中國醫藥(600056.SH):子公司藥品阿奇黴素片通過仿製藥一致性評價
格隆匯12月6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(“天方有限”)收到國家藥品監督管理局核准簽發的阿奇黴素片《藥品補充申請批准通知書》,該藥品通過仿製藥質量和療效一致性評價。
阿奇黴素是一種大環內酯類抗菌藥物,適用於治療由指定微生物敏感菌株在具體病症中引起的輕度至中度感染。FDA於1996年批准輝瑞的250mg、600mg阿奇黴素片劑,2002年批准500mg片劑,商品名ZITHROMAX,輝瑞在中國地產化阿奇黴素片(0.25g、0.5g)(商品名:希舒美)也獲得上市批准。
截至公吿披露日,天方有限在該藥品研發項目累計投入約為1215.73萬元人民幣(未經審計)。
根據PDB數據庫樣本醫院用藥銷售統計顯示,2020年該藥品樣本醫院銷售總金額約為2.05億元,天方有限2020年該藥品銷售收入約為213萬元。
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