信達生物(01801.HK)達伯舒新適應症上市申請獲受理
信達生物(01801.HK)公佈,國家藥品監督管理局已正式受理創新PD-1抑制劑達伯舒(信迪利單抗注射液)聯合貝伐珠單抗注射液及化療(培美曲塞+順鉑)治療經表皮生長因子受酪氨酸激(酉每)抑制劑治療失敗的EGFR基因突變陽性的局部晚期或轉移性非鱗狀非小細胞肺癌的新適應症上市申請。
信迪利單抗,中國商品名爲達伯舒是公司和禮來製藥共同合作研發的具有國際品質的創新PD-1抑制劑藥物,其已在中國獲批四項適應症,併成功納入中國國家醫保目錄。
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