智通财经APP获悉，诺诚健华(09969)涨超5%，截至发稿，涨5.32%，报14.26港元，成交额2259.16万港元。
消息面上，据诺诚健华官微消息，近日，公司自主研发的靶向PSMA和STEAP1的双抗ADC新药ICP-B381获国家药品监督管理局(NMPA)药品审评中心(CDE)批准开展临床试验，用于治疗前列腺癌等实体瘤。这是公司首款双抗ADC获批临床，也是公司第三款ADC创新药进入临床。PSMA和STEAP1在前列腺癌细胞显著高表达，是前列腺癌尤其是转移性去势抵抗性前列腺癌(mCRPC)极具潜力的治疗靶点。目前，全球尚无靶向PSMA和STEAP1的双抗ADC获批上市。
ICP-B381是诺诚健华基于自主研发ADC平台开发的首个双抗ADC，由人源化抗PSMA/STEAP1抗体、公司自主研发的新一代不可逆连接子和强效有效载荷偶联而成。临床前研究显示，在22Rv1人前列腺癌异种移植模型中，ICP‑B381展现出强效、剂量依赖性的抗肿瘤活性。同等给药剂量下，药效优于对应的单靶点 PSMA‑ADC和STEAP1‑ADC，且耐受性良好。
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