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榮昌生物-B(09995.HK):國家藥監局已批准注射用維迪西妥單抗靜脈注射聯合注射用鹽酸吉西他濱膀胱灌注治療非肌層浸潤性膀胱癌的新藥臨牀研究申請

格隆匯1月3日丨榮昌生物-B(09995.HK)公吿,國家藥品監督管理局(NMPA)已經批准注射用維迪西妥單抗(RC48,商品名:愛地希)靜脈注射聯合注射用鹽酸吉西他濱(商品名:澤菲)膀胱灌注治療既往未接受過卡介苗(bacillus calmette guerin, BCG)膀胱灌注治療或BCG治療無應答高危非肌層浸潤性膀胱癌(NMIBC)患者的新藥臨牀研究申請(IND)。

本次研究為一項單臂、開放、單中心的II期臨牀研究,旨在評價注射用維迪西妥單抗靜脈注射聯合注射用鹽酸吉西他濱膀胱灌注治療對於既往未接受過卡介苗膀胱灌注治療或BCG治療無應答高危非肌層浸潤性膀胱癌(NMIBC)患者治療的療效和安全性。

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12月31日,國家藥品監督管理局(NMPA)正式附條件批准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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