恆瑞醫藥(600276.SH):依託泊苷軟膠囊獲藥品GMP證書
格隆匯11月15日丨恆瑞醫藥(600276.SH)公佈,公司近日獲得江蘇省藥品監督管理局頒發的《藥品GMP證書》,本次《藥品GMP證書》認證生產車間為2203車間,設計年產能3000萬粒,代表產品為依託泊苷軟膠囊。
依託泊苷為細胞週期特異性抗腫瘤藥物,作用於DNA拓撲異構酶II,形成藥物-酶-DNA穩定的可逆性複合物,阻礙DNA修復。本品主要用於治療小細胞肺癌,惡性淋巴瘤,惡性生殖細胞瘤,白血病,對神經母細胞瘤,橫紋肌肉瘤,卵巢癌,非小細胞肺癌,胃癌和食管癌等有一定療效。
依託泊苷軟膠囊(商品名Vepesid)由百時美施貴寶公司開發,隨後該品種被Cheplapharm公司收購。百時美施貴寶公司開發的依託泊苷軟膠囊1981年7月在英國獲批,後相繼在美國、日本獲批。1987年3月日本化藥株式會社的依託泊苷軟膠囊在日本獲批,商品名Lastet;2001年9月邁蘭製藥依託泊苷軟膠囊在美國獲批。2002年,日本化藥株式會社的依託泊苷軟膠囊在中國獲批,商品名拉司太特,規格25mg。國內已有兩家企業的依託泊苷軟膠囊獲批上市,分別為恆瑞醫藥、青島正大海爾製藥。
經查詢IMS數據庫,2018年依託泊苷膠囊全球總銷售額約為2623萬美元,國內銷售額約為262萬美元。
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