復旦張江(01349.HK):奧貝膽酸片獲得藥物臨牀試驗申請受理通知書
格隆匯 4 月 23日丨復旦張江(01349.HK)發佈公吿,公司的附屬公司泰州復旦張江藥業有限公司收到國家藥品監督管理局核准簽發的《受理通知書》,奧貝膽酸片(規格:5mg、10mg)的臨牀試驗申請獲得受理。
根據披露,該藥物屬於法尼酯 X 受體(“FXR”)激動劑。FXR 是一種在肝臟和腸道中高水平表達的核受體,在膽酸代謝調節中起關鍵性作用。該藥物是化學藥品3類仿製藥,其首個目標適應症為原發性膽汁性膽管炎(PBC),目前已完成與原研藥的人體生物等效性研究,下一步將開展一項小規模驗證性橋接臨牀研究,支持仿製藥批准上市。
中國作為肝膽疾病高發的國家,市場容量非常龐大。集團對於原研藥物的專利限制進行了突破,並在中國大陸獲得了相應的專利授權。2021年3月15日,國家衞健委聯合科技部、工業和信息化部、國家醫保局、國家藥監局、國家知識產權局六部門,組織專家對國內專利即將到期尚未提出註冊申請及臨牀供應短缺(競爭不充分)的藥品進行遴選論證,制定了《第二批鼓勵仿製藥品目錄》,明確了鼓勵仿製的十七種藥品及劑型,其中包括奧貝膽酸片。
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