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中國醫藥子公司非諾貝特膽堿獲CFDA批臨床

中國醫藥3月31日公告稱,下屬子公司天方藥業于近日收到CFDA核準簽發的非諾貝特膽堿原料《審批意見通知件》及緩釋膠囊《藥物臨床試驗批件》。

非諾貝特膽堿緩釋膠囊為雅培艾伯維(ABBVIE)于 2008 年 12 月在 FDA 上市的氯貝丁酸衍生物類血脂調節藥,上市產品商品名為 TRILIPIX,已在多國上市。經大量臨床實驗和藥物研究證實:非諾貝特的疏水性導致其生物利用度低,并且受食物的影響大,與非諾貝特相反,非諾貝特膽堿在小腸區有較高的溶解度,因此增加了非諾貝酸的生物利用度,并且生物利用度不受食物的影響,同時,使用劑量減少,毒副作用也隨之降低。通過化學修飾后的非諾貝特膽堿,是非諾貝特生物利用度終極解決方案,可以預見它將取代以往所有已上市的非諾貝特制劑,而且大大改善其療效,降低毒性。

目前本品未在國內上市,根據統計,艾伯維非諾貝特膽堿緩釋膠囊 2014 年銷售額約為 23,590 萬美元,2015 年銷售額約為 16,310 萬美元。

天方藥業于 2015 年 11 月 25 日向國家藥監局提交臨床試驗注冊申請。該類藥物的適應癥為調血脂藥,能降低嚴重高甘油三酯血癥患者的 TG,降低LDL-C,總膽固醇,TG 和載脂蛋白 B,使原發性高脂血癥患者或混合型血脂異常患者 HDL-C 升高。

截止公告日,天方有限在該類藥品研發項目上已累計投入研發費用約298萬元人民幣。

 

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