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基石藥業-B(02616.HK)治療急性髓系白血病新藥上市申請獲批
阿思達克 02-09 12:01
基石藥業-B(02616.HK)公布,國家藥監局(NMPA)已批准同類首創藥物拓舒沃的新藥上市申請,用於治療攜帶異檸檬 酸脫氫(酉每)-1易感突變的成人復發或難治性急性髓系白血病,為該患者人群提供了新的精準治療選擇。 繼兩款同類首創精準治療藥物普吉華和泰吉華和腫瘤免疫治療藥物擇捷美獲批上市後,拓舒沃為基石藥業在12個月內成功獲批上市的第四款創新藥。 拓舒沃是一種針對IDH1突變(酉每)的口服靶向抑制劑。拓舒沃的新藥上市申請已經獲得NMPA批准,用於治療攜帶IDH1易感突變的成人R/R AML患者。
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