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君實生物(688180.SH):特瑞普利單抗一線治療HER2表達的尿路上皮癌的新適應症上市申請獲得受理

格隆匯8月8日丨君實生物(688180.SH)公佈,收到國家藥品監督管理局覈準簽發的《受理通知書》,特瑞普利單抗(商品名:拓益,產品代號:JS001)聯合榮昌生物製藥(煙臺)股份有限公司自主研發的抗體偶聯藥物維迪西妥單抗用於HER2表達的(HER2表達定義爲HER2免疫組織化學檢查結果爲1+、2+或3+)局部晚期或轉移性尿路上皮癌患者的新適應症上市申請獲得受理。

本次新適應症的上市申請主要基於RC48-C016研究(NCT05302284),該研究是一項多中心、隨機、開放、陽性藥對照的Ⅲ期臨牀研究,旨在比較特瑞普利單抗聯合維迪西妥單抗對比吉西他濱聯合順鉑/卡鉑在既往未接受系統抗腫瘤治療的HER2(人表體生長因子受體-2)表達的局部晚期或轉移性尿路上皮癌患者中的有效性和安全性。該研究由北京大學腫瘤醫院郭軍教授和中國醫學科學院腫瘤醫院周愛萍教授擔任主要研究者,在全國74家臨牀中心開展。

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