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健友股份(603707.SH):健進製藥注射用鹽酸苯達莫司汀獲國家藥監局藥品註冊證書
格隆匯 01-18 16:16

格隆匯1月18日丨健友股份(603707.SH)公佈,公司子公司健進製藥有限公司(以下簡稱“健進製藥”)產品於近日收到國家藥監局關於核准簽發注射用鹽酸苯達莫司汀(規格:25mg、100mg)藥品註冊證書的通知(藥品批准文號:國藥準字H20213019、國藥準字H20213020)。

注射用鹽酸苯達莫司汀,為烷化劑,主要用於慢性淋巴細胞性白血病(CLL)和B-細胞非霍奇金淋巴瘤(NHL),原研藥品於2008年首次在美國上市(商品名:TREANDA®),申請人為CEPHALON,規格有25mg/瓶,100mg/瓶,其中100mg規格原研藥品於2018年在中國獲批,25mg規格僅有正大天晴藥業集團股份有限公司一家仿製藥上市。

健進製藥注射用鹽酸苯達莫司汀25mg、100mg已於2020年4月獲美國FDA暫時性批准,國內藥品上市申請於2019年獲得國家藥品監督管理局受理,2020年7月9日被國家藥品監督管理局藥品審評中心納入擬優先審評品種公示名單。

截至目前,該產品項目已投入研發費用約為1175.15萬元人民幣。

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