艾迪藥業(688488.SH):ACC007片境內生產藥品註冊申請獲受理
格隆匯 7 月 23日丨艾迪藥業(688488.SH)公佈,公司於近日收到國家藥監局簽發的關於公司抗艾滋病領域在研1類新藥ACC007片(“ACC007”)境內生產藥品註冊申請的《受理通知書》。
產品名稱:ACC007片;劑型:片劑;規格:75mg/片;申請事項:境內生產藥品註冊;申請人:江蘇艾迪藥業股份有限公司;受理號:CXHS2000022國;審批結論:根據《中華人民共和國行政許可法》第三十二條的規定,經審查,決定予以受理。
ACC007是全新結構的非核苷類逆轉錄酶抑制劑,為公司首個抗艾滋病1類新藥,被列入國家十三五“重大新藥創制”科技重大專項。
ACC007目前已經完成III期臨牀試驗,試驗結果良好、到達主要臨牀終點指標,ACC007和對照組(目前臨牀一線治療方案普遍應用的依非韋倫)相互非劣等效,在不良反應尤其是各類神經系統和精神類不良事件的發生率方面,ACC007優於對照組,提示ACC007在安全性、耐受性和依從性方面具有優勢。公司根據ACC007的III期臨牀試驗結果向國家藥監局提交了境內生產藥品註冊申請,並於2020年7月23日獲得受理。
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