D&D Pharmatech Soars on MASH Breakthrough [K-bio pulse]

[Kim Jinsoo, Edaily Reporter] Shares of South Korean biopharmaceutical companies rallied Wednesday, led by D&D Pharmatech, which hit the daily trading limit after unveiling significant clinical trial results for its metabolic dysfunction-associated steatohepatitis (MASH) treatment. The positive data also lifted shares of Olix Pharmaceuticals and Hanmi Pharmaceutical, which are developing similar therapies.

Meanwhile, Cha Vaccine Institute saw its stock jump following news that Eli Lilly acquired the shingles vaccine developer Curevo, highlighting the value of related pipelines in the sector.

D&D Pharmatech stock trend. (KG Zeroin)

D&D Pharmatech hits upper limit

According to market tracker KG Zeroin‘s MP Doctor, D&D Pharmatech shares soared by the 30% daily limit to close at 98,800 won. The stock has surged approximately 63% over four consecutive trading sessions since closing at 58,800 won on May 20.

The rally was driven by the release of 48-week liver biopsy results from the U.S. Phase 2 clinical trial of “DD01” (zabo-pegdutide), a MASH treatment candidate. The data was presented at the European Association for the Study of the Liver (EASL) Congress, which opened Wednesday.

The study showed DD01 achieved statistically significant improvements over a placebo across all key histological endpoints for MASH treatments. These include fibrosis improvement without worsening of MASH, MASH resolution without worsening of fibrosis, and a composite endpoint of both MASH resolution and fibrosis improvement.

Specifically, the proportion of patients achieving “fibrosis improvement without MASH worsening” in the DD01 group was 34.2 percentage points higher than the placebo group (p=0.0323). Those achieving “MASH resolution without worsening of fibrosis” was 57.2 percentage points higher (p=0.0003). The composite endpoint was met by 32.2 percentage points more patients in the DD01 group (p=0.0192).

Non-invasive measures crucial for MASH treatments, such as MRI-PDFF (liver fat reduction) and MRE (liver stiffness improvement), demonstrated that the positive effects reported at the 12-week mark last June were sustained through 48 weeks.

DD01 also exhibited excellent tolerability throughout the 48-week period. The most commonly reported adverse events were gastrointestinal symptoms, which were mostly mild to moderate and resolved temporarily.

Notably, despite a short two-week dose-escalation period, DD01 showed a treatment discontinuation rate similar to other GLP-1 therapies that require escalation periods of up to 20 weeks. This is expected to enhance DD01’s competitiveness in real-world prescription settings.

D&D Pharmatech is actively pursuing global out-licensing and strategic partnerships for DD01, efforts that are expected to accelerate following the data release.

“Interest from global pharmaceutical companies in MASH treatments is higher than ever,” said Seulki Lee, CEO of D&D Pharmatech. “Based on these clinical results, we will do our best to accelerate global partnering discussions and achieve large-scale technology transfer.”

MASH expectations boost Olix, Hanmi Pharmaceutical

Expectations surrounding the MASH sector also boosted Olix Pharmaceuticals, which rose 7% to 177,200 won, and Hanmi Pharmaceutical, which gained 4.26% to 489,000 won. The successful data derivation by D&D Pharmatech drew renewed investor attention to other domestic MASH developers.

Olix is currently conducting a Phase 1 multiple ascending dose (MAD) study of OLX702A, a MARC1-targeting candidate co-developed with Eli Lilly. Lilly is expected to lead the development from Phase 2 onward.

“OLX702A is competitive because it shows efficacy with just a single dose,” an Olix representative said. “It also ensures differentiation by targeting MARC1, which is applicable to a broad population of MASH patients rather than being limited to specific genetic mutations.”

Hanmi Pharmaceutical holds two MASH pipeline candidates. Its partner, MSD, completed a Phase 2b trial for “efinopegdutide” late last year, with data expected to be released in the second half of this year.

Additionally, Hanmi‘s proprietary triple-agonist “efocipegtrutide,” which directly targets the liver, demonstrated up to an 81.2% reduction in liver fat at 12 weeks in a Phase 2a trial. A Phase 2b trial involving 215 MASH patients is currently underway.

“Efinopegdutide proved its competitiveness with superior data compared to semaglutide in Phase 2a, and efocipegtrutide showed differentiated efficacy in improving liver fibrosis an unmet need among existing candidates through its triple-action mechanism,” a Hanmi representative said. “We aim to lead a new treatment paradigm in the global MASH market.”

Cha Vaccine Institute jumps 22%

Shares of Cha Vaccine Institute surged 22.79% to close at 3,960 won, as the market reassessed the value of its lead pipeline candidate, “CVI-VZV-001.”

The jump followed a morning announcement by GC Biopharma that its U.S. affiliate, Curevo Vaccine, agreed to sell all its issued shares to Eli Lilly in a deal valued at up to $1.5 billion. Through the acquisition, Lilly secured rights to Curevo’s next-generation shingles vaccine candidate, “amezosvatein” (CRV-101).

Lilly has been aggressively expanding its vaccine pipeline, recently acquiring Swiss firm LimmaTech Biologics and another U.S. vaccine company. The pharmaceutical giant views vaccines as a vital preventative measure for infectious diseases, which are increasingly linked to neurological disorders and cancer.

Against this backdrop, Cha Vaccine Institute drew investor attention as it holds its own shingles vaccine candidate, CVI-VZV-001, which is currently in Phase 2 clinical trials in South Korea.

CVI-VZV-001 is a recombinant shingles vaccine utilizing “Lipo-pam,” an in-house developed immune-enhancing adjuvant. Lipo-pam is designed to induce both humoral and cellular immune responses to suppress viral activity, specifically addressing the limitations of existing live vaccines that show restricted immune responses in older adults.

Studies have indicated that CVI-VZV-001 causes less pain and fewer side effects compared to GSK‘s “Shingrix,” the dominant recombinant shingles vaccine on the market, positioning it favorably for future out-licensing opportunities.