每(mei)日經(jing)濟新聞 2025-09-30 17:49:54
每(mei)經(jing)AI快訊,9月30日(ri),恒瑞醫(yi)藥(yao)(yao)(yao)(600276.SH)公(gong)(gong)告稱,子公(gong)(gong)司(si)蘇州盛迪亞生(sheng)物(wu)(wu)(wu)醫(yi)藥(yao)(yao)(yao)有(you)限公(gong)(gong)司(si)收到(dao)國家(jia)藥(yao)(yao)(yao)監(jian)局(ju)核(he)準(zhun)簽發(fa)(fa)關(guan)于(yu)SHR-4298注(zhu)射液的《藥(yao)(yao)(yao)物(wu)(wu)(wu)臨(lin)(lin)床試(shi)驗(yan)(yan)(yan)(yan)批準(zhun)通知書》,將于(yu)近期(qi)開(kai)展晚(wan)期(qi)實體(ti)瘤的臨(lin)(lin)床試(shi)驗(yan)(yan)(yan)(yan)。SHR-4298注(zhu)射液是(shi)公(gong)(gong)司(si)自主(zhu)研發(fa)(fa)的1類治療用生(sheng)物(wu)(wu)(wu)制品,擬(ni)用于(yu)治療晚(wan)期(qi)實體(ti)瘤。截(jie)至目前,相關(guan)項目累(lei)計(ji)研發(fa)(fa)投(tou)入約2,879萬(wan)元。根據我(wo)國藥(yao)(yao)(yao)品注(zhu)冊相關(guan)的法律法規要求,藥(yao)(yao)(yao)物(wu)(wu)(wu)在(zai)獲得藥(yao)(yao)(yao)物(wu)(wu)(wu)臨(lin)(lin)床試(shi)驗(yan)(yan)(yan)(yan)批準(zhun)通知書后(hou),尚需開(kai)展臨(lin)(lin)床試(shi)驗(yan)(yan)(yan)(yan)并(bing)經(jing)國家(jia)藥(yao)(yao)(yao)監(jian)局(ju)審(shen)評、審(shen)批通過后(hou)方可(ke)生(sheng)產(chan)上市。
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