君實生物(01877.HK)特瑞普利單抗注射液新適應症上市申請獲得受理
格隆匯5月7日丨君實生物-B(01877.HK)發佈公告,公司及其子公司蘇州眾合生物醫藥科技有限公司收到國家藥品監督管理局核准簽發的特瑞普利單抗注射液(商品名:拓益,產品代號:JS001)用於治療既往接受過系統治療的局部進展或轉移性尿路上皮癌的新適應症上市申請的《受理通知書》。
公告表示,尿路上皮癌是目前最常見的膀胱癌類型,POLARIS-03研究(NCT03113266)是一項在中國開展的評估特瑞普利單抗注射液治療既往標準治療失敗後的局部進展或轉移性尿路上皮癌患者的有效性和安全性的II期、開放標籤、多中心、關鍵註冊臨牀研究。2020年2月,美國臨牀腫瘤學會泌尿生殖系統腫瘤研討會(ASCO GU)發佈了POLARIS-03研究的最新數據,截至數據截止日(2020年1月6日),在148例符合療效分析條件的患者中,客觀緩解率(ORR)為25.7%,疾病控制率(DCR)為45.9%。在中國,標準化療失敗的晚期尿路上皮癌患者治療手段非常有限,特瑞普利單抗注射液的註冊申報將為廣大患者提供更好的藥物治療選擇。
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