榮昌生物-B(09995.HK):注射用維迪西妥單抗再次獲得NMPA授予突破性治療藥物認證
格隆匯6月28日丨榮昌生物-B(09995.HK)發佈公吿,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®)再次獲得中國國家藥品監督管理局(NMPA)授予的突破性治療藥物認證,用於治療既往接受過曲妥珠單抗和紫杉類藥物治療的HER2陽性存在肝轉移的晚期乳腺癌患者。公司目前針對該適應症正在中國開展III期臨牀試驗。
這是繼2020年NMPA和FDA授予本藥品在中國和美國治療尿路上皮癌適應症突破性療法後的第二個突破性療法認證。
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