With Korea's bio industry securing about 13 trillion won in technology exports in just the first half of this year, D&D Pharmatech is drawing attention as a big-ticket technology transfer candidate for the second half.
Results from phase 2 trials of "DD01," a MASH (metabolic dysfunction–associated steatohepatitis) treatment unveiled on the 27th at the European Association for the Study of the Liver (EASL 2026), fueled expectations. On the day of the announcement, D&D Pharmatech's share price hit the upper price limit and closed at 98,800 won.
On the 11th as well, it finished the session at 94,400 won, up 8.63% from the previous trading day. Its market capitalization is about 4.1351 trillion won, ranking 23rd on KOSDAQ.
According to the industry, Lee Seul-gi, CEO of D&D Pharmatech, presented additional detailed data at a corporate presentation (IR) for domestic institutional investors that day and said, "We have in mind signing a technology transfer agreement within the year."
Executive Vice President Hong Sung-hoon told ChosunBiz in response to related questions, "We have been in talks with multiple potential partners since the disclosure of the first primary endpoint data in June last year," and noted, "Compared with past technology transfer cases in the MASH field, negotiations are proceeding quickly."
He added, "Given the potential of the MASH market, it is virtually a given that the total contract size will exceed the trillion-won level," and said, "The size of the upfront payment is the key variable in the negotiations, and based on global precedents, we expect it to be in the several-hundred-billion-won range."
◇Meeting FDA accelerated approval endpoints…competitiveness confirmed in biopsy
MASH is a disease in which fatty liver progresses to inflammation and fibrosis and, in severe cases, leads to cirrhosis and liver cancer. Developing treatments is highly challenging, and although global pharmaceutical companies have tried for decades, the U.S. Food and Drug Administration (FDA) has approved only two drugs so far: "RezdiFrä" and "Wegovy."
The global MASH therapeutics market is expected to grow more than 35% annually and expand to $30 billion (about 46 trillion won) by 2030. The FDA is applying an accelerated approval pathway to MASH treatments and requires biopsy data as the core basis for approval decisions. Biopsy evaluates improvement by directly sampling liver tissue.
The DD01 phase 2 trial was conducted at 12 sites in the United States in a randomized, double-blind, placebo-controlled design. A total of 67 MASLD/MASH patients were enrolled, and among them, 52 patients who were confirmed by biopsy to have MASH and fibrosis stages F1–F3 were included in the histologic assessment.
This announcement presents the analysis of 35 patients (19 in the placebo group and 16 in the treatment group) who completed both baseline and week-48 biopsies and faithfully adhered to the clinical protocol.
The results were positive. All three key endpoints required by the FDA achieved statistical significance. The proportion of patients whose steatohepatitis resolved without worsening of liver fibrosis was 62.5% in the treatment group, outperforming the placebo group (5.3%). The proportion of patients whose liver fibrosis improved without worsening of steatohepatitis was also higher in the treatment group at 50.0% versus 15.8% in the placebo group. The proportion of patients who achieved both key endpoints—resolution of steatohepatitis and improvement of liver fibrosis—was likewise higher in the treatment group at 37.5% versus 5.3% in the placebo group.
Among these, "fibrosis improvement" is particularly meaningful because it is a threshold that "survodutide" from Germany's C. H. Boehringer Sohn AG & Co. KG and "pemvidutide" from the United States' Altimmune, which are in the same GLP-1/GCG class, did not clear.
◇Liver improvement effect independent of weight…safety also a strength
Non-biopsy endpoints were also positive. Liver fat decreased by an average of 68.2%. After already dropping 62.3% at week 12, the reduction grew through week 48. In contrast, the placebo group saw only a 7.8% decrease.
What stands out in particular is the role of the GCG (glucagon) receptor. DD01 is a dual agonist that targets both GLP-1, which suppresses appetite, and GCG, which acts directly on the liver. In this analysis, liver fat decreased 81% in patients who lost at least 5% of their body weight, but even among patients with little weight loss, a 37% reduction was observed. This suggests that GCG may act directly on the liver, apart from weight-loss effects.
This also connects to the potential to expand the eligible patient population. A fair number of MASH patients are of normal weight or are older, and existing GLP-1 drugs tend to rely on weight-loss effects, which may limit their effectiveness in these patients.
Safety results were also positive. Although DD01's dose-escalation period was two weeks—shorter than survodutide's 22 weeks and Wegovy's 16 weeks—the discontinuation rate due to gastrointestinal adverse events was only 8%.
◇Rising expectations for a big deal with DD01…the final gate is the CSR
Global big pharma companies have recently been moving aggressively to secure MASH assets with biopsy data. Notable examples include Switzerland's Roche acquiring 89bio ($3.5 billion) and Denmark's Novo Nordisk acquiring Akero Therapeutics ($5.2 billion) last year.
A frequently compared candidate to DD01 is "epimorphospermin," which the United Kingdom's GSK plc in-licensed. In a 24-week trial, epimorphospermin showed a 49% reduction in liver fat, 39% MASH resolution, 24% fibrosis improvement, and 21% composite achievement. DD01, at 48 weeks, recorded 68.2%, 57%, 34%, and 32%, respectively, showing numerical superiority.
After completing phase 2, epimorphospermin led to a transaction totaling $2 billion (about 3 trillion won. While direct comparisons are difficult due to differences in trial design and assessment periods, DD01's numerical edge on key efficacy endpoints has the market using that deal as a yardstick to gauge potential tech-export size. Analysts also say that the scarcity of late-stage MASH assets available for technology transfer will further bolster negotiating leverage.
Expectations are also discernible inside and outside the company. Three U.S. co-founders recently placed a voluntary selling restriction on all shares acquired through exercising stock options, effective through May 2027. Because U.S. tax law triggers a tax burden at the time of stock option exercise, the market views this move as reflecting management's confidence in DD01's technology transfer and commercialization prospects.
A shift in biopsy reading methods is also seen as favorable to DD01. Although pathology reads are the standard in MASH trials, variability among readers has been a persistent issue. In response, standardizing histologic assessments using artificial intelligence (AI) is taking hold as a new trend in the global industry.
D&D Pharmatech used the AI-based tissue analysis tool qFibrosis alongside pathologist reads in this trial. The fibrosis improvement rate by qFibrosis was 72.7% (12.5% for placebo), and statistical significance was confirmed in both pathologist-only reads (50.0%) and combined AI–pathologist reads (44.4%).
Executive Vice President Hong Sung-hoon said, "Because this trial achieved statistical significance even with AI analysis tools used by global developers, it will help strengthen our negotiating power going forward."
However, these results are based on an analysis of 35 patients who faithfully adhered to the clinical protocol out of 52 patients eligible for histologic assessment. The final clinical study report (CSR), which will include all evaluable patients, is slated for release in the third quarter, and the industry views the key final gate in the technology transfer talks as whether the efficacy confirmed this time is consistently reproduced across the entire patient population.