智通财经APP讯，山东新华制药股份(00719)发布公告，近日，公司收到国家药品监督管理局核准签发的LXH-1211片《药物临床试验批准通知书》。
根据《中华人民共和国药品管理法》及有关规定，经审查，2025 年7 月10 日受理的LXH-1211 片临床试验申请符合药品注册的有关要求，同意本品开展肺动脉高压的临床试验。
LXH-1211片是针对肺动脉高压的临床表现和疾病病理本质设计的结构全新的化合物。研究显示LXH-1211具有双重作用机制，既能通过刺激可溶性鸟苷酸环化酶(sGC)产生血管舒张效应，降低肺动脉高压，也能通过抑制AMP-激活蛋白激酶(AMPK)阻止血管重构和纤维化进程。本品拟定的临床适应症为治疗肺动脉高压。
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