藥明康德為中裕新藥生產的艾滋病新藥Ibalizumab獲得美國FDA批准用於新藥臨床試驗 鉅亨網新聞中心(來源：美通社)2014-05-06 09:04:11 PR Newswire Asia上海和台北, 2014年5月6日上海和台北2014年5月6日電 /美通社/ -- 藥明康德（NYSE：WX）與中裕新藥今日宣佈，藥明康德無錫生物製藥研發生產基地為中裕新藥生產的首批艾滋病治療單克隆抗體藥物ibalizumab（TMB-355）的原液及無菌生物製品獲得美國FDA批准，用於新藥臨床試驗中對艾滋病患者的持續治療。這是目前已知國內生產的無菌生物產品首次獲得美國FDA認可，用於經美國FDA批准的新藥臨床試驗，標誌著中國生物製藥發展的一個重要里程碑。Ibalizumab是中裕新藥開發的治療艾滋病毒/艾滋病感染的人源單克隆抗體藥物，是一種被稱為「病毒侵入抑制劑」的創新艾滋病療法。藥明康德無錫生物製藥研發生產基地是中國目前唯一一家同時符合美國、歐盟以及中國cGMP標準，採用國際最先進的生產技術和設備建成的生物製藥生產車間。該基地生產ibalizumab原液的細胞培養工廠日前剛獲得國際製藥工程師協會（ISPE）頒發的「2014年度cGMP廠房特別獎」。生產ibalizumab無菌生物製品的cGMP制劑生產工廠新近落成，與細胞培養工廠位於同一園區。該制劑線採用國際先進的自動化小容量無菌灌裝系統，可以生產2-50毫升液體和凍干瓶產品，靈活滿足全球臨床試驗及產品上市的生產需求。「我們祝賀中裕新藥ibalizumab的這一重大進展朝最終走向市場邁出了堅實的一步。」藥明康德董事長兼首席執行官李革博士表示。「藥明康德致力於通過公司一體化的生物醫藥發現、開發、製造和檢測服務平台為廣大客戶提供全方位的解決方案，幫助他們的創新生物製藥產品早日推向全球及中國市場。」中裕新藥首席執行官張念原博士表示，「中裕新藥非常滿意與藥明康德ibalizumab合作項目的推進速度與執行情況。我們非常期待雙方下一階段的合作，最終推動這一重要藥物成功獲批進入市場，服務廣大病患。」
WuXi PharmaTech Toxicology Facility in Suzhou Passes FDA Inspection June 20, 2014, 8:00 a.m. EDT SHANGHAI, June 20, 2014 /PRNewswire/ -- WuXi PharmaTech (Cayman) Inc. WX -0.21% , a leading pharmaceutical, biotechnology, and medical device R&D services company with operations in China and the United States, today announced that its toxicology facility in Suzhou recently passed a surveillance Good Laboratory Practice (GLP) inspection by the U.S. Food and Drug Administration (FDA) with no major observations. This was the first FDA GLP inspection in the facility's five years of operation. The inspection was extensive, lasting five days and including the review of numerous processes and the audit of four studies. WuXi's toxicology facility in Suzhou has completed 92 IND-enabling programs for global submissions."The outcome of the FDA inspection further demonstrates the consistency of our GLP compliance and quality services following the excellent results of earlier OECD and CFDA inspections," said Dr. Ge Li, Chairman and CEO of WuXi PharmaTech.
About WuXi PharmaTech WuXi PharmaTech is a leading pharmaceutical, biotechnology, and medical device R&D outsourcing company, with operations in China and the United States. As a research-driven and customer-focused company, WuXi PharmaTech provides a broad and integrated portfolio of laboratory and manufacturing services throughout the drug and medical device R&D process. WuXi PharmaTech's services are designed to assist its global partners in shortening the cycle and lowering the cost of drug and medical device R&D. WuXi PharmaTech's operating subsidiaries are known as WuXi AppTec. For more information, please visit http://www.wuxiapptec.com or contact:
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