Huadong Medicine's Subsidiary Receives Chinese Clinical Approval for DR10624, the World’s First Long-Acting Triple Agonist, Accelerating Innovation in Obesity Treatment

On July 30, 2023, Huadong Medicine (000963) announced that its controlling subsidiary, Zhejiang Doer Biologics Co., Ltd. ("Doer Biologics"), had received the "Drug Clinical Trial Approval Notice" issued by the National Medical Products Administration (NMPA). The clinical trial application for the weight management of overweight or obese populations using injectable DR10624, submitted by Doer Biologics, has been approved.
The announcement shows that DR10624 is a global first-in-class long-acting triple agonist targeting GLP-1R, GCGR, and FGF21R. Preclinical animal studies have demonstrated that DR10624 has significant therapeutic effects on lipid reduction, weight loss, and blood sugar control. In July 2023, DR10624 completed the first subject dosing in a Phase I multiple ascending dose (MAD) clinical trial for obesity treatment in New Zealand.
Triple-Target Agonists Emerge as a Blue Ocean Track; Huadong Medicine Ranks Among the Top Two Globally in R&D Progress
GLP-1 (Glucagon-like Peptide-1) is currently a significant target and popular field in global new drug research and development. The mechanism of action of GLP-1 is diverse, not only available in various drug forms such as peptides and small molecules, but also widely used in the design of differentiated drugs with multiple targets. As a peptide hormone, its receptor GLP-1R is mainly expressed in pancreatic β-cells in the pancreas, and is also widely expressed in tissues such as the stomach, small intestine, heart, kidneys, and brain. Therefore, it has broad applications in multiple indications such as diabetes, weight loss, NASH, and AD. Currently, the indications for GLP-1 drugs are mostly concentrated in the fields of blood sugar reduction and weight loss.
It is worth mentioning that most of the multi-target agonists currently under research globally are concentrated in the GLP-1/GIPR and GLP-1/GCGR fields, with drug designs predominantly focusing on dual targets. There are no long-acting triple-target agonist drugs targeting GLP-1R, GCGR, and FGF21R available on the market yet. According to a research report by Minsheng Securities, there are only five GLP-1 triple-target candidates in clinical trials globally. AstraZeneca and Hanmi Pharmaceuticals’ trials for NASH indications have advanced their respective products to Phase II clinical trials. Only Eli Lilly, Huadong Medicine, and Minwei Biotech have GLP-1 triple-target pipelines targeting obesity indications, with DR10624’s clinical progress ranking second globally, just behind Eli Lilly.

Global GLP-1 Multi-Target Drug Development Progress (Source: Minsheng Securities)
Minsheng Securities stated that, unlike dual-target agonists, triple-target agonists may exhibit stronger efficacy. According to the latest data simultaneously released by Eli Lilly at the 83rd Scientific Session of the American Diabetes Association in June this year, the weight-loss capability of triple-target drugs is more outstanding compared to dual-target drugs.
DR10624 is not only expected to meet clinical treatment needs but also holds immense potential market space. According to Morgan Stanley estimates, by 2030, the market size for obesity drugs is projected to exceed $54 billion, potentially surpassing PD-1/PD-L1 to become the largest pharmaceutical market globally.

Huadong Medicine: The Most Comprehensive GLP-1 Layout in China, Innovation in Full Swing

The DR10624, which has been approved this time as the GLP-1 receptor agonist with the fastest clinical progress in China for obesity indications and targets three mechanisms, is not the only leading GLP-1 product from Huadong Medicine.
On March 30, 2023, Huadong Medicine's liraglutide injection (brand name: Liluping) received marketing authorization approval for controlling blood glucose in adults with type 2 diabetes (T2DM), becoming the first domestically produced liraglutide injection approved for marketing in China. After its approval, Liluping quickly advanced to benefit patients in China, with the first prescription in China issued at Sishui People’s Hospital in Shandong Province in May 2023. On July 4, 2023, the liraglutide injection officially received marketing authorization for obesity or overweight indications, making it the first GLP-1 drug in China approved for this indication.
While seizing the first-mover advantage in China, Huadong Medicine is committed to expanding the overseas market for liraglutide. In June 2022, the company granted Julphar, a well-known company in the Middle East, the production and commercialization rights in 17 countries across the Middle East and North Africa, including the United Arab Emirates, Saudi Arabia, Egypt, and Kuwait. According to the 2021 report by the International Diabetes Federation, the Middle East and North Africa (MENA) region has the highest prevalence of adult diabetes globally, with a market size of approximately $7.6 billion.
In fact, based on liraglutide, Huadong Medicine has built a comprehensive and differentiated product pipeline around the GLP-1 target, including long-acting and multi-target global innovative drugs and biosimilars in both oral and injectable forms, and possesses several blockbuster products.
Among them, Huadong Medicine has made multiple advancements in GLP-1 single-target receptor agonists. In addition to liraglutide, the company's semaglutide injection has completed dosing and follow-up for all participants in its Phase I clinical trial. The original developer of semaglutide injection is Novo Nordisk, which received approval from the China National Medical Products Administration in April 2021, with the Chinese patent set to expire in 2026. Huadong Medicine took the lead in challenging the original semaglutide patent, and on September 5, 2022, the China National Intellectual Property Administration declared the invalidation request filed by Novo Nordisk as invalid.
In addition, Huadong Medicine's self-developed small molecule GLP-1 receptor agonist HDM1002 for adult Type 2 diabetes indications submitted an IND application in China in February 2023 and was approved for clinical trials in March. An IND application was submitted in the United States in April 2023 and received clinical approval in May. Preclinical studies have shown that HDM1002 can strongly activate the GLP-1 receptor, induce the production of cyclic adenosine monophosphate (cAMP), and has potent effects in improving glucose tolerance, lowering blood sugar, and reducing weight, while also demonstrating good safety.
Due to GLP-1's ability to regulate multiple indications, conditions such as NASH (non-alcoholic steatohepatitis), neurodegenerative diseases, and cardiovascular diseases have become new promising areas for GLP-1 exploration. In addition to weight loss and blood sugar reduction, Huadong Medicine has also targeted the NASH indication in its dual-receptor agonist portfolio. Data shows that there are currently no approved drugs for NASH on the market. According to Frost & Sullivan predictions, the market size for NASH treatment drugs is expected to exceed $10 billion by 2025, with a compound annual growth rate of 20.19% from 2016 to 2025.
Huadong Medicine has introduced SCO-094, a GLP-1R/GIPR dual-target agonist, and its derivative products from Japan's SCOHIA for the treatment of diseases such as type 2 diabetes, obesity, and NASH. This drug targets dual receptors like GLP-1R and GIP, similar to Eli Lilly's tirzepatide, and has successfully completed Phase I clinical trials in the UK.
This time, the clinical approval of Huadong Medicine's DR10624 will further extend its advantage in the comprehensive layout of the endocrine field, continuously broaden the width of China’s GLP-1 research and development track, deeply explore innovative "fountainheads," and constantly generate innovative momentum, solidifying Huadong Medicine's leading position as the king of China’s GLP-1 track. Huadong Medicine stated that in the future, the company will continue to seize new development opportunities, focus on cutting-edge R&D innovation, meet the needs of more patients worldwide, and strive for growth with relentless effort.