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在這裡購買西式素色禮服 - 275983 有限時折扣優惠,趕快跟大家分享這個好消息
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對了~我還google了一下評論,很多網友都說很好用!
所以趕快來看介紹吧^^!
生活達人
商品訊息功能:
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商品訊息簡述: #UTF8#
↓↓↓限量特優價格按鈕↓↓↓
西式素色禮服 - 275983 討論,推薦,開箱,CP值,熱賣,團購,便宜,優惠,介大力推薦紹,排行,精選,特價,周年慶,體驗,限時
以下為您可能感興趣的商品
注意:下方具有隨時更新的隱藏版好康分享,請暫時關閉adblock之類的廣告過濾器才看的到哦!!
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下面附上一則新聞讓大家了解時事
(中央社記者韓婷婷台北6日電)永昕自行開發的生物藥TuNEX正式向衛福部食品藥物管理署申請新藥查驗登記(NDA),有機會成為第一個由台灣廠商開發上市的生物藥。TuNEX的適應症是類風濕性關節炎。
TuNEX的適應症是類風濕性關節炎,類風濕性關節炎是一種自體免疫反應所引起的全身性發炎疾病,會破壞身體正常的關節結構。患者病況輕微時,僅會感到局部關節僵硬疼痛,病況嚴重時,則會引起全身的關節腫痛、損壞。
如果未接受治療控制病情的發展,關節會受到侵犯而逐漸變形、僵直,最後將失去活動能力。目前在台灣健保署已核准了6種用於治療類風濕性關節炎的生物製劑,包括TNF-alpha抑制劑(恩博、復邁、欣普尼)、IL-6抑制劑(安挺樂)、T細胞偕同細胞調節素(恩瑞舒)、B-cell抑制劑(莫須瘤)等,TuNEX即屬於腫瘤壞死因子抑制劑。
永昕於2004年完成生物藥廠建置,同年引進TuNEX細胞株,遵循國際法規完成了產程開發、臨床前試驗及台灣第一/二期人體臨床試驗,2011年與東生華(8432)簽署TuNEX藥品合作開發契約,由東生華執行第三期人體臨床試驗,永昕負責其他藥品上市審核所需之工作,如藥品生產製造、相關的確效作業、非臨床試驗 (包含體內及體外有效性試驗、藥品動力學試驗及藥品毒理試驗)、及藥品查驗登記申報等。
未來藥品取得上市藥證之後,將由東生華取得台灣獨家銷售權,永昕則掌握了藥品生產製造。今年3月TuNEX完成其中一個第三期臨床試驗解盲結果,根據解盲數據結果顯示,用藥組與對照組相比,主要療效指標(Primary endpoint)呈現統計上的顯著意義,6月將公佈第二個三期臨床試驗的解盲結果。
永昕總經理溫國蘭表示,隨著環境變遷,人們的生活壓力越來越大,免疫類的疾病越來越多,類風濕性關節炎的發生也逐年增加,根據台灣健保資料庫顯示,2014年健保給付於類風濕性關節炎生物製劑已達新台幣33億元,目前所有的生物藥品全都仰賴國外原廠進口,永昕成立的目的就是希望國內廠商能夠有自行開生物藥品上市及生產製造的能力。
為了建立治療類風濕性關節炎生物製劑的完整產品線,永昕也將在TuNEX計畫上所得的寶貴經驗,應用於LusiNEX計畫,LusiNEX屬於IL-6抑制劑與TuNEX的TNF-alpha抑制劑作用機轉不同,今年第一季已完成上市批量(2000公升/槽)產程放大開發,今年預計將完成臨床前相關開發及動物試驗,目標在2017年向歐盟衛生單位(EMA)申請人體臨床試驗審查(IND)。
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