邁威生物(688062.SH):邁粒生®獲得國家藥品監督管理局批准上市
格隆匯5月29日丨邁威生物(688062.SH)公佈,公司全資子公司江蘇泰康生物醫藥有限公司提交的注射用阿格司亭α(商品名:邁粒生®,曾用名:注射用重組(酵母分泌型)人血清白蛋白-人粒細胞集落刺激因子(I)融合蛋白,產品代號:8MW0511)上市申請獲得國家藥品監督管理局批准,適用於成年非髓性惡性腫瘤患者在接受容易引起發熱性中性粒細胞減少症的骨髓抑制性抗癌藥物治療時,使用本品降低以發熱性中性粒細胞減少症為表現的感染髮生率。邁粒生®為公司首個創新藥上市品種,亦是首個國內上市的採用白蛋白長效融合技術開發的
G-CSF
藥物。
注射用阿格司亭α(8MW0511)為一款注射用重組(酵母分泌型)人血清白蛋白-人粒細胞集落刺激因子(I)融合蛋白,屬於治療用生物製品1 類。
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