恆瑞醫藥(600276.SH):鹽酸伊立替康脂質體注射液獲批開展臨牀試驗
格隆匯 1 月 18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”)核准簽發關於鹽酸伊立替康脂質體注射液的《藥物臨牀試驗批准通知書》,將於近期開展臨牀試驗。
根據《中華人民共和國藥品管理法》及有關規定,經審查,2020年10月31日受理的鹽酸伊立替康脂質體注射液符合藥品註冊的有關要求,同意開展臨牀試驗。具體為:一項評價伊立替康脂質體聯合奧沙利鉑、5-FU/LV治療晚期胰腺癌的安全性與耐受性的I期臨牀研究(HR-YLTKL-101)。
國外上市的鹽酸伊立替康脂質體注射液商品名為Onivyde®,開發公司為Merrimack Pharmaceuticals公司,於2015年10月22日獲美國FDA批准,並於2016年10月在歐盟獲批,適應症為與氟尿嘧啶和亞葉酸合用用於治療已經使用吉西他濱化療不佳的晚期胰腺癌患者。經查詢,目前國內石藥集團歐意藥業、南京綠葉、四川科倫藥物研究院、齊魯製藥、江蘇奧賽康五家企業已獲批臨牀。智擎生技製藥、艾昆緯醫藥科技(上海)提交進口臨牀註冊申請並獲批臨牀。施維雅(天津製藥有限公司)提交進口報產註冊申請,目前正在審評審批中。國內暫無鹽酸伊立替康脂質體注射劑上市銷售。經查詢EvaluatePharma數據庫,鹽酸伊立替康脂質體注射液Onivyde®全球總銷售額約2.33億美元。
截至目前,該產品累計已投入研發費用約6243萬元人民幣。
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