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健友股份(603707.SH):香港健友注射用硼替佐米獲美國FDA暫批文號
格隆匯 03-24 16:16

格隆匯3月24日丨健友股份(603707.SH)公佈,公司子公司香港健友實業有限公司(以下簡稱“香港健友”)近日收到美國食品藥品監督管理局(以下簡稱“FDA”)通知,香港健友向美國FDA申報的注射用硼替佐米ANDA申請已獲得暫時批准(暫時批准的原因為美國FDA已經完成該藥品的所有審評流程,但存在相關專利未到期的情形)。

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。目前本品包括原研在內的同規格國內獲批企業有六家,包括:齊魯製藥、江蘇豪森、正大天晴、南京正大天晴、南京先聲。經查IMS數據庫,2019年注射用硼替佐米美國銷售額約為6.35億美元。截至目前,公司在該產品研發項目上已投入研發費用約為606.71萬元人民幣。

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