海普瑞(09989.HK):注射用Oregovomab III期临床试验申请获得受理
格隆汇4月27日丨海普瑞(09989.HK)发布公告,近日,公司控股子公司深圳昂瑞生物医药技术有限公司收到通知,其拥有大中华区权益的针对肿瘤抗原CA125的鼠源IgG1单克隆抗体Oregovomab的III期药品临床试验申请已获国家药品监督管理局受理。
Oregovomab是一个针对肿瘤抗原CA125的鼠源IgG1单克隆抗体。通过在体内与CA125结合成为一种新抗原,从而使其作为免疫靶点且更具免疫原性;进而通过树突状细胞的抗原递呈,可以激活人体细胞免疫系统和抗原特异性T细胞。Oregovomab的全球Ⅱb期临床试验数据显示了其联合现有的卵巢癌一线标准化疗(以下简称“SOC”)与SOC相比,对无进展生存期(PFS)和总生存期(OS)都可带来显着临床获益。其中中位无进展生存期(mPFS)达到对照组的3.5倍(分别为41.8个月和12.2个月);与现有SOC相比,病情进展和死亡的风险降低了50%以上;而且安全性数据表明,Oregovomab联合SOC的治疗并没有导致更多的毒性,这有利于在获批后Oregovomab与现有卵巢癌一线SOC联合的治疗方案得到临床广泛应用。
Oregovomab获得了美国食品和药品监督管理局(FDA)和欧洲药品管理局(EMA)的孤儿药资质认定。目前,Oregovomab全球多中心III期临床试验在全球多个临床试验中心招募患者,其中美国临床试验中心已于2020年四季度完成了首例患者给药。
昂瑞生物为公司与加拿大Oncoquest Inc.在深圳设立的合资公司,纳入公司的合并范围。截至本公告日,公司在昂瑞生物的持股比例约为 54%。
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