MRK.US, a major new drug for pulmonary hypertension, Sotatercept has been approved for marketing in China

The Zhitong Finance App learned that on January 5, MSD (MRK.US) announced that its new pulmonary hypertension (PAH) drug Sotatercept (Chinese product name: Xinruilai) has been approved for marketing in China. The drug is the first activin signaling inhibitor therapy approved for PAH and only requires subcutaneous injections every 3 weeks.

According to reports, Sotatercept is a first-in-class Acvr2a-FC fusion protein developed by Acceleron Pharma. It can selectively bind TGF-beta superfamily ligands to restore the balance between proliferative and anti-proliferative signaling pathways associated with pulmonary artery wall and right ventricular remodeling, and has the effect of inhibiting cell proliferation, reversing vascular remodeling, and unblocking blood vessels. SotaTercept is also currently the only acvr2a-targeted drug designed to treat PAH. In September 2021, Acceleron Pharma was acquired by MSD for US$11.5 billion, and the product was also owned by MSD.

In March 2024, SotaTercept was approved and marketed by the FDA based on the positive results of the phase III Stellar study to treat adult PAH (WHO category 1) to increase exercise capacity, improve WHO functional classification (FC), and reduce the risk of clinical worsening events. As a new PAH drug with a completely revolutionary mechanism, Sotatercept sold 419 million US dollars in less than a year after launch, handed over an impressive report card, and became a rising star in MSD's performance.