君實生物(01877.HK)特瑞普利單抗上市許可申請獲受理
君實生物(01877.HK)公布,收到歐洲藥品管理局(EMA)通知,特瑞普利單抗(產品代號:TAB001/JS001)聯合順鉑和吉西他濱用於局部復發或轉移性鼻咽癌患者的一線治療、特瑞普利單抗聯合紫杉醇和順鉑用於不可切除局部晚期/發或轉移性食管鱗癌患者的一線治療的上市許可申請已獲得受理。
特瑞普利單抗是中國首個批准上市的以PD-1為靶點的國產單抗藥物,至今已在全球(包括中國、美國、東南亞及歐洲等地)開展了覆蓋超過15個適應症的30多項由公司發起的臨床研究。
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