D&D Pharmatech's MASH Treatment DD01 Approved for Patent Registration in China and India

D&D Pharmatech, a company specializing in the development of new GLP-1 (glucagon-like peptide-1) drugs, announced on January 20 that it has decided to register patents for its MASH (metabolic dysfunction-associated steatohepatitis) treatment candidate DD01 in China and India.

This patent registration decision is significant as it marks the full-scale expansion of DD01's intellectual property rights into the Asian region, one of the world's largest markets, following previous registrations in key countries such as the United States, Australia, and Russia. In particular, China and India have the largest populations globally and are experiencing a rapid increase in patients with obesity and metabolic diseases. These countries are expected to become critical strategic hubs in the future global commercialization phase of DD01.

China is witnessing a sharp rise in obesity and diabetes cases due to rapidly westernizing lifestyles and an aging population, and is estimated to have over 200 million patients with metabolic dysfunction-associated steatotic liver disease (MASLD)-the highest number in the world. Despite this, there are currently no approved standard treatments in China, resulting in a very high level of unmet medical need. India, where patent registration has also been decided, is experiencing a rapid increase in the prevalence of metabolic diseases due to recent economic growth and diversification of lifestyles, making it a region expected to see explosive growth in the future.

Meanwhile, DD01 is a long-acting dual agonist targeting both GLP-1 and glucagon receptors, developed in-house by D&D Pharmatech. A 48-week Phase 2 clinical trial is currently underway in the United States for patients with MASLD/MASH. By the end of 2025, all patients will have completed the 48-week dosing period, and top-line results-including liver biopsy data to confirm the extent of liver fat reduction and improvement in liver fibrosis-are expected to be available in the first half of this year.

In previous interim clinical results (at 12 and 24 weeks), rapid improvement in liver fat and positive changes in fibrosis-related biomarkers such as MRE imaging were already observed. As a result, the company expects to secure competitive data regarding changes in liver fibrosis, which remains an unmet need in MASH treatment.

Lee Seulgi, CEO of D&D Pharmatech, stated, "China and India are massive markets and strategic hubs that cannot be overlooked in the global metabolic disease therapeutics market. This patent registration decision not only recognizes the technological uniqueness of DD01, but also provides a strong foundation for ongoing global partnering and future commercialization efforts." She added, "We will focus all our capabilities on successfully completing the ongoing Phase 2 trial and maximizing the business value of DD01 through proactive partnering with global pharmaceutical companies based on the data obtained."