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2022.01-¤@´Á¼Æ¾Ú¤§Àu¤Æ²³ø(Y¥h¦~¤E¤ë®³³oª©À³¸Ó·|¦n¤@ÂI):ir.aslanpharma.com/static-files/2a7f1481-a0b3-47d1-87ef-e6ed30321475 2022.01-KOL²³ø:ir.aslanpharma.com/static-files/379e7107-c421-4401-b035-e43c4b682d19 2022.05.12- ir.aslanpharma.com/static-files/20941066-3bc3-418b-a970-9951565de0f2 2022.06²³ø-ir.aslanpharma.com/static-files/1c525489-d209-42c4-af7e-992f23c4251c 2022.09.15²³ø-ir.aslanpharma.com/static-files/1511fefc-ba34-4ee4-aac0-32f8bc4754a8 |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2020/6/30 ¤U¤È 10:20:15²Ä 2815 ½g¦^À³
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¥xÁÞ¤j¡A ASLAN004 ADªºÃĵý10®³10áA¥¼¨Ó¤W¥«¦PMOAªº Dupilumab ¥«³õ»{¦P¥i¾P°â110»õ¬ü¤¸¡C ¦ÓÄvª§¤O¡AASLAN004 VS Dupilumab ,¥i¹w¨£Àu¶Õ¯S¦â¡AYÀq§JÃļt¨Óµo®i¤T´Á¡A¤Î¾P°â¡A¹ïDupilumab ¥«³õ¥Ê¤À¥i¯à¬Û·í¤j¡C |
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·|û¡G¥xÁÞ10138776 µoªí®É¶¡:2020/6/30 ¤U¤È 09:52:38²Ä 2814 ½g¦^À³
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¤½¥q¤»¤ë15¤é¤½§i¡A·í¤é¦P¨B¦b¬ü°êµýºÞ·|¤½§i ir.aslanpharma.com/financial-information/sec-filings Board of Directors¡¦ Meeting to consider next steps after advice from Taipei Exchange (¡§TPEx¡¨) on possible delisting of ASLAN Pharmaceuticals Limited from TPEx As previously reported on Form 6-K dated June 9, 2020, ASLAN Pharmaceuticals Limited (the ¡§Company¡¨) disclosed that as a result of irregular trading of its ordinary shares, TPEx had requested the Company publish certain regulatory and financial information on TPEx¡¦s Market Observation Post System (¡§MOPS¡¨). Such MOPS notice identified that as a result of the Company¡¦s anticipated negative net worth and lack of operating revenue for the six months ending June 30, 2020, the Company anticipated that TPEx would delist the Company¡¦s ordinary shares from trading on TPEx (the ¡§TPEx Delisting¡¨). As previously reported, the Company also confirmed that in the event of the TPEx Delisting, the listing of the Company¡¦s ADSs on the Nasdaq Global Market (¡§Nasdaq¡¨) in the United States would be unaffected, and ADS would continue to trade on Nasdaq. On June 15, 2020, the Company announced that the Board of Directors of the Company (the ¡§Board¡¨) held a meeting to discuss the potential impact of a TPEx Delisting. Among other things, the Board confirmed that in order to help achieve and preserve value for its shareholders if a TPEx Delisting occurs, it was authorizing and directing the Company to develop a comprehensive conversion plan, by which the Company would facilitate the ability of its shareholders, at their option, to convert its ordinary shares into ADSs listed on Nasdaq over a 6-12 month time frame. The Company intends to update its shareholders as to details of such plan once formalized and approved by the Board. The Company also confirmed that a TPEx Delisting would have the effect that all Taiwan and TPEx laws, regulations and rules regarding its securities would cease to apply to the Company. It was noted by the Board that this change could potentially benefit the Company¡¦s ability to raise capital through the sale of its securities in ways that are currently prohibited or not feasible under TPEx rules and Taiwanese laws. Forward-looking statements This Form 6-K contains forward-looking |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2020/5/11 ¤U¤È 06:01:10²Ä 37 ½g¦^À³ nª¾¹D¥¼¨ÓASLAN004 1b 200mg/400mg/600mg--¨C¶g¤@°w*8¶g¦U«ü¼Ð ! ½Ð°Ñ¦Ò ©³¤U dupilumab 2a ,¨C¶g¤@°w/12¶g ASLAN004 600mg>=400mg>=200mg --- ----没·N¥~aslan004/200mg ´N¥i¹Fdupilumab ¤ô·Ç. **¤½¥qºÙ¦P¯Å³ÌÀu ªí-3 pooled-dupilumab-300mg/qw/12 weeks/ 1.EASI-50 83.9%(99/118=83.9%) 2.EASI-75 59.3%(70/118=59.3%) 3.EASI-90 34.7%(41/118=34.7%) 4.IGA 0/1 36.4%(43/118=36.4%) pooled-placebo-300mg/qw/12 weeks 1.EASI-50 28.7%(33/115=28.7%) 2.EASI-75 13.9%(16/115=13.9%) 3.EASI-90 6.1%(7/115=6.1%) 4.IGA 0/1 4.7%(4/115=4.7%) journals.lww.com/jaanp/Fulltext/2018/09000/Efficacy_and_safety_of_dupilumab_for_the_treatment.10.aspx Efficacy and safety of dupilumab for the treatment of moderate-to-severe atopic dermatitis in adults A pooled analysis of two phase 2 clinical trials |
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www.berich.com.tw/dp/TalkTalk/Talk_Detail.asp?ii=204490&CNpg=1#reply_a Evaluate the Efficacy and Safety of ON101 Cream for the Treatment of Chronic Diabetic Foot Ulcers (ON101 (WH-1)) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating.Read our disclaimer for details. ClinicalTrials.gov Identifier: NCT01898923 Recruitment Status ƒÊ :Recruiting First Posted ƒÊ : July 15, 2013 Last Update Posted ƒÊ : January 22, 2020 See Contacts and Locations Sponsor: Oneness Biotech Co., Ltd. Information provided by (Responsible Party): Oneness Biotech Co., Ltd. Study Details Tabular View No Results Posted Disclaimer How to Read a Study Record Study Description Go to sections Brief Summary: The primary objective of this study is to evaluate the efficacy of the new treatment of WH-1 ointment compared to Aquacel® Hydrofiber® dressing, applied to chronic diabetic foot ulcers for up to 16 weeks.An additional objective of this study is to collect safety information including adverse events and clinical laboratory abnormalities. Condition or disease ƒÊ Intervention/treatment ƒÊ Phase ƒÊ Diabetic Foot Drug: ON101 Cream Other: Aquacel® Hydrofiber® dressing Phase 3 Detailed Description: This trial is designed as a randomized, evaluator blinded, active-controlled, multi-center study comparing the efficacy and safety of WH-1 ointment and Aquacel® Hydrofiber® dressing in the treatment of diabetic foot ulcers. Independent evaluators who blinded to subjects¡¦ treatment will evaluate whether the wound has healed. Eligible subjects will be randomized to receive either WH-1 ointment or Aquacel® Hydrofiber® dressing in a 1:1 allocation. The study treatment will be applied to the selected ulcer for a maximum period of 16 weeks, until the wound/ulcer closure (wound size of 0) for two consecutive visits at least 2 weeks apart, or until the subject exited the study as treatment failure. After that, all subjects regardless of wound healing at the end of comparison period will be followed for 12 weeks to investigate durability. During the follow-up period, Aquacel® Hydrofiber® dressing will be applied for subjects who have unhealed or with recurrent wound. Each target ulcer with wound photographs for blind assessment will be monitored at each scheduled visit. One interim analysis is planned at around 50% of study information; the final analysis will be conducted at the end of the study. Study Design Go to sections 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 Resource links provided by the National Library of Medicine MedlinePlus related topics: Diabetic Foot Foot Health U.S. FDA Resources Arms and Interventions Go to sections Arm ƒÊ Intervention/treatment ƒÊ Experimental: ON101 Cream ON101 Cream (1.25%),15g ointment per tube. Twice daily for up to 16 weeks. Drug: ON101 Cream Aquacel® Hydrofiber® dressing Aquacel® Hydrofiber® dressings will be changed daily, on alternate days or three times a week according to need, but not longer than 7 days. Other: Aquacel® Hydrofiber® dressing Outcome Measures Go to sections Primary Outcome Measures ƒÊ : 1.The incidence of complete ulcer closure [ Time Frame: 16 weeks ] The primary variable is the number of target ulcers healed in each group within 16 weeks. The primary efficacy outcome is the comparison of the incidence of complete healing of the target ulcer between the two treatment groups at the end of treatment. For the purpose of this study a complete healing will be defined as complete epithelialization which is maintained with no drainage for at least 2 weeks and is confirmed by a blinded assessor. Secondary Outcome Measures ƒÊ : 1.The time of healing rate [ Time Frame: 16 weeks ] Time to complete ulcer healing, The time of the original healing will be taken as the time to healing. 2.change in ulcer area [ Time Frame: 16 weeks ] Percentage change in ulcer surface area from baseline 3.50% reduction in ulcer area [ Time Frame: 16 weeks ] Percentage of subjects with a 50% reduction of ulcer surface area 4.Incidence of infection of the target ulcer [ Time Frame: 16 weeks ] Incidence of infection of the target ulcer Eligibility Criteria Go to sections Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. Ages Eligible for Study: 20 Years to 80 Years (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria 1.Has signed a written informed consent prior to the first study evaluation; 2.Male or female is at least 20 and < 80 years of age; 3.Diabetes mellitus (type 1 or 2) with an HbA1c < 12.0% measured during screening or within three months prior to randomization; 4.An ankle brachial index on the target limb at least 0.8 measured during screening or within three months prior to randomization; 5.The target ulcer must have the following characteristics: ◦Grade 1 or 2 per Wagner Ulcer Classification System; ◦No higher than the ankle; ◦No active infected; ◦A cross-sectional area of between 1 and 25 cm2 post-debridement; ◦Present for at least 4 weeks before randomization; 6.If female and of childbearing potential has a negative pregnancy test and is not breastfeeding at screening visit; 7.Able and willing to attend the scheduled visits and comply with study procedures. Exclusion Criteria: 1.Presence of necrosis, purulence or sinus tracts that cannot be removed by debridement; 2.Acute Charcot¡¦s neuroarthropathy as determined by clinical and/or radiographic examination; 3.Has undergone revascularization procedure aimed at increasing blood flow in the treatment target limb < 4 weeks prior to randomization; 4.Poor nutritional status defined as an albumin < 2.5 g/dL; 5.Aspartate Aminotransferase(AST, GOT) and/or Alanine Aminotransferase(ALT, GPT) >3 x the normal upper limit; 6.Serum Creatinine >2 x the normal upper limit; 7.Treatment with immunosuppressive or chemotherapeutic agents, radiotherapy or systemic corticosteroids less than 4 weeks before randomization; 8.Use of any investigational drug or therapy within the 4 weeks prior to randomization; 9.A psychiatric condition (e.g., suicidal ideation), current or chronic alcohol or drug abuse problem, determined from the subject¡¦s medical history, which, in the opinion of the Investigator, may pose a threat to subject compliance; 10.Judged by the investigator not to be suitable for the study for any other reason. Contacts and Locations Go to sections Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01898923 Contacts Contact: Liu +886-2-2703-1098 ext 594 Locations Show Hide Hide 21 study locations United States, California Limb Preservation Platform, Inc. Active, not recruiting Fresno, California, United States China, Guangdong Sun Yat-sen Memorial Hospital, Sun Yat-sen University Recruiting Guangzhou, Guangdong, China Nanfang Hospital of Southern Medical University Recruiting Guanzhou, Guangdong, China The First Affiliated Hospital, Sun Yat-sen University Recruiting Guanzhou, Guangdong, China China, Henan The First Affiliated Hospital of Henan Science & Technology University Recruiting Luoyang, Henan, China China, Jiangsu The First Affiliated Hospital of Soochow University Recruiting Suzhou, Jiangsu, China Affiliated Hospital of Jiangsu University Recruiting Zhenjiang, Jiangsu, China China, Shandong Shandong Provincial Hospital Recruiting Jinan, Shandong, China China, Shanghai Ruijin Hospital, Shanghai Jiaotong University School of Medicine Recruiting Shanghai, Shanghai, China Shanghai TCM-Interated Hospital Recruiting Shanghai, Shanghai, China Taiwan Chang Gung Medical Hospital_Kaohsiung Active, not recruiting Kaohsiung, Taiwan Buddhist Tzu Chi Medical Hospital Active, not recruiting New Taipei City, Taiwan MacKay Memorial Hospital-Tamsui Branch Active, not recruiting New Taipei City, Taiwan China Medical University Hospital Active, not recruiting Taichung City, Taiwan Chi Mei Medical Center-Yongkang Active, not recruiting Tainan City, Taiwan MacKay Memorial Hospital-Taipei Branch Active, not recruiting Taipei City, Taiwan National Taiwan University Hospital Active, not recruiting Taipei City, Taiwan Taipei Veterans General Hospital Active, not recruiting Taipei City, Taiwan Tri-Service General Hospital Active, not recruiting Taipei City, Taiwan Chang Gung Medical Hospital_Linkou Active, not recruiting Taoyuan City, Taiwan China Medical University Hospital-Beigang Branch Active, not recruiting Yunlin, Taiwan Sponsors and Collaborators Oneness Biotech Co., Ltd. More Information Go to sections Responsible Party: Oneness Biotech Co., Ltd. ClinicalTrials.gov Identifier: NCT01898923 History of Changes Other Study ID Numbers: ON101CLCT02 First Posted: July 15, 2013 Key Record Dates Last Update Posted: January 22, 2020 Last Verified: January 2020 Keywords provided by Oneness Biotech Co., Ltd.: WH-1,Diabetic Foot,Ulcer Additional relevant MeSH terms: Diabetic Foot Foot Ulcer Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases Leg Ulcer Skin Ulcer Skin Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases Diabetic Neuropathies Foot Diseases Carboxymethylcellulose Sodium Laxatives Gastrointestinal Agents |
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