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上海醫藥(601607.SH):Prolgolimab 注射液獲批III期臨牀試驗
格隆匯 02-22 16:42

格隆匯2月22日丨上海醫藥(601607.SH)公佈,近日,公司合資公司上藥博康生物醫藥(香港)有限公司(SPH-BIOCAD (HK) Limited,以下簡稱“上藥博康”)開發的“Prolgolimab注射液”收到國家藥監局核准簽發的《藥物臨牀試驗批准通知書》。

“Prolgolimab注射液”是一種以單克隆IgG1抗體為骨架的全人抗PD-1單抗注射液,來源於轉基因CHO-S/aPD-1細胞系,是國際上第一款具有Fc沉默“LALA”突變的IgG1抗PD-1單抗,一定程度上降低了可能的副作用。Prolgolimab通過阻斷PD-1與配體PD-L1和PD-L2的相互作用,可以增強T細胞抗腫瘤應答,進而使腫瘤縮小。

經上藥博康與國家藥監局藥品審評中心溝通,基於該項目已在俄羅斯上市,國家藥監局同意按照已提交的方案開展III期臨牀試驗。上藥博康將於近期啟動國際多中心晚期非鱗狀非小細胞肺癌以及進展性、複發性或轉移性宮頸癌成人患者III期臨牀試驗。截至目前,該項目上藥博康已累計投入研發費用約151.9萬元人民幣。

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