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信達生物(01801.HK)與馴鹿醫療共同開發BCMA CAR-T候選產品獲美國FDA孤兒藥資格
阿思達克 02-15 10:12
信達生物(01801.HK)宣佈,與創新生物製藥公司馴鹿醫療共同開發的候選產品全人源自體B細胞成熟抗原(BMCA)嵌合抗原受體自體T細胞(CAR-T)注射液,近日獲得美國食品藥品監督管理局(FDA)授予孤兒藥資格認定,用於治療復發/難治性多發性骨髓瘤。 信達生物高級副總裁周輝表示,FDA授予孤兒藥認證爲公司開發BCMA靶向CAR-T的一個裏程碑,將進一步加快產品臨牀開發和註冊上市。
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