亚盛医药(06855.HK)新药获美国FDA第二个孤儿药资格认定
亚盛医药(06855.HK)公布,美国食品和药品监督管理局(FDA)授予公司在研原创新药Bcl-2抑制剂APG-2575孤儿药资格认定,用於治疗慢性淋巴细胞白血病(CLL)。这是APG-2575获得的第二个由FDA授予的孤儿药资格认定。今年7月,FDA授予APG-2575首个孤儿药资格认定,用於治疗华氏巨球蛋白血症(WM)。
公告指APG-2575是亚盛医药在研的新型口服Bcl-2选择性小分子抑制剂,APG-2575现已获得美国、中国、澳大利亚多项Ib/II期临床试验许可,正在全球同步推进多个血液肿瘤适应症的临床开发。其中作为单药或联合治疗复发╱难治CLL/SLL(小淋巴细胞淋巴瘤)的一项全球Ib/II期临床研究在进行中,正在美国和澳大利亚进行患者招募。(el/a) ~
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