Hanmi, D&D, LigaChem to Reveal Key Pipeline Data in H2

Korean biotech companies are preparing to unveil major clinical trial results in the second half of 2025, fueling expectations for a new wave of global licensing negotiations. With a focus on oncology and metabolic disorders, the sector anticipates increased valuation and partnership activity tied to upcoming data releases.

According to GlobalData, cited by Hana Securities, early-stage licensing deals have declined over the past four years. However, assets in Phase 1 or 2 continue to generate strong transaction volumes. Against this backdrop, Korean firms are expected to enter strategic discussions with global pharmaceutical companies, particularly around the timing of key clinical disclosures.

In oncology, Hanmi Pharmaceutical will present interim Phase 1 data for its dual EZH1/2 inhibitor, HM97662, at ESMO 2025. The candidate is being tested in Korea and Australia for advanced solid tumors. Designed to improve efficacy and overcome resistance seen with EZH2-selective inhibitors, HM97662 has already shown significant tumor growth inhibition as monotherapy in B-cell lymphoma models, as reported in June.

LigaChem Biosciences' partner, Iksuda Therapeutics, is also set to present global Phase 1 data for the antibody-drug conjugate (ADC) LCB14 at ESMO 2025. In a Chinese Phase 1 trial led by Fosun Pharma, LCB14 achieved an objective response rate (ORR) of 53.7% in HER2-positive breast cancer. Interim Phase 2 data in HER2-positive gastric cancer showed a 37.5% ORR among heavily pretreated patients—slightly outperforming Enhertu (35.6%). Iksuda launched a global Phase 1a trial in Australia in October 2023, with results to be unveiled at the upcoming conference.

In metabolic diseases, Hanmi is nearing completion of its Phase 3 trial for efpeglenatide, a GLP-1-based obesity treatment, with topline data expected by year-end following the September trial conclusion.

Phase 2b data for efinopegdutide, a MASH (nonalcoholic steatohepatitis) candidate out-licensed to MSD, is also anticipated later this year. In a prior Phase 2a study, efinopegdutide demonstrated a 72.7% reduction in liver fat content at week 24—35.4 percentage points higher than semaglutide. The current trial evaluates fibrosis improvement at week 52 via liver biopsy. MSD has highlighted the program as a key pipeline asset for the 2025 J.P. Morgan Healthcare Conference.

Meanwhile, D&D Pharmatech is concluding a 48-week Phase 2 trial for DD01, another MASH treatment. Interim 12-week data released in June showed that 75.8% of patients in the treatment arm achieved more than 30% liver fat reduction, compared to 11.8% in the placebo group. With rising interest from global pharma in MASH, the final results from DD01 could serve as a catalyst for licensing talks.