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亞盛醫藥-B(06855.HK):胃癌治療藥APG-115獲美國FDA孤兒藥資格認定
格隆匯 09-14 18:28

格隆匯 9 月 14日丨亞盛醫藥-B(06855.HK)宣佈,美國食品和藥品監督管理局(FDA)授予公司在研原創新藥MDM2-p53抑制劑APG-115孤兒藥資格認定,用於治療胃癌。這是APG-115獲得的首個FDA授予的孤兒藥資格認定。

"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。根據美國國家癌症研究所最新的SEER(Surveillance Epidemiology and End Results Program)數據,2017年美國胃癌的患病人數估計為116,5251,在美國被認為是一種罕見病。此次APG-115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,以及於獲批准治療胃癌後可獲得美國市場7年獨佔權。

APG-115 為亞盛醫藥在研的一種口服生物可利用的、高選擇性的小分子MDM2-p53蛋白質間相互作用抑制劑,對MDM2具有高度結合親和力,通過阻斷MDM2-p53蛋白質間相互作用從而恢復p53的腫瘤抑制活性。APG-115是首個在中國進入臨牀階段的MDM2-p53抑制劑,已在中國和美國展開多項治療實體瘤以及血液瘤的臨牀研究,並在治療胃癌的臨牀前研究中顯示了相當的潛力。

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