MSD has received marketing authorisation in China for Winrevair (sotatercept), its first-in-class pulmonary arterial hypertension (PAH) therapy. The drug, administered via subcutaneous injection every three weeks, is the first activin signalling inhibitor approved for PAH, targeting a key pathway involved in pulmonary vascular remodelling. The product is a fusion protein that selectively binds ligands in the TGF-β superfamily to restore balance between pro-proliferative and anti-proliferative signalling.

The approval is based on positive results from the pivotal Phase III STELLAR trial, which demonstrated that sotatercept, when added to background therapy, significantly improved patients' exercise capacity compared to a placebo. After 24 weeks, the sotatercept group showed a 34.4-metre increase in the six-minute walk distance, a key efficacy measure. The drug, which generated USD 419 million in sales in its first year following US approval in March 2024, represents a novel mechanism of action for a disease where existing treatments primarily focus on vasodilation rather than addressing underlying vascular remodelling.

According to PharmCube's NextBiopharm® database, Winrevair will compete with ove 30 other innovative drugs approved for PAH in the China market. Click here to request a free trial for NextBiopharm®.