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


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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


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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.¡¨

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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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1. Dupilumab ¦­´Á¥|­Ó AD Á{§É 4¶g/12¶g ,
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2. Dupilumab 2a/2b Á{§É ,2018/SEP

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www.nejm.org/doi/10.1056/NEJMoa1314768
Dupilumab Treatment in Adults with Moderate-to-Severe Atopic Dermatitis

2014/07/10

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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¡^

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¦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
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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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