榮昌生物-B(09995.HK):注射用維迪西妥單抗聯合特瑞普利單抗注射液治療圍手術期肌層浸潤性膀胱癌的新藥臨牀研究申請獲受理
格隆匯12月10日丨榮昌生物-B(09995.HK)公吿,2021年12月10日國家藥品監督管理局(NMPA)已經正式受理注射用維迪西妥單抗(RC48,商品名:愛地希?)聯合特瑞普利單抗注射液(商品名:拓益)治療圍手術期肌層浸潤性膀胱癌(MIBC)的新藥臨牀研究申請(IND)。
本次研究為一項單臂、開放、多中心的II期臨牀研究,旨在評價注射用維迪西妥單抗聯合特瑞普利單抗注射液對於計劃進行外科根治性手術的MIBC患者治療的療效和安全性。
膀胱癌是起源於膀胱尿路上皮癌的惡性腫瘤,是泌尿系統最常見的惡性腫瘤之一。圍手術期的系統治療對於改善MIBC患者預後非常重要。該領域尚存在巨大未被滿足的臨牀需求。公司希望為中國MIBC患者儘快帶來新的治療方案。
據悉,注射用維迪西妥單抗(RC48,商品名:愛地希)是一款抗HER2的抗體-藥物偶聯物,針對具有大量未被滿足醫療需求的常見癌症,且是在中國第一個獲批上市的由國內公司自主研發的ADC產品。該產品已於2021年6月9日正式獲得中國國家藥品監督管理局(NMPA)附條件上市批准,用於治療局部晚期或轉移性胃癌(包括胃食管結合部腺癌(GEJ))。同年7月14日,中國國家藥品監督管理局(NMPA)正式受理了注射用維迪西妥單抗治療HER2表達局部晚期或轉移性尿路上皮癌的新藥上市申請。
注射用維迪西妥單抗已獲美國食品藥品監督管理局(FDA)授予用於治療局部晚期或轉移性尿路上皮癌的突破性療法及快速通道資格認定。其亦已就先前使用帕妥珠單抗及紫杉醇治療HER2表達局部晚期或轉移性尿路上皮癌及HER2陽性乳腺癌肝轉移患者獲NMPA授予突破性療法資格認定。
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