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信達生物(01801.HK)治療肝細胞癌藥物新適應症上市申請獲中國批準
阿思達克 10-10 08:37
信達生物(01801.HK)公佈,國家藥監局(NMPA)已正式批準抗血管生成藥物希冉擇(R)(雷莫西尤單抗)用於既往接受過索拉非尼治療且甲胎蛋白(AFP)的肝細胞癌(HCC)患者的治療的新適應症上市申請(sNDA)。 希冉擇(R)(雷莫西尤單抗)於今年3月已在內地獲批聯合紫杉醇用於在含氟尿嘧啶類或含鉑類化療期間或化療後出現疾病進展的晚期胃或胃食管結合部腺癌患者的治療,是內地首個且唯一被批準用於晚期胃癌二線治療的靶向藥物。
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