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華東醫藥(000963.SZ):獲得阿那曲唑片藥品註冊批件
格隆匯 08-03 18:10

格隆匯 8 月 3日丨華東醫藥(000963.SZ)公佈,近日,公司全資子公司杭州中美華東製藥有限公司(“中美華東”)收到國家藥品監督管理局核准簽發阿那曲唑片藥品註冊批件。

阿那曲唑片適用於絕經後婦女的晚期乳腺癌的治療;對雌激素受體陰性的病人,若其對他莫昔芬呈現陽性的臨牀反應,可考慮使用本品;適用於絕經後婦女激素受體陽性的早期乳腺癌的輔助治療;適用於曾接受23年他莫昔芬輔助治療的絕經後婦女激素受體陽性的早期乳腺癌的輔助治療。

截止公告日,中國境內阿那曲唑片生產廠商有原研企業阿斯利康以及5家國內企業其中,中美華東、揚子江藥業集團有限公司、浙江海正藥業股份有限公司、重慶華邦製藥有限公司4家企業已通或視同通過一致性評價。

公司該產品累計已投入研發費用約為人民幣2500萬元。

中美華東此次獲得阿那曲唑片藥品註冊批件並視同通過一致性評價,將進一步豐富公司抗腫瘤領域產品有助於發揮原料製劑一體化生產優勢積極拓展市場覆蓋及產品銷售,提升公司在抗腫瘤用藥領域的市場競爭力

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