恆瑞醫藥(600276.SH):來曲唑片通過仿製藥一致性評價
格隆匯11月6日丨恆瑞醫藥(600276.SH)公佈,公司近日收到國家藥品監督管理局(“國家藥監局”)核准簽發的關於來曲唑片的《藥品補充申請批件》,公司來曲唑片首批通過仿製藥質量和療效一致性評價(“仿製藥一致性評價”)。
藥品名稱:來曲唑片;劑型:片劑;規格:2.5mg;註冊分類:化學藥品;受理號:CYHB1850079;批件號:2019B04100;審批結論:根據《中華人民共和國藥品管理法》、《國務院關於改革藥品醫療器械審評審批制度的意見》(國發[2015]44號)和《關於仿製藥質量和療效一致性評價工作有關事項的公告》(2017年第100號)的規定,經審查,本品通過仿製藥質量和療效一致性評價。
2018年6月,公司遞交的本品仿製藥一致性評價申請獲受理。來曲唑片是一種選擇性、非甾體類芳香化酶抑制劑,主要用於以下適應症:1)對絕經後早期乳腺癌患者的輔助治療,此類患者雌激素或孕激素受體陽性;2)對已經接受他莫昔芬輔助治療5年的、絕經後早期乳腺癌患者的輔助治療,此類患者雌激素或孕激素受體陽性;3)治療絕經後、雌激素受體陽性、孕激素受體陽性或受體狀況不明的晚期乳腺癌患者,這些患者應為自然絕經或人工誘導絕經。2013年5月,公司生產的來曲唑片通過美國FDA認證,獲准在美國市場銷售。
來曲唑由諾華製藥研發,1996年12月首次在歐盟獲批上市,商品名為Femara®,規格為2.5mg,適應症為對絕經後早期乳腺癌患者的輔助治療。1999年7月在美國獲批上市,2006年1月在日本獲批上市。2001年4月,諾華製藥的來曲唑片首次在中國獲批,用於絕經後早期乳腺癌患者輔助治療。除諾華製藥研發的來曲唑片外,國內僅有恆瑞醫藥及浙江海正獲批上市,浙江海正2019年1月提交了仿製藥一致性評價申請,另有海南錦瑞、北京以嶺、杭州中美華東等廠家申報生產,目前還未見相關獲批信息。經查詢IMS數據庫,2018年來曲唑片全球總銷售額約為5.65億美元,國內銷售額約為1.49億美元。
截至目前,該產品項目已投入研發費用約為621萬元人民幣。
公司的來曲唑片通過仿製藥一致性評價,有利於提升該藥品的市場競爭力,同時為公司後續產品開展仿製藥一致性評價工作積累了寶貴的經驗。
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