亞盛醫藥-B(06855.HK)：APG-115和APG-1252獲美國FDA孤兒藥資格認證
格隆匯 10 月 9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)授予公司細胞凋亡管線在研原創新藥MDM2-p53抑制劑APG-115、Bcl2/Bcl-xL抑制劑APG-1252兩項孤兒藥資格認定，分別用於治療急性髓系白血病 (AML)、小細胞肺癌(SCLC)。截至該公告日期，亞盛醫藥共有4個在研新藥獲得6項FDA孤兒藥認證。
“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。AML是一種具有高度異質性的血液系統惡性腫瘤，且主要為一種老年患者疾病，診斷時的中位年齡為68歲。美國國家癌症所最新的SEER (Surveillance Epidemiology and End Results Program)數據顯示，2020年美國預計將有19,940例新診AML病例，預計將有11,180人死於該疾病。肺癌按組織病理學分型可分為兩大類，即非小細胞肺癌(NSCLC)和SCLC，其中約13–15%被劃分為SCLC。SCLC是一種罕見的、侵襲性較高的惡性腫瘤，5年生存率較低。AML和SCLC在美國被認為是一種罕見病。本次APG-115和APG-1252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AML 及SCLC後後可獲得美國市場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。
APG-1252為亞盛醫藥自主研發的新型高效小分子藥物，可通過選擇性抑制 Bcl-2及Bcl-xL蛋白修復細胞凋亡。目前APG-1252正在美國和澳大利亞進行鍼對晚期癌症患者的臨牀I期劑量爬坡試驗，在美國進行鍼對聯合紫杉醇治療復發難治SCLC患者的Ib/II期試驗，並在中國進行鍼對SCLC患者的單藥臨牀I期劑量爬坡試驗。目前的臨牀數據表明APG-1252在SCLC及其他晚期實體瘤患者中具有良好的安全性，並初步顯示療效。
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