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奧賽康(002755.SZ):子公司新藥注射用格列本脲獲批臨試
格隆匯 09-07 17:19

格隆匯9月7日丨奧賽康(002755.SZ)宣佈,公司全資子公司江蘇奧賽康於近日收到國家藥監局下發的注射用格列本脲《藥物臨牀試驗批准通知書》,由江蘇奧賽康和中國人民解放軍軍事科學院軍事醫學研究院共同申報的注射用格列本脲已獲臨牀試驗批准。

注射用格列本脲是江蘇奧賽康與軍科院醫學研究院聯合研發、具有自主知識產權的2類新藥;注射用格列本脲主要用於治療急性CNS損傷(急性脊髓損傷、急性顱腦外傷、缺血性卒中等),是一種選擇性磺脲類受體1(SUR1)抑制劑,通過阻斷SUR1-TRPM4(瞬時受體電位M4)通道發揮神經保護作用;注射用格列本脲高效阻斷SUR1-TRPM4通道,防止Na+、Cl-和水的病理性內流,減輕神經細胞水腫,減少神經元的凋亡和壞死。

江蘇奧賽康完成了注射用格列本脲的藥學研究、藥理毒理研究以及臨牀試驗方案設計,向藥監局提交了臨牀試驗申請(IND)並獲得了臨牀試驗批准。該產品國內外尚無同類產品獲批上市,一旦研發成功將進一步豐富公司產品線,增強公司市場競爭力。

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