石四药集团(02005):SYN045片已取得国药监局新增三种不同规格(10mg、25mg及50mg)的一期临床试验许可

智通财经网
03 Apr

石四药集团(02005)发布公告,该集团的化学药品1类新药SYN045片已取得中国国家药品监督管理局新增三种不同规格(10mg、25mg及50mg)的一期临床试验许可,可以满足临床试验多样化需求,针对不同年龄段患者实现剂量梯度给药,进一步优化精准给药方案,提升SYN045片的临床应用价值。

SYN045为高度选择性PGI2受体激动剂。目前,在集团的临床前研究当中,SYN045具有良好的靶点选择性、化合物活性及安全性,在动物体内抗肺动脉高压效果明显,且其毒性低,有利于实现口服长期给药。随着SYN045片一期临床试验的推进,集团进入了1类新药的“快车道”。

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