Huadong Medicine's DR10624 Receives NMPA Approval for MAFLD and MASH Clinical Trials

Huadong Medicine’s DR10624 Receives NMPA Approval for MAFLD and MASH Clinical Trials

China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with clinical trials for its protein drug DR10624 in metabolic related fatty liver disease (MAFLD) and metabolic associated steatohepatitis (MASH).

DR10624’s Mechanism and Pre-Clinical Performance
DR10624 is a protein drug that targets FGFR1c/Klothoβ, GLP-1R, and GCGR, showing strong metabolic regulation and improved pharmacological effects in pre-clinical studies. This multi-target approach positions DR10624 as a potential treatment for complex metabolic conditions.

Clinical Trial Progression
DR10624 was cleared for a Phase I study in New Zealand in April 2022 and is now subject to Phase Ib/IIa studies in obesity combined with hypertriglyceridemia in the same country. In China, the drug is currently undergoing a Phase II clinical study in severe hypertriglyceridemia. Last year, DR10624 received clinical approvals for weight management, type 2 diabetes, and severe hypertriglyceridemia, indicating its broad potential application in metabolic disorders.-Fineline Info & Tech

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