南京新百(600682.SH):上海丹瑞“Sipuleucel-T注射液”新藥申請獲受理
格隆匯5月13日丨南京新百(600682.SH)公佈,公司控股子公司上海丹瑞生物醫藥科技有限公司(以下簡稱上海丹瑞)於近日收到《受理通知書》,上海丹瑞的產品“Sipuleucel-T注射液”獲國家藥監局藥物臨牀試驗審評受理。
美國Dendreon Pharmaceuticals LLC.的Sipuleucel-T細胞注射液(商品名Provenge),主要用於治療成年男性的無症狀或輕微症狀的轉移性去勢抵抗性前列腺癌(mCRPC)。2010年4月,Provenge獲美國FDA(食品藥品監督管理局)批准於美國上市,是全球首個獲批上市的治療實體瘤的細胞免疫治療藥物。2013年9月,Provenge獲歐洲EMA(歐洲藥品管理局)批准於歐洲上市。2015年5月,出於運營策略考慮Provenge從歐洲撤市。
上海丹瑞已獲得與該產品相關的全部知識產權授權,現擬於中國境內(不包括港澳台地區,下同)進行本地化生產。截至本公告日,Provenge仍為全球唯一用於治療前列腺癌的已上市細胞免疫治療藥物,中國境內尚無與該產品具有相同靶點的同類藥物獲批上市。
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