翰宇藥業(300199.SZ):醋酸阿託西班注射液通過仿製藥一致性評價
格隆匯1月13日丨翰宇藥業(300199.SZ)公佈,公司於2022年1月13日通過國家藥監局官方網站獲悉公司的醋酸阿託西班注射液通過了仿製藥質量和療效的一致性評價,醋酸阿託西班注射液獲批文件在國家藥監局網站的辦理狀態變更為“藥品批准證明文件待領取”,簽發日期2022年01月07日。“藥品批准證明文件待領取”狀態表示公司醋酸阿託西班注射液一致性評價已通過國家藥監局批准,目前公司尚未收到正式藥品批件。
繼卡貝縮宮素注射液、注射用胸腺法新、依替巴肽注射液、注射用生長抑素、注射用特利加壓素之後,醋酸阿託西班注射液通過一致性評價,截止目前公司已有6個多肽產品通過一致性評價。公司在多肽原料藥及製劑研發、註冊、產業化方面具有較強的競爭力。本產品於2019年12月在國內首次獲批上市。2020年,本產品相繼獲得西班牙、德國上市許可,成為公司首個在歐盟國家獲得上市許可的注射劑產品。本次通過一致性評價的處方工藝、生產線與通過歐盟上市的產品保持一致。本次批准的產品有效期長達48個月,和原研產品保持一致。
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