China-based Humanwell Healthcare (Group) Co., Ltd (SHA: 600079) announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its generic version of La Jolla Pharmaceutical Company’s Giapreza (angiotensin II). The drug is intended for use as a pressor therapy in adult patients with septic shock or other forms of distributive shock.
Drug Mechanism and Originator Status
Angiotensin II, a naturally occurring polypeptide hormone in the renin-angiotensin-aldosterone system (RAAS), works by constricting blood vessels and raising blood pressure. While the originator Giapreza is not yet approved in China, Humanwell’s generic version is filed as a Category III chemical drug.-Fineline Info & Tech