艾迪藥業(688488.SH):撤回烏司他丁注射液仿製藥項目註冊臨牀試驗申請
格隆匯9月2日丨艾迪藥業(688488.SH)公佈,公司根據仿製藥審批的相關政策並結合在研項目進度現狀,經審慎考慮,決定撤回烏司他丁注射液仿製藥項目(簡稱“該項目”)註冊臨牀試驗申請。公司已向國家藥品監督管理局提交《藥品註冊撤回申請》主動申請撤回烏司他丁注射液的註冊臨牀試驗申請,並於近日收到國家藥監局《藥品註冊申請終止通知書》,同意終止註冊程序。
此次撤回申請涉及的烏司他丁注射液仿製藥項目為公司抗炎領域在研管線“AD105”的子項目,具體為AD105(烏司他丁仿製,水針劑型)。烏司他丁是一種從人尿中分離純化的、由143個氨基酸組成的糖蛋白,為廣譜絲氨酸蛋白酶抑制劑。烏司他丁注射液系基於現有上市產品開發,適應症為急性胰腺炎(外傷,外科手術和ERCP術後急性胰腺炎)、慢性複發性胰腺炎急性發作期。
截至2022年7月31日,公司使用自有資金就該項目累計投入446.67萬元,按照相關企業會計準則和公司會計政策,該項目累計投入446.67萬元全部費用化並計入相應會計期間損益(以上數據未經審計)。
該項目註冊臨牀試驗申請過程中,經國家藥監局藥品審評中心專家審評,認為該項目需進一步完善相關研究後才符合開展臨牀試驗的要求,故公司決定主動撤回該項目註冊臨牀試驗申請,待公司完善相關研究後擇期重新提交註冊臨牀試驗申請。此次撤回申請並非終止該項目。
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