华东医药：子公司道尔生物DR10624注射液药品临床试验申请已获FDA批准

Core Viewpoint - The announcement from East China Pharmaceutical indicates that its subsidiary, Zhejiang Daer Biotechnology Co., Ltd., has received FDA approval for the clinical trial application of the DR10624 injection, targeting severe hypertriglyceridemia [1] Group 1: Clinical Trial Approval - The DR10624 injection has been approved by the FDA to conduct clinical trials in the United States for the indication of severe hypertriglyceridemia [1] - The drug has successfully completed Phase II clinical studies for severe hypertriglyceridemia, yielding positive topline results post-blinding [1] Group 2: Clinical Research Results - At the EASL Congress 2025, Daer Biotechnology reported that the Phase Ib/IIa clinical study of DR10624 for obesity combined with hypertriglyceridemia showed a maximum liver fat reduction of 89% and a relative triglyceride reduction exceeding 70% from baseline [1] - A Phase II clinical study for DR10624, targeting metabolic-associated fatty liver disease with high risk of liver fibrosis and alcohol-related fatty liver disease, is set to complete its first subject enrollment by April 2025 [1] Group 3: Additional Approvals - The clinical trial application for DR10624 targeting weight management in type 2 diabetes and overweight or obese populations has also been approved in China [1] - Daer Biotechnology submitted the clinical trial application for DR10624 to the FDA in September 2025 and has recently received approval [1]