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健友股份(603707.SH):注射用硼替佐米正式納入優先審評程序
格隆匯 06-05 19:07

格隆匯6月5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”)產品注射用硼替佐米於2020年05月12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,現已正式納入優先審評程序。

藥品名稱:注射用硼替佐米;劑型:注射劑;規格:3.5mg;受理號:CYHS1900843。

硼替佐米是雙肽基硼酸鹽類似物,是全球第一種人工合成的用於臨牀的新型蛋白酶體競爭性抑制劑,用於多發性骨髓瘤和套細胞淋巴瘤的治療。注射用硼替佐米由Millennium Pharmaceuticals, Inc開發,商品名為Velcade,於2003年05月13日獲得美國FDA批准上市,2004年04月25日在歐盟授權上市。該產品因療效確切,在2005年得以快速進入中國市場,商品名為萬珂。

截至目前,該產品項目已投入研發費用約為718.79萬元人民幣。

值得注意的是,由於醫藥產品具有高科技、高風險、高附加值的特點,藥品研發容易受到技術、審批、政策等多方面因素的影響,審評政策及未來產品市場競爭形勢等存在諸多不確定性風險,上述產品能否成功上市及上市時間具有不確定性。敬請廣大投資者謹慎決策,注意防範投資風險。

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