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Huadong Medicine's subsidiary gets FDA approval for severe hypertriglyceridemia trial

October 21, 2025 at 12:09 PM UTCBy FilingReader AI

Huadong Medicine's wholly-owned subsidiary, Zhejiang Daor Biology, announced that its DR10624 injection has received U.S. FDA approval to commence clinical trials in the United States. The drug, with IND ID 170485, is intended to treat severe hypertriglyceridemia (SHTG). This approval marks a significant step for the company in its endocrine therapy development.

DR10624 is a first-in-class multi-specific agonist, developed by Daor Biology, targeting Fibroblast growth factor 21 receptor (FGF21R), Glucagon receptor (GCGR), and Glucagon-like peptide-1 receptor (GLP-1R). The drug has already completed Phase II clinical trials for SHTG, yielding positive top-line results. Previous Phase Ib/IIa data presented at EASL Congress 2025 showed up to 89% reduction in liver fat and over 70% reduction in triglycerides from baseline in obese patients with hypertriglyceridemia.

The company submitted the clinical trial application to the U.S. FDA in September 2025. While this approval is a key advancement, the company noted that drug development involves substantial investment, long timelines, and inherent risks. Future market competition and regulatory factors will influence the drug's path to market.

This report was generated by FilingReader's AI system from regulatory filings and company disclosures. To request a correction, contact editorial@filingreader.com

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