Huadong Medicine Subsidiary's DR10624 Injection Receives NMPA Approval for Clinical Trials in MASLD/MASH

ZhiTong Finance APP reported that Huadong Medicine (000963.SZ) announced recently that its controlling subsidiary, Zhejiang Doer Biologics Co., Ltd. ("Doer Biologics"), has received the "Drug Clinical Trial Approval Notice" (Notice No.: 2024LP02586) issued by the National Medical Products Administration (NMPA). The clinical trial application for DR10624 Injection submitted by Doer Biologics has been approved. Indication for the drug: Metabolic Associated Fatty Liver Disease (MAFLD)/Metabolic Associated Steatohepatitis (MASH).

To date, there is no long-acting triple agonist drug targeting FGF21R, GLP-1R, and GCGR available on the global market. The recent approval of DR10624 for a new indication clinical trial in China marks a significant advancement in the development process and global clinical translation of this novel drug. This progress will further enrich the company’s product pipeline in the field of endocrine therapy, accelerate Huadong Medicine's integration into the global innovative pharmaceuticals industry, and enhance the company’s overall competitiveness.