邁威生物(688062.SH):注射用7MW4911臨牀試驗申請獲得國家藥品監督管理局和美國FDA受理
格隆匯7月31日丨邁威生物(688062.SH)公佈,公司收到:1)國家藥品監督管理局(NMPA)簽發的《受理通知書》,注射用7MW4911的臨牀試驗申請已獲正式受理;2)美國食品藥品監督管理局(FDA)出具的INDAcknowledgementLetter,確認已收到公司就注射用7MW4911遞交的IND申請。
7MW4911是基於公司自主知識產權的IDDC?抗體偶聯技術平臺開發的靶向鈣黏蛋白17(CDH17)的創新抗體偶聯藥物(ADC)。CDH17作爲經泛癌種多組學驗證的潛力治療靶點,在正常組織中侷限於腸上皮基底外側膜表達,而在結直腸癌、胃癌及胰腺癌等消化道惡性腫瘤中呈現顯著過表達,其異常高表達與腫瘤侵襲轉移及不良預後密切相關,爲精準幹預提供了理想靶點。7MW4911採用高度工程化設計,整合三大核心元件:具有快速內化特性及跨物種(人/猴)中等親和力的CDH17高特異性單抗Mab0727、新型可裂解連接子、以及爲克服多藥耐藥機制設計的專有DNA拓撲異構酶I抑制劑MF-6載荷。MF-6通過卓越的血漿穩定性、可控的藥物釋放及強效旁觀者效應,顯著增強抗腫瘤活性。
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