Chinese Biotech Doer Biologics Unveils First-in-Class Tri-Agonist DR10624 for Severe Hypertriglyceridemia, Seeks Global Partners

Chinese biotech unveils first-in-class tri-agonist for high lipids, seeks partner

Original Author: Elizabeth Cairns

Original article link: https://endpoints.news/zhejiang-doer-biologics-unveils-first-in-class-tri-agonist-for-high-lipids/

Meet the latest Chinese biotech company, Doer Biologics, which owns technology products in the metabolic field and is now preparing to seek cooperation.

Zhejiang Doer Biologics Co., Ltd. announced Phase 2 clinical data, indicating that its first-in-class drug can effectively reduce blood lipid levels. The company has already initiated discussions on cooperation with potential Western partners.

The product, named DR10624, is an injectable tri-agonist targeting glucagon-like peptide-1 (GLP-1), glucagon (GCG), and fibroblast growth factor 21 (FGF21) receptors. In a Phase 2 trial conducted in China among patients with severe hypertriglyceridemia, at the highest dose (50 mg weekly), triglyceride levels were reduced by an average of 69% after four months. This result showed a statistically significant difference compared to the 8% reduction in the placebo group.

In patients using DR10624, 90% successfully reduced their triglyceride levels to below 500 mg/dL, compared to only 25% of patients using a placebo. This effectively means they no longer suffer from severe hypertriglyceridemia. Among treated patients, 79% achieved at least a 50% reduction in triglyceride levels, compared to only 5% in the placebo group. Both differences were statistically significant.

Another result from this clinical trial also indicated that Doer Biologics will consider a second indication for the drug: Metabolic Dysfunction-Associated Steatohepatitis (MASH). Compared with the placebo group, patients receiving DR10624 treatment showed a significantly greater reduction in liver fat at week 12, with reductions of 64% versus 8%, respectively.

In this study involving 79 patients, DR10624 was well-tolerated, with the most common side effects being gastrointestinal reactions or injection site reactions. The data were presented on November 8 at the American Heart Association Annual Meeting.

First-in-class

Dr. Yongliang Fang, Chief Operating Officer of Doer Biologics, told Endpoints News that this triple-agonist therapy aims to maximize the therapeutic effects of different mechanisms while mitigating their side effects.

Fang Yongliang stated that combining GCG and FGF21 agonist activity may create a more effective lipid-lowering therapy. However, glucagon agonists increase blood glucose levels — which is not ideal for individuals typically suffering from diabetes or prediabetes.

"This is why we incorporated GLP-1 activity," said Fang Yongliang, "to compensate for GCG activity." GLP-1 activity also aids in the treatment of metabolic disorders such as MASH by reducing patient weight.

The next step for severe hypertriglyceridemia is to initiate Phase 3 clinical trials. "We must test this therapy for a longer duration in a large-scale patient population," said Yongliang Fang.

Doer Biologics Plans to Launch Phase 3 Clinical Trial for DR10624 in China in the First Quarter of 2026. The company has also conducted some clinical trials in New Zealand: a small Phase IIa clinical trial targeting obese patients with elevated triglyceride levels. In these patients, the drug significantly reduced triglycerides and liver fat content. Fang Yongliang said, "We now know that our agonist is highly effective in both Chinese and Western populations."

Doer Biologics is also conducting a Phase 3 trial in the West for severe hypertriglyceridemia. Mixed hyperlipidemia is "an obvious subsequent indication to be developed," said Fang Yongliang, adding that the company may also study certain cardiovascular diseases in the future.

Another focus is Metabolic Dysfunction-Associated Steatohepatitis (MASH). The company is about to complete full patient enrollment in a four-month Phase 2 MASH study, which will use non-invasive diagnostic methods to evaluate endpoint indicators such as liver fat content. If the trial is successful, Doer Biologics will also advance to a Phase 3 trial targeting Metabolic Dysfunction-Associated Steatohepatitis.

Fang Yongliang stated that the drug is not suitable for obesity because the FGF21 agonist action increases appetite.

Seeking Partners

This biotech company is seeking to license the rights of DR10624 outside of China.

"We need to conduct large-scale, longer-duration research to fully understand its safety profile, which requires time, funding, and resources. That's why we believe that large pharmaceutical companies could be a potentially good collaboration choice," said Fang Yongliang. He added that Doer Biologics is also open to collaborating with biotech companies or forming joint ventures.

"As long as they can push this project further into the critical clinical trial phase, we are interested in negotiating," he said.

Fang Yongliang stated that Doer Biologics was originally established in 2014, initially supported by local investors and some venture capital firms. In 2021, Huadong Medicine, located in Hangzhou, China, acquired 75% of Doer Biologics' equity.

The company's R&D pipeline also includes several other products, such as a GLP-1/GIP dual-target agonist and a GLP-1/GIP/GCG triple-target agonist. The latter has a shorter half-life, and its clinical development has been paused so that Doer Biologics can focus on modifying it into a formulation suitable for once-weekly dosing.

Doer Biologics has three other novel anti-cancer drugs in its pipeline, including a trispecific antibody targeting PD-L1, VEGF, and TGF-β that is in early clinical development for the treatment of solid tumors.