中國醫藥(600056.SH)：阿加曲班注射液(2ml:10mg、20ml:10mg)獲批上市
格隆匯10月17日丨中國醫藥(600056.SH)公佈，近日，公司下屬全資子公司天方藥業有限公司(簡稱“天方有限”)收到國家藥監局核准簽發的兩份阿加曲班注射液(2ml:10mg、20ml:10mg)《藥品註冊證書》。
阿加曲班是一種新型的凝血酶抑制劑，屬於抑制纖維蛋白形成藥。該藥品適用於：(1)發病48小時內的缺血性腦梗死急性期病人的神經症狀(運動麻痺)、日常活動(步行、起立、坐位保持、飲食)的改善；(2)對慢性動脈閉塞症(血栓閉塞性脈管炎，閉塞性動脈硬化症)患者的四肢潰瘍，靜息痛及冷感等的改善。
該藥品為田邊三菱製藥株式會於1990年2月首先在日本上市，規格為20ml:10mg，之後於2005年在日本上市了規格為2ml:10mg的濃縮產品。2010年經批准進口進入中國市場，商品名：諾保思泰®。
截至該公吿披露日，天方有限在該藥品研發項目的累計投入約為1993萬元人民幣(未經審計)。該藥品原料藥已通過國家藥監局藥品審評中心的技術審評。
國內阿加曲班注射液共有13個批准文號，其中2ml:10mg規格6個，20ml:10mg規格7個。除天方有限，國內另有包括山東新時代藥業有限公司、博瑞製藥(蘇州)有限公司等5家企業的阿加曲班注射液(2ml:10mg)規格與參比製劑(諾保思泰®)一致，其中2家為通過質量和療效一致性評價的藥品，3家為按化學藥品新註冊分類批准的仿製藥，視同通過一致性評價。
根據PDB數據庫樣本醫院用藥銷售統計顯示，2021年該藥品樣本醫院銷售總金額約為1.94億元，2022年第二季度累計銷售金額約為8024萬元。
公司表示，該次天方有限阿加曲班注射液按照化學藥品新註冊分類方法獲得藥品註冊批件，可優化公司的品種結構，有利於提升公司在該藥品領域的市場競爭力，同時為公司後續仿製藥開發積累了寶貴的經驗。
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