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石药集团(01093.HK)同类首创在研产品ALMB-0168 获美国FDA颁发罕见儿童疾病资格认定
格隆汇 10-18 16:33

格隆汇10月18日丨石药集团(01093.HK)发布公告,公司附属公司AlaMab Therapeutics Inc(. “AlaMab”)自主研发的在研产品人源化connexin 43(Cx43)单克隆抗体(ALMB-0168)获得美国食品药品监督管理局(FDA)颁发针对治疗骨癌 (Osteosarcoma)的罕见儿童疾病资格认定。这是继ALMB-0168于2019年9月获得美国FDA 颁发孤儿药资格认定后的另一个资格认定。

骨癌是发生于人体长骨组织中的一种恶性肿瘤,多发生于儿童和青少年,一般造成截肢或死亡等严重后果。目前骨癌的治疗药物和疗法十分有限,主要采用常规化疗和截肢手术等,属于未被满足的临床需求。ALMB-0168为一款同类首创(First-in-Class)针对半通道膜蛋白Cx43 的人源化单克隆抗体激动剂。临床前体外和体内的动物实验显示ALMB-0168能有效通过激活Cx43蛋白释放抑癌性物质而起到治疗骨癌和癌症骨转移的作用。

根据美国FDA罕见儿童疾病资格认定计划,ALMB-0168针对儿童骨癌适应症的上市申请会获得优先审评,而当ALMB-0168针对儿童骨癌适应症的上市申请获得批准,美国FDA 会向AlaMab颁发一张可用于另外一款产品上市申请的可转让优先审评劵(Priority Review Voucher)。AlaMab计划于2019年第四季度提交该在研药物的临床试验申请。

AlaMab为一家位于美国致力于同类首创抗体药物开发的创新生物医药公司,其另一个针对同一靶点的在研产品ALMB-0166亦已于2018年11月获得美国FDA颁发就治疗急性脊髓损伤的孤儿药资格认定。

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