New drug MSD (MRK.US) for pulmonary hypertension declared marketing in China

The Zhitong Finance App learned that on October 17, the China National Drug Administration (NMPA) Drug Evaluation Center (CDE) official website recently announced that the marketing application for injectable sotatercept declared by MSD (MRK.US) was accepted. According to public information, this is a “first-in-class” novel activin signaling inhibitor biologic preparation. The product was approved for marketing by the US FDA in March of this year to treat pulmonary hypertension (PAH). This treatment was previously rated by industry media Evaluate as one of the potentially major treatments in 2024.

Screenshot source: CDE official website

According to reports, sotatercept is a type IIa activin receptor (ActriIA) fusion protein. It combines the modified extracellular domain of ActriIA with the Fc terminal of the antibody to block activin binding to receptors on the cell membrane, thereby reducing activin-mediated signaling. In preclinical studies, it can reverse the remodeling of the pulmonary artery wall and right ventricle. This product is also a key therapy obtained by MSD's acquisition of Acceleron Pharma for approximately US$11.5 billion in 2021. Previously, Sotatercept was recognized as a breakthrough therapy by the FDA for the treatment of pulmonary hypertension.