智通财经APP讯，科兴制药(688136.SH)发布公告，近日，公司全资子公司深圳科兴药业有限公司(以下简称“深圳科兴”)收到美国食品药品监督管理局(以下简称“FDA”)的通知，深圳科兴自主研发的创新药GB18注射液药品临床试验申请已获得FDA批准，可在美国开展临床试验，适应症为治疗肿瘤恶病质。
GB18注射液是一种针对GDF15(生长分化因子15)靶点的创新型药物，用于治疗肿瘤恶病质。该分子采用了独特的Fc融合纳米抗体结构设计，不仅提高了药物的稳定性和生物利用度，还显著增强了其在抑制信号通路传递中的表现。
近年来，公司聚焦抗病毒、肿瘤、自免等治疗领域，持续加强创新药管线布局。公司GB18注射液项目在中国、美国同步开展临床试验申报，本次GB18注射液美国临床试验获批，是公司创新药全球化布局进程中的重要一步。若该药品研发未来实现成功上市，将有利于进一步丰富公司产品布局，提升公司竞争力。本次GB18注射液美国临床试验获批，对公司近期的财务状况、经营业绩不会构成重大影响。
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