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金斯瑞(1548.HK)高開6.49% 子公司傳奇生物CAR-T獲美國FDA“突破性療法認定”
格隆匯 12-09 09:22
格隆匯12月9日丨金斯瑞生物科技(1548.HK)高開6.49%,開報21港元,盤前成交2457萬港元,最新總市值391.9億港元。金斯瑞生物科技子公司傳奇生物12月7日宣佈,美國食品藥品監督管理局(FDA)正式授予Janssen Research&Development,LLC(Janssen)的JNJ-68284528(JNJ-4528)突破性療法認定(BTD)。這也是該產品今年上半年獲得美國FDA孤兒藥認證和歐洲藥品管理局優先藥物認定(PRIME)資格後,再次獲得國際權威認可。JNJ-4528是一種結構新穎的CAR-T細胞療法,含有4-1BB共刺激結構域和兩個靶向BCMA的單域抗體,旨在增加抗體親和力。公司稱相信JNJ-4528獲FDA授予突破性療法認定是一個重大的監管里程碑,而 Legend和Janssen將繼續致力於為多發性骨髓瘤患者提供一種新的治療方法。JNJ-4528獲授予突破性療法認定,肯定了該療法尚未滿足的需求,並加快了日後該療法的開發。
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