亚盛医药Bcl-2抑制剂再获FDA孤儿药资格认定,治疗慢性淋巴细胞白血病

2020-09-08 医药魔方 医药魔方

9月7日,亚盛医药宣布,FDA授予其在研原创新药Bcl-2抑制剂APG-2575孤儿药资格认定,用于治疗慢性淋巴细胞白血病(CLL)。这是APG-2575获得的第二个FDA授予的孤儿药资格认定。今年7

9月7日,亚盛医药宣布,FDA授予其在研原创新药Bcl-2抑制剂APG-2575孤儿药资格认定,用于治疗慢性淋巴细胞白血病(CLL)。这是APG-2575获得的第二个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,适应症为华氏巨球蛋白血症(WM)。

「孤儿药」又称为罕见药,指用于预防、治疗、诊断罕见病的药品。在美国,罕见疾病是指患病人数少于20万人的疾病。自1983年以来,美国通过《孤儿药法案》的实施,给予企业相关政策扶持,以鼓励罕见病药品的研发。本次APG-2575获得美国FDA授予的孤儿药资格认定,将有助于该药物在美国的后续研发及商业化开展等方面享受一定的政策支持,包括享有临床试验费用税收减免、免除NDA申请费用、获得研发资助等,特别是批准上市后可获得美国市场7年独占权。

CLL是一种成人白血病,以外周血、骨髓、脾脏和淋巴结等淋巴组织中出现大量克隆性B淋巴细胞为特征。据美国癌症协会(American Cancer Society)统计数据显示,到2020年美国将有约21,040例CLL新病例,约有4,060例死于该疾病1。而根据最新的SEER(Surveillance Epidemiology and End Results)数据,2020年美国CLL患者低于20万人2。现有的布鲁顿酪氨酸蛋白激酶(BTK)抑制剂和Bcl-2抑制剂的开发改善了CLL患者的预后,但医学上仍然迫切需求更安全有效、能在短期治疗中达到深度缓解的、免化疗的治疗方案。

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,通过选择性抑制Bcl-2蛋白来恢复肿瘤细胞程序性死亡机制(细胞凋亡),从而杀死肿瘤,拟用于治疗多种血液恶性肿瘤。APG-2575是首个在中国进入临床阶段的、本土研发的Bcl-2选择性抑制剂。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。

亚盛医药首席医学官翟一帆博士表示:「CLL的治疗是全球层面目前尚未完全满足的临床需求。作为公司细胞凋亡产品管线的重要临床开发品种,APG-2575在继WM适应症之后,再次迅速获得FDA第二个孤儿药资格认定,是对我们的高度认可与鼓励。我们将在孤儿药相关政策的扶持下,加快这一药物的全球临床开发与产品上市,早日为CLL患者提供更多的治疗选择。」

参考文献:1. Cancer Statistics 2020, American Cancer Society2. 2020 Cancer Incidence Data, Surveillance, Epidemiology, and End Results Program, National Cancer Institute

关于APG-2575

APG-2575是亚盛医药在研的新型口服Bcl-2选择性抑制剂,通过选择性抑制Bcl-2蛋白来恢复肿瘤细胞程序性死亡机制(细胞凋亡),从而杀死肿瘤,拟用于治疗多种血液恶性肿瘤。此前公司已在美国、澳大利亚、中国启动该药物的单药I期临床试验。今年3月以来,APG-2575接连获得美国、中国多项Ib/II期临床试验许可,正在全球层面同步推进包括复发/难治慢性淋巴细胞白血病/小淋巴细胞淋巴瘤、华氏巨球蛋白血症、复发/难治急性髓性白血病等多个血液肿瘤适应症的临床开发。APG-2575已有两个适应症相继获得美国FDA授予的孤儿药资格认定,分别为华氏巨球蛋白血症和慢性淋巴细胞白血病。

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    2020-09-15 jklm09
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    2020-09-09 cathymary

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