默沙东宣布动脉型肺动脉高压（PAH）创新药物sotatercept在北京获批临时进口

Core Viewpoint - Merck has announced the temporary import approval of sotatercept (WINREVAIR) in China, supported by local policies aimed at facilitating the import of urgently needed clinical drugs and medical devices [1] Group 1: Product Information - Sotatercept is the world's first and currently the only activin signaling inhibitor (ASI) for the treatment of pulmonary arterial hypertension (PAH) [1] - The drug captures excess activin A, helping to restore imbalanced signaling pathways, inhibit cell proliferation, improve vascular structure, and restore lumen patency [1] - Sotatercept has received several designations, including breakthrough therapy designation and orphan drug status in the U.S., as well as priority medicine designation and orphan drug status in the EU [1] Group 2: Disease Context - PAH is a rare, progressive, and life-threatening vascular disease characterized by pulmonary artery narrowing due to vascular remodeling, leading to increased pulmonary artery pressure and resistance [1] - If not treated effectively and timely, PAH can progress to right heart failure and can be life-threatening [1] - Idiopathic pulmonary arterial hypertension was included in the first batch of rare diseases published by the National Health Commission in 2018 [1]