上海医药(02607.HK)：Prolgolimab注射液获III期临床试验批准通知书
格隆汇 2 月 22日丨上海医药(02607.HK)公告，近日，上海医药集团股份有限公司(以下简称“公司”)合资公司上药博康生物医药(香港)有限公司(SPH-BIOCAD(HK)Limited，以下简称“上药博康”)开发的“Prolgolimab注射液”(以下简称“该项目”)收到国家药品监督管理局(以下简称“国家药监局”)核准签发的《药物临床试验批准通知书》。“Prolgolimab注射液”是一种以单克隆IgG1抗体为骨架的全人抗PD-1单抗注射液，由上药博康于2019年9月License-in，具体内容详见公司公告临2019-048号及临2019-071号。
经上药博康与国家药监局药品审评中心沟通，基于该项目已在俄罗斯上市，国家药监局同意按照已提交的方案开展III期临床试验。上药博康将于近期启动国际多中心晚期非鳞状非小细胞肺癌以及进展性、复发性或转移性宫颈癌成人患者III期临床试验。
“Prolgolimab注射液”是一种以单克隆IgG1抗体为骨架的全人抗PD-1单抗注射液，来源于转基因CHO-S/aPD-1细胞系，是国际上第一款具有Fc沉默“LALA”突变的IgG1抗PD-1单抗，一定程度上降低了可能的副作用。Prolgolimab通过阻断PD-1与配体PD-L1和PD-L2的相互作用，可以增强T细胞抗肿瘤应答，进而使肿瘤缩小。2020年4月，Prolgolimab(商品名为Forteca)已经作为俄罗斯本土首个PD-1抑制剂获得俄罗斯卫生部(RMH)批准上市，用于治疗无法手术切除或转移性黑色素瘤。2020年11月该项目的临床试验申请获得国家药监局正式受理。
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