【石药集团：SYH2051获美国临床试验批准】金十数据3月13日讯，石药集团(01093.HK)公告，本集团开发的SYH2051已获得美国FDA批准可以在美国开展临床研究。该产品为本集团自主研发的化药1类新药，选择性靶向抑制ATM蛋白激酶及其下游信号蛋白CHK2和KAP1的磷酸化，延迟DNA双链断裂修复，导致持续的DNA双链断裂和ATM介导的细胞周期阻滞，从而抑制肿瘤细胞增殖。本次获批适应症为晚期实体瘤。临床前研究显示，该产品对ATM靶点选择性好，并表现出较优的体内外活性，具有较高的临床开发价值。该产品在国内已经完成单药在晚期实体瘤的Ia期爬坡试验，获得了单药的安全性及人体药代动力学数据，目前正在积极开展联合放疗、联合抗体偶联药物(ADC)及联合化疗等一系列临床试验。
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