Huadong Medicine's Oral GLP-1 HDM1002 Achieves Phase III Primary Endpoint, NDA Filing Planned for Q4 2026

By VB Data
August 26, 2026

Huadong Medicine Co., Ltd. announced Tuesday that its oral small-molecule GLP-1 receptor agonist HDM1002, also known as conveglipron, has met the primary endpoint in its Phase III clinical trial for weight management in China. The Hangzhou-based pharmaceutical company plans to file a New Drug Application in the fourth quarter of 2026, marking a significant milestone in China's domestic oral weight-loss drug race.

The Phase III study achieved its primary clinical endpoint at 44 weeks, with data already read out. The remaining 52-week treatment period and 4-week safety follow-up are expected to be completed by September 2026. The company had already submitted a Pre-NDA application in July, signaling that the clinical data integrity and study quality compliance have met the prerequisite requirements for market approval.

If the NDA is filed on schedule in the fourth quarter, HDM1002 will officially enter the regulatory review process, joining the commercialization race among domestic oral weight-loss drugs in China.

Dual Indications in Parallel

Beyond weight management, HDM1002 is also advancing in diabetes treatment. Two Phase III clinical studies for type 2 diabetes have completed full enrollment, with primary endpoint data expected to be read out in the fourth quarter of 2026. The company also plans to submit a Pre-NDA consultation application in the same quarter.

The parallel development of dual indications maximizes the clinical value coverage of the product and lays the foundation for rapid expansion into metabolic disease treatment scenarios after market launch.

Phase II Results Show Promising Weight-Loss Potential

According to previously disclosed Phase II clinical study results, the trial enrolled 185 overweight or obese subjects without diabetes. After 12 weeks of treatment, subjects in the twice-daily 200 mg group and the once-daily 400 mg group experienced body weight reductions of 6.08% and 6.83% from baseline, respectively, compared to a 2.88% reduction in the placebo group.

In sensitivity analysis, the two groups achieved weight reductions of 7.01% and 8.46%, respectively. Notably, 63.0% and 56.5% of subjects in these groups achieved at least 5% weight loss. Both once-daily and twice-daily dosing regimens demonstrated significant weight-loss effects, providing flexible dosing options for future clinical applications.

On the safety front, no serious adverse events were reported during the Phase II study. Common adverse events were primarily gastrointestinal reactions such as nausea, vomiting, and diarrhea, mostly mild to moderate in severity, consistent with the class-effect characteristics of GLP-1 drugs. Overall tolerability was favorable. The specific weight-loss magnitude, long-term performance across different doses, and complete safety data from the Phase III study have not yet been officially released, and the comprehensive clinical value of the product awaits further validation from large-sample, long-term study data.

Building a Comprehensive Metabolic Portfolio

Beyond the single-target HDM1002, Huadong Medicine has established a layered and progressive product pipeline in the metabolic field. The GLP-1R/GIPR dual-target agonist HDM1005 is advancing with its Phase III weight management study, with 40-week data expected to be read out in September 2026 and a Pre-NDA consultation application planned for the fourth quarter.

A head-to-head Phase II study comparing HDM1005 with tirzepatide is expected to report 40-week data by the end of 2026. Additionally, a head-to-head Phase III study for type 2 diabetes indication versus mazdutide is projected to read out its primary endpoint in the second quarter of 2027. The advancement of dual-target products is expected to achieve further breakthroughs in weight-loss magnitude and comprehensive metabolic benefits, while head-to-head studies provide direct comparative evidence for product positioning.

The company has also deployed a differentiated portfolio across multiple technology platforms, including the FGF21R/GCGR/GLP-1R triple-target agonist DR10624, the GalNAc-siRNA weight-loss drug HDM1014, and a semaglutide biosimilar. This covers oral small molecules, peptides, siRNA, and biosimilars—diverse technology routes that address different clinical needs from basic weight management to intensive metabolic intervention, forming a short-, medium-, and long-term product sequence.

Intensifying Competition in China's Oral Weight-Loss Market

With the Phase III completion of HDM1002, domestic oral small-molecule GLP-1 weight-loss drugs are entering an intensive clinical readout and filing phase. The sector is transitioning from early-stage research and development toward commercialization, with domestic product portfolios taking shape and expected to further enhance the accessibility of weight-loss treatment drugs in China.

As pharmaceutical companies at home and abroad accelerate their deployments, the competitive focus in oral GLP-1 has shifted from single-dimension weight-loss efficacy validation to multi-dimensional competition encompassing weight-loss magnitude, gastrointestinal tolerability, dosing convenience, and long-term adherence. Companies are building long-term competitiveness through layered pipeline deployment and molecular structure optimization, driving the industry from an accessibility competition of "whether it exists" to a value competition of "how good it is"—ultimately propelling continuous upgrades in clinical treatment options.

Note: All financial and clinical data referenced in this article are denominated in RMB (Chinese Yuan) unless otherwise specified. Clinical trial data is sourced from Huadong Medicine's official announcements.