Hybio Pharmaceutical Co., Ltd (SHE: 300199), a Chinese pharmaceutical company, has announced that it has received a Drug Master File (DMF) First Adequate Letter from the U.S. Food and Drug Administration (FDA) for its tirzepatide raw materials.
Tirzepatide, a first-to-market dual GIP/GLP-1 receptor agonist, has been approved in the U.S. for the treatment of type 2 diabetes (T2DM) and obesity. The approvals came in May and December 2023, respectively. The drug is marketed under the brand name Zepbound for obesity and is currently under marketing review in China for this indication. In May 2024, Zepbound received approval in China for the treatment of T2D.- Flcube.com
