Huadong Medicine's DR10624 gets US FDA clinical trial approval

Huadong Medicine’s subsidiary, Doer Biologics, has received US FDA approval for the clinical trial application of DR10624 Injection, targeting severe hypertriglyceridemia (SHTG). This approval marks a crucial advancement in the product's R&D pipeline and enhances the company's core competitiveness in endocrine treatment. DR10624 is a self-developed first-in-class triple-specific agonist that has already completed Phase II clinical studies for SHTG, showing positive top-line results. The drug was also recognized at the EASL Congress 2025 and the AHA Scientific Sessions 2025 for its pioneering clinical trials in cardiometabolic diseases.

In Q1 2025, the Phase Ib clinical trial for DR30206 for NSCLC was successfully dosed, and the Phase Ib/IIa combination therapy for advanced gastrointestinal tumors has commenced enrollment. The company reported a total R&D investment in the pharmaceutical industry of 1.484 bn yuan in the first half of 2025, a year-on-year increase of 33.75%, with direct R&D expenditure up 54.21%.

The company continues to expand its innovative drug pipeline, with over 80 innovative drugs in development. It also actively pursues international registration, with several drug submissions and approvals in various stages for markets including the US, UAE, and Japan, further solidifying its global presence.