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亞盛醫藥-B(06855.HK):APG-2575獲美國FDA第二個孤兒藥資格認定
格隆匯 09-07 17:12

格隆匯 9 月 7日丨亞盛醫藥-B(06855.HK)發佈公告,美國食品和藥品監督管理局(FDA)授予公司在研原創新藥Bcl-2抑制劑APG-2575孤兒藥資格認定,用於治療慢性淋巴細胞白血病(CLL)。這是APG-2575獲得的第二個由FDA授予的孤兒藥資格認定。今年7月,FDA授予APG-2575首個孤兒藥資格認定,用於治療華氏巨球蛋白血癥(WM)。

據悉,“孤兒藥”又稱為罕見病藥,指用於預防、治療、診斷罕見病的藥品。CLL是一種成人白血病,以外周血、骨髓、脾臟和淋巴結等淋巴組織中出現大量克隆性B淋巴細胞為特徵。

APG-2575是亞盛醫藥在研的新型口服Bcl-2選擇性小分子抑制劑。APG-2575現已獲得美國、中國、澳大利亞多項Ib/II期臨牀試驗許可,正在全球同步推進多個血液腫瘤適應症的臨牀開發。其中作為單藥或聯合治療復發╱難治CLL/SLL (小淋巴細胞淋巴瘤)的一項全球Ib/II期臨牀研究在進行中,正在美國和澳大利亞進行患者招募。

本次APG-2575獲得FDA授予的孤兒藥資格認定,將有助於該藥物的後續研發方面享受一定的政策支持,包括享有臨牀試驗費用税收減免、免除新藥上市申請 (NDA)費用、獲得FDA的研發資助,以及於獲批准治療CLL後可獲得美國市場7 年獨佔權。

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