¤©dupilumab¬ð¯}©ÊªvÀøªººÙ¸¹±w¦³¤¤«×¦Ü««×ªº¯SÀ³©Ê¥Öª¢¡]AD¡^ªº¦¨¦~¤H¡A³o¨Ç±wªÌµLªk³q¹L§½³¡³B¤èªvÀø±o¨ì¥R¤À±±¨î©M/©Î¤£¾A¦X³o¨ÇªvÀø¡C Dupilumab¬O¤@ºØ¬ã¨s©ÊÀøªk¡A¥iªýÂ_IL-4©MIL-13¡A³o¬OTh2§K¬ÌÀ³µª©Ò»Ýªº¨âºØ²ÓM¦]¤l¡C¸Ó¦WºÙ°ò©ó1´Á©M2´ÁÁ{§É¸ÕÅ窺¥¿¦Vµ²ªG¡C ¡§¤¤«×¦Ü««×¯SÀ³©Ê¥Öª¢¬O¤@ºØ¨Ï¤H°I®z¡A§ïÅܥͩRªº¯e¯f¡AªvÀø¿ï¾Ü«D±`¦³¡C³\¦h±wªÌ¦h¦~¨Ó¾D¨ü¼sªxªº¥Ö½§µoª¢¡A¼@¯Pªºæ±Äo¡AºÎ¯v»Ùê©M¨ä¥L¬D¾Ô¡A¡¨º®u°õ¦æ©x¦¶²ú¡P¥¬¬¥§J»¡¡A¥þ°êÀã¯l¨ó·|¡C ¡§§ÚÌ«Ü°ª¿³¬Ý¨ìFDA»{ÃѨì»Ýn¥[§Ö©MÀu¥ý¦Ò¼{³o¨Ç±wªÌªº¼ç¦b·s¿ï¾Ü¡C¡¨ FDA³Ð«Ø¤F¬ð¯}©ÊÀøªk¦WºÙ¡A¥H¥[§Ö°w¹ïÄY«©Î¦M¤Î¥Í©Rªº¯e¯fªºÃĪ«ªº¶}µo©M¼f¬d¡C¬ð¯}©ÊªvÀøÃĪ«¥²¶·Åã¥Ü¥Xªì¨BªºÁ{§ÉÃÒ¾Ú¡Aªí©ú¦bÁ{§É¤WÅãµÛ§ïµ½ªº²×ÂIÅãµÛÀu©ó²{¦³Àøªk¡A¦pªG¨S¦³¥i¥ÎÀøªk¡A«hÀu©ó¦w¼¢¾¯¡C¸Ó¦WºÙ¥]¬A©Ò¦³Fast Trackp¹º¥\¯à¡A¥H¤Î§ó²`¤JªºFDA«ü¾É©M°Q½×¡C¬ð¯}©ÊÀøªkªº¦WºÙ¤£¦P©ó¥[³t§åã©MÀu¥ýÅv¼f¬d¡A¦pªGº¡¨¬¬ÛÃö¼Ð·Ç¡A¤]¥i¥H±Â¤©¦P¤@ÃĪ«¡C ¥¿¦b¶i¦æ¤¤«×¦Ü««×¯SÀ³©Ê¥Öª¢¦¨¤Hªºdupilumabªº¥þ²y3´ÁÁ{§É¸ÕÅçp¹º¡C¦³Ãö§ó¦h«H®§¡A½Ð³X°Ýclinicaltrials.gov¡C Ãö©óDupilumab©MIL-4 / IL-13«H¸¹¶Ç¾É ¥þ¤HÃþ³æ§J¶©§ÜÅéDupilumab°w¹ï¦@¨ÉªºIL-4¨üÅé£\¨È°ò¡A«áªÌ¥iªýÂ_¨Ó¦ÛIL-4©MIL-13ªº«H¸¹¶Ç¾É¡C IL-4©MIL-13¬O¤Þµo©Mºû«ùTh2¡]2«¬»²§U©ÊT²ÓM¡^§K¬ÌÀ³µª©Ò»ÝªºÃöÁä²ÓM¦]¤l¡ATh2³Q»{¬°¬O¹L±Ó©Êª¢¯gªºÃöÁä³~®|¡C Dupilumab¬O¨Ï¥ÎRegeneronªº¶}³Ð©ÊVelocImmune®§Þ³N³Ð«Øªº¡A¨Ã»PÁÉ¿Õµá¦@¦P¶}¾v¥Î©ó¯SÀ³©Ê¥Öª¢¡Aý³Ý©MºC©Ê»óÄuª¢¥H¤Î»ó®§¦×¯f¡C Dupilumab¬O³B©óÁ{§É¶}µo¶¥¬qªº¬ã¨sÃĪ«¡A¨ä¦w¥þ©Ê©M¦³®Ä©Ê©|¥¼±o¨ì¥ô¦óºÊºÞ¾÷ºcªº¥þ±µû¦ô¡C |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2020/7/24 ¤W¤È 09:36:23²Ä 3200 ½g¦^À³
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¥|¶g¤@°w¡A«e/\¶g°w¾¯¶q¡A¤ñ«á8¶g«¾¯¶q¬O¦X²z³]p¡C 600mg/600mg/200mg/200mg,¦Xp1600mg ´N«Ü¼F®`ªº谮¤O¡C «e5-8¶g¡A¤w¡B1200mg,¤§³]p¡C §C©ó1600mg,´N³Æ¦Ó¤£¥Î ¦p600mg/400mg/200mg/200mg =1400mg¥ç¨Î |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2020/7/24 ¤W¤È 08:57:00²Ä 3199 ½g¦^À³
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ASLAN004 200mg/¨C¶g¤@°w¡A«e¤T¦ì¥§¡ESAI°´T71%¬O4-6¶gªºªvÀø¡AY¥§¡5¶g¡A1000mg ¤w±µªñDupilumab ¤W¥«¡A¤T´ÁÁ{§É¡A¤G¶g¤@针ªº¤ô·Ç¡C 9x300mg=2700mg ¤]´N¬O»¡ASLAN004 1000mg µ¥¦PDupilumab2700mg ªº¹w«áÀø®Ä¡C 10/27=38% Ävª§¤O¶WüL¡AY¥[¤W¥|¶g¤@针³]p¡A§C°Æ§@¥Î¡C ºÙ¥¼¨ÓAD/ý³ÝÃĤý¡A«Ü¸Ø¤j¶Ü¡H û¡G¤Ñ©R10141925 µoªí®É¶¡:2020/7/24 ¤W¤È 06:06:17²Ä 3196 ½g¦^À³ 1b AD ASLAN004 200mg /¨C¶g¤@°wx8¶g¡A¤w±µªñ³Ì¨Î¾¯¶q, 400mg/600mg ¦b´ú@¨ü©Ê/¦w¥þ©Ê/¥|¶g¤@°w©Ò¶·¼Æ¾Ú ¦pDupilumab ¤T´ÁÁ{§É ¨C¶g¤@°w¾¯¶q¦Xp5100mg /¨C¤G¶g¤@°w¾¯¶q2700mg =188% ¦ý¤GªÌESAI °´T®t²§¤£¤j¡C ¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X ASLAN004 1b 200mg/¨C¶g¤@°w*8¶g=1600mg «e¤T¦ì 85%/70%/59%(4-6¶g) ESAI ¥§¡°´T 71%.---¦ô²Ä8¶g ESAI ¥§¡°´T 77%-78% (¤w±µªñ³Ì¨Î) Dupilumab 2a/2b/¤T´ÁÁ{§É¹w«áÀø®Ä (1)2a/12 ¶gªº§¹¥þ§í¨îÀø®Ä(300mg/¨C¶g¤@°w) 3900mg ESAI ¥§¡°´T 73.6% (2)2b/12 ¶gªº§¹¥þ§í¨îÀø®Ä(300mg/¤G¶g¤@°w) 2100mg ESAI ¥§¡°´T 66.7% (3) ¤T´Á /16 ¶gªº§í¨îÀø®Ä(300mg/¤@¶g¤@°w) ,5100mg,ESAI ¥§¡°´T 72%/69.1% (4) ¤T´Á /16 ¶gªº§í¨îÀø®Ä(300mg/¤G¶g¤@°w) ,2700mg,ESAI ¥§¡°´T 72.3%/67.1% 2. Dupilumab 2a/2b Á{§É , 300mg/¨C¶g¤@°w/300mg/¨C¤G¶g¤@°w x12¶g 2018/SEP, journals.lww.com/jaanp/Fulltext/2018/09000/Efficacy_and_safety_of_dupilumab_for_the_treatment.10.aspx 3.Dupilumab AD 2Ó¤T´ÁÁ{§É, 300mg/¨C¶g¤@°w/300mg/¨C¤G¶g¤@°wx16¶g 2016/12/15 Two Phase 3 Trials of Dupilumab versus Placebo in Atopic Dermatitis www.nejm.org/doi/full/10.1056/nejmoa1610020 |
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¥¼¨Ó AD/ý³ÝÃĤý¡X¡XASLAN004 ¤@¡B¨È·à±d¤½¥q³Ìªñ²¤¶ 2020,05,26 ¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X ASLAN004¦³¼ç¤O¦¨¬°¦P¯e¯f³Ì¨ÎÀøªk 1. IL-13R£\1 §í¨î¾¯: ASLAN004¬O°ß¤@Âê©wIL-13R£\1ªº³æ®è§ÜÅé¡A¦³¼ç¤O¦¨¬°ªvÀø²§¦ì©Ê ¥Ö½§ª¢»P®ð³Ý¤§³Ì¨ÎÀøªk 2.¾÷Âà¤wÀòÃÒ¹ê :»PdupilumabÂê©w¬Û¦Pªº¸ô®|»P¨üÅé½Æ¦XÅé(·¥Àø®ÄÀ³¬Û·í) 3.Âê©w¥«³õ°Ï¹j®ÄªG:¨ãÀø®Ä¼W¶i¤§¼ç¤O¡B´î¤Ö¤£¨}¤ÏÀ³(µ²½¤ª¢) ¡B¨C¤ëµ¹ÃĤ@¦¸(«¤jªºÄvª§Àu¶Õ) §¹¦¨³æ¤@¾¯¶q»¼¼W¸ÕÅç. 4.¤w§¹¦¨°·±d¨ü¸ÕªÌªº¤@´Á³æ¤@¾¯¶q»¼¼W¸ÕÅç¡C¦Ü¤µ©|¥¼µo²{©ú Å㤣¨}¤ÏÀ³¡C¥ÎÃÄÀW²v¥i±æ¬°¨C¤ë¤@¦¸¡C ¦h¾¯¶q»¼¼W¸ÕÅç/·§©À ©ÊÅçÃÒ¶i¦æ¤¤ 5.¦h¾¯¶q»¼¼W¸ÕÅç/·§©À©ÊÅçÃÒªº²Ä¤G¾¯¶q±Ú¸s²{¥¿¦¬®×¤¤¡C ªì´ÁÀø®Ä¥O¤H®¶¾Ä¡C aslanpharma.com/app/uploads/2020/05/20-05-19-ASLAN-CN.pdf ¤G¡BDupilumab ¾P°â¹w´Á110»õ¬ü¤¸/¦~°ªÂI¡C 2019/12 REGNªº CEO «Å¥¬Dupilumab ¥¼¨Ó¾P°â°ªÂI110»õ¬ü¤¸¡A¶W¥X¥«³õ¹w´Á50»õ¬ü¤¸¡Cªñ¥b¦~ªÑ»ù¥«È¤jº¦300»õ¬ü¤¸. 2017/Q3¤W¥« 2018¾P°â8»õ¬ü¤¸ 2019¾P°â23»õ¬ü¤¸ 2020¦ô ¾P°â40»õ¬ü¤¸ 2021¦ô ¾P°â60»õ¬ü¤¸ 2022¦ô ¾P°â80»õ¬ü¤¸ 2023¦ô ¾P°â100/110»õ¬ü¤¸ ¤T¡B¹w´ÁASLAN004 ¾P°â°ªÂI70»õ¬ü¤¸¡A¬°Duilumab 110»õ¬ü¤¸64%. 1.Ävª§Àu¶Õ: A. IL-13R£\1 §í¨î¾¯: ASLAN004¬O°ß¤@Âê©wIL-13R£\1ªº³æ®è§ÜÅé¡A¦³¼ç¤O¦¨¬°ªvÀø²§¦ì©Ê ¥Ö½§ª¢»P®ð³Ý¤§³Ì¨ÎÀøªk B.¾÷Âà(MOA)¤wÀòÃÒ¹ê :»PdupilumabÂê©w¬Û¦Pªº¸ô®|»P¨üÅé½Æ¦XÅé C.¨C¥|¶g¥ÎÃĤ@¦¸¡A 16¶gÀøµ{¥ÎÃĶq¹wp¬°800mg~1600mg,¬°Dupilumab 2700mg ªº30%~60%ªº¼ç¤O. D.. ASLAN004 1a Á{§Éµ²½× °w¹ï¤U´å¤¶½è©Ò¶i¦æ¤§¤ÀªRÅã¥Ü¡A ¦bIVµ¹ÃĪº¤@¤p®É¤º¡A¥]¬A¦b¹L±Ó©Êµoª¢¤ÏÀ³¤¤§êºt«n¨¤¦â¤§¤¶½è,¡§ÁC»Ä¤ÆSTAT6 (pSTAT6)¡¨§Y¨ü¨ì§¹¥þ§í¨î¡A¥B¤@ÃĪ«°Ê¤O¦±½u¹Ï(pharmacokinetic profile)Åã¥ÜASLAN004ªºµ¹ÃÄÀW²v¥i±æ¬°¨C¤ë¤@¦¸¡C ¯S§Oȱoª`·Nªº¬O¡A¸ÕÅç¼Æ¾Ú«ü¥XASLAN004§¹¥þ§í¨î¨ü¾¹°T¸¹¶Ç»¼©Ò»Ýªº³Ì§C¿@«× (trough level)¤ñ²{¦³ªvÀø¤è¦¡©Ò»Ýªº¿@«×§C¡A¿@«×®t¶Z¶W¹L¤@Ӽƶq¯Å(10~99¿)¡C ¥|¡BÄvª§µ¦²¤: ¥Ñ©óASLAN004 ¤W¥«®É¶¡¡A¹w¦ô¦b¤¦~«á¡A±Á{Dupilumab ±M§Q¨ì´Á¡A¨ä¥é¥ÍÃıN¥HDupilumab q»ù80%¶i¤JÉ]³õ¡A 1.§C¦¨¥»/(§C¥´°wÀW²v/§CÃĶq),§C°Æ§@¥Î ¥Ñ©óASLAN004,¥ÎÃĶq¬Û·í§C¡A ¦ôp¥H16¶g/¨C¥|¶g¤@°w, Àøµ{¥Î¶q1600mg vs Dupilumab ,2¶g¤@°w 2700mg, »â¥ý¥«³õ¡C (ASLAN004 800mg~1400mg ,³Æ¦Ó¤£¥Î) DUPILUMAB ¥ÎªÌ 25%~50%µ²½¤ª¢¡AASLAN004 µL¦¹°Æ§@¥Î¡C 2.q»ùµ¦²¤: ¥HDUPILUMAB x64%(§C©ó¨ä¥é¥ÍÃÄ»ù¦A¥´80%)¶i¤JÉ]³õ¡C ¬ü°êªk¥O³W©w: ¤½¡B¨p«O¡A¥ÎÃÄ¡A§CÃÄ»ù¥ý¥Î¡C 3.¾P°â¹Î¶¤; ¹w´Á¥@¬É²Ä¤G ªºÀq§JÃļt¹Î¶¤ ¤¡B¥Ø¼Ð¾P°â : DUPILUMAB 110»õ¬ü¤¸x64%=70»õ¬ü¤¸. |
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·|û¡G¥xÁÞ10138776 µoªí®É¶¡:2020/7/24 ¤W¤È 08:13:40²Ä 3197 ½g¦^À³
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¸É¥R»¡©ú «e«h¶K¤å¤À¨É¬O°²³]ASLAN004Àø®ÄÀu²§ ¡]¥]¬A¥ý«e¤j®a¤wª¾ªº¦w¥þ©Ê¡A¬I¥´¤è«K©Ê¡A¼u©ÊªºÃĪ«Àx¦sµ¥Ävª§Àu¶Õ¡^ ¦b°Ï¤À¤»Ó¤£¦P®É¬q½æ¥X«ùªÑ¡A»ù®æ·|¤£¤@¼Ë¡A²³æ»¡»ù®æ·|®t«Ü¤j¡A¨Ì¤Ñ©R¤jµû¦ô³Q¨ÖÁÊ»ùȳ̰ª |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2020/7/24 ¤W¤È 06:06:17²Ä 3196 ½g¦^À³
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1b AD ASLAN004 200mg /¨C¶g¤@°wx8¶g¡A¤w±µªñ³Ì¨Î¾¯¶q, 400mg/600mg ¦b´ú@¨ü©Ê/¦w¥þ©Ê/¥|¶g¤@°w©Ò¶·¼Æ¾Ú ¦pDupilumab ¤T´ÁÁ{§É ¨C¶g¤@°w¾¯¶q¦Xp5100mg /¨C¤G¶g¤@°w¾¯¶q2700mg =188% ¦ý¤GªÌESAI °´T®t²§¤£¤j¡C ¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X ASLAN004 1b 200mg/¨C¶g¤@°w*8¶g=1600mg «e¤T¦ì 85%/70%/59%(4-6¶g) ESAI ¥§¡°´T 71%.---¦ô²Ä8¶g ESAI ¥§¡°´T 77%-78% (¤w±µªñ³Ì¨Î) Dupilumab 2a/2b/¤T´ÁÁ{§É¹w«áÀø®Ä (1)2a/12 ¶gªº§¹¥þ§í¨îÀø®Ä(300mg/¨C¶g¤@°w) 3900mg ESAI ¥§¡°´T 73.6% (2)2b/12 ¶gªº§¹¥þ§í¨îÀø®Ä(300mg/¤G¶g¤@°w) 2100mg ESAI ¥§¡°´T 66.7% (3) ¤T´Á /16 ¶gªº§í¨îÀø®Ä(300mg/¤@¶g¤@°w) ,5100mg,ESAI ¥§¡°´T 72%/69.1% (4) ¤T´Á /16 ¶gªº§í¨îÀø®Ä(300mg/¤G¶g¤@°w) ,2700mg,ESAI ¥§¡°´T 72.3%/67.1% 2. Dupilumab 2a/2b Á{§É , 300mg/¨C¶g¤@°w/300mg/¨C¤G¶g¤@°w x12¶g 2018/SEP, journals.lww.com/jaanp/Fulltext/2018/09000/Efficacy_and_safety_of_dupilumab_for_the_treatment.10.aspx 3.Dupilumab AD 2Ó¤T´ÁÁ{§É, 300mg/¨C¶g¤@°w/300mg/¨C¤G¶g¤@°wx16¶g 2016/12/15 Two Phase 3 Trials of Dupilumab versus Placebo in Atopic Dermatitis www.nejm.org/doi/full/10.1056/nejmoa1610020 |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2020/7/24 ¤W¤È 05:39:59²Ä 3195 ½g¦^À³
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·|û¡G¬õ¹Ð¦³¹Ú10150039 µoªí®É¶¡:2020/7/24 ¤W¤È 04:52:47²Ä 3194 ½g¦^À³
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2020/7/23 ¤U¤È 04:14:11²Ä 3192 ½g¦^À³
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MOA ! «D±`¡A«D±` «n¡I ¤½¥q«ÅºÙ¤w½T»{¡C »PdupilumabÂê©w¬Û¦Pªº¸ô®|»P¨üÅé½Æ¦XÅé. ¤ñ¹ï ¨âÃÄMOA ¼v¤ù¡A½T¹ê¤@¼Ë ASLAN004 MOA -¼v¤ù aslanpharma.com/drug/aslan004/ 2.Dupilumab MOA -¼v¤ù www.dupixenthcp.com/atopicdermatitis/about/mechanism-of-action ¥¼¨Ó ASLAN004 2b/¤T´Á 16 ¶g Á{§É ¦U«ü¼Ð ¤ñ¹ï Dupilumab ¤T´ÁÁ{§É ¸ê®Æ§Y¥i¡C Dupilumab AD 2Ó¤T´ÁÁ{§É, 300mg/¨C¶g¤@°w/300mg/¨C¤G¶g¤@°w 2016/12/15 Two Phase 3 Trials of Dupilumab versus Placebo in Atopic Dermatitis www.nejm.org/doi/full/10.1056/nejmoa1610020 |
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EASI-50 ¥i»¡¬O1bªº«ü¼Ð¤¤¡A³Ì«n¡C ¥Nªí¦³ÃĪ«¤ÏÀ³¡CÃþ¥ÜªvÀø¸~½FªºORR¡C ASLAN004 2019/12/03 ,¤½¥¬3¦ì EASI-50,3/3=100% ¥t¥~¤T¦ì¡A¤w°µ§¹¡A²Ä¥|©u¤½¥¬¡C ¥t¥~¤T¦ì¡AEASI-50³Ì¤j¥i¯à¡A¤]¬O100%¡A ¦]¬°¨C¶g¤@°wx200mgSC ¨C¥|¶g800mg,¤w¶W¹LIV 10mg/kg,¥i§¹¥þ§í¨îªº¶q¡A§é¦X60kg SC 690mg ¨Ì¾ÚDupilumab 300mg/¨C¶g¤@°w¡A¦´ÁÁ{§É12¶g/8¶g¨£°ªûß°Ï¡A EASI-50 85% 预测ASLAN004«á¤T¦ì¡A100%ªº¾÷·|°ª¡C ¡K¡K¡K¡K¡K¡K¡K¡K¡K¡K¡K¡K Dupilumab ¤T´ÁÁ{§É¡A¤j°约50%ªº°w¾¯¶q¡A¨â¶g¤@°w¡A ¨Ï±oEASI-50 µ²ªG¡A¤j°¬°65%-69%¡A ¤ñ85%¤@¶g¤@°w¡AÀø®Ä¤j°20%¥ª¥k¡C ³o´N¬OASLAN004Àø®ÄÀu©óDupilumabªº¼ç¦b¾÷·|¡C 2bÁ{§É³]p¡A¨ì¥iªñ§¹¥þ§í¨îªº°w¾¯¶q/¥|¶g¤@针¡C ¤é«áq»ù¥Ø¼Ð¬°Dupilumab 64%,(¨¾¤îDupilumab ¥¼¨Ó±M§Q¨ì´Á«á¤j¶q¥é¥ÍÃĶi¤J¥«Ô·) ²Å¦X¬ü°ê¤½¡B¨p«OÀI¡A«K©yÃÄ¥ý¥Îªk¥O¡C ¥[¤WÀq§J¾P°âºô¸ô 110»õ¬ü¤¸x64%=70»õ¬ü¤¸ªºAD/ý³Ý ¥Ø¼Ð¥«³õ ¤j¤jÌ »{¬°®e©öÁÙ¬O§xÃø¡H ¤½¥q²¤¶¡A´±¼g¥X ¡K¡K¦P¬Ì¯f(AD/ý³Ý)³Ì¨ÎÀøªk¡K¡K ¥²¦³Ävª§¥«³õMOA/Á{§É¼Æ¾Ú¦õÃÒ¡A¤£¬OÀH«K¼gªº¡C Dupilumab ¤T´ÁÁ{§É,¤GÓÁ{§É (¤@).300 mg Q2W(¨â¶g¤@°w/16¶g) EASI-50 65%/69% ¡K¡K¡K¡K¡K¡K¡K¡K¡K¡K ¹Ï1 ESAI-50 ,¨ì²Ä35¤Ñ(²Ä¤¶g), ¤w¹F°ª®p°Ï, 300mg/¨C¶g¤@°w*12¶g.(°_©l¶q600mg+300mg *3=1500mg) , www.nejm.org/doi/10.1056/NEJMoa1314768 2.ªí2 Dupilumab ¦´Á 12¶g--¨C¶g¤@°w*300mg(°_©l¶q600mg) N=55 EASI-50 ¦b²Ä29¤Ñ,¹F69% ¦b²Ä85¤Ñ,¹F85% |
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¤½¥q²¤¶ ¤§«e ºÙASLAN004 ¦³¼ç¤O¦P¯Å³ÌÀu ¤w§ï¬° ¡X¡X¡X ASLAN004 ¦³¼ç¤O¦¨¬°¦P¯e¯f¡]AD¤Îý³Ý) ¤§³Ì¨ÎÀøªk¡X¡X¡X ¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X ASLAN004¦³¼ç¤O¦¨¬°¦P¯e¯f³Ì¨ÎÀøªk 1. IL-13R£\1 §í¨î¾¯: ASLAN004¬O°ß¤@Âê©wIL-13R£\1ªº³æ®è§ÜÅé¡A¦³¼ç¤O¦¨¬°ªvÀø²§¦ì©Ê ¥Ö½§ª¢»P®ð³Ý¤§³Ì¨ÎÀøªk 2.¾÷Âà¤wÀòÃÒ¹ê :»PdupilumabÂê©w¬Û¦Pªº¸ô®|»P¨üÅé½Æ¦XÅé 3.Âê©w¥«³õ°Ï¹j®ÄªG:¨ãÀø®Ä¼W¶i¤§¼ç¤O¡B´î¤Ö¤£¨}¤ÏÀ³(µ²½¤ª¢) ¡B¨C¤ëµ¹ÃĤ@¦¸ §¹¦¨³æ¤@¾¯¶q»¼¼W¸ÕÅç 4.¤w§¹¦¨°·±d¨ü¸ÕªÌªº¤@´Á³æ¤@¾¯¶q»¼¼W¸ÕÅç¡C¦Ü¤µ©|¥¼µo²{©ú Å㤣¨}¤ÏÀ³¡C¥ÎÃÄÀW²v¥i±æ¬°¨C¤ë¤@¦¸¡C ¦h¾¯¶q»¼¼W¸ÕÅç/·§©À ©ÊÅçÃÒ¶i¦æ¤¤ 5.¦h¾¯¶q»¼¼W¸ÕÅç/·§©À©ÊÅçÃÒªº²Ä¤G¾¯¶q±Ú¸s²{¥¿¦¬®×¤¤¡C ªì´ÁÀø®Ä¥O¤H®¶¾Ä¡C¹wp2021¦~¤W¥b§¹¦¨¡C aslanpharma.com/app/uploads/2020/05/20-05-19-ASLAN-CN.pdf p.7 |
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Dupilumab ¥ÎÃĶq¤@©wASLAN004 °ªªºì¦],°£¤F©M¸ÑÂ÷¨t¼Æ¤ñ¦³Ãö¥~ ¥t¤@Ó¦]¯À: ¦]¬°Dupilumab¦h¤@Óµ²¦X¸ô®|(A) , ¥h©M£^C ²Õ¦¨²Ä¤@«¬¨üÅé.¦ÓASLAN004¤£¥Î. A.²Ä¤@«¬¨üÅé(Type I Recepter)¬O¥ÑIL-4R£\ ¤Î£^C ²Õ¦¨¡A¥u¯à©MIL-4 µ²¦X¡C B.²Ä¤G«¬¨üÅé(Type II Recepter)¬O¥ÑIL-4R£\ ¤ÎIL-13R£\1 ²Õ¦¨¡A ¥i¥H©MIL-4 ©ÎIL-13µ²¦X¡C Dupilumab MOA -¼v¤ù www.dupixenthcp.com/atopicdermatitis/about/mechanism-of-action §Ü¤¶¥Õ¯À-4 ¤Î§Ü¤¶¥Õ¯À-13 ¥Íª«»s¾¯¥Î©óÄY««¬®ð³Ý www.tsim.org.tw/journal/jour29-6/02.PDF?fbclid=IwAR2B85aLqBUAt5agx6K7u0NkCGTGpr7w6HDCagHhLuu54ZH7FEqHMAdXG3M |
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ASLAN001 ±¹ï¶PÀù¥¤Îªñ10ºØ¥é¥ÍÃÄ,µLÄvª§¤O. ¦Ó©ñ±¼³Ì¦³Ävª§¤O¥i¦¨ORR ªºHER2/IHC+3 ¥«³õ. ¥i±¤«á¨Ó¨ä¥LHER1/HER3/HER4 §Ü·½¥«³õ¤Ó¤p. ASLAN004 n¥´Ä¹ÀsÀYDupilumab ¤Î¨ä¥é¥ÍÃÄ¥«³õªº¦¨¬°¥¼¨ÓADÀsÀY. ´N¾a, Àø®Ä¬Û·í §C¦¨¥» :ASLAN004004 800mg-1600mg vs Dupilumab ¥Î¶q2700mg/16¶g, 30%-60%(Ó¤H¦ôp) ·À¤Ö¥´°w¦¸¼Æ: ASLAN004 (¥|¶g¤@°w) vs Dupilumab (¨â¶g¤@°w) ·À¤@¥b °Æ§@¥Î: µLDupilumab¥ÎªÌ 25~50% µ²½¤ª¢°Æ§@¥Î. ¤½¥q5/26 ¤¤¤å²³ø ½Ð¸ÔŪ¨Ã¿Ë¦Û«ä¦ÒÅçÃÒ. aslanpharma.com/app/uploads/2020/05/20-05-19-ASLAN-CN.pdf ¤è¯à©êªº¦í,¨ì³Q¨ÖÁÊ. ¤£²`¤J«Ü®e©ö³Q¬~¥X¥h. |
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MOA www.tsim.org.tw/journal/jour29-6/02.PDF?fbclid=IwAR2B85aLqBUAt5agx6K7u0NkCGTGpr7w6HDCagHhLuu54ZH7FEqHMAdXG3M ¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X ³o½g¤¤¤å¬ã¨s¤å³¹¤@ ´N¬O§e²{¤TÃĪºý³Ý ¤T´ÁÁ{§É¼Æ¾Ú ¥u¦³Dupilumab ¹LÃö¡A¨ä¥LLebrikizumab¤ÎTralokinumab¬Ò¥¢±Ñ¡C Lebrikizumab & Tralokinumab MÆâA , ¥u¯àªýÂ_IL13 °T¸¹¶Ç»¼¡AµLªk§¹¥þªýÂ_IL4 °T¸¹¶Ç»¼¡A¥\¯à¤j´î75%~50%¡C µLªkªýÂ_ A¸ô®| (2): IL4 & IL-4R£\ ¦A±µ¦XIL-13R£\1 , ²Õ¦¨ªºII«¬¨üÅé, ¦]¦Ó±Ò°Ê²ÓM¤ºªº«H¸¹¶Ç»¼¡A¶i¦Ó¬¡¤ÆÂà¿ý¿E¬¡³J¥Õ6 (signal transducer and activator of transcription 6, STAT6) ¶Ç¾É¸ô®|,¾ÉP¹L±Ó©Êµoª¢¤ÏÀ³¡C ¥u¯àªýÂ_B¸ô®| : Lebrikizumab ±µ¦X IL13 ªºB¡BCÁ³±Û , ¦ýIL13 & IL-13R£\1 ¤´¥i±µ¦X¡A¥u¬OµLªk¦A±µ¦X IL-4 R£\,µLªk²Õ¦¨ II«¬ ¨üÅé Tralokinumab ±µ¦XIL13 ªºA¡BDÁ³±Û ¨Ï IL13 & IL-13R£\1 µLªk±µ¦X¡A¤]µLªk¦A±µ¦X IL-4 R£\,µLªk²Õ¦¨ II «¬¨üÅé ¥H¤W¸ÑÄÀ Tralokinumab ¤T´ÁÁ{§É¹w«á«ü¼Ð¡AÀø®Ä´X¥G¥u¦³Dupilumab 50%¡C¡Aý³Ý¤T´Á¸Ñª¼¥¢±Ñ¡C ¦]Lebrikizumab , IL13 & IL-13R£\1 ¤´¥i±µ¦X¦û¾Ú IL-13R £\1, ¼vÅT0~50% IL4 °T¸¹¶Ç»¼¡C ¤]¸ÑÄÀ Lebrikizumab ¤G´ÁÁ{§É¹w«á¥Dn«ü¼Ð»P¹ï·Ó²Õ¤ñ È ¥u¦³Dupilumab 50%~75%¡C¡C ý³Ý¤T´ÁÁ{§É¸Ñª¼¡A¤GÁ{§É¡A¥u¦³¤@Á{§É¦¨¥\¡A¥t¥~¤@Ó¥¢±Ñ¡C |
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Development History and FDA Approval Process for Dupixent Date Article Jun 19, 2020 Approval FDA Approves New Dupixent (dupilumab) Pre-Filled Pen Designed to Support More Convenient Self-Administration May 26, 2020 Approval FDA Approves Dupixent (dupilumab) as First Biologic Medicine for Children Aged 6 to 11 Years with Moderate-to-Severe Atopic Dermatitis Jun 26, 2019 Approval FDA Approves Dupixent (dupilumab) for Chronic Rhinosinusitis with Nasal Polyposis Mar 11, 2019 Approval FDA Approves Dupixent (dupilumab) for Moderate-to-Severe Atopic Dermatitis in Adolescents Oct 19, 2018 Approval FDA Approves Dupixent (dupilumab) for Moderate-to-Severe Asthma Mar 28, 2017 Approval FDA Approves Dupixent (dupilumab) for Eczema www.drugs.com/history/dupixent.html ¦P¤@ÃĦhºØ¾AÀ³¯g¡AIL-4/il-13 Âù¼ÐªýÂ_´N¬O¼F®`¡A ¥þ¥@¬É°ß¤G¡CASLAN04¡ÏDupilumab (Dupixent¡^ |
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This move is also in line with the shift in our commercial focus towards the U.S. market as we prepare to initiate a Phase 2b study of ASLAN004 in atopic dermatitis in 2021.¡¨ ½Ķ§ó¥¿ ¦¹Á|¤]»P§Ú̷dzƦb2021¦~±Ò°ÊASLAN004¦b¯SÀ³©Ê¥Öª¢ªº2b´ÁÁ{§É¬ã¨s¤¤ªº°Ó·~«ÂIÂà¦V¬ü°ê¥«³õ¬Û¤@P¡C¡¨ |
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GOOGLE ½Ķ¤§ ·s»D½Z ¨È·à±d»sÃÄ«Å¥¬±N¨ä¥DnªÑ²¼¤W¥«¦Ü¯Ç´µ¹F§J¡A¨Ã±q¥x¥_¥æ©ö©Ò°£µP 2020¦~7¤ë17¤é¡A·s¥[©Y¡V±Mª`©óÁ{§É¶¥¬q§K¬Ì¾Ç©M¸~½F¾Çªº¥Íª«»sÃĤ½¥qASLAN Pharmaceuticals¡]Nasdaq¡GASLN¡ATPEx¡G6497¡^¤µ¤Ñ«Å¥¬«Å¥¬¶i¤@¨B¦b¯Ç´µ¹F§Jº¦¸¤½¶}µo¦æªº¶i®i¥þ²y¥«³õ¡]¡§ Nasdaq¡¨¡^¨Ã¦¬¨ì¥x¥_¥æ©ö©Ò¡]TPEX¡^ªº°h¥«³qª¾¡A³o¬OTPEx°h¥«¹Lµ{¤¤ªº¹w´Á¨BÆJ¡C¸Ó¤½¥q±N«O¯d¨ä¦b¬ü°ê¯Ç´µ¹F§J¦b¬ü°ê¯Ç´µ¹F§J¤W¥«ªº¬ü°ê¦s°UªÑ²¼¡]ADS¡^¡A¨Ã¥B¥»¤½§iªº²{¦³«ù¦³¤HµL»Ý±Ä¨ú¥ô¦ó¦æ°Ê¡C ASLAN Pharmaceuticalsº®u°õ¦æ©xCarl Firth³Õ¤h»¡¡G¡§Å²©ó§Ṳ́£¦A¨üTPExªk³Wªº¬ù§ô¡A§Ú֦̾³§ó¤jªºÆF¬¡©Ê¡A¦]¦¹±N¤½¥q¦b¯Ç´µ¹F§Jªº¥Dn¤W¥«Åܧ󬰯Ǵµ¹F§J¡A±N¼W±j§ÚÌÄw¶°¸êª÷ªº¯à¤O¡C¹L¥h¤»Ó¤ë¤¤¡A§ÚÌ90¢HªºÃÒ¨é¥æ©ö³£¦b¯Ç´µ¹F§J¶i¦æ¡A¦Û2017¦~¥H¨Ó§Ú̦b¥xÆW¥¼Äw¶°¥ô¦ó¸êª÷¡C¦¹Á|¤]²Å¦X§Ú̷dzƶ}©l¦V¬ü°ê¥«³õÂಾ°Ó·~«¤ß¦b2021¦~§¹¦¨¤FASLAN004¦b¯SÀ³©Ê¥Öª¢¤¤ªº2b´Á¬ã¨s¡¨¡C ASLAN¹wp¨ä´¶³qªÑ±N©ó2020¦~8¤ë25¤é°±¤î¦bTPEx¤W¥æ©ö¡A¨Ã¥BTPExªk³W±N¦b¦¹«á¤£¤[°±¤î¾A¥Î¡C¸Ó¤½¥q´¶³qªÑªº«ù¦³¤H¥i¥H¦b2020¦~9¤ë25¤é¤§«e¥Ó½Ð±N¨äªÑ²¼Âà´«¬°¬ü°ê¦s°U¾ÌÃÒ¡A¹wpÂà´«±N¦b10¤ë©³¤§«e§¹¦¨¡C ASLAN¥Ø«e¥¿¦b©Û¶Ò±wªÌ°Ñ¥[ASLAN004¦b¤¤«×¦Ü««×¯SÀ³©Ê¥Öª¢ªº1´ÁÀH¾÷¡AÂùª¼¡A¦w¼¢¾¯¹ï·Ó¦h¾¯¶q»¼¼W¬ã¨sªº¤TÓ¾¯¶q²Õ¤¤ªº²Ä¤GÓ¡CÀHµÛ·s¥[©Y¬F©²¹ï¹K¨îCOVID-19¶Ç¼½ªº¨î³v¨B¨ú®ø¡A¹wp±N©ó8¤ë«·s¶}©l©Û¶Ò±wªÌ¡C¿D¤j§Q¨È©M¬ü°êªººô¯¸¤]·Ç³Æ¤W½u¥H¥[§Ö©Û¸u³t«×¡C¸Ó¤½¥q¹wp±N¦b2020¦~²Ä¥|©u«×¤½§G¸Ó¬ã¨sªºÁ{®É«Dª¼¼Æ¾Ú¡C |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2020/7/18 ¤U¤È 03:06:34²Ä 3120 ½g¦^À³
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¥xÁÞ¤j, 2020/07/17 ·s»D½Z ¦p¤U¡G 2021¦~ ±N啓°Ê ASAN004 2b ADÁ{§É¡C PRESS RELEASE ASLAN PHARMACEUTICALS ANNOUNCES THE MOVE OF ITS PRIMARY LISTING TO NASDAQ AND DELISTING FROM TAIPEI EXCHANGE Singapore, July 17, 2020 ¡V ASLAN Pharmaceuticals (Nasdaq: ASLN, TPEx:6497), a clinical-stage immunology and oncology focused biopharmaceutical company developing innovative treatments to transform the lives of patients, today announced further progress towards a primary listing on the Nasdaq Global Market (¡§Nasdaq¡¨) and receipt of a Notice of Delisting from the Taipei Exchange (¡§TPEx¡¨), an expected step in the TPEx delisting process. The company will retain its listing of American Depositary Shares (¡§ADS¡¨) on Nasdaq in the United States and existing holders of ADS do not need to take any action as a result of this announcement. Dr Carl Firth, Chief Executive Officer, ASLAN Pharmaceuticals, said: ¡§Changing the company¡¦s primary listing to Nasdaq will enhance our ability to raise capital given the greater flexibility afforded to us when we are no longer subject to TPEx regulations. 90 percent of trading in our securities the last six months has taken place on Nasdaq and we have not raised any capital in Taiwan since 2017. This move is also in line with the shift in our commercial focus towards the U.S. market as we prepare to initiate a Phase 2b study of ASLAN004 in atopic dermatitis in 2021.¡¨ ASLAN expects its ordinary shares to cease trading on TPEx on August 25, 2020, and TPEx regulations will cease to apply shortly thereafter. Holders of the company¡¦s ordinary shares can apply before September 25, 2020, to convert their shares into ADS and it is anticipated that the conversion will be completed before the end of October. ASLAN is currently recruiting patients into the second of three dose cohorts of its Phase 1 randomised, double-blind, placebo-controlled multiple ascending dose study of ASLAN004 in moderate to severe atopic dermatitis. Recruitment of patients into the study is expected to restart in August as restrictions put in place by the Singapore government to contain the spread of COVID-19 are gradually lifted. Sites in Australia and the U.S. are also preparing to come online to accelerate recruitment. The company expects to announce interim, unblinded data from the study in the fourth quarter of 2020. |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2020/7/18 ¤U¤È 02:51:06²Ä 3119 ½g¦^À³
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¬ÝÀ´MOA ,ª¾¹DASLAN004¤ÎDupilumab ¦³¬Û¦P¸ô®|ªÌ ------------------------------------- 1.ASLAN004 MOA -¼v¤ù aslanpharma.com/drug/aslan004/ 2.Dupilumab MOA -¼v¤ù www.dupixenthcp.com/atopicdermatitis/about/mechanism-of-action MOA www.tsim.org.tw/journal/jour29-6/02.PDF?fbclid=IwAR2B85aLqBUAt5agx6K7u0NkCGTGpr7w6HDCagHhLuu54ZH7FEqHMAdXG3M ------------------------------------------------ ¤£¥Îµ¥¤½§G¼Æ¾Ú, §Y¥i¨Ìdupilumab 2a Á{§É¸ê®Æ, ¥i ¹w´ú ASLAN004 2019/12/03 ¤½¥¬3¦ì ASLAN004 200mg /¨C¶g¤@°w 1bÁ{§É , EASI¥§¡°´T71% (4-6¶g) ¦ôp EASI¥§¡°´T ,²Ä8¶g¦b77~78% ----------------------------------- ¦ÛµM±µªñDupilumab ¨C¶g¤@°w 2a Á{§É ªº²Ä¤¶gEASI °´T67%¡B²Ä¤»¶g¥§¡°EASI 70% ²Ä12¶g¥§¡°EASI 73.6% Dupilumab 2a/2b Á{§É ,2018/SEP journals.lww.com/jaanp/Fulltext/2018/09000/Efficacy_and_safety_of_dupilumab_for_the_treatment.10.aspx |
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¬Q¤Ñ¨È·à±dµo§G°ê»Ú·s»D½Z¡C ±N¯Ç´µ¹F§J¥«³õ§ï¬°²Ä¤@¤W¥«¦aÂI¡C ASLAN Pharmaceuticals Announces the Move of its Primary Listing to Nasdaq and Delisting From Taipei Exchange finance.yahoo.com/news/aslan-pharmaceuticals-announces-move-primary-100838247.html ASLN ADR ¤Wº¦10% ¼y¯¬¡C 2.04 ¬ü¤¸/ªÑ¦¬½L¡C 368(¤dªÑ)=¬ù1800±i¥xªÑ¦¨¥æ¶q |
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¥xÁÞ¤j , Dupilumab AD ,¦U´ÁÁ{§É¸ê®Æ¡A¦p¤U´Á¥Z¡A 1. Dupilumab ¦´Á¥|Ó AD Á{§É 4¶g/12¶g , 2014/07/10 Dupilumab Treatment in Adults with Moderate-to-Severe Atopic Dermatitis www.nejm.org/doi/10.1056/NEJMoa1314768 2. Dupilumab 2a/2b Á{§É ,2018/SEP journals.lww.com/jaanp/Fulltext/2018/09000/Efficacy_and_safety_of_dupilumab_for_the_treatment.10.aspx 3.Dupilumab AD 2Ó¤T´ÁÁ{§É, 300mg/¨C¶g¤@°w/300mg/¨C¤G¶g¤@°w 2016/12/15 Two Phase 3 Trials of Dupilumab versus Placebo in Atopic Dermatitis www.nejm.org/doi/full/10.1056/nejmoa1610020 |
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n¬Ý¼Æ¾Úªº¤j¤j, DUPILUMAB ¦´Á¥|ÓÁ{§É¸ÕÅçµ²ªG¡A¦³³\¦h¹Ïªí ¡G¦p¤U www.nejm.org/doi/10.1056/NEJMoa1314768 Dupilumab Treatment in Adults with Moderate-to-Severe Atopic Dermatitis 2014/07/10 µ²ªG ¦b¬°´Á4¶gªº³æÃĪvÀø¬ã¨s¤¤¡Adupilumab¾ÉPÁ{§É«ü¼Ð¡A¥Íª«¼Ð»xª«¤ô¥©MÂà¿ý²Õªº§Ö³t¥B¾¯¶q¨Ì¿à©Ê§ïµ½¡C dupilumab³æÃĪvÀø12¶g¬ã¨sªºµ²ªG«²{¨Ã©µªø¤F4¶gªº¬ã¨sµ²ªG¡Gdupilumab²Õ±wªÌ¤¤85¢Hªº±wªÌEASI±o¤À°§C¤F50¢H¡A¦Ó¦w¼¢¾¯²Õ±wªÌ¤¤³o¤@¤ñ¨Ò¬°35¢H ¡]EASI-50¡A¦bEASI¤¤±o¤À¸û°ªªí¥ÜÀã¯lÄY«µ{«×§ó°ª¡^¡]P <0.001¡^ ¡F¦b¬ã¨sªÌªºÁ`Åéµû¦ô¤¤¡A dupilumab²Õ¤¤40¢Hªº±wªÌ»P¦w¼¢¾¯²Õ¤¤ªº7¢H¬Û¤ñ¸û¡A±o¤À¬°0¡G1¡]ªí©ú¥Ö½§¯fÅܤw²M°£©Î±µªñ²M°£¡^¡]P <0.001¡^¡F dupilumab²Õªºæ±Äoµû¤À°§C¤F55.7¢H¡]ªí©úæ±Äo´î¤Ö¡^¡A¦Ó¦w¼¢¾¯²Õ°§C¤F15.1¢H¡]P <0.001¡^¡C ¦b³o¶µÁp¦X¬ã¨s¤¤¡A¾¨ºÞ±µ¨ü¤F¦w¼¢¾¯ª`®gªº±wªÌ¤¤¡Adupilumab²Õªº±wªÌ¤¤¦³100¢H²Å¦XEASI-50ªº¼Ð·Ç¡]P = 0.002¡^¡A¦Ó±µ¨ü¦w¼¢¾¯ª`®gªº§½³¡¿}¥Ö½è¿E¯Àªº±wªÌ¬°50¢H¡C dupilumab¥[¿}¥Ö½è¿E¯Àªº¨Ï¥Î¶q¤Ö©ó±µ¨ü¦w¼¢¾¯¥[§½³¡ÃĪ«ªº±wªÌ©Ò¥Î§½³¡¿}¥Ö½è¿E¯Àªº¤@¥b¡]P = 0.16¡^¡C¦w¼¢¾¯µ¥¤£¨}¨Æ¥ó¦p¥Ö½§·P¬Vªºµo¥ÍÀW²v§ó°ª¡C»ó«|ª¢©MÀYµh¬Odupilumab³Ì±`¨£ªº¤£¨}¨Æ¥ó¡C µ²½× ¥ÎdupilumabªvÀøªº±wªÌ¦b©Ò¦³µû¦ôªº¯SÀ³©Ê¥Öª¢¯e¯f¬¡°Ê©Ê«ü¼Ð¤¤§¡¨ã¦³©úÅã¥B§Ö³tªº§ïµ½¡C°Æ§@¥Î¨S¦³¾¯¶q¨î¡C Funded by Regeneron Pharmaceuticals and Sanofi; ClinicalTrials.gov numbers, NCT01259323. opens in new tab, NCT01385657. opens in new tab, NCT01639040. opens in new tab, and NCT01548404. opens in new tab.) RESULTS In the 4-week monotherapy studies, dupilumab resulted in rapid and dose-dependent improvements in clinical indexes, biomarker levels, and the transcriptome. The results of the 12-week study of dupilumab monotherapy reproduced and extended the 4-week findings: 85% of patients in the dupilumab group, as compared with 35% of those in the placebo group, had a 50% reduction in the EASI score (EASI-50, with higher scores in the EASI indicating greater severity of eczema) (P<0.001); 40% of patients in the dupilumab group, as compared with 7% in the placebo group, had a score of 0 to 1 (indicating clearing or near-clearing of skin lesions) on the investigator¡¦s global assessment (P<0.001); and pruritus scores decreased (indicating a reduction in itch) by 55.7% in the dupilumab group versus 15.1% in the placebo group (P<0.001). In the combination study, 100% of the patients in the dupilumab group, as compared with 50% of those who received topical glucocorticoids with placebo injection, met the criterion for EASI-50 (P=0.002), despite the fact that patients who received dupilumab plus glucocorticoids used less than half the amount of topical glucocorticoids used by those who received placebo plus the topical medication (P=0.16). Adverse events, such as skin infection, occurred more frequently with placebo; nasopharyngitis and headache were the most frequent adverse events with dupilumab. CONCLUSIONS Patients treated with dupilumab had marked and rapid improvement in all the evaluated measures of atopic dermatitis disease activity. Side-effect profiles were not dose-limiting. (Funded by Regeneron Pharmaceuticals and Sanofi; ClinicalTrials.gov numbers, NCT01259323. opens in new tab, NCT01385657. opens in new tab, NCT01639040. opens in new tab, and NCT01548404. opens in new tab.) |
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