MSD’s Breakthrough Drug Sotatercept (Winrevair®) Approved in China for Pulmonary Arterial Hypertension
Shanghai Securities News (Reporter: Zhang Xue) — On January 5, MSD (known as Merck & Co. in the U.S. and Canada) announced that Winrevair® (Sotatercept for Injection), the world’s first and currently only breakthrough activin signaling inhibitor (ASI) therapy, has been approved by China’s National Medical Products Administration (NMPA). The drug is indicated for the treatment of adults with Pulmonary Arterial Hypertension (PAH, WHO Group 1) who have WHO Functional Class (FC) II-III symptoms, aiming to improve exercise capacity and WHO functional class.
PAH is a relatively rare and difficult-to-treat cardiovascular disease. Research suggests that the median survival period for patients with idiopathic PAH who do not receive targeted treatment is only 2.8 years after the onset of symptoms. As the disease progresses, patients face increasing limitations in physical activity; in severe cases, they may become unable to perform any physical tasks, significantly impacting their quality of life. The 5-year mortality rate for newly diagnosed patients remains as high as 40%.

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