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健友股份(603707.SH):子公司產品注射用左亞葉酸鈣獲得藥品註冊證書
格隆匯 01-06 17:23

格隆匯1月6日丨健友股份(603707.SH)公佈,公司子公司健進製藥有限公司(“健進製藥”)產品於近日收到國家藥品監督管理局關於核准簽發注射用左亞葉酸鈣(規格:50mg)藥品註冊證書的通知(藥品批准文號:國藥準字H20213965)。

注射用左亞葉酸鈣與5-氟尿嘧啶化療藥物聯用,治療胃癌和結直腸癌。

SPECTRUM公司開發的原研藥品(商品名Fusilev®)於2008年3月7日得到FDA批准在美國上市。公司注射用左亞葉酸鈣,50mg規格已於2019年8月獲得美國FDA的批准。

目前本品國內無原研上市。經查詢,國內江蘇恆瑞醫藥股份有限公司、齊魯製藥有限公司、正大天晴藥業集團股份有限公司、廣東嶺南製藥有限公司、山西普德藥業有限公司和重慶華邦製藥有限公司的注射用左亞葉酸鈣仿製藥已獲批上市。

截至目前,公司在注射用左亞葉酸鈣研發項目上已投入研發費用約人民幣959.91萬元。

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