亞盛醫藥(06855.HK)APG-2575獲得美國FDA孤兒藥資格認定
格隆匯7月15日丨亞盛醫藥(06855.HK)公告,美國食品和藥品監督管理局(FDA)已授予公司在研原創新藥Bcl-2抑制劑APG-2575孤兒藥資格認定,用於治療華氏巨球蛋白血癥(WM)。這是APG-2575被授予的首個孤兒藥資格認定,也是亞盛醫藥從FDA獲得的第二個孤兒藥資格認定。
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。WM是一種淋巴細胞性淋巴瘤,以淋巴漿細胞浸潤骨髓、同時伴血清單克隆性免疫球蛋白M增高(IgM)為特點。WM是一種罕見病,在美國約佔非霍奇金淋巴瘤患者不到2%1。
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,現已就多個血液腫瘤適應症獲得美國及中國多項Ib/II期臨牀試驗許可。
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WM後可獲得美國市場7年獨佔權。
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