君實生物(01877.HK)單抗藥物新適應症上市申請獲批准
君實生物(01877.HK)公布,收到國家藥監局核准簽發的《藥品註冊證書》,特瑞普利單抗(商品名:拓益,產品代號:JS001)用於含鉑化療失敗包括新輔助或輔助化療12個月內進展的局部晚期或轉移性尿路上皮癌的治療的新適應症上市申請獲得附條件批准。
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,至今已在中、美等多國開展了覆蓋超過15個適應症的30多項臨床研究。
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