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邁威生物(688062.SH):9MW2821聯合免疫檢查點抑制劑治療三陰性乳腺癌適應症(TNBC)的臨牀試驗申請已獲得藥監局受理
格隆匯 05-12 15:44

格隆匯5月12日丨邁威生物(688062.SH)公佈,公司採用自主知識產權研發的創新藥9MW2821目前針對尿路上皮癌、宮頸癌、食管癌、乳腺癌等多個適應症正在開展多項臨牀研究。近日,9MW2821聯合免疫檢查點抑制劑治療三陰性乳腺癌適應症(TNBC)的臨牀試驗申請已獲得國家藥品監督管理局受理。根據目前單藥治療的臨牀數據顯示,在接受1.25mg/kg劑量治療並可腫瘤評估的20例局部晚期或轉移性三陰性乳腺癌受試者中,客觀緩解率(ORR)和疾病控制率(DCR)分別為50%和80%。

9MW2821為邁威生物靶向Nectin-4的定點偶聯ADC新藥,為公司利用ADC藥物開發平台聯合自動化高通量雜交瘤抗體分子發現平台兩項平台技術開發的創新品種,是國內同靶點藥物中首個開展臨牀試驗的品種,亦是全球同靶點藥物中首個在宮頸癌、食管癌以及乳腺癌適應症披露臨牀有效性數據的品種。9MW2821於2024年2月、2024年5月先後獲得美國食品藥品監督管理局授予“快速通道認定”(FTD)和“孤兒藥資格認定”(ODD)分別用於治療晚期、復發或轉移性食管鱗癌和食管癌。

該品種通過具有自主知識產權的偶聯技術連接子及優化的ADC偶聯工藝,實現抗體的定點修飾。9MW2821注射入體內後,可與腫瘤細胞表面的Nectin-4結合並進入細胞,通過酶解作用,定向釋放細胞毒素,從而實現對腫瘤的精準殺傷。

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