pharm edaily

[Song young-doo, Edaily Reporter] D&D Pharmatech surged to the daily trading limit after demonstrating superior efficacy of its MASH(metabolic dysfunction-associated steatohepatitis) treatment candidate compared to those under development by global pharmaceutical companies. Tomocube also posted sharp gains as it was grouped among organoid-related firms following Samsung Biologics’ announcement of a new drug screening service using organoids. Meanwhile, S.Biomedics, which is developing a stem cell-based Parkinson’s treatment, also rose after presenting additional clinical data at an international conference.

D&D Pharmatech stock trend (Source: KG Zeroin MP DOCTOR)

◇D&D Pharmatech Soars on Promising U.S. Phase 2 Results

According to KG Zeroin’s MP DOCTOR(formerly Market Point) on June 16, D&D Pharmatech closed at 127,000 KRW, up 29.99%(29,300 KRW) from the previous trading day a record high since the company’s IPO.

The rally was driven by positive Phase 2 results in the U.S. for its lead MASH candidate, DD01, which met its primary endpoint with statistical significance. Notably, the liver fat reduction seen with DD01 matched the effects of Boehringer Ingelheim’s investigational drug but achieved them in a shorter time span.

The U.S. Phase 2 trial involved 67 MASLD/MASH patients with BMI ≥ 25kg/m² across 12 clinical sites. It used a randomized, double blind, placebo controlled design. The primary endpoint was the proportion of patients experiencing ≥30% reduction in liver fat at Week 12, measured by MRI-PDFF, compared to placebo.

Among the 33 patients treated with DD01, 75.8%(25 individuals) achieved the ≥30% liver fat reduction, compared to just 11.8% in the placebo group a statistically significant result(p<0.0001). The mean liver fat reduction at Week 12 in the DD01 group was 62.3%, significantly higher than the placebo group’s 8.3%.

Using a conservative intention to treat analysis including dropouts, the company reported an estimated Week 12 liver fat reduction rate of 67.3% and a responder rate(≥30% reduction) of 85.7% among patients who completed dosing and MRI imaging.

“DD01 has shown fibrosis improvement and achieved liver fat reduction comparable to Boehringer Ingelheim’s survodutide?which reached this effect after 48 weeks in just 12 weeks,” said the company. “This positions DD01 as a highly competitive MASH therapeutic candidate.”

Analysts believe the promising data increases the likelihood of a major license-out deal. D&D Pharmatech recently signed a consulting contract with a leading U.S. investment bank to facilitate global partnering efforts. Given that GSK licensed Boston Pharmaceuticals’ MASH drug Acimaspermin for 3.7 trillion KRW last May, and DD01 has shown greater efficacy, a multibillion-won deal is now anticipated.

CEO Seulgi Lee commented, “We will proactively seek partnerships based on these compelling results and work toward a successful large-scale license-out.”

◇Tomocube Surges on Samsung Biologics‘ Organoid News

Shares of organoid-focused biotech firms rose across the board. Organoid Sciences climbed 4.56% to 32,100 KRW, while Tomocube jumped 17.98% to 29,200 KRW.

The surge followed Samsung Biologics’ announcement of launching an organoid-based CRO service, “Samsung Organoid,” amid growing global interest in alternatives to animal testing. Both the U.S. FDA and European EMA have moved toward phasing out animal testing, spotlighting organoids and holotomography as potential alternatives for drug toxicity evaluation.

Tomocube is the sole global holder of holotomography technology, a 3D high resolution, label free imaging method using light based microscopy. This technology allows for toxicity detection in organoids without the need for staining or other modifications. Holotomography enables visualization and quantitative analysis of drug efficacy and toxicity in 3D organoids critical for replacing animal models.

According to industry sources, organoids are emerging as the leading alternative to animal testing, and holotomography is believed to be the only technology that allows non-invasive imaging of organoids for efficacy and toxicity assessment.

A Tomocube representative stated, “Today’s stock surge appears to be influenced by Samsung Biologics’ organoid CRO launch. While there is no direct partnership, investor expectations for our technology are likely reflected given the entry of a major domestic player into the organoid field.”

◇S.Biomedics Presents TED-A9 Mechanism Data at ISSCR

S.Biomedics drew global attention at the 2025 ISSCR Annual Meeting in Hong Kong, the world’s largest stem cell conference, by presenting mechanistic data for its Parkinson’s cell therapy, TED-A9. The stock rose 12.16% to close at 24,450 KRW.

TED-A9, now in Phase 1/2a clinical trials, was shown to correlate behavioral improvements with dopamine PET imaging(18FP-CIT-PET) in transplant patients offering strong evidence for the therapy’s mechanism of action. The imaging modality tracks dopamine transporter(DAT) density, which indirectly indicates structural restoration of dopaminergic neural circuits.

CEO Dongwook Kim commented, “This is the first time we’ve shown a meaningful correlation between behavioral recovery and dopamine imaging across the entire transplant group. These findings directly support TED-A9’s mechanism and are regarded as clinically valuable data.”