拜耳周一在声明中表示，中国国家药品监督管理局批准了其中风预防药物 Asundexian，该药将以 Sunharbo（苏哈博）为商品名上市，用于降低既往中风成年患者的再发风险。
AG won approval for its stroke prevention drug in China, bolstering the pipeline of the German company’s pharmaceutical unit as some of its biggest medicines face generic competition. China’s National Medical Products Administration endorsed the drug Asundexian, which will be marketed under the brand name Sunharbo, to reduce the risk of stroke in adults who already suffered one, Bayer said in a statement Monday.
此次获批基于一项临床研究，结果显示该疗法在联合抗血小板治疗的基础上，可将继发性中风风险降低 26%，且未增加严重出血风险。
The approval follows a clinical study that showed the therapy reduced the risk of secondary strokes by 26% when added to antiplatelet therapy, without increasing serious bleeding.
阅读：研究显示拜耳 Asundexian 将中风风险降低 26% 周一早盘拜耳股价一度上涨 3.4%。今年以来股价累计上涨近 23%。
Read: Bayer’s Asundexian Drug Reduces Stroke Risk by 26% in Study Shares of Bayer rose as much as 3.4% in early trading on Monday. The stock is up nearly 23% since the start of the year.
拜耳的这款口服药物通过阻断一种名为因子 XIa 的蛋白发挥作用，该蛋白在血液凝固中发挥作用。Asundexian 是该类药物中首个获批上市的产品。竞争对手百时美施贵宝和强生正在测试同类药物 milvexian。
Bayer’s oral treatment works by blocking a protein called Factor XIa, which plays a role in blood clotting. Asundexian is the first drug of this class to win approval. Rivals Bristol Myers Squibb Co. and Johnson & Johnson are testing a similar drug called milvexian.
据拜耳介绍，在中国，中风是致死和致残的首位原因，且患病率近年来持续上升。尽管已有预防策略，约每 10 位非心源性缺血性中风幸存者中就有 1 人在一年内复发。
In China, stroke is the leading cause of death and disability and the prevalence has increased over the past years, according to Bayer. About one in ten people who survive a non-cardioembolic ischemic stroke experience another one within one year despite existing prevention strategies.
这款药物有望帮助这家德国企业集团推动其制药部门增长，该部门正面临抗凝血药 Xarelto 和眼科药 Eylea 遭遇仿制药竞争的挑战。公司较新的药物包括更年期用药 Lynkuet 和心脏治疗药 Beyonttra。
The medicine is expected to help the German conglomerate drive growth in its pharma unit, which is grappling with generic competition to blood-thinner Xarelto and eye medicine Eylea. The company’s newer drugs include the menopause medicine Lynkuet and heart treatment Beyonttra.
制药部门负责人 Stefan Oelrich 此前表示，该药物虽早前作为心脏疾病疗法失败，但作为中风治疗药物具有重磅炸弹级潜力。拜耳还已在美国和欧洲等国家提交该药物的上市审批申请。
The head of the pharma unit, Stefan Oelrich, previously said the drug — which earlier failed as a therapy for a heart condition — has blockbuster potential as a stroke treatment. Bayer has also submitted the drug for review in countries including the US and Europe.