百濟神州(06160.HK)替雷利珠單抗相關上市申請獲納入優先審評
百濟神州(06160.HK)今日(8日)宣布,國家藥監局已將其具有獨特Fc的在研抗PD-1抗體替雷利珠單抗用於治療既往接受過治療的局部晚期,或轉移性尿路上皮癌患者的新適應症上市申請(sNDA)納入優先審評。
優先審評是為加強藥品註冊管理,加快具有臨床價值的新藥的研發上市;料審批時限將被縮短。尿路上皮癌(UC),又稱移行細胞癌(TCC),是目前最常見的一種膀胱癌。2018年,中國預計共有82,270新增膀胱癌案例,佔全世界膀胱癌新增案例的15%。儘管UC最常見於膀胱中,但在可發生在泌尿系統的其他部分中。
替雷利珠單抗用於治療既往接受過治療的局部晚期或轉移性尿路上皮癌患者的新適應症上市申請,於2019年5月被國家藥監局受理。
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