博瑞醫藥(688166.SH)簽署甲磺酸艾立布林注射液仿製藥在美國關於產品開發和商業化獨家合作協議
格隆匯3月31日丨博瑞醫藥(688166.SH)公佈，近日，公司與美國A公司簽署甲磺酸艾立布林注射液仿製藥在美國關於產品開發和商業化的獨家合作協議。
協議標的情況如下：甲磺酸艾立布林注射液是一種抗腫瘤藥物，原研公司為日本衞材公司(Eisai)，於2010年被美國FDA批准上市。甲磺酸艾立布林注射液被美國FDA批准的適應症包括：(1)用於治療已經接受過至少2種化療方案治療的轉移性乳腺癌患者，且化療方案中應包括蒽環黴素或紫杉烷；(2)不可切除或轉移性的肉瘤患者，且已接受過包含蒽環黴素的化療方案。
甲磺酸艾立布林在美國的化合物專利到期時間為2023年7月20日。除化合物專利外，原研公司還在美國佈局有其他若干專利。除需符合美國FDA制定的藥品審評審批政策外，仿製藥需待相關專利到期，才可被美國FDA批准上市。
甲磺酸艾立布林在中國的化合物專利已於2019年6月16日到期。根據中國《專利法》和美國相關專利法律規定，博瑞醫藥與A公司合作開發甲磺酸艾立布林注射液仿製藥處於產品的研發和註冊階段，適用“博拉例外條款”，不侵犯專利權。
博瑞醫藥已擁有甲磺酸艾立布林原料藥及注射液仿製藥一定的技術儲備。
A公司是一家位於美國的仿製藥開發公司，專注於開發複雜仿製藥，如以複雜的製劑配方、富有挑戰的生產和供應鏈過程以及獨特的法規審批路徑等為代表的產品。
協議主要條款：1、合作產品：甲磺酸艾立布林注射液仿製藥；2、目標商業化區域：美國；3、主要約定事項：博瑞醫藥與美國A公司在美國開展合作產品的開發和商業化的獨家合作。博瑞醫藥負責合作產品的部分開發環節，並在研發及未來商業化階段提供甲磺酸艾立布林原料藥。4、首付款：協議簽訂且收到公司發票後30天內，美國A公司將向公司支付首付款50萬美元。5、里程碑付款：從研發階段到合作產品ANDA獲得批准並商業化上市，根據不同的情景，美國A公司將向公司支付共計上限為800萬美元的里程碑付款。
該協議的簽署和履行標誌着，公司依託在高端原料藥和特殊注射劑開發領域的技術積累，正在踐行國際化戰略。今後，公司將繼續開展海外項目合作，加快海外市場開拓，讓公司的產品惠及更多全球患者。
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