字号·· | 护眼
华尔街日报

拜耳在中国获批全球首个XIa因子抑制剂类防卒中新药Bayer Gets in China Its First Global Approval for Stroke Prevention Drug

点「原文对照」整页切到原文,或双击某段只看那段的原文。

拜耳公司表示,中国批准是经过优先审查后作出的,并且基于一项关键研究的积极数据。赫克托·雷塔马尔 / 法新社 / 盖蒂图片社Bayer said the Chinese approval followed a priority review and was based on positive data from a pivotal study. hector retamal / Agence France-Presse / Getty Images

拜耳(BAYN)股价上涨2.50%。公司宣布,已获得中国监管部门批准,可在中国上市一款用于预防复发性卒中的新药,从而拿下全球首个针对新一类药物的批准。

Bayer BAYN 2.50%increase; up pointing triangle said it received regulatory authorization to launch a new drug to prevent recurrent stroke in China, winning the first global approval for a new class of medicines.

这家德国制药集团表示,中国国家药品监督管理局的这一决定,使其获得了全球首个针对XIa因子抑制剂类药物的批准。这类药物旨在减缓一种调节人体凝血过程的蛋白质的活性,且不增加出血风险。

The German pharmaceutical group said the decision from China’s National Medical Products Administration hands it the first approval worldwide for a class of drugs called Factor XIa inhibitors, which aim to slow down the activity of a protein that regulates how the body forms clots without increasing the risk of bleeding.

阅读媒体原文 ↗