君實生物(688180.SH):特瑞普利單抗用於晚期腎細胞癌一線治療的新適應症上市申請獲得受理
格隆匯7月11日丨君實生物(688180.SH)公佈,收到國家藥品監督管理局核准簽發的《受理通知書》,特瑞普利單抗(商品名:拓益®,產品代號:JS001)聯合阿昔替尼用於不可切除或轉移性腎細胞癌患者一線治療的新適應症上市申請獲得受理。
本次新適應症上市申請主要基於RENOTORCH研究。作為國內首個晚期腎癌免疫治療關鍵III期研究,RENOTORCH研究為一項多中心、隨機、開放、陽性藥對照的III期臨牀研究,旨在評估特瑞普利單抗聯合阿昔替尼對比舒尼替尼一線治療中高危的不可切除或轉移性腎細胞癌患者的有效性和安全性。
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