石药集团(01093.HK)于澳大利亚提交在研同类首创新药ALMB-0166的临床试验申请
格隆汇8月15日丨石药集团(01093.HK)宣布,公司附属公司Ala Mab Therapeutics Inc.已向澳大利亚相关伦理委员会提交在研新药Connexin43(Cx43)人源化单克隆抗体(ALMB-0166)首次进入人体临床试验(First-in-human)申请。
ALMB-0166为针对全新靶点Cx43半通道膜蛋白的同类首创(First-in-class)人源化抗体。作为Cx43的抑制剂,ALMB-0166由集团自主研发用于治疗急性脊髓损伤,缺血性中风及其它多种临床急需的神经性疾病。ALMB-0166於2018年获得美国FDA颁发孤儿药资格认定,用于治疗急性脊髓损伤。基于体外药理学和动物体内药效学实验结果,以及在临床前毒理研究中显示的安全性,该在研生物药成功在澳大利亚提交临床试验申请。ALMB-0166在澳大利亚启动临床试验是Ala Mab Therapeutics Inc.成为临床阶段生物制药公司的重要里程碑。集团并计画在中国及美国等国家启动该在研生物药的相关临床研究。
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