榮昌生物-B(09995.HK)：國家藥品監督管理局批准注射用維迪西妥單抗用於治療HER2表達局部晚期或轉移性尿路上皮癌在中國附條件批准上市
格隆匯1月5日丨榮昌生物-B(09995.HK)公吿，公司自主研發的抗HER2抗體－藥物偶聯物(ADC)注射用維迪西妥單抗(RC48，商品名：愛地希®)於2021年12月31日正式獲得中國國家藥品監督管理局(NMPA)在中國的附條件上市的批准，用於治療HER2表達局部晚期或轉移性尿路上皮癌(UC)。NMPA於2022年1月5日作出相關的網站公示公吿。
這是繼注射用維迪西妥單抗(RC48，商品名：愛地希®)於2021年6月9日成功獲得中國國家藥品監督管理局(NMPA)在中國的附條件上市批准，用於治療局部晚期或轉移性胃癌(包括胃食管結合部腺癌)(GC)後該藥品在中國的第二個獲批上市的適應症。自2021年7月本公司向NMPA遞交該適應症的新藥上市申請至獲批上市僅耗時5個月。
這也是首個由國內公司自主研發的在中國獲批上市的用於治療HER2表達局部晚期或轉移性尿路上皮癌的ADC產品。該適應症曾在2020年9月及12月分別獲美國FDA及中國NMPA授予的突破性療法認證。
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))，並在當年被中國國家醫療保障局(NHSA)納入更新後的國家醫保目錄(NRDL)。同年7月14日，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。
公司就注射用維迪西妥單抗正在針對目前尚缺乏治療的HER2表達適應症實施差異化開發和商業策略，包括(i)胃癌(GC)，(ii)尿路上皮癌(UC)，(iii)乳腺癌(BC)，以及(iv)HER2表達的其他癌症適應症。
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