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發表時間:2018/10/18 上午 08:51:24
第 583 篇回應
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依據公告異位性皮膚炎與氣喘病患數約五億人，ASLAN004的臨床往前推進也表示其價值的提升，一顆很有潛力的藥物
m.moneydj.com/f1a.aspx?a=c7a28928-4c7c-449b-aafd-fc7a79fffc0e
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發表時間:2018/10/18 上午 08:51:05
第 582 篇回應
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亜獅的公告
第53款
1.事實發生日:107/10/17
2.公司名稱:亞獅康股份有限公司
3.與公司關係(請輸入本公司或子公司):本公司
4.相互持股比例:不適用
5.發生緣由:亞獅康ASLAN004-001臨床試驗首位受試者已接受藥物測試，此為亞獅康團隊
首次將研究項目從臨床前階段推進至人體試驗
6.因應措施:無
7.其他應敘明事項:
一、研發新藥名稱或代號：ASLAN004
二、用途：ASLAN004為全人源單株抗體，鎖定IL-13受體α1次單位(IL-13Rα1)。
ASLAN004預計適用於異位性皮膚炎與氣喘。ASLAN004-001臨床試驗之參與者為自
願參加之健康受試者。
三、預計進行之所有研發階段：第一期、第二期、第三期臨床試驗、新藥查驗登記
四、目前進行中之研發階段：
(一)、提出申請/通過核准/不通過核准：第一期臨床試驗進行中
(二)、未通過目的事業主管機關許可者，公司所面臨之風險及因應措施：不適用
(三)、已通過目的事業主管機關許可者，未來經營方向：將試驗推進至
ASLAN004-002多劑量遞增試驗 (Multiple Ascending Dose in Patient
Population)。
(四)、已投入之研發費用：基於商業機密與保密協定不予揭露。
五、將再進行之下一階段研發：
(一)、預計完成時間：
1.預計於2019年完成試驗組藥物測試
2.預計於2019年完成最終版臨床研究報告(CSR)
(二)、預計應負擔之義務：將試驗推進至ASLAN004-002多劑量遞增試驗
(Multiple Ascending Dose in Patient Population)。
六、市場現況：
(一)、 重度異位性皮膚炎的市場現況
異位性皮膚炎為最常見的皮膚疾病，全球超過2億名病患深受其擾，異位
性皮膚炎的特點為皮膚紅腫、持續搔癢，可能嚴重影響病患生活品質。
高達三分之一成人病患的病情程度達中度至重度，現有治療方式不多，
且對大多數病患的病情控制有限。
異位性皮膚炎現有治療方案主要為局部塗抹製劑。2016年12月，美國
FDA核准輕度至中度異位性皮膚炎外用藥Eucrisa(由輝瑞藥廠開發)。
2017年3月，美國FDA核准了dupilumab用於成人中度至重度異位性皮膚炎
(由賽諾菲與Regeneron Pharmaceuticals開發)。
(二)、氣喘的市場現況
全球約莫有3億人患有氣喘，氣喘是一種慢性呼吸道發炎的疾病，伴隨支
氣管過度反應導致呼吸短促、喘鳴、咳嗽等症狀，可能急性發作導致送醫
或死亡。逾450萬名重度氣喘病患的症狀無法透過如支氣管擴張藥或吸入
型類固醇等常規療法有效控制。
七、新藥開發時程長、投入經費高且未保證一定能成功，此等可能使投資面臨風險，
投資人應審慎判斷謹慎投資。 |
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發表時間:2018/10/18 上午 08:35:27
第 581 篇回應
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百億美元市場的藥物 第一位人體試驗開始了!
提早3個月!
亞獅康-KY(6497)ASLAN004-001臨床試驗首位受試者已接受藥物測試，此為亞獅康團隊首次將研究項目從臨床前階段推進至人體試驗。
ASLAN004為全人源單株抗體，鎖定IL-13受體α1次單位(IL-13Rα1)。ASLAN004預計適用於異位性皮膚炎與氣喘。ASLAN004-001臨床試驗之參與者為自願參加之健康受試者。預計於2019年完成試驗組藥物測試、最終版臨床研究報告(CSR)，將試驗推進至ASLAN004-002多劑量遞增試驗(Multiple Ascending Dose in Patient Population)。（編輯整理：葉時安） |
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發表時間:2018/10/17 上午 10:03:50
第 580 篇回應
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複習一下:
• 於 2018年Q4取得 varlitinib 胃癌全球二期臨床試驗初步臨床數據 (至關重要的公佈!!!)
• 2018 年Q4取得 ASLAN003 於急性骨髓性白血病(AML)二期臨床試驗期中數據 |
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發表時間:2018/10/15 下午 12:59:02
第 579 篇回應
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哈囉帥偉大你好!
認同你講得現在亞獅康ADR股本小，價格相對沒有比較沒有參考價值，所以我覺得亞獅康假設如果這次股東會募資通過，應該是會直接在美國發行新的ADR的股票，讓ADR的股本變大，這樣對台股來說更有參考價值，最多可以直接讓ADR股本也變到13億，和台股幾乎相當，這樣ADR漲跌應該對台灣這裡會比較有參考性，不會像現在價差那麼大。
謝謝! |
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發表時間:2018/10/15 上午 12:35:12
第 578 篇回應
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我覺得憨獅ADR一點參考價值也沒
股本小成交量少
幾股就可以讓股價大漲大跌
所以就算現在與台獅有價差也沒用
因為台獅根本不跟漲
主要還是要看台獅自身的表現比較重要 |
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發表時間:2018/10/12 上午 07:56:42
第 577 篇回應
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亞獅康 在昨天美股大跌500多點，ADR報價7.37 上漲0.32，漲幅4.46%，換算成台股價格，是45.69，與現在台股價格35.5相比，已經有10塊的價差，大家可以參考。
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發表時間:2018/10/11 下午 11:55:07
第 576 篇回應
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修正版 ( 前兩篇作廢 )
今天全球股市大地震 以下是是要深入思考的幾個方向
1美國經濟指標數據如何?
經濟指標很多 , 最少先看美國ISM 製造業&非製造業採購經理人指數 ( 還在50以上)
www.macromicro.me/charts/7/ism
2道瓊2016年2月約是15500點，2018年10月最高接近26900 漲幅高達百分之73.5
美股最近跌幅是健康理性還是非理性 ? (2年7個月漲幅高達百分之73.5,到目前還跌不到百分之6)
3 中國會拋售美債？個人的基本常識告訴自己-機會很低, 因為沒有比美債更好的投資標的可選
拋售美債,美國有能力接手,何況這會兩敗俱傷的事
4 十年期公債殖利率是長期站上百分之三 還是短期現象?
5 看到影子就開槍 你頭殼壞掉嗎? 台灣跌幅竟然比兩個當事國還大 !!!
以上分享僅供參考,自己要學習當投資決策的主人 |
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發表時間:2018/10/11 下午 11:31:00
第 575 篇回應
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更正
個人的基本常識告訴自己--美股最近跌幅其實還算健康理性 (2年7個月漲幅高達百分之73.5,到目前還跌不到百分之七) |
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發表時間:2018/10/11 下午 11:14:04
第 574 篇回應
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今天全球股市大地震 很多投資人看到影子就開槍 沒有去思考美國經濟指標數據很好 失業率屢創新低的事實
經濟指標很多 , 最少先看美國ISM 製造業&非製造業採購經理人指數 ( 還在50以上)
www.macromicro.me/charts/7/ism
道瓊2016年2月約是15500點，2018年10月最高接近26900 漲幅高達百分之73.5
個人的基本常識告訴自己 --最近跌幅其實很好(跌不到百分之七)
中國會拋售美債？ 個人的基本常識告訴自己--- 機會很低, 因為沒有比美債更好的投資標的可選
拋售美國有能力接手,何況這會兩敗俱傷的事
看到影子就開槍 你頭殼壞掉嗎?
以上分享僅供參考,自己要學習當投資決策的主人 |
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發表時間:2018/10/10 下午 09:48:24
第 573 篇回應
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獅子2018 ESMO 發表的是varlitinib + oxaliplatin and capecitabine (COX) or oxaliplatin and 5-FU (FOL) in advanced solid tumours.( 一期臨床 )
個人看法分享:
1 這30位受試 平均用了3線的化療藥, 在可評估的28位中 ORR 還有10.7%,疾病控制率DCR 68% (3+16)/28 = 68%
DCR至少12週還有46% (看看膽道癌二線的 ORR 與 DCR 的其他生技公司的研究數據)
2 varlitinib + oxaliplatin and capecitabine (COX) or oxaliplatin and 5-FU (FOL) in advanced
solid tumours 在大腸癌與膽道癌看到持久的療效
( 已平均用了3線化療藥 5位受試PFS 達220天(超過7個月) 中一位達645天 (21.5個月 )
3 如果篩選Her家族 不知道 ORR DCR PFS OS 是否能更長 更高 ?
4 獅子2018 ESMO 發表的 varlitinib + oxaliplatin and capecitabine (COX) or oxaliplatin and 5-FU (FOL)研究中我們發現varlitinib 的潛力
以上分享 僅供參考 |
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發表時間:2018/10/10 下午 08:26:56
第 572 篇回應
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ESMO兩項新的研究發表文章及連結如下 :
1.Phase I study: Safety and tolerability of varlitinib (VAR) in combination with Oxaliplatin and Capecitabine (COX) or Oxaliplatin and 5-FU (FOL) in advanced solid tumours
2.A phase IIA dose optimization study of ASLAN003 in acute myeloid leukemia (AML)
globenewswire.com/news-release/2018/10/09/1618324/0/en/ASLAN-Pharmaceuticals-to-Present-Posters-on-Varlitinib-and-ASLAN003-at-European-Society-for-Medical-Oncology-Congress.html |
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發表時間:2018/10/10 下午 06:23:45
第 571 篇回應
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中國膽道癌人數眾多，依亞獅康去年法說簡報高達14萬人，無藥可用，本次大部分進口藥品談判後的支付標準低於周邊國家或地區市場價格，平均低36%，讓中國一般所得的病患也能用到標靶藥。 |
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發表時間:2018/10/10 下午 05:41:05
第 570 篇回應
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udn.com/news/story/7332/3414471?from=udn-catelistnews_ch2
大陸醫療保障局今天印發了「關於將17種藥品納入國家基本醫療保險、工傷保險和生育保險藥品目錄乙類範圍的通知」。經過3個多月的談判，17種抗癌藥納入大陸醫保報銷目錄，大部分進口藥品談判後的支付標準低於周邊國家或地區市場價格，將大幅減輕中國大陸腫瘤患者的用藥負擔。
網友則稱，這是受到今年大陸電影「我不是藥神」的影響，大陸官方跟進民間訴求。
中新社報導，這次納入藥品目錄的17個藥品中包括12個實體腫瘤葯和5個血液腫瘤葯，均為臨床必需、療效確切、參保人員需求迫切的腫瘤治療藥品，涉及非小細胞肺癌、腎癌、結直腸癌、黑色素瘤、淋巴瘤等多個癌種。17個談判藥品與平均零售價相比，平均降幅達56.7%，大部分進口藥品談判後的支付標準低於周邊國家或地區市場價格，平均低36%。
中共國家醫療保障局局長胡靜林稱，特別是這次機構改革為這次談判工作創造了很好的條件，一方面就是醫保制度整合，使醫保有更大的戰略購買力，讓在談判中有更強的話語權，能夠更好的實現以量換價這個目的。這些抗癌藥納入醫保以後，會使大量的原本負擔不起的患者用得上新葯，改善他們的治療效果。
報導指抗癌藥醫保准入專項談判充分體現了對醫藥創新的重視和支持，17種談判抗癌藥品中有10種藥品均為2017年之後上市的品種。
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發表時間:2018/10/9 上午 09:22:37
第 569 篇回應
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蝨子最近都沒有啥消息，加上ADR成交量萎縮及台股近期盤勢不好，所以股價滑落也是正常的，只能繼續等待消息的發布了，近期可能就10/30要開股東會吧!
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發表時間:2018/10/5 下午 06:51:40
第 568 篇回應
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發表時間:2018/10/1 上午 08:30:14
第 567 篇回應
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亞獅長期(1~3年)投資可能價值估計
1~2年内可申請藥証臨床解盲一一中國、全球膽道癌二缐.
1~2年內2期臨床完成數個(膽道癌一線/血癌/胃癌一線)，且3期臨床/銷售可授權
2－3年 膽道癌上市的可能性
2~3年大授權要發生—-百億美元2期臨床(異位性皮膚炎//哮喘)可完成且開始授權3期臨床及全球銷售.
籌碼
原始股東持績增資持股
外資持續買進
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發表時間:2018/9/28 上午 09:26:08
第 566 篇回應
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TO: 台糖大
這應該沒把股價放入評判標準吧 (哈哈,開個玩笑,老獅的勇哥別介意啊!!) |
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發表時間:2018/9/27 下午 09:47:28
第 565 篇回應
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ASLAN CEO Dr Carl Firth is a finalist for Executive of the Year at the 14th Annual Scrip Award
Executive of the Year – For Small Cap & Private Pharma Companies
Eduardo Bravo, CEO of TiGenix
Jurgi Camblong, CEO and founder of SOPHiA GENETICS
Carl Firth, CEO and founder of ASLAN Pharmaceuticals
Antony Loebel, executive vice president, chief medical officer, head of global clinical development of Sunovion Pharmaceuticals
Amy Schulman, CEO and co-founder of Lyndra
Raman Singh, CEO of Mundipharma Singapore
pharmaintelligence.informa.com/events/awards/scrip-awards-2018/shortlist
個人評論：the 14th Annual Scrip Award 選出六位入圍小型生技公司年度執行長,全球小型生技公司那麼多家
能入圍代表 ASLAN CEO Dr Carl Firth 能力獲得肯定
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發表時間:2018/9/26 上午 10:05:28
第 564 篇回應
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天命大
膽道癌，AML雖是中小菜，二線潛在市場也不比裕哥五線市場小（有可能更大? 市場這方面領域天命大是專業），ASLAN004的確是大菜，胃癌，乳癌也是大菜。
以上分享 僅供參考 |
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發表時間:2018/9/26 上午 09:24:48
第 563 篇回應
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亞獅百億美元市場的ASLAN004 一期臨床公司估明年Q2完成
二期臨床個人估後年(2020年)Q2~Q3完成.
2020~2021 超過30億美元的授權上場.
聰明資金:如新加坡淡馬錫 5再買7000張,成本54元.
有閒錢再來跟進6497.
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發表時間:2018/9/26 上午 07:49:26
第 562 篇回應
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台醣大,
真、假外資可以數千張的借券賣出.
多也可做.
空也可做.
只要股價大幅波動就是行情.
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| 會員：天命10141925 |
發表時間:2018/9/26 上午 07:30:32
第 561 篇回應
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| 會員：台醣10138776 |
發表時間:2018/9/26 上午 12:00:08
第 560 篇回應
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道瓊，標普前幾天創下歷史新高，NBI生技指數約差百分之10也將創下歷史新高，
只有台灣生技股還趴在地上。
www.stockq.org/index/NBI.php |
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| 會員：天命10141925 |
發表時間:2018/9/25 下午 10:56:31
第 559 篇回應
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當(真、假)外資大量買進，股價大幅上漲時，在網路上一路叫人家小心.
當(真、假)外資大量借券賣出，股價大幅下跌時，在網路上一路叫不理股價。
這種人可能就是真、假外資。
在浩X，中x 版皆如此大費周章。
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發表時間:2018/9/21 下午 05:47:17
第 558 篇回應
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21屆中国临床肿瘤学会(CSCO)學術年會
重要时间
会议日期
2018年9月19日-23日
征文投稿截止日期
2018年6月30日
meeting.csco.org.cn/1/cn
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發表時間:2018/9/21 下午 04:51:32
第 557 篇回應
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ir.aslanpharma.com/news-releases/news-release-details/aslan-pharmaceuticals-presents-two-posters-varlitinib-chinese
News Release
𤐵 View printer-friendly version
<< Back
Sep 21,2018
ASLAN Pharmaceuticals Presents Two Posters on Varlitinib at Chinese Society of Clinical Oncology Annual Meeting
SINGAPORE, Sept. 21, 2018 (GLOBE NEWSWIRE) -- ASLAN Pharmaceuticals (NASDAQ:ASLN, TPEx:6497), a clinical-stage biopharmaceutical company targeting cancers that are both highly prevalent in Asia and orphan indications in the United States and Europe, announced today the presentation of two posters on varlitinib at the 21st Annual Meeting of Chinese Society of Clinical Oncology (CSCO) held in Xiamen, China, from 19 to 23 September 2018.
Varlitinib is a potent, reversible, small molecule pan-HER inhibitor and is currently being developed by ASLAN across multiple indications including a global pivotal trial in biliary tract cancer and a global study in gastric cancer.
Details of the posters presented are as follows:
Poster title: Multicenter Phase 2 trial of varlitinib versus lapatinib in combination with capecitabine in patients with HER2+ metastatic breast cancer (MBC) who failed prior trastuzumab therapy.
Board number: P-38
Abstract number: 1148
Date:21 September 2018
Location: 2nd Floor of Xiamen International Conference Center, Front Porch of Strait Hall
Poster title: JADETREE: A phase 2A, single arm, multicentre study of varlitinib plus capecitabine in Chinese patients with advanced or metastatic biliary tract cancer (BTC).
Board number: C-12
Date: 20 September to 22 September 2018
Location: 2nd Floor of Xiamen International Conference Center, Area for the Innovative Drug Clinical Research Session
Copies of the posters are available to view and download from ASLAN Pharmaceuticals’ website.
Media and IR contacts
Emma Thompson Robert Uhl
Spurwing Communications Westwicke Partners
Tel: +65 6340 7287 Tel: +1 858 356 5932
Email: ASLAN@spurwingcomms.com Email: robert.uhl@westwicke.com
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發表時間:2018/9/21 上午 10:07:18
第 556 篇回應
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亞獅胃癌一缐臨床 有篩檢生物指標HER1/HER2 及 IHC ,和國際標靶藥物臨床最像似。
一、亞獅的胃癌一線，二期臨床 ,估計 11月10日 後，隨時可公布主要指標ORR.
8月10日 + 12 週 = 11月10 曰.
clinicaltrials.gov/ct2/show/NCT03130790
Varlitinib in Combination With mFOLFOX6 for Advanced or Metastatic Gastric Cancer (First Line)
Official Title: A Two-Part Phase 2/ 3 Multicentre, Double-Blind, Randomized, Placebo Controlled Study of Varlitinib Plus mFOLFOX6 Verses Placebo Plus mFOLFOX6 In Subjects With HER1/ HER2 Co Expressing Advanced or Metastatic Gastric Cancer Without Prior Exposure to Systemic Therapy
Primary Outcome Measures :
Percentage change from baseline in tumor size at Week 12 - Phase 2 part [ Time Frame: At baseline and every 6 weeks for 24 weeks, after which reduced to once every 12 weeks until progression (up to approximately 3 months) ]
Phase 2 part: Percentage change in tumour size defined as the percentage change from baseline in the sum of longest diameters of target lesions as assessed by ICR and defined by the RECIST v1.1 criteria
篩檢條件
4.Subjects with tumors with IHC evidence of expression of HER1 (at level of + or ++ or +++) and HER-2 (at level of +, or ++) using standard criteria in the local lab. Subjects with HER-2 over expression at level of +++ determined by IHC and subject confirmed HER2 2+ by IHC with HER2 gene amplification confirmed by FISH but has contradiction to trastuzumab*.
*For details of contraindication related to trastuzumab, refer to package insert or US treatment guideline.
二、
本公司研發中之varlitinib (ASLAN001)作為胃癌一線療法
之全球二期臨床試驗完成收案
符合條款 第 53 款 事實發生日 107/08/10
說明
1.事實發生日:107/08/10
2.公司名稱:亞獅康股份有限公司
3.與公司關係(請輸入本公司或子公司):本公司
4.相互持股比例:不適用
5.發生緣由:本公司研發中之varlitinib (ASLAN001)完成作為HER1/HER2共同表現晚期
或轉移性胃癌一線治療全球二/三期臨床試驗之二期收案，共招募52名受試者。臨床試
驗編號001-012。 |
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發表時間:2018/9/20 下午 11:11:12
第 555 篇回應
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能及早發現調整受試者條件是很重要的，雖然開獎延期，但是真的總比失敗好太多了 |
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| 會員：台醣10138776 |
發表時間:2018/9/20 下午 10:46:59
第 554 篇回應
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投資生技股不要以為研發的適應症都會成功 !
以亞獅康來說二線膽道癌全球樞鈕試驗與中國樞鈕試驗 (兩個拼過一個 )
急性骨隨性白血病與一線胃癌 (這兩個孤兒藥 兩個拼過一個 )
Aslan004 異位性皮膚炎與過敏氣喘 (兩個拼過一個 )
以小股本的亞獅康來說能拼過三個藥證總市值就不可同日而語
膽道癌中國市場的確不小但還是比不上歐美日的市場大 , 中國新藥法規不斷改革與歐美接軌 , 我們不能排除中國承認美國FDA藥證,如同台灣一樣,中國樞紐試驗雖然時程有延宕但總比數據公告後不如預期好太多了
以上分享僅供參考,自己要學習當投資決策的主人
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發表時間:2018/9/20 上午 08:44:25
第 553 篇回應
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這則訊息看起來應該算短空長多。
不知道其他前輩對這訊息的解讀如何？ |
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發表時間:2018/9/20 上午 08:27:54
第 552 篇回應
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Edison issues update on ASLAN Pharmaceuticals (ASLN)
Edison Investment Research Limited (GLOBE NEWSWIRE)
2 hrs ago
www.bakersfield.com/ap/national/edison-issues-update-on-aslan-pharmaceuticals-asln/article_7767a625-dbdc-5340-880f-b756c7ec9f5b.html
LONDON, Sept. 19, 2018 (GLOBE NEWSWIRE) -- ASLAN announced it would be amending the protocol for its ongoing Chinese pivotal trial of varlitinib in biliary tract cancer. The patients being enrolled in China had more severe disease than expected based on historical controls, which manifested as a weaker than expected response to treatment on the trial. Due to delays, the Chinese study may not complete before the ongoing TREETOP study, which would then serve as a pivotal study for approval in China and is expected to complete in 2019.
We have slightly adjusted our valuation of ASLAN to $389m from $399m. This is driven by increased development costs and a longer timeline in China (2020 approval vs 2019 before), as well as lower net cash, and is partly offset by advancing our NPVs. Click here to view the full report.
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| 會員：台醣10138776 |
發表時間:2018/9/19 下午 01:24:25
第 551 篇回應
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一般來說臨床試驗收案標準的修正是生技公司決定的，再通知臨床醫院醫師，當然也要報主管機關核准變更，核准前就能按新標準收案，這是單臂試驗的優點，可以即時修正。
近期要召開的臨時股東會可再問清楚。 |
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發表時間:2018/9/19 下午 01:04:48
第 550 篇回應
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篩檢條件若增加基因HER家族受器，不違背於先前的條件。
只是原先28人，可能當做功徳。 |
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發表時間:2018/9/19 下午 12:53:44
第 549 篇回應
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以下分享僅供參考
亞獅康二線膽道癌中國樞紐試驗納入條件修正，就是說現在繼續收案的病人已經採用新標準，再加上先前已經收案中符合標準的人數，其餘不足的人數再補足，不是經主管機關核准後才看始重新收案 |
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| 會員：孤兒藥10140658 |
發表時間:2018/9/19 上午 10:57:04
第 548 篇回應
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To :飛人大
您說得非常正確,參考以下連結與您所提完全符合~~
www.genetinfo.com/investment/featured/item/20000.html |
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發表時間:2018/9/19 上午 09:56:03
第 547 篇回應
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天命大
謝謝提供分享，還好公司提早發現問題，立刻處理。 |
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| 會員：飛人卡特10145479 |
發表時間:2018/9/19 上午 09:53:51
第 546 篇回應
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關於第一二線治療藥的區分甚至市面上還有第三線治療，如果第一第二線都沒有有效療效的話，就會出現第三線治療像中裕在研發的新藥，而為啥亞獅康不直接去發展第一線治療藥物呢? 原因很簡單因為第一線可能會有比較多競爭對手，像這次膽道癌因為沒有核准的標準療法，但是一般來說傳統化療就算第一線，而亞獅康是做第二線，那第二線要怎樣怎樣從第一線來看第二線的效果反應呢?不是說第一線效果好接下來第二線效果好也就是好，第二線收進來的病人原先要求是有受過第一線治療就好，但是有些病患接受過一次或兩次化療可能身體就受不了，所以就沒辦法接受第二線治療即亞獅康研發的新藥，所以修改實驗招收病人的標準，必須要對第一線治療有耐藥性的病人，才來接受第二線治療，否則原本病人可能受不了第二線治療方法甚至死亡，這樣根本沒辦法做測試反而會降低ORR，所以才需要修改實驗招收病患的標準。
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發表時間:2018/9/19 上午 09:52:11
第 545 篇回應
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search.yahoo.com/search?p=ARQL&fr=uh3_finance_vert&fr2=p%3Afinvsrp%2Cm%3Asb&.tsrc=fin-srch
ARQL 的市值，目前還是五獅的2.4倍。
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發表時間:2018/9/19 上午 09:46:25
第 544 篇回應
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篩檢完的二線膽管癌市场，估4-7成，仍然是
ARQ087不到1成的4-7倍。 |
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發表時間:2018/9/19 上午 09:17:01
第 543 篇回應
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台醣大，
可能增加的篩檢
1.篩檢 HER2/HER4
2.篩檢 IHC +2/+3 |
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| 會員：台醣10138776 |
發表時間:2018/9/19 上午 08:59:59
第 542 篇回應
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天命大
公司在公告資訊中有提到要修正收案標準，以準確評估藥物的療效，請問要修正那些招募標準？看起來是有招募到進入臨床試驗前
一線治療時ORR太低，這是我的解讀，可能有誤僅供參加。 |
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發表時間:2018/9/19 上午 08:39:42
第 541 篇回應
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台醣大,
Based on a review of patients recruited to-date and discussions with key investigators, it was agreed that a protocol amendment should be submitted to local authorities to modify enrolment criteria and to ensure the study will provide an accurate evaluation of varlitinib’s efficacy. Review and implementation of the voluntary amendment is expected to take approximately 4 months. In the interim,
ASLAN will continue to recruit patients into the study and provide a further update on study timelines in early 2019. |
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發表時間:2018/9/19 上午 08:30:55
第 540 篇回應
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天命大
公司公告27人的收案狀況沒有錯，從原文來看是二線治療前的一線狀況與一線反應率評估，如果到九月17才收27人請問如果如原先規劃在年底公告數據？因為最後一位收完案還要觀察追蹤一段時間。 |
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發表時間:2018/9/19 上午 06:10:50
第 539 篇回應
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台醣大，
公司報告是
前27位收案的狀況，且在往後4個月要繼續收案，何來已收完案？
且僅14位掃描资料，何來已完68位？
放心，這只是topline 28人，2a 的小驗床， |
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發表時間:2018/9/19 上午 06:00:03
第 538 篇回應
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ASLAN Pharma faces longer timeline for China study of varlitinib + capecitabine in biliary tract cancer
Sep. 17, 2018 10:45 AM • SA Editor Douglas W. House
Citing the need for a protocol amendment to ensure that its China-based study of varlitinib plus capecitabine (second-line setting) in patients with advanced/metastatic biliary tract cancer (BTC) will provide an accurate assessment of varlitinib’s efficacy, ASLN Pharmaceuticals (ASLN +1.2%) will modify the enrollment criteria.
The review and implementation of the voluntary amendment should take about four months. In the meantime, recruitment in the 68-subject trial will continue. The company will update investors again in early 2019.
ASLN says the reason for the change is worse-than-expected response rates in the first-line setting prior to participation in its second-line study. In the first 27 subjects, the first-line response rate was ~7% and progression-free survival (PFS) was 2.7 months, well below the 26% and 8 months observed in the ABC-02 study of cisplatin + gemcitabine, the current standard-of-care for first-line BTC.
So far, in 14 participants who have received a six-week scan, the disease control rate (DCR) was 50% (1 partial responder + 6 with stable cancer). In the first-line setting, the DCR in the same 14 patients was ~43% (2 partial responders + 4 with stable cancer).
台醣大，
公司的對外電話法說，講的全是中國的二線膽道癌病人，收案前的一線之治療结果。
並公布已收案28人，及其中14人掃描的ORR、SD。
請參造另一篇報導，如上。
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發表時間:2018/9/19 上午 12:03:34
第 537 篇回應
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以下個人解讀分享僅供參考
1 中國二線試驗的受試者對於一線治療的反應明顯較全球性研究中的數據不理想。在前 27 名受試者中，第
一線治療的反應率約為 7%，無惡化存活期(PFS)為 2.7 個月。相比之下，膽道癌現有一線標準療法所根據的
ABC-02 1試驗在併用 cisplatin 及 gemcitabine 的治療反應率為 26%，無惡化存活期(PFS)為 8 個月
2原本年底公告數據,應已收完案的推測是合理的 protocol amendment 修改受試者的納入條件
猜測是要再加收一些受試讓 ORR 接近一線標準療法的ORR ,以確保此項研究能準確評估 varlitinib 的療效
公司有先評估27名受試者在一線治療中ORR與一線標準療法ORR26% 落差太大 , 其中41位招收的病患猜測應該
有接近一線標準療法的ORR , 分析HER家族療效也不排除其可能性
3 全球樞紐 2019 年初完成受試者收案 個人預估第二季數據出來 (Time Frame: the later of 3 months after last subject in or when 70% of the subjects (84 subjects) have experienced a PFS event )
4 公告資訊有些不是很清出 下個月有參加臨時股東會的獅友再問清楚
5 看起來二期AML 與 二期一線胃癌期中數據會先出來 , 異位性皮膚炎2019年完成一期
以上分享 僅供參考 |
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發表時間:2018/9/18 下午 06:11:20
第 536 篇回應
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Patients enrolled into the second line study in China appear to have performed significantly worse, prior to recruitment, in the first line setting than observed in published global studies. In the first 27 patients enrolled, the first line response rate was approximately 7% and progression free survival (PFS) was 2.7 months. In comparison, the ABC-021 study that compared cisplatin plus gemcitabine to gemcitabine alone, the current standard of care for first line treatment of patients with advanced BTC, showed a first line response rate of 26% and PFS of 8 months for patients on cisplatin and gemcitabine.
In the 14 patients that received a 6-week scan in the study, 1 partial response and 6 patients with stable disease were reported based on site assessment. For the same 14 patients in the first line setting, there were 2 partial responses and 4 patients with stable disease.
aslanpharma.com/app/uploads/2018/09/180917-Press-release-ASLAN001-China-Study_EN.pdf
以上從亜獅康的新聞稿檔案而來，和先前所貼一模一樣。
請問大大們，如何解讀? |
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| 會員：小林10142678 |
發表時間:2018/9/18 下午 05:14:28
第 535 篇回應
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G網文章標題與內文自行下的副標，很有問題，還改來改去。(這壞習慣一直有)
建議亞獅康的投資人要自行參閱官方提供的第一手新聞稿(中英文都有)，還有對投資人說明的電話會議。
不看官方第一手的資訊，引用二手(流)媒體的報導不是很奇怪?
aslanpharma.com/2018/09/17/aslan-pharmaceuticals-provides-update-on-timelines-for-clinical-trial-of-varlitinib-in-biliary-tract-cancer-in-china/
ir.aslanpharma.com/webcasts-presentations
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發表時間:2018/9/18 下午 04:52:54
第 534 篇回應
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阿隆索 大,
中國 2缐68人臨床，無對照組,是OPEN LABEL (開放標籤),68人預定使用, ASLAN001 ＋ 化療單藥.
所以沒解盲問題.
中國的臨床資料如下:
clinicaltrials.gov/ct2/show/NCT03231176?term=ASLAN001&draw=2&rank=12
亞獅康目前收28人, 審查14人的資料後，修改收案條件，預計用4個月的時間來申請CFDA核准,
核準後要再收多少人? 是否涵蓋先前28人?皆未知?
比較保守估計 明年下半年Q3/Q4才能知道 中國的主要指標數據. ORR ?
其實晚 全球120人的 樞鈕約1~2季，但更能達標靶的治療療效.
以上個人見解，詳見公司公告. |
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發表時間:2018/9/18 下午 04:33:31
第 533 篇回應
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Patients enrolled into the second line study in China appear to have performed significantly worse, prior to recruitment, in the first line setting than observed in published global studies. In the first 27 patients enrolled, the first line response rate was approximately 7% and progression free survival (PFS) was 2.7 months. In comparison, the ABC-021 study that compared cisplatin plus gemcitabine to gemcitabine alone, the current standard of care for first line treatment of patients with advanced BTC, showed a first line response rate of 26% and PFS of 8 months for patients on cisplatin and gemcitabine.
In the 14 patients that received a 6-week scan in the study, 1 partial response and 6 patients with stable disease were reported based on site assessment. For the same 14 patients in the first line setting, there were 2 partial responses and 4 patients with stable disease.
參加中國二線研究的患者在招募之前的表現似乎比在已發表的全球研究中觀察到的一線表現更差。
在入組的前27名患者中，第一線反應率約為7％，無進展生存期（PFS）為2.7個月。
相比之下，ABC-021研究將順鉑加吉西他濱與單用吉西他濱進行比較，目前治療晚期BTC患者的一線治療標準，順鉑患者的一線反應率為26％，PFS為8個月。 和吉西他濱。
在接受6週掃描的14名患者中，基於試驗機構評估報告了1名部分反應和6名患有穩定疾病的患者。
對於在第一線設置中的相同的14名患者，有2個部分反應和4個患有穩定疾病的患者。
———————
台醣大
本次只提供中國2線膽道癌14名,在六週已掃瞄的患者樣本.
ORR 只有一位(1/14)，其實只和原來預估差一個, 應該要2/14 , (14.3%),
因本次是單藥化療,另外或許IHC +3 ,少上1b臨床1個,
少比較多的是SD ,本次只有 6/14,
上次 1B 臨床10/15.
影響PFS/OS.較多。
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發表時間:2018/9/18 下午 04:06:02
第 532 篇回應
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ASLAN Pharmaceuticals Provides Update on Timelines for Clinical Trial of Varlitinib in Biliary Tract Cancer in China
By GlobeNewswire, September 17, 2018, 06:58:00 AM EDT
Vote upAAA
Management will host a conference call and webcast today, Monday, 17 September at 8:30am ET/8:30pm SGT
SINGAPORE, Sept. 17, 2018 (GLOBE NEWSWIRE) -- ASLAN Pharmaceuticals (NASDAQ:ASLN, TPEx:6497), a clinical-stage biopharmaceutical company targeting cancers that are both highly prevalent in Asia and orphan indications in the United States and Europe, today announced an update to its planned timelines for the ongoing single-arm clinical trial in China testing varlitinib plus capecitabine in patients with advanced or metastatic biliary tract cancer (BTC). The open-label study planned to enrol 68 patients with BTC who had progressed on at least one line of prior chemotherapy.
Based on a review of patients recruited to-date and discussions with key investigators, it was agreed that a protocol amendment should be submitted to local authorities to modify enrolment criteria and to ensure the study will provide an accurate evaluation of varlitinib’s efficacy. Review and implementation of the voluntary amendment is expected to take approximately 4 months. In the interim, ASLAN will continue to recruit patients into the study and provide a further update on study timelines in early 2019.
ASLAN’s global pivotal study in second line BTC, TREETOPP, remains on track to complete patient enrolment in early 2019. TREETOPP is a randomised, double-blind, placebo-controlled clinical trial in second line BTC comparing varlitinib and capecitabine to placebo and capecitabine. If positive, data from the TREETOPP study will be used in regulatory approval submissions for varlitinib globally.
Patients enrolled into the second line study in China appear to have performed significantly worse, prior to recruitment, in the first line setting than observed in published global studies. In the first 27 patients enrolled, the first line response rate was approximately 7% and progression free survival (PFS) was 2.7 months. In comparison, the ABC-021 study that compared cisplatin plus gemcitabine to gemcitabine alone, the current standard of care for first line treatment of patients with advanced BTC, showed a first line response rate of 26% and PFS of 8 months for patients on cisplatin and gemcitabine.
In the 14 patients that received a 6-week scan in the study, 1 partial response and 6 patients with stable disease were reported based on site assessment. For the same 14 patients in the first line setting, there were 2 partial responses and 4 patients with stable disease.
Dr Mark McHale, Chief Operating Officer, ASLAN Pharmaceuticals said: Based on our team’s experience developing drugs such as gefitinib and afatinib that showed differences in outcomes between US and Chinese patients, we have been monitoring the China study closely. This has allowed us to identify significant differences in the patient population compared to historical studies and take measures to ensure this study will provide an accurate evaluation of varlitinib’s efficacy. Single-arm studies are inherently prone to these risks and we do not see any impact on our other ongoing placebo-controlled studies. We are working closely with some of China’s leading biliary tract cancer experts to understand the differences in disease outcomes we are seeing.
ASLAN Pharmaceutical’s management will host a conference call and webcast for analysts and investors on Monday, 17 September at 8:30am ET/8:30pm SGT.
台醣大, 原文報導如上,
www.nasdaq.com/press-release/aslan-pharmaceuticals-provides-update-on-timelines-for-clinical-trial-of-varlitinib-in-biliary-20180917-00222
www.genetinfo.com/investment/featured/item/20000.html?start=1
G網的翻譯沒問題.
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發表時間:2018/9/18 下午 03:56:41
第 531 篇回應
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發表時間:2018/9/18 下午 03:49:35
第 530 篇回應
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天命大
你好像把一線二線搞錯了，而且說的有些離譜。中國膽道癌收的是二線病人，目前要修正是因為所收的病人在一線的反應率偏低，不是Varlitinib在二線反應率百分之七，猜是要調整加收反應率與一線標準療法接近的病患。以上分享 僅供參考 |
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發表時間:2018/9/18 下午 02:55:32
第 529 篇回應
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www.genetinfo.com/investment/featured/item/20000.html?start=1
ASLAN001＋單化療 2缐膽道癌 ,OPEN LABEL, 臨床
中國大陸預定68人的臨床,已召募27人,
其中14 人經6週治療後掃描.
結果 ORR=1/14 , SD=6/14 ,
DCR=ORR＋SD=7/14=50%
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和ASLAN001+雙化療 1b臨床 ,15 人 结果
ORR = 3/15
SD = 10/15
DCR= ORR+SD=13/15(87%)
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個人評論
本次DCR=7/14=50%, 可能是14人中，患者帶著HER2/HER4患者比率偏低, 且IHC 可能偏低多為+2/+1 而 IHC＋3者 偏少。
—————-
4個月後最保險的篩檢 是加入HER2 或 HER4 且 IHC +3 .
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發表時間:2018/9/18 下午 02:34:24
第 528 篇回應
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www.genetinfo.com/investment/featured/item/20000.html?start=1
中國68人的2線膽道癌臨床。
目前收27人，
其中在第6週做掃描
oRR |
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發表時間:2018/9/18 上午 06:24:39
第 527 篇回應
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參考一下ARQ 087 FGFR2 基因的 二線膽道癌臨床篩檢, 如下
ARQ 087 in Subjects With FGFR2 Gene Fusion Positive Inoperable or Advanced Intrahepatic Cholangiocarcinoma
clinicaltrials.gov/ct2/show/NCT03230318
Criteria
Inclusion Criteria:
1.Signed written informed consent granted prior to initiation of any study-specific procedures
2.18 years of age or older
3.Histologically or cytologically confirmed locally advanced, inoperable (where surgery is not indicated due to disease extension, co-morbidities, or other technical reasons), or metastatic iCCA or mixed histology tumors (combined hepatocellular-cholangiocarcinoma [cHCC-CCA])
4.FGFR2 gene fusion status confirmed by NGS or FISH testing
—Test positive by FISH by the central laboratory designated by the Sponsor
—Have FGFR2 gene fusion documented by a local or central laboratory using standard protocols and approved by local IRB/EC, by CLIA or other similar agency. If the FGFR2 gene fusion is identified by a laboratory other than the Sponsor’s central laboratory, then archival and/or recent tissue biopsy samples or a tissue block suitable for genetic testing must be available for confirmatory testing by FISH by the Sponsor’s central laboratory. If a subject has documentation from the central laboratory indicating that they test negative for FGFR2 gene fusion, that subject may not be enrolled in the study. |
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發表時間:2018/9/18 上午 12:11:17
第 526 篇回應
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以老獅背後兩大老闆(中國及淡馬錫)的投資角度而言,protocol amendment後,讓治療目標更明確,最後能讓Varlitinib先在中國上市開賣豈不樂哉?
該試驗最後修改的連結~~~不知今天公告的是否為同一件事?(日期相當接近)
clinicaltrials.gov/ct2/history/NCT03231176?A=1&B=8&C=merged#StudyPageTop |
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發表時間:2018/9/17 下午 11:22:05
第 525 篇回應
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從中國的 data， BTC 一線用藥 ORR 居然只有 7%!! 那一線失敗後，二線用藥 Capecitabine ORR 應該抓多少? (應該很低吧) Varlitinib 如果有 placebo control 對於BTC 是否相當容易有顯著差異!! 如此思考 Tree Topp 前途就明朗許多!!
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| 會員：台醣10138776 |
發表時間:2018/9/17 下午 10:59:32
第 524 篇回應
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protocol amendment 在臨床試驗是一個很常見的現象,
如搜尋: 臺大醫院研究倫理委員會行政中心在會議記錄中可發現 protocol amendment在臨床試驗
是一個很常見的現象,不必大驚小怪! 一個臨床試驗 protocol amendment 1-3 次 是常見的事
本次獅子提出臨床試驗設計修正案(protocol amendment)，主要是修改受試者的納入條件，以確保
此項研究能準確評估varlitinib之療效, 這應是一個中性的資訊 , 是不試篩選HER家族或其他納入條件
( 都有可能 ? ) ASLAN 001 屬於泛HER抑制劑, 這次中國樞紐試驗沒篩選病患 , 為了能準確評估varlitinib之療效
protocol amendment 是必要的 , 修正納入條件,在做分析前要先報備核准才算數, 沒有修正臨床試驗計畫書就做
分析是不被認可的
以上是個人解讀 僅供參考 |
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發表時間:2018/9/17 下午 09:50:57
第 523 篇回應
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| 會員：阿隆索10147365 |
發表時間:2018/9/17 下午 07:48:50
第 522 篇回應
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今天發布這則訊息，中國的膽道癌試驗解盲時間就要從今年年底延後至明年初了？是利多還是利空？ |
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發表時間:2018/9/17 下午 07:37:16
第 521 篇回應
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1.事實發生日:107/09/17
2.公司名稱:ASLAN Pharmaceuticals Limited(亞獅康股份有限公司)
3.與公司關係(請輸入本公司或子公司):本公司
4.相互持股比例:不適用
5.發生緣由:經公司對受試者進行檢視及與主要研究人員討論後，各方同意應向當地主管
機關提出臨床試驗設計修正案(protocol amendment)，修改受試者的納入條件，以確保
此項研究能準確評估varlitinib之療效。審查與實際執行此項自願性修正案所需要的時
間預計約為四個月。在此期間，亞獅康-KY將繼續招收病患，並於2019年初更新進一步
的試驗進度。
6.因應措施:無
7.其他應敘明事項:新藥開發時程長、投入經費高且未保證一定能成功，此等可能使投資
面臨風險，投資人應審慎判斷謹慎投資。
———————————-
各人猜測
增加HER2/HER4 受器的事先篩檢, 使ORR 更高(20% 以上),
且讓30%無HER家族受器者可尋求未來其他治療方法。 |
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發表時間:2018/9/12 下午 11:21:52
第 520 篇回應
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天命大
獅子二線膽道癌是以二期臨床數據達標直接取得中國與美國藥證，要做三期也是授權後別家公司的事。獅子花1.29億買入商品化個人認為只要獅子日本授權金就足以支付，用一個日本賺回歐美中三大市場，很划算。就算要做三期，亞洲區收的病患會比美歐多很多，花費省很多。以上分享僅供參考。 |
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發表時間:2018/9/12 下午 02:40:16
第 519 篇回應
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港交所目前非常渴望新藥公司到港掛牌.
亞獅的胃癌/膽道癌 3期臨床共須600人, 需18億跑不掉.
另支付ASLAN001 上游1億美元，上市前須付出.
2~3年內需大量資金.
有港股的高本益比為下次再募資的基礎。
所以我猜 再增港交所非常有可能。
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| 會員：飛人卡特10145479 |
發表時間:2018/9/12 下午 02:29:24
第 518 篇回應
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天命大你好!
我覺得亞獅康假設如果這次股東會募資通過，應該是會直接在美國發行新的ADR的股票，讓ADR的股本變大，這樣對台股來說更有參考價值，可以直接讓ADR股本也變到13億，和台股幾乎相當，應該不大可能在到香港去發行GDR，比較少有公司發行ADR之後又發行GDR，何況還要重新花時間準備資料去申請，ADR已經發行成功了，要再增資相比再去申請其他國家的GDR，覺得應該ADR增資比較可能，以下一點意見!
謝謝! |
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發表時間:2018/9/12 下午 12:30:18
第 517 篇回應
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2018/05/05 資本額13傯
2018/05/06 資本額16億 ---美國ADR-5股台股為一美股.共6000張ADR,相當30,000張,3億資本額台股
2019/04/01 ?資本額19~22億 ? 港股ADR?
亞獅CEO 美林生技投資出生,發ADR是他的專長.
中國的錢很多,大都跑到香港.
亞獅第二大股東是後頭公司是上海註冊.
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發表時間:2018/9/12 上午 11:56:21
第 516 篇回應
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亞獅康已經在美國掛牌ADR了。還可以再第三地發行ADR? |
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發表時間:2018/9/12 上午 08:05:26
第 515 篇回應
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去年召開臨時股東會2017/12/08,ADR上市2018/05/06
今年召開臨時股東會2018/10/30,估ADR上市2019/04/01
中國68人臨床數據2018年底公布。
没意外準確申請中國藥證。
香港ADR本益比最高。
所以因缘足已。
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發表時間:2018/9/12 上午 07:53:44
第 514 篇回應
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天命大
本次募資時間與重要數據公告可能重疊，這有何含義？數據不好能募到資金嗎？你有何看法分享？港股ADR因緣具足是何意思? |
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發表時間:2018/9/12 上午 07:31:04
第 513 篇回應
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| 會員：台醣10138776 |
發表時間:2018/9/11 上午 08:42:36
第 512 篇回應
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| 會員：飛人卡特10145479 |
發表時間:2018/9/11 上午 08:39:00
第 511 篇回應
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董事會：亞獅康-KY(6497)決議10/30召開107年第1次股東臨時會，擬選任獨董
2018/09/11 07:30 財訊快報 編輯部
本公司董事會決議召開107年第1次股東臨時會相關事宜
1.董事會決議日期:107/09/10
2.股東臨時會召開日期:107/10/30
3.股東臨時會召開地點:維多麗亞酒店大宴會廳(臺北市中山區敬業四路168號1樓)
4.召集事由一、報告事項:無
5.召集事由二、承認事項:無
6.召集事由三、討論事項:
(1).擬增加本公司授權資本額（普通決議）。
(2).擬修訂本公司公司章程（特別決議）。
(3).擬辦理現金增資發行普通股參與發行海外存託憑證或辦理國內現金增資發行普通
股案（普通決議）。
(4).擬辦理私募海外存託憑證案（重度決議）。
(5).擬選任本公司獨立董事案。
(6).擬解除本公司新任獨立董事競業禁止義務案（重度決議）。
7.召集事由四、選舉事項:新任獨立董事。
8.召集事由五、其他議案:無
9.召集事由六、臨時動議:無
10.停止過戶起始日期:107/10/01
11.停止過戶截止日期:107/10/30
12.其他應敘明事項:
(1)本次股東會股東得以電子方式行使表決權，行使期間為：自2018年10月15日至2018
年10月27日止，請股東逕登入臺灣集中保管結算所股份有限公司「股東會e票通」
(網址：www.stockvote.com.tw)，依相關說明投票。
(2)依據本公司章程第92條規定，受理股東提名獨立董事候選人之期間自2018年9月18
日起至2018年9月27日止。請將提名相關資料寄至亞獅康股份有限公司，地址為臺
北市忠孝東路5段68號35樓。
這次有線上投票歐，應該是投募資方式看是要發行ADR還是國內現金增資，個人是比較希望發行ADR啦，這樣ADR比重越高，參考價值也越大，才不會像現在ADR跟台灣亞獅康價差那麼大，大家記得去投票歐! 看來後續的實驗要開始進行了，才開始需要增資。 |
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第 510 篇回應
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亞獅康-KY
公司當日重大訊息之詳細內容
本資料由 (上櫃公司) 亞獅康-KY 公司提供
序號
3
發言日期
107/09/10
發言時間
20:43:33
發言人
傅勇
發言人職稱
董事長暨執行長
發言人電話
0227583333
主旨
公告本公司董事會通過辦理私募海外存託憑證
符合條款
第 11款
事實發生日
107/09/10
說明
1.董事會決議日期:107/09/10
2.私募有價證券種類:普通股
3.私募對象及其與公司間關係:
依證券交易法第43條之6及2002年6月13日臺財證字第0910003455規定，選擇特定人，
以符合主管機關所定條件之自然人、法人或基金為限。因應藥品研發時程長且投入經
費高等產業發展特性，引進符合條件之自然人、法人或基金等穩健的資金有其必要性
。
4.私募股數或張數:上限為100,000,000股，但本公司辦理現金增資發行普通股參與發行
海外存託憑證及/或國內現金增資發行普通股及/或私募海外存託憑證，所發行的全部
股數不得超過100,000,000股。
5.得私募額度:上限為100,000,000股，但本公司辦理現金增資發行普通股參與發行海外
存託憑證及/或國內現金增資發行普通股及/或私募海外存託憑證，所發行的全部股數
不得超過100,000,000股。金額未定。
6.私募價格訂定之依據及合理性:
(1)本次參考價格以下列二基準計算價格較高者定之：
a.訂價日前一、 三或五個營業日擇一計算普通股收盤價簡單算數平均數扣除無償
配股除權及配息，並加回減資反除權後之股價。
b.訂價日前三十個營業日普通股收盤價簡單算數平均數扣除無償配股除權及配息，
並加回減資反除權後之股價。
(2)本次私募海外存託憑證發行價格，以不低於參考價格之七成為訂定私募價格之依據
，俟股東會通過私募海外存託憑證案後授權董事會，實際參與海外存託憑證所發行
的普通股私募價格以不得低於參考價格之七成定之。針對訂價的依據及合理性，本
公司已委請獨立專家緯騰會計師事務所朱建成會計師出具獨立專家意見。
(3)在董事會經股東會決議授權進行私募海外存託憑證後，上述發行價格之訂定，係參
考相關法令規範及普通股收盤價而定，應屬合理。
(4)訂價日將由股東會通過私募海外存託憑證股案後授權董事會視情況洽定特定人情形
決定之。
7.本次私募資金用途:
預計用於因應本公司候選藥物之臨床發展、既有或新開啟之研發、營運資金以及本公
司其他日常營運所需。
8.不採用公開募集之理由:
採私募方式相對具時效性及便利性等因素，故不採用公開募集而以私募方式辦理現金
增資發行海外存託憑證。
9.獨立董事反對或保留意見:無。
10.實際定價日:未訂。
11.參考價格:未訂。
12.實際私募價格、轉換或認購價格:未訂。
13.本次私募新股之權利義務:
普通股參與私募海外存託憑證發行之權利義務與本公司原有股份相同；惟依證券交易
法之規定，本次私募海外存託憑證經兌回之股份，於該私募海外存託憑證交付日起三
年內，除符合證券交易法第 43 條之 8規定之轉讓條件外，不得再行賣出。
14.附有轉換、交換或認股者，其換股基準日:不適用。
15.附有轉換、交換或認股者，對股權可能稀釋情形:不適用。
16.附有轉換或認股者，於私募公司債交付且假設全數轉換或認購普通股後對上櫃普通股
股權比率之可能影響（上櫃普通股數A、A/已發行普通股）:不適用。
17.前項預計上櫃普通股未達500萬股且未達25%者，請說明股權流通性偏低之因應措施:
不適用。
18.其他應敘明事項:
本次私募海外存託憑證計劃之主要內容，包含但不限於發行股數(金額)、發行價格(惟
發行價格不得低於參考價格之七成)、發行條件、承銷方式、發行辦法、計畫項目、預
計進度及預計可能產生效益等及其他一切有關發行作業之相關事宜，授權董事會全權
處理之，並視公司資金需求情形及實際市場狀況調整、訂定與辦理。未來如有因主管
機關要求或因應客觀環境需要予以修正或變更，亦授權董事會全權處理之。
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發表時間:2018/9/10 上午 03:55:53
第 509 篇回應
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ASLAN001 ,n=120(60:60)人 膽道癌 二缐的樞鈕（二期)臨床 ,ORR/PFS , p 值 < 0.05 , 來申請BTD
加上
中國大陸68人數據 N達188人，來算p值更小.更容易取得BTD及FDA藥証.
假設
1.兩臨床人數合併的P值
實驗組 60＋68=128人 , ORR=15.6% (20/128).
對照組 60 人,ORR=1.7% (1/60)
四方格 P值 =0.98%
20 //108// 128
1//59//60
21//167//188
x^2 6.676
2.
單一臨床人數的P值
實驗組 60人 , ORR=15.0% (9/60).
對照組 60 人,ORR=1.7% (1/60)
四方格 P值 =2.08%
9 //51// 60
1//59//60
10//110//120
x^2 5.345
3.
單一臨床人數的P值
實驗組 60人 , ORR=16.7% (10/60).
對照組 60 人,ORR=1.7% (1/60)
四方格 P值 =1.14%
10//550// 60
1//59//60
11//109//120
x^2 6.405 |
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| 會員：台醣10138776 |
發表時間:2018/9/10 上午 12:41:26
第 508 篇回應
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獅子臨床數據依據9月法說簡報 即將進入下半年的密集公告期, 假設中國二線膽道癌數據達標,個人評估全球二線膽道癌數據與中國二線膽道癌數據會有很高相關性與參考性
二線膽道癌數據達標 申請藥證的時間需多久時間請參考以下相關統計研究
A 在2012年至2016年期間，113個被批准的孤兒藥物 (Orphan藥物認定ODD)相關統計: 重點如下
1 113顆被批准的藥物 (Orphan藥物認定ODD) 平均FDA審查時間為9.2個月，90.3 ％ 在第一輪審查中獲得批准。
2 Orphan藥物認定ODD需要諮詢委員會（AC會議中有27顆藥物（23.9％），需要AC的審查時間為10.6個月，
不需提交AC會議審核時間則為8.9個月。
3在ODD認證中有54.9％也獲得了優先審查認定
4獲得ODD認定和優先審查認定中只有6.5％在第一輪審查中沒有獲得藥證批准。
5同時具有ODD和優先審查中29.0％需要AC，這導致平均審核時間比具有相同指定但未由AC評估核證時間長3.3個月。
6 2013年至2016年期間，113顆被批准的孤兒藥物 (Orphan藥物認定ODD) 中有 33顆藥獲得了突破性治療指定（BTD），平均FDA審查時間為6.6個月，並且在第一輪查週期中除了一個之外的所有申請都獲得批准。
7所有BTD申請也都獲得了優先審查。這些申請中只有12.1％在批准前需要AC，這使平均審核時間延長了2個月以上：需要AC的申請時間為8.7個月，如果沒有AC申請則為6.2個月。
個人評論:沒有BTD或優先審查認定 只拿到ODD 認定 核准藥證時間只多2-3個月左右 ( 沒差很多) 需要AC 審查的多
2-3 個月左右 ( 需AC審查比率並不高 )
www.diaglobal.org/en/flagship/dia-2017/program/posters/Poster-Presentations/Poster-Presentations-Details?ParentProductID=5583268&ProductID=6534996&AbstractID=74094
B Rare Disease and FDA’s Priority Review Designation
1FDA Orphan Drug Approvals Since 2013* (核准91顆孤兒藥(新藥)
2 拿到BTD 又拿到 Priority Review Designation 佔32% ( 兩樣都拿到被核准藥證佔32% )
3 沒有拿到BTD 也沒有拿到 Priority Review Designation 佔27% ( 兩樣都沒拿到被核准藥證佔27%)
4 拿到 Priority Review Designation 沒拿到BTD 佔41%
(只拿到Priority Review Designation 被核准藥證佔41%)
個人評論: 拿到BTD + 拿到Priority Review Designation 佔 73% ( 比率相當高)
(核准藥證時間約6-7個月左右)
C Rare Disease and FDA’s Breakthrough Therapy Designation Program
1 FDA Breakthrough Therapy Approvals Since 2013* ( 自2013年來有 87顆藥拿到BTD )
2 在87顆藥拿到BTD中孤兒藥癌症類佔37% , 孤兒藥非癌症類 23%
3 在87顆藥拿到BTD中非孤兒藥癌症類佔19%, 非孤兒藥非癌症類佔21%
4 BTD 有60% 核准給孤兒藥 ( rare disease )
www.fda.gov/downloads/forindustry/developingproductsforrarediseasesconditions/ucm581335.pdf
以上分享僅供參考,要學習當投資決策的主人
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發表時間:2018/9/7 下午 10:33:30
第 507 篇回應
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[題目對了]
個人解讀: (1)競爭力:
新藥在實驗室或臨床實驗數據是否為業界的no.1 ? 如 腫瘤細胞的殺死能力/抑制成長能力/ORR/PFS/OS/...
(2)可主宰的市場大小:
—————
生技產業即使規劃了99分都可能出問題，新創團隊要看二件事，「題目對了、團隊對了」就投，突顯出生技產業對「人」的要求。 |
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第 506 篇回應
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………………………………
瞿志豪：生技創業者不是光頭就是白頭髮
2018-09-05 16:56中央社 台北5日電
橡子園創投台灣合夥人瞿志豪今天表示，生技業需要有豐富經驗的人，因此生技業創業的人才不是光頭就是白頭髮，台灣的ITC很強，醫院資訊化很高是發展生技產業的優勢。
行政院生技產業策略諮議委員會議(BTC)進入第二天議程，行政院政務委員吳政忠、衛生福利部部長陳時中、經濟部部長沈榮津、國家發展委員會副主委鄭貞茂、金融監督管理委員會副主委黃天牧及財政部次長莊翠雲等人出席，邀請產學界知名人士就「發展產業生態鏈，建構友善法規環境」、「善用招商引資策略，加速新創動能」二大議題發表專業見解及建議。
甫接下新台幣60億元規模國家級生技基金，台杉旗下「水牛2號」總經理一職的沈志隆今天參與BTC會議時表示，發展新興產業，創投扮演重要角色，台灣生技產業的發展需要更多的氧氣。
沈志隆指出，創投資金具有長期投資的效益，台灣創投發展中，政策面藉由投資抵減吸引資金，股票分紅吸引人才，在1980至1999年間造就新竹科學園區高科技產業的蓬勃發展。
不過，2000年至2018年台灣創投資金募集不易，沈志隆分析主要原因為2000年取消創投股東投資總額20%可減免所得稅、創投設立架構遲遲未能國際化，以致錯失打造具備區域特色的創投基金並與國際投資人連接的機會。
沈志隆表示，2012年生技資本市場突然吸引大量資金投入，帶動生技投資，2012年至2015年國外生技公司及創投探詢及評估台灣IPO的可行性，當時多家生技公司來台註冊，啟動IPO準備程序，可惜仍存有許多法令限制，造成國外生技公司來台投資轉趨保留。同時也讓早期投資人產生疑慮。
他指出，這期間陸續發生的基亞及浩鼎事件，對資本市場的衝擊，進一步改變生技公司掛牌的規則，今年以來更面臨港交所的威脅。
國發會副主委鄭貞茂則回應指出，未來國發基金將採取更積極主動的態度，努力營造更好的投資環境。水牛2號基金就是希望能發揮點火的工作。
橡子園創投台灣合夥人、生醫產業創新推動方案執行中心創新長瞿志豪表示，網路新創產業規劃60分就上陣，生技產業即使規劃了99分都可能出問題，新創團隊要看二件事，「題目對了、團隊對了」就投，突顯出生技產業對「人」的要求。
瞿志豪說，同為新創產業，網路與生技業有極大差異，網路領域的人才要夠年輕、積極、有想法。生技產業的人才不是光頭就是白頭髮，其實在這個產業需要的人都很資深，產業規劃太重要了，需要有豐富經驗的人來創業。每個區域都有各自的特色跟強項，台灣的ITC很強，醫院資訊化很高是發展生技產業的優勢。
udn.com/news/story/7241/3350359?from=udn-ch1_breaknews-1-cate6-news |
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第 505 篇回應
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Table 1a. Ryan White HIV/AIDS Program clients (non-ADAP), by year and selected characteristics, 2012–2016—United
States and 3 territories
Housing status (居住狀態)
Stable (穩定)449,267 人, 86.1 %
Temporary(臨時) 45,767 人 8.8%
Unstable(不穏定)26,907人 5.2%
合計 551,567 人
p.21
hab.hrsa.gov/sites/default/files/hab/data/datareports/RWHAP-annual-client-level-data-report-2016.pdf
這是美國政府的統計數據 |
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| 會員：孤兒藥10140658 |
發表時間:2018/9/4 上午 11:00:52
第 504 篇回應
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亞獅康受邀參加H.C. Wainwright主辦之第20屆Annual Global Investment Conference法說會資料連結:
第25頁為此資料重點~~
mops.twse.com.tw/nas/STR/649720180903M001.pdf
請參考,誤當投資依據~~~ |
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發表時間:2018/9/4 上午 08:49:26
第 503 篇回應
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www.news.sanofi.us/2018-05-21-New-England-Journal-of-Medicine-publishes-two-positive-Phase-3-trials-showing-Dupixent-R-dupilumab-improved-moderate-to-severe-asthma
Dupilumab 3期臨床主要指標資料
New England Journal of Medicine publishes two positive Phase 3 trials showing DupixentR (dupilumab) improved moderate-to-severe asthma
QUEST Data Summary
Placebo-adjusted reduction in annualized rate of severe asthma exacerbations over 52 weeks
用藥量200 mg Dupixent (n=631) vs.
Placebo (n=317)
48 percent*
(實驗組為對照組的48%嚴重惡化事件年化率) ,p <0.001
用藥量300 mg Dupixent (n=633) vs.
Placebo (n=321)
46 percent*
(實驗組為對照組46%的嚴重惡化事件年化率), p<0.001
Placebo-adjusted absolute (percent) change in lung function (measured by FEV1) from baseline to week 122
肺功能指標
FEV1是通過肺活量計測量的強制呼氣的第一秒呼出的空氣量。
用藥量200 mg Dupixent (n=611) vs.
Placebo (n=307)
140 mL* P<0.001 ((對照組比實際組少140ml)
(9 percent) (對照組比實際組少9%)
用藥量300 mg Dupixent (n=610) vs.
Placebo (n=313)
Overall population1
130 mL* p<0.001
(9 percent)
————————————
哮喘3期臨床主要指標:
1.
52周治療期間嚴重惡化事件的年化率：意向治療（ITT）人群[時限：基線至第52週]
嚴重惡化被定義為哮喘惡化需要：使用全身性皮質類固醇≥3天; 或因哮喘住院或急診室就診，需要全身性皮質類固醇激素。 年度事件發生率是治療期間發生的惡化總數除以治療的參與者年數。
2.
1週內前支氣管擴張劑強制呼氣量（FEV1）的基線絕對變化：第12週：ITT人群[時間範圍：基線，第12週]
FEV1是通過肺活量計測量的強制呼氣的第一秒呼出的空氣量。
of participant-years treated.
Absolute Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 12: ITT Population [ Time Frame: Baseline, Week 12 ]
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. |
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Dupilumab 的哮喘3期臨床n=1902 人, 2年取得主要指標.
clinicaltrials.gov/ct2/show/NCT02414854
Evaluation of Dupilumab in Patients With Persistent Asthma (Liberty Asthma Quest)
Study Design
Go to sections
Study Type : Interventional (Clinical Trial)
Actual Enrollment : 1902 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Persistent Asthma
Study Start Date : April 27, 2015
Actual Primary Completion Date : July 29, 2017
Actual Study Completion Date : November 23, 2017
Primary Outcome Measures :
Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: Intent-to-Treat (ITT) Population [ Time Frame: Baseline to Week 52 ]
A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for ≥3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated.
Absolute Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 12: ITT Population [ Time Frame: Baseline, Week 12 ]
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Secondary Outcome Measures :
Percent Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population [ Time Frame: Baseline, Week 12 ]
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: ITT Population With Baseline Eosinophil ≥0.15 Giga/L [ Time Frame: Baseline to Week 52 ]
A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for ≥3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated.
.......
Criteria
Inclusion criteria:
-Adults and adolescent participants with a physician diagnosis of asthma for ≥12 months, based on the Global Initiative for Asthma (GINA) 2014 Guidelines and the following criteria:
a) Existing treatment with medium to high dose ICS (≥250 mcg of fluticasone propionate twice daily or equipotent ICS daily dosage to a maximum of 2000 mcg/day of fluticasone propionate or equivalent) in combination with a second controller (eg, long-acting beta agonist, leukotriene receptor antagonist) for at least 3 months with a stable dose ≥1 month prior to Visit 1.
i) Note for Japan: for participants aged 18 years and older, ICS must be on ≥200 mcg of fluticasone propionate twice daily or equivalent; for participants aged 12 to 17 years, ICS must be ≥100 mcg of fluticasone propionate twice daily or equivalent).
ii) Participants requiring a third controller for their asthma will be considered eligible for this study, and it should also be used for at least 3 months with a stable dose ≥1 month prior to Visit 1.
Exclusion criteria:
Participants <12 years of age or the minimum legal age for adolescents in the country of the investigative site, whichever is higher (For those countries where local regulations permit enrollment of adults only, participant recruitment will be restricted to those who are ≥18 years of age).
Weight is less than 30 kilograms.
Chronic obstructive pulmonary disease or other lung diseases (eg, idiopathic pulmonary fibrosis, Churg-Strauss Syndrome, etc) which may impair lung function.
A participant who experiences a severe asthma exacerbation (defined as a deterioration of asthma that results in emergency treatment, hospitalization due to asthma, or treatment with systemic steroids at any time from 1 month prior to the Screening Visit up to and including the Baseline Visit).
Evidence of lung disease(s) other than asthma, either clinical evidence or imaging (Chest X-ray, CT, MRI) within 12 months of Visit 1 or at the screening visit, as per local standard of care.
Note for Japan: According to the request from the health authority, chest X-ray should be performed at screening visit if there is no chest imaging (Chest X-ray, computed tomography [CT], magnetic resonance imaging [MRI]) available within 3 months prior to screening to exclude participants with suspected active or untreated latent tuberculosis.
Current smoker or cessation of smoking within 6 months prior to Visit 1.
Previous smoker with a smoking history >10 pack-years.
Comorbid disease that might interfere with the evaluation of Investigational Medicinal Product.
The above information is not intended to contain all considerations relevant to a participant’s potential participation in a clinical trial. |
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儘管有可用的治療方法，大約20％的哮喘患者仍然存在不受控制的中度至重度症狀，“馬里奧卡斯特羅，醫學博士，艾倫A.和華盛頓大學醫學院肺與重症醫學教授Edith L. Wolff說。
聖路易斯。“今天發表在新英格蘭醫學雜誌上的研究結果顯示，來自3期試驗的證據表明，生物製劑可能有助於廣大人群在加入標準治療時改善多種關鍵的哮喘治療目標。 Dupixent旨在抑制2型炎症中涉及的兩種重要蛋白（IL-4和IL-13）的信號傳導，導致許多中重度哮喘患者出現不受控制的症狀。
About 20 percent of people with asthma continue to have uncontrolled moderate-to-severe symptoms despite available treatments, said Mario Castro, M.D., Alan A. and Edith L. Wolff Professor of Pulmonary and Critical Care Medicine at Washington University School of Medicine in St. Louis. The results published today in the New England Journal of Medicine show evidence from a Phase 3 trial that a biologic may have the potential to help a broad population of patients improve multiple key asthma treatment goals when added to standard treatments. Dupixent was designed to inhibit signaling from two important proteins (IL-4 and IL-13) involved in Type 2 inflammation that contribute to uncontrolled symptoms in many people with moderate-to-severe asthma.
www.news.sanofi.us/2018-05-21-New-England-Journal-of-Medicine-publishes-two-positive-Phase-3-trials-showing-Dupixent-R-dupilumab-improved-moderate-to-severe-asthma
New England Journal of Medicine publishes two positive Phase 3 trials showing DupixentR (dupilumab) improved moderate-to-severe asthma
* In steroid-sparing VENTURE trial, Dupixent-treated patients substantially reduced use of oral corticosteroids, yet had fewer exacerbations and improved lung function compared to placebo.
* Results showed Dupixent demonstrated a significant improvement in multiple asthma endpoints in two Phase 3 clinical trials in a broad population of patients with uncontrolled asthma, irrespective of minimum baseline eosinophil levels or other biomarkers of Type 2 inflammation
* Greater benefit observed in patients with higher levels of markers of Type 2 inflammation, as evidenced by eosinophils or exhaled nitric oxide levels
* In both trials, Dupixent treated patients showed significant lung function improvement two weeks after first dose that was sustained over 52 weeks
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都柏林，2018年1月4日/美通社/ -
“全球哮喘和COPD(慢性阻塞性肺病 )—-560億美元全球市場
市場規模，市場份額，應用分析，區域展望，增長趨勢，主要參與者，競爭戰略和預測，2017年至2025年”報告已添加到Research and Markets的產品中。
2016年全球哮喘和COPD市場價值為39,021.2百萬美元，預計到2025年將達到56,507.7百萬美元，從2017年到2025年的複合年增長率為4.2％。
在全球範圍內，哮喘和COPD是一種主要的慢性呼吸道疾病，流行率高，醫療保健和經濟負擔增加。因此，疾病代表了製藥公司的利潤豐厚的市場。
COPD被評為死亡的第四大常見原因，並且預計到2030年將達到第三位，以防止吸煙，污染等風險得不到解決。隨著時間的推移，哮喘和COPD的治療逐漸顯現出新的藥物和治療策略以及非藥物治療的使用。
據觀察，發達國家和發展中國家的哮喘和COPD患病率正在激增。在發達國家，由於飲食習慣，運動水平低等方面的生活方式改變，哮喘的患病率有所上升，而在發展中國家，流行是由於污染和吸煙造成的。
截至目前的市場情況，北美共同主導全球哮喘和COPD市場，其次是歐洲市場。由於污染，生活方式的改變，仿製藥的進入和市場上的新療法導致的哮喘和COPD患病率上升。
預計亞太地區將成為預測期內增長最快的市場。新興經濟體如印度，中國由於工業化，人口結構變化，城市化存在污染上升，從而增加了哮喘患病率和COPD人群。
www.prnewswire.com/news-releases/global-asthma-and-copd-market-2017-2025---market-value-expected-to-reach-56-billion-300577584.html
DUBLIN, Jan. 4, 2018 /PRNewswire/ --
The Global Asthma and COPD Market Size, Market Share, Application Analysis, Regional Outlook, Growth Trends, Key Players, Competitive Strategies and Forecasts, 2017 to 2025 report has been added to Research and Markets’ offering.
The global asthma and COPD market was valued at US$ 39,021.2 Million in 2016, and is expected to reach US$ 56,507.7 Million by 2025, expanding at a CAGR of 4.2% from 2017 to 2025.
Globally, asthma and COPD is one the leading chronic respiratory diseases, with high prevalence and increasing health care and economic burden. Thus, disease represent a lucrative market for pharmaceutical companies.
COPD is rated to be the fourth most common cause of mortality, and expected to reach third position by 2030, in case the risk such as smoking, pollution is not addressed. Gradually over the period of time the treatment of asthma and COPD shows improvement, with novel drugs and treatment strategies, along with usage of non-pharmacologic treatment.
It has being observed there is being surge in prevalence of asthma and COPD in developed and developing countries. In developed countries, there is being rise in prevalence of asthma due to lifestyle changes in terms of food habit, low level of exercise, etc., while in developing countries the prevalence is due to pollution and smoking.
As of the current market scenario, North America together dominate the global asthma and COPD market followed by the European market. Rising prevalence of asthma and COPD due to pollution, change in lifestyle, entry of generics and novel therapies in the market.
Asia Pacific is anticipated to be the fastest growing market for the forecast period. Emerging economies such India, China due to industrialization, demographic changes, urbanization there is been rise in pollution thus increase in prevalence of asthma and COPD population.
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GBI Research表示，到2020年美國哮喘治療市場價值將達到140億美元
商業情報提供商GBI Research表示，美國哮喘治療市場價值將從2013年的117億美元上升至2020年的140億美元，複合年增長率（CAGR）為2.6％。
該公司的最新報告*指出，美國是全球最大的單一哮喘治療市場，反映出該國人口眾多，疾病流行率高，與其他主要市場相比治療成本上漲。
然而，根據GBI Research副研究員Fiona Chisholm的說法，哮喘治療市場的特點是通用侵蝕將影響預測期內的幾個主要品牌，包括Singulair（孟魯司特鈉），Advair（丙酸氟替卡松/沙美特羅） xinafoate）和Symbicort（布地奈德/福莫特羅富馬酸鹽）。
Chisholm解釋說：“Singulair的專利於2012年到期，美國食品和藥物管理局隨後批准了幾家製造商，包括Teva，Sandoz和Mylan，以銷售這種藥物的仿製藥。因此，Singulair的銷售收入近年來大幅下降。
“Advair和Symbicort最近也失去了在美國的專利保護。然而，由於監管障礙以及試圖生產生物等效吸入皮質類固醇/長效β激動劑（ICS / LABA）組合藥物和吸入器裝置所固有的困難，尚未發生實質性的一般性侵蝕。
雖然專利到期將限製到2020年的市場增長，但其影響將被最近批准和有希望的管道藥物的吸收所抵消。
Chisholm繼續說道：“Arnuity是目前ICS市場領導者Flovent的後續產品，於2014年8月在美國獲得批准，而當前ICS / LABA市場領導者Advair的後續產品Relvar則處於前期 - 註冊階段。 GBI Research認為這兩種藥物都有助於維持各自課程的銷售收入。
“此外，幾種高價，新型IL靶向單克隆抗體的潛在批准，雖然受到目標人群的限制，但也有助於增長。”
分析人員補充說，這些IL靶向治療以及其他新藥的開發也產生了潛在的表型靶向治療，這對於患有嚴重哮喘的患者尤其有用。
“如果獲得批准，這些藥物將代表哮喘治療方面向前邁出的重要一步，幫助實現針對每個患者量身定制的個性化治療，”Chisholm總結道。
US Asthma Treatment Market Value to Hit $14 Billion by 2020, says GBI Research
gbiresearch.com/media-center/press-releases/us-asthma-treatment-market-value-to-hit-14-billion-by-2020-says-gbi-research
The US treatment market for asthma will rise in value from $11.7 billion in 2013 to an estimated $14 billion by 2020, representing a Compound Annual Growth Rate (CAGR) of 2.6%, says business intelligence provider GBI Research.
The company’s latest report* states that the US is the single biggest asthma treatment market globally, reflecting the country’s large population size, high disease prevalence and the inflated cost of therapeutics in comparison with other major markets.
However, according to Fiona Chisholm, Associate Analyst for GBI Research, the asthma therapeutics market will be strongly characterized by generic erosion that will impact several of the leading brands over the forecast period, including Singulair (montelukast sodium), Advair (fluticasone propionate/salmeterol xinafoate), and Symbicort (budesonide/formoterol fumarate).
Chisholm explains: “Singulair’s patent expired in 2012, with the US Food and Drug Administration subsequently granting approval to several manufacturers, including Teva, Sandoz and Mylan, to market generic versions of the drug. As a consequence, sales revenue for Singulair has declined substantially in recent years.
“Advair and Symbicort have also recently lost patent protection in the US. However, substantial generic erosion has not occurred, due to regulatory hurdles and the difficulties inherent in trying to produce a bioequivalent Inhaled Corticosteroid/Long-Acting Beta Agonist (ICS/LABA) combination drug and inhaler device.”
While patent expirations are set to limit market growth to 2020, the impact of this will be offset by the uptake of recently approved and promising pipeline drugs.
Chisholm continues: “Arnuity, the follow-on product to the current ICS market leader Flovent, was approved in the US in August 2014, while Relvar, the follow-on product to the current ICS/LABA market leader Advair, is at the pre-registration phase. GBI Research believes both drugs will help to maintain sales revenue for their respective classes.
“Furthermore, the potential approval of several premium-priced, novel IL-targeting monoclonal antibodies, although limited by their target populations, will also contribute to growth.”
The analyst adds that the development of these IL-targeting therapies, as well as other novel drugs, also gives rise to potential phenotype-targeted treatment, which could be particularly useful for patients with severe asthma.
“If approved, these drugs will represent a significant step forward in asthma therapeutics, helping to achieve personalized treatment tailored to each individual patient,” Chisholm concludes.
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GBI Research表示，由於製造商希望解決未滿足的需求，到2023年，亞太地區的哮喘市場將達到60億美元
gbiresearch.com/media-center/press-releases/asiapacific-asthma-market-will-hit-6-billion-by-2023-as-manufacturers-look-to-address-unmet-needs-says-gbi-research
亞太（APAC）哮喘治療市場覆蓋印度，中國，澳大利亞，韓國和日本，預計將從2016年的41億美元大幅增長至2023年的60億美元左右，複合年增長率為5.4％據商業情報提供商GBI Research稱。
該公司的最新報告指出，這種強勁的增長將受到人口老齡化，空氣污染增加，有前景的產品線以及推出一流分子的推動。
GBI研究分析師Gautam Arora解釋說：“目前有許多針對哮喘的療法正在開發中，旨在解決市場上未滿足的需求，這將取決於臨床醫生的使用，推動與疾病相關的年度治療費用。最突出的例子是白細胞介素靶向單克隆抗體（mAb），包括reslizumab，dupilumab，tralokinumab和benralizumab。
“Mepolizumab和omalizumab代表了明確轉向個性化藥物治療哮喘。這些生物製劑的高價格，這是由於製造生物製劑的成本，以及重症哮喘的潛在首次上市狀態，將有助於高銷售數字。“
哮喘市場生物學發展的增加可能歸因於Xolair（omalizumab）的成功，Xolair是目前上市的單克隆抗體之一，於2014年達到了重磅炸彈的地位。該藥物於2003年在印度，澳大利亞，日本和南方獲得批准。韓國，作為12歲及以上中度至重度過敏性哮喘患者的附加療法，並且吸入糖皮質激素不能充分控制症狀。這是第一個進入亞太地區哮喘市場的生物製劑，其推出解決了哮喘個性化治療的重大需求。
Arora繼續說道：“藥物開發商現在正在尋找Xolair的例子，Xolair在日本，澳大利亞和韓國被廣泛開處方，通過開發針對特定患者亞型的高度靶向的生物製劑和單克隆抗體，希望以前受益服務不足的患者並產生強勁的收入。
“哮喘藥物開發的創新水平高於歷史水平，這是令人樂觀的原因。目前的管道分子可能能夠解決未滿足的患者需求，並且可以為嚴重哮喘患者提供額外的替代治療選擇，這些患者不受標準治療的控制。
Asia-Pacific asthma market will hit $6 billion by 2023 as manufacturers look to address unmet needs, says GBI Research
The Asia-Pacific (APAC) asthma therapeutics market, which covers India, China, Australia, South Korea and Japan, is expected to grow significantly from $4.1 billion in 2016 to around $6 billion by 2023, representing a compound annual growth rate of 5.4%, according to business intelligence provider GBI Research.
The company’s latest report states that this strong growth will be driven by an expanding aging population, increases in air pollution, a promising product pipeline and the launch of first-in-class molecules.
Gautam Arora, Analyst for GBI Research, explains: “There are a number of therapies currently in development for asthma designed to address unmet needs in the market that will, depending on clinician uptake, drive the annual cost of therapy associated with the disease. The most prominent examples are interleukin-targeting monoclonal antibodies (mAbs), including reslizumab, dupilumab, tralokinumab, and benralizumab.
“Mepolizumab and omalizumab represent a clear shift towards personalized medicine for the treatment of asthma. The high price of these biologics, which is due to the costliness of manufacturing a biologic agent, as well as the potential first-to-market status for severe asthma, will contribute to the high sales figures.”
A rise in biologic development in the asthma market is possibly attributable to the success of Xolair (omalizumab), one of the currently marketed mAbs, which reached blockbuster status in 2014. The drug was approved in 2003 in India, Australia, Japan, and South Korea, as an add-on therapy for those aged 12 and over with moderate-to-severe allergic asthmas and symptoms not adequately controlled with inhaled corticosteroids. It was the first biologic to reach the APAC asthma market, and its launch addressed a significant unmet need for personalized therapy in asthma.
Arora continues: “Drug developers are now looking to follow the example of Xolair, which is widely prescribed in Japan, Australia, and South Korea, by developing highly targeted biologics and mAbs aimed at specific patient sub-types, with the hope of benefiting previously underserved patients and generating strong revenues.
“The level of innovation in asthma drug development is greater than that seen historically, which is a cause for optimism. The current pipeline molecules may be able to address unmet patient needs, and could provide additional alternative treatment options for patients with severe asthma that is uncontrolled with standard treatment.”
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Dupilumab Development Program
Sanofi and Regeneron are studying dupilumab in a broad range of clinical development programs for diseases driven by Type 2 inflammation, including asthma (Phase 3), pediatric atopic dermatitis (Phase 3, ages 6 months - 11 years), nasal polyps (Phase 3) and eosinophilic esophagitis (Phase 2). Future trials are planned for chronic obstructive pulmonary disease, grass allergy and food allergy (including peanut). These potential uses are investigational and the safety and efficacy have not been evaluated by any regulatory authority. Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement.
Dupilumab開發計劃
賽諾菲和Regeneron正在研究用於2型炎症引起的疾病的廣泛臨床開發項目中的dupilumab，
包括哮喘（3期），小兒特應性皮炎（3期，6個月 - 11歲），鼻息肉（3期） 和嗜酸性粒細胞性食管炎（第2階段）。 未來的試驗計劃用於慢性阻塞性肺病，草過敏和食物過敏（包括花生）。 這些潛在的用途是研究性的，任何監管機構都沒有對安全性和有效性進行評估。 Dupilumab由Sanofi和Regeneron根據全球合作協議共同開發。一 |
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| 會員：天命10141925 |
發表時間:2018/9/2 上午 08:01:34
第 496 篇回應
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www.news.sanofi.us/2018-05-16-Dupixent-R-dupilumab-showed-positive-Phase-3-results-in-adolescents-with-inadequately-controlled-moderate-to-severe-atopic-dermatitis
Dupixent 12-17 歲，中重度異位性皮膚炎3期臨床指標達標。
另用藥频率每4週一次的P值也達標。 |
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| 會員：台醣10138776 |
發表時間:2018/9/1 下午 11:44:07
第 495 篇回應
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ASLAN004除了針對中重度異位性皮膚炎，氣喘等進行研發外根據公司網站提到未來亦可能針對其他發炎性適應症進行研究，例如慢性阻塞性肺病 (COPD)。 2011年統計美國COPD人數在1270萬-2400萬人之間
www.healthline.com/health/copd/facts-statistics-infographic#6 |
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發表時間:2018/9/1 下午 12:25:27
第 494 篇回應
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中－重度異位皮膚炎
三期臨床指標:
全球評估（IGA）得分為0或1的參與者百分比，第16週時基線降低≥2分[時間範圍：第16週]
IGA是一種評估量表，用於根據紅斑和丘疹/ 浸潤,
5點量表確定AD的嚴重程度和治療的臨床反應
（0 =清除; 1 =幾乎清除; 2 =輕微; 3 =中度; 4 =嚴重） 。
治療反應是IGA評分為0（清除）或1（幾乎清除）。
報告了IGA評分為0或1且第16週時基線降低≥2分的參與者。
在第16週時IGA評分的第一次挽救治療後的值被設定為缺失的參與者被認為是無應答者。
Percentage of Participants With Investigator’s Global Assessment (IGA) Score of 0 or 1 and Reduction From Baseline of ≥2 Points at Week 16 [ Time Frame: Week 16 ]
IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear). Participants with IGA score of 0 or 1 and a reduction from baseline of ≥2 points at Week 16 were reported. Values after first rescue treatment were set to missing and participants with missing IGA scores at Week 16 were considered as non-responders.
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發表時間:2018/8/31 下午 06:54:36
第 493 篇回應
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HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use DUPIXENT safely and effectively. See full prescribing information for DUPIXENT.
www.accessdata.fda.gov/drugsatfda_docs/label/2017/761055lbl.pdf |
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發表時間:2018/8/31 下午 06:38:11
第 492 篇回應
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一個異位皮膚炎3期臨671人 ,14個月取得主要指標,
從3期臨床2014年10月開始,到取得藥証2017年3月 ,只花2年半.
(已取得BTD) |
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| 會員：天命10141925 |
發表時間:2018/8/31 下午 06:21:33
第 491 篇回應
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Dupilumab的三期臨床之一
Study of Dupilumab Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis (SOLO 1)
clinicaltrials.gov/ct2/show/NCT02277743
Study Type : Interventional (Clinical Trial)
Actual Enrollment : 671 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3 Confirmatory Study Investigating the Efficacy and Safety of Dupilumab Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis
Study Start Date : October 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : February 2016
主要指標一個,治療16週的效果.（14個月完成)
次要指標20個
Primary Outcome Measures :
Percentage of Participants With Investigator’s Global Assessment (IGA) Score of 0 or 1 and Reduction From Baseline of ≥2 Points at Week 16 [ Time Frame: Week 16 ]
IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear). Participants with IGA score of 0 or 1 and a reduction from baseline of ≥2 points at Week 16 were reported. Values after first rescue treatment were set to missing and participants with missing IGA scores at Week 16 were considered as non-responders.
Secondary Outcome Measures :
Percentage of Participants With Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) at Week 16 [ Time Frame: Week 16 ]
The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-75 responders were the participants who achieved ≥75% overall improvement in EASI score from baseline to Week 16. Values after first rescue treatment use were set to missing and participants with missing EASI score at Week 16 were considered as non-responders.
Percentage of Participants With Improvement (Reduction ≥4 Points) of Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16 [ Time Frame: Baseline to Week 16 ]
Pruritus NRS was an assessment tool that was used to report the intensity of a participant’s pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 16 were reported. Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 16 were considered as non-responders.
Percentage of Participants With Improvement (Reduction ≥3 Points) of Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16 [ Time Frame: Baseline to Week 16 ]
Pruritus NRS was an assessment tool that was used to report the intensity of a participant’s pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥3 points from baseline in weekly average of peak daily pruritus NRS score at Week 16 were reported. Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 16 were considered as non-responders.
Percent Change From Baseline in Peak Daily Pruritus Numerical Rating Scale (NRS) Score to Week 16 [ Time Frame: Baseline to Week 16 ]
Pruritus NRS was an assessment tool that was used to report the intensity of a participant’s pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]).
Percentage of Participants With Improvement (Reduction ≥4 Points) of Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 4 [ Time Frame: Baseline to Week 4 ]
Pruritus NRS was an assessment tool that was used to report the intensity of a participant’s pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 4 were reported. Values after first rescue treatment were set to missing and subjects with missing peak NRS at Week 4 were considered as non-responders.
Percentage of Participants With Improvement (Reduction ≥4 Points) of Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 2 [ Time Frame: Baseline to Week 2 ]
Pruritus NRS was an assessment tool that was used to report the intensity of a participant’s pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 2 were reported. Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 2 were considered as non-responders.
Change From Baseline in Peak Daily Pruritus Numerical Rating Scale (NRS) Score to Week 16 [ Time Frame: Baseline to Week 16 ]
Pruritus NRS was an assessment tool that was used to report the intensity of a participant’s pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]).
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score to Week 16 [ Time Frame: Baseline to Week 16 ]
The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.
Percentage of Participants With Eczema Area and Severity Index-50 (EASI-50) (≥50% Improvement From Baseline) at Week 16 [ Time Frame: Week 16 ]
The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-50 responders were the participants who achieved ≥50% overall improvement in EASI score from baseline to Week 16. Values after first rescue treatment were set to missing and participants with missing EASI-50 scores at Week 16 were considered as non-responders.
Percentage of Participants With Eczema Area and Severity Index-90 (EASI-90) (≥90% Improvement From Baseline) at Week 16 [ Time Frame: Week 16 ]
The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-90 responders were the participants who achieved ≥90% overall improvement in EASI score from baseline to Week 16. Values after first rescue treatment were set to missing and participants with missing EASI-90 scores at Week 16 were considered as non-responders.
Change From Baseline in Percent Body Surface Area (BSA) to Week 16 [ Time Frame: Baseline to Week 16 ]
BSA affected by AD was assessed for each section of the body (the possible highest score for each region was: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]). It was reported as a percentage of all major body sections combined.
Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Score to Week 16 [ Time Frame: Baseline to Week 16 ]
SCORAD is a clinical tool for assessing the severity of AD developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23-31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).
Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 16 [ Time Frame: Baseline to Week 16 ]
The DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL). The 10 questions assessed QOL over the past week, with an overall scoring of 0 (absent disease) to 30 (severe disease); a high score was indicative of a poor QOL.
Change From Baseline in Patient Oriented Eczema Measure (POEM) to Week 16 [ Time Frame: Baseline to Week 16 ]
The POEM is a 7-item questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (high score indicative of poor quality of life [QOL]).
Change From Baseline in Hospital Anxiety Depression Scale (HADS) to Week 16 [ Time Frame: Baseline to Week 16 ]
HADS is a fourteen item scale. Seven of the items relate to anxiety and seven items relate to depression. Each item on the questionnaire is scored from 0 (minimum score) - 3 (maximum score) and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. Cut-offs for identifying psychiatric distress has been reported as 7 to 8 for possible presence, 10 to 11 for probable presence, and 14 to 15 for severe anxiety or depression.
Percent Change From Baseline in Global Individual Signs Score (GISS) to Week 16 [ Time Frame: Baseline to Week 16 ]
Individual components of the AD lesions (erythema, infiltration/ papulation, excoriations, and lichenification) were rated globally (each assessed for the whole body, not by anatomical region) on a 4-point scale (0= none, 1= mild, 2= moderate and 3= severe) using the EASI severity grading criteria. Total score ranges from 0 (absent disease) to 12 (severe disease).
Percent Change From Baseline in Peak Daily Pruritus NRS Score to Week 2 [ Time Frame: Baseline to Week 2 ]
Pruritus NRS was an assessment tool that was used to report the intensity of a participant’s pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]).
Percentage of Participants With Skin Infection Treatment Emergent Adverse Events (TEAEs) Requiring Systemic Treatment [ Time Frame: Baseline up to Week 16 ]
Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to the end of study [Week 28]). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs. Statistical significance in the hierarchical testing of secondary hypotheses was broken at this endpoint. Therefore, subsequent secondary efficacy endpoints were not tested for statistical significance.
Percentage of Participants With Treatment Emergent Serious Adverse Events (TESAEs) From Baseline Through Week 16 [ Time Frame: Baseline up to Week 16 ]
Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to the end of study [Week 28]). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Treatment Discontinuation From Baseline Through Week 16 [ Time Frame: Baseline up to Week 16 ]
Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to the end of study [Week 28]). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.
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| 會員：台醣10138776 |
發表時間:2018/8/31 下午 06:02:56
第 490 篇回應
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預計於2019年第2季完成ASLAN004-001第一期臨床試驗，比我預估的還快，快的話有機會明年下半年進入二期臨床，這顆大藥因為不需看CT影像追蹤評估，節省時間與經費，以上分享僅供參考。 |
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| 會員：飛人卡特10145479 |
發表時間:2018/8/31 下午 05:33:05
第 489 篇回應
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 從今天的籌碼來看，法銀跟國泰還是繼續有在進貨，只是不知為何賣出那些券商今天會一起倒獲呢?
從券商來看也都不是之前賣超的大戶，很高興看到ASLAN004有進展了，希望憨獅繼續加油!!! |
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| 會員：投資者10141485 |
發表時間:2018/8/31 下午 05:08:59
第 488 篇回應
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本公司ASLAN004-001臨床試驗獲第一個衛生主管機關新加坡 衛生科學局(HAS)同意進行之人體臨床試驗審查(IND)
1.事實發生日:107/08/31
2.公司名稱:亞獅康股份有限公司
3.與公司關係(請輸入本公司或子公司):本公司
4.相互持股比例:不適用
5.發生緣由:亞獅康ASLAN004-001臨床試驗獲第一個衛生主管機關-新加坡衛生科學局(HAS
)同意進行之人體臨床試驗審查(IND)。
6.因應措施:無
7.其他應敘明事項:
一、研發新藥名稱或代號：ASLAN004
二、用途：ASLAN004為全人源單株抗體，鎖定IL-13受體α1次單位 (IL-13Rα1)。ASLAN
004預計適用於異位性皮膚炎與氣喘。ASLAN004-001臨床試驗之參與者為自願參加之健康
受試者。
三、預計進行之所有研發階段：第一期、第二期、第三期臨床試驗、新藥查驗登記
四、目前進行中之研發階段：
(一)、提出申請/通過核准/不通過核准：人體臨床試驗審查(IND)通過核準
(二)、未通過目的事業主管機關許可者，公司所面臨之風險及因應措施：不適用
(三)、已通過目的事業主管機關許可者，未來經營方向：將試驗推進至ASLAN004-002多
劑量遞增試驗(Multiple Ascending Dose in Patient Population)
(四)、已投入之研發費用：基於商業機密與保密協定不予揭露
五、將再進行之下一階段研發：
(一)、預計完成時間：
1.預計於2019年取得倫理審查核准
2.預計於2019年第2季完成ASLAN004-001第一期臨床試驗
(二)、預計應負擔之義務：將試驗推進至ASLAN004-002多劑量遞增試驗(Multiple
Ascending Dose in Patient Population)
六、市場現況：
1. 重度異位性皮膚炎的市場現況
異位性皮膚炎為最常見的皮膚疾病，全球超過2億名病患深受其擾，異位性皮膚炎的特點
為皮膚紅腫、持續搔癢，可能嚴重影響病患生活品質。高達三分之一成人病患的病情程
度達中度至重度，現有治療方式不多，且對大多數病患的病情控制有限。
異位性皮膚炎現有治療方案主要為局部塗抹製劑。2016年12月，美國FDA核准輕度至中度
異位性皮膚炎外用藥Eucrisa(由輝瑞藥廠開發)。2017年3月，美國FDA核准了dupilumab
用於成人中度至重度異位性皮膚炎(由賽諾菲與Regeneron Pharmaceuticals開發)。
2. 氣喘的市場現況
全球約莫有3億人患有氣喘，氣喘是一種慢性呼吸道發炎的疾病，伴隨支氣管過度反應導
致呼吸短促、喘鳴、咳嗽等症狀，可能急性發作導致送醫或死亡。逾450萬名重度氣喘病
患的症狀無法透過常規療法有效控制，如支氣管擴張藥或吸入型類固醇。
七、新藥開發時程長、投入經費高且未保證一定能成功，此等可能使投資面臨風險，投
資人應審慎判斷謹慎投資。 |
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發表時間:2018/8/31 下午 03:16:27
第 487 篇回應
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這樣比較清楚..
8/31-6497外資買進113 賣出73 淨買進 40 |
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| 會員：孤兒藥10140658 |
發表時間:2018/8/31 下午 03:11:12
第 486 篇回應
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飛人大~~
買進 賣出
117 6497 亞獅康-KY 113 73 40
至於券商進出要等晚一點才有.... |
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| 會員：飛人卡特10145479 |
發表時間:2018/8/31 下午 01:19:55
第 485 篇回應
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今天亞獅康盤中急速下挫，感覺應該是有某一券商大量出脫亞獅康的持股，轉進另一檔生技股，我猜測有可能是中裕，因為中裕它的MSCI權重調升，不知道各位獅友如何看待今天的走勢呢? 先開低走高在急速下挫!
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發表時間:2018/8/31 下午 12:03:04
第 484 篇回應
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美國分析師評價亞獅康各適應癌臨床成功率x市場滲透年x折現=預期淨現值 DCF
以上是新藥股的標準評價.
HC Wainwright 的評價中未見西獅康
Aslan001 治一缐胃癌的價值.,(已取得孤兒藥証)
52人的2期臨床主要指標, ORR將在年底公布.
clinicaltrials.gov/ct2/show/NCT03130790
ORR 期望值47.3% VS 34.5%,
參考,賀癌平的一線胃癌臨床ToGA資料 , :
www.slideshare.net/mobile/jtcancercenter/grothey-gi-malignancies-11111
P.80
二、未見ASLAN002 , 哩程金5000萬美元的未來收入之評估. |
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