Pulmonary Arterial Hypertension Drug 'Winrevair Injection' Approved by Ministry of Food and Drug Safety

Designated as a Target for the Global Innovation Product Fast Track (GIFT) System

The Ministry of Food and Drug Safety announced on July 23 that it has approved the import of the rare medicines 'Winrevair Injection (active ingredient: sotatercept) 45mg·60mg' and 'Winrevair Kit Injection (sotatercept) 45mg·60mg'.

This drug is an 'activin' signaling inhibitor that lowers pulmonary arterial pressure by reducing elevated levels of the glycoprotein activin-A in patients with pulmonary arterial hypertension, thereby controlling vascular proliferation and other related effects. Activin is a glycoprotein belonging to the 'transforming growth factor-beta (TGF-β)' ligand group and is involved in cell proliferation, differentiation, and inflammatory responses.

This treatment has been approved for use in combination with other pulmonary arterial hypertension therapies to improve exercise capacity in adult patients classified as World Health Organization (WHO) functional class II or III. The Ministry designated this drug as a target for the Global Innovation product Fast Track (GIFT) system in December 2023 and has supported its expedited review process since then.

A Ministry official stated, "We will continue to do our utmost to ensure that safe and effective treatments for life-threatening or rare and serious diseases can be supplied as quickly as possible."

This content was produced with the assistance of AI translation services.