艾迪藥業(688488.SH):AD108注射液獲得藥物臨牀試驗批准通知書
格隆匯3月13日丨艾迪藥業(688488.SH)公佈,公司及控股子公司南京南大藥業有限責任公司收到國家藥品監督管理局於2025年3月12日核准簽發的《藥物臨牀試驗批准通知書》(簡稱“通知書”),同意公司在研2.2類改良型新藥AD108注射液開展I期臨牀試驗。
AD108注射液為改良型新藥(化學藥品2.2類),活性成份為人尿激肽原酶,即組織型激肽釋放酶-1(KLK-1),是由腎臟分泌的一種絲氨酸蛋白酶,通過激肽釋放酶-激肽系統(KKS)在人體內發揮生物學效應,其與腎素-血管緊張素系統(RAS)之間相互作用和平衡,共同維持血液循環系統的穩定和功能。
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