Beijing News (Reporter Wang Kala) On September 4, the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration showed that the clinical trial application for MSD's Class 1 new drug, injectable Sotatercept, has received tacit clinical approval in China, with the indication for treating pulmonary arterial hypertension.
Pulmonary arterial hypertension is a rare, rapidly progressing, and ultimately life-threatening disease, characterized by constriction of the small pulmonary arteries and elevated blood pressure in the pulmonary circulation. It can lead to a significant increase in cardiac load, resulting in limited physical activity, heart failure, and reduced life expectancy, with a five-year mortality rate of 43%.
Sotatercept is a potential "first-in-class" type IIA activin receptor (ActRIIA) fusion protein, which fuses the modified extracellular domain of ActRIIA with the Fc portion of an antibody, blocking the binding of activin to receptors on the cell membrane and thereby reducing activin-mediated signaling.
In September 2021, Merck & Co., Inc. completed the acquisition of Acceleron Pharma, gaining access to sotatercept, an innovative investigational therapy. Prior to this, MSD had submitted a Biologics License Application (BLA) for sotatercept to the U.S. Food and Drug Administration (FDA). The drug has also received "Orphan Drug" designation and Breakthrough Therapy designation from the FDA.
Proofread by Baoqing Liu