邁威生物(688062.SH):在研品種9MW2821獲美國FDA快速通道認定
格隆匯2月25日丨邁威生物(688062.SH)公佈,公司在研品種9MW2821獲美國食品藥品監督管理局(稱“FDA”)授予“快速通道認定”(“Fast
Track Designation”,稱“FTD”)用於治療晚期、復發或轉移性食管鱗癌(for advanced, recurrent, or
metastatic esophageal squamous cell
carcinoma,稱“ESCC”)。
9MW2821為靶向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,是國內企業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、食管癌適應症披露臨牀有效性數據的品種。
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