The K-Bio Deal Summit 2026, held under the theme “K-Bio: Solutions for Global Success Through Innovation,” was organized to examine the success strategies of companies leading the global market and to share insights on the growth direction of the domestic biotech industry and investment opportunities.
Hong Seong-hun, Vice President of D&D Pharmatech Inc.(347850), made this statement during his presentation titled “Strategies for Addressing the Full Lifecycle of MASH” at the “Edaily K-Bio Deal Summit 2026,” held on the 9th at Harmony Hall in KG Tower, Jung-gu, Seoul.
MASH is a disease in which fat accumulates in the liver due to metabolic abnormalities, leading to inflammation and fibrosis, and eventually progressing to cirrhosis. Vice President Hong explained, “Diabetes, obesity, and MASH are often referred to as the ‘three metabolic diseases,’ and since MASH is the one that can be fatal, there is a large market and unmet medical need.”
MASH patients are classified into stages F1 through F4 based on the degree of liver fibrosis. He stated, “Even for the same MASH treatment, the patient population varies depending on the degree of fibrosis, so the treatment approach must also differ,” and presented a full-lifecycle strategy utilizing “DD01” (generic name: zabopegduotide) for early-stage fibrosis and “TLY012” for late-stage fibrosis.
DD01 underwent a U.S. Phase 2 clinical trial funded by 35 billion won raised through the company’s initial public offering. Vice President Hong stated, “A new drug development company must prove its value through competitive clinical results,” adding, “DD01 has secured statistically significant results in resolving MASH and improving fibrosis.”
D&D Pharmatech Inc. plans to advance DD01 into late-stage clinical trials through global technology transfers and partnering. Executive Vice President Hong remarked, “We have confirmed fibrosis improvement results that are on par with those of competing products,” and added, “We expect these data to be of great help in the partnering efforts currently underway.”
For patients with advanced fibrosis, the company will target them with TLY012. TLY012 is a candidate compound that selectively kills myofibroblasts that are overactive and produce collagen. Executive Vice President Hong explained, “We are not merely in the discovery phase of testing candidate compounds; we have already received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for chronic pancreatitis and systemic sclerosis, as well as approval of our Investigational New Drug (IND) application.”
He added, “We are currently working with the FDA to change the indication to liver fibrosis,” and noted, “If the change is approved, we expect to begin patient enrollment and administer the first doses in the first half of next year.”
