智通财经APP讯,石药集团(01093)公布,该集团开发的I类新药双功能融合蛋白药物JMT108已获中华人民共和国国家药品监督管理局批准,可在中国开展临床试验。
该产品是一种重组全人源抗PD-1且融合IL-15的双功能融合蛋白,通过靶向PD-1阳性肿瘤浸润免疫细胞,解除PD-1和PD-L1相互作用导致的免疫抑制,并通过PD-1抗体结合依赖性地激活IL-15下游信号通路,进一步促进相关免疫细胞的增殖和活化,从而达到增强的抗肿瘤疗效。本次获批的临床适应症为晚期恶性肿瘤。临床前研究显示,该产品的适应症广泛,在多种恶性肿瘤模型中具有显著的抗肿瘤作用及良好的安全性,具有较高的临床开发价值。
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